Hier een aantal aanbevolen abstracten over studies bij vormen van kanker in het bloed, zoals vormen van leukemie en kanker in botten en beenmerg zoals multiple myeloma - ziekte van Kahler / botkanker door artsen die werken voor ASCO zelf.
Klik op de nummers van de abstracten om het abstractverslag te zien:
Deze abstracten worden aanbevolen door David J. Straus MD
Poster Discussion Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Available Starting on Friday, June 4, 2021; 9:00 EDT
7508 Efficacy and safety of tisagenlecleucel (Tisa-cel) in adult patients (Pts) with relapsed/refractory follicular lymphoma (r/r FL): Primary analysis of the phase 2 Elara trial. SJ Schuster, MJ Dickinson, MH Dreyling, et al
Take-Home Message
- In the single-arm, phase II ELARA trial, investigators evaluated tisagenlecleucel after lymphodepleting chemotherapy in 97 patients with relapsed/refractory follicular lymphoma (median age, 57; 85% with stage III–IV disease). The complete response rate and overall response rate were 66% and 86%, respectively, and were similar across high-risk patient subgroups. In total, 94% of patients with a complete response continued to have this response after 6-months of follow-up. The 6-month progression-free survival was 76%. Adverse events of grade ≥3 occurred in 65% of patients; the most common of grade ≥3 were neutropenia (28%) and anemia (13%).
- Study findings indicate that tisagenlecleucel is effective and has manageable safety for treatment of patients with relapsed/refractory follicular lymphoma, including those who had previously received multiple lines of therapy.
7510 Copanlisib + rituximab versus rituximab + placebo in patients with relapsed follicular (FL) or marginal zone lymphoma (MZL): Subset analysis from the phase III CHRONOS-3 trial. MJ Matasar, M Capra, M Özcan, et al
Take-Home Message
- In the phase II CHRONOS-3 trial, investigators compared copanlisib plus rituximab (C+R) with rituximab plus placebo (P+R) for the treatment of relapsed indolent non-Hodgkin lymphoma. In total, 458 patients with follicular lymphoma (FL) or marginal zone lymphoma (MZL) who were progression- and treatment-free for >6 months after rituximab-based therapy were randomly assigned to receive C+R or P+R. After a median follow-up of 18.5 months, C+R was associated with a significantly lower risk of disease progression or death compared with P+R (HR, 0.55), and longer progression-free survival (median, 19.1 vs 15.4 months). Frequencies of adverse events, including those grade ≥3, were similar between the study arms.
- These findings demonstrate a significant survival benefit of adding copanlisib to rituximab monotherapy for the treatment of relapsed FL or MZL, with a safety profile similar to that of monotherapy.
7512 Polatuzumab vedotin (Pola) + rituximab (R) + lenalidomide (Len) in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): Primary analysis of a phase 1b/2 trial. CS Magid Diefenbach, P Abrisqueta, E Gonzalez-Barca, et al
Take-Home Message
- In this single-arm, phase Ib/II study, investigators evaluated whether polatuzumab vedotin (Pola) plus rituximab (R) plus lenalidomide (Len) enhanced anti-tumor responses in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). Patients received 6 months of induction treatment with Pola+R+Len; patients responding to induction therapy received a further 6 months of R+Len therapy. Among 57 patients (median age, 71 years; Ann Arbor stage III–IV, 86%), 36 (74%) had a best overall response, including 17 (35%) with a complete response. Median progression-free survival was 6.3 months, and overall survival was 10.9 months. In total, 75% of patients had adverse events of grade ≥3.
- Trial findings demonstrate an acceptable safety profile and promising clinical responses for the novel combination therapy Pola+R+Len for treatment of patients with R/R DLBCL.
7515 Outcomes in ZUMA-5 with axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory (R/R) indolent non-Hodgkin lymphoma (iNHL) who had the high-risk feature of progression within 24 months from initiation of first anti-CD20–containing chemoimmunotherapy (POD24). CA Jacobson, JC Chavez, A Sehgal, et al
Take-Home Message
- This study reports updated outcomes of the ZUMA-5 trial after ≥18 months of follow-up in 129 patients with relapsed/refractory indolent non-Hodgkin lymphoma (iNHL) after two or more previous lines of treatment. There were 81 patients who had the high-risk feature of progression within 24 months from initiation of first anti-CD20–containing chemoimmunotherapy (POD24); 48 patients did not have POD24. Study participants underwent leukapheresis followed by conditioning therapy and infusion. Efficacy-evaluable patients with POD24 (n = 61) and without POD24 (n = 37) demonstrated a 92% overall response rate. Complete response rates were 75% and 86%, respectively. Patients with and without POD24 demonstrated similar adverse events grade ≥3 (84% and 88%).
- Patients with POD24 iNHL exhibited a high degree of reliable response to treatment with axicabtagene ciloleucel. Rates of efficacy and adverse events were similar in patients with POD24 and patients without POD24 who received the treatment.
Oral Abstract Session Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Monday, June 7, 2021; 11:30 AM–2:30 PM EDT
7500 First results of a head-to-head trial of acalabrutinib versus ibrutinib in previously treated chronic lymphocytic leukemia. JC Byrd, P Hillmen, P Ghia, et al
Take-Home Message
- In this phase III noninferiority trial, investigators randomly assigned patients with previously treated chronic lymphocytic leukemia (CLL) to receive acalabrutinib (Aca; n = 268) or ibrutinib (Ib; n = 265). After a median follow-up of 40.9 months, Aca was noninferior to Ib (median progression-free survival, 38.4 months in both arms), and mortality was similar in the Aca (23.5%) and Ib arms (27.5%). Compared with patients who received Ib, those who received Aca had a lower incidence of all-grade atrial fibrillation (9.4% vs 16.0%) and fewer adverse event–related treatment discontinuations (14.7% vs 21.3%).
- In the setting of Bruton tyrosine kinase inhibitor therapy for CLL, Aca was associated with noninferior efficacy, lower cardiotoxicity, and fewer adverse event–related treatment discontinuations than Ib.
7503 ECOG-ACRIN E1411 randomized phase 2 trial of bendamustine-rituximab (BR)-based induction followed by rituximab (R) ± lenalidomide (L) consolidation for Mantle cell lymphoma: Effect of adding bortezomib to front-line BR induction on PFS. MR Smith, O Jegede, P Martin, et al
Take-Home Message
- In the phase II E1411 study, patients were randomly assigned to receive bendamustine–rituximab (BR; n = 180) or BR plus bortezomib (BVR; n = 179) as initial therapy for mantle cell lymphoma. Treatment response and survival were similar in the BVR and BR arms (2-year progression-free survival, 79.6% vs 74.5%; overall response rate, 88.9% vs 89.5%; complete response rate, 65.5% vs 60.5%). Toxicities of grade ≥3 were 88.1% and 77.5% in the BVR and BR arms, respectively.
- The addition of bortezomib to BR as initial therapy for mantle cell lymphoma did not significantly enhance survival.
7504 Real-world (RW) treatment (tx) patterns and outcomes of 3,455 previously untreated mantle cell lymphoma (MCL) patients (pts) in U.S. routine clinical practice. P Martin, M Wang, A Kumar, et al
Take-Home Message
- Using a nationwide health record database, study investigators evaluated treatment patterns for mantle cell lymphoma (MCL) over a 10-year period (2011–2020) in the US. Most patients with treated MCL (n = 2946; median age, 69.5 years) were managed in a community oncology setting and received first-line treatment with chemoimmunotherapy, primarily bendamustine + rituximab (BR; 45%). Following first-line treatment, median survival and median time to the next treatment were 45.3 months and 24 months, respectively. About 24% of younger patients (<65 years old) received stem cell replacement therapy as first-line therapy.
- Data from this pragmatic, primarily community-based, US cohort demonstrate that MCL is usually managed with standard BR therapy, and half of patients progress to second-line treatment within 2 years of starting treatment. Use of first-line transplant for MCL is uncommon, even among younger patients.
7505 The combination of venetoclax, lenalidomide, and rituximab in patients with newly diagnosed mantle cell lymphoma induces high response rates and MRD undetectability. TJ Phillips, AV Danilov, DA Bond, et al
Take-Home Message
- This ongoing phase Ib study examines the safety and efficacy of the combination of lenalidomide, rituximab, and venetoclax in 28 patients with newly diagnosed mantle cell lymphoma. The overall response rate was 96% (27 patients) and MRD testing was negative in all patients. The most reported grade ≥3 treatment-emergent adverse events were neutropenia (68%) and thrombocytopenia (50%). At time of submission no patients had withdrawn or discontinued treatment due to treatment-emergent events.
- The combination treatment of lenalidomide, rituximab, and venetoclax in newly diagnosed patients with mantle cell lymphoma suggests high overall response with an acceptable safety profile comparable with the safety profile known for each individual drug.
Oral Abstract Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Friday, June 4, 2021; 2:30 PM–5:30 PM EDT
7001 Combination of ponatinib and blinatumomab in Philadelphia chromosome-positive acute lymphoblastic leukemia: Early results from a phase II study. NJ Short, HM Kantarjian, M Konopleva, et al
Take-Home Message
- The authors of this phase II study investigated the combination of ponatinib and blinatumomab in 28 adults with newly diagnosed or relapsed/refractory Ph+ positive acute lymphoblastic leukemia. Blinatumomab was given at standard doses up to five cycles, with ponatinib administered during the first cycle at 30 mg daily (decreased to 15 mg daily upon achievement of complete molecular remission ). In patients who responded, ponatinib was continued for 5 years or longer after blinatumomab was completed. Patients also received prophylactic intrathecal chemotherapy. All of the newly diagnosed patients and 88% of those with relapsed/refractory disease responded; of these, 87% in the newly diagnosed cohort and 86% in the relapsed/refractory cohort achieved CMR (median time to CMR was 1 month). For all patients, the estimated 1-year overall survival and event-free survival rates were 94% and 81%, respectively, at median follow-up of 14 months.
- The combination of ponatinib and blinatumomab was well-tolerated, with no early deaths (within 4 weeks) and with high rates of CMR. The results suggest that use of this combination may reduce the need for chemotherapy and allogeneic HSCT in patients with Ph+ acute lymphoblastic leukemia.
7004 Letermovir prophylaxis and cytomegalovirus reactivation in adult allogeneic hematopoietic cell transplant recipients with graft versus host disease. D Wolfe, Q Zhao, EG Siegel, et al
Take-Home Message
- In this single-center retrospective study, the authors evaluated the effectiveness of letermovir for reducing cytomegalovirus (CMV) infection after allogeneic HSCT in patients who develop graft-versus-host disease (GVHD) and continue letermovir therapy past day 100. Of 262 CMV-seropositive patients included in the study, 111 had been treated for clinically significant CMV infection; of these, 29 had received prophylactic letermovir. The use of letermovir was associated with a significantly lower incidence of CMV viremia in all patients and in patients with acute GVHD grade >2 within 200 days after transplant (P < .001 for both). Moreover, patients who received letermovir had lower non-relapse mortality and greater overall survival rates.
- Letermovir prophylaxis is effective for reducing clinically significant CMV infection and improving overall survival in this patient population. Continuing it past day 100 may be beneficial for those who develop acute GVHD.
7006 Effect of olutasidenib (FT-2102) on complete remissions in patients with relapsed/refractory (R/R) mIDH1 acute myeloid leukemia (AML): Results from a planned interim analysis of a phase 2 clinical trial. S De Botton, KWL Yee, C Recher, et al
Take-Home Message
- The authors present interim results of a phase II trial of the use of olutasidenib monotherapy (150 mg twice daily) in patients with relapsed/refractory mutant IDH1 acute myeloid leukemia. Of the 153 patients enrolled, 43 remain on olutasidenib and 110 discontinued treatment (most commonly because of disease progression, adverse events, or patient death); median duration of treatment was 5.5 months.
- The drug was well-tolerated, and all response groups achieved transfusion independence. Olutasidenib led to durable complete remission in a subset of high-risk patients.
7007 Efficacy and safety of aspacytarabine (BST-236) as a single-agent, first-line therapy for patients with acute myeloid leukemia unfit for standard chemotherapy. JK Altman, J Koprivnikar, JK McCloskey, et al
Take-Home Message
- This phase IIb open-label, single-arm study was designed to investigate the safety and efficacy of aspacytarabine, a prodrug of cytarabine, as first-line therapy for patients newly diagnosed with acute myeloid leukemia (AML) unfit for intensive chemotherapy. A total of 46 patients (median age, 75 years) completed one to four courses of aspacytarabine 4.5 g/m2/day. To date, 43 patients could be evaluated for efficacy analysis; of these, 15 achieved complete remission with hematologic recovery (median, 27.5 days) after one or two courses.
- The results thus far support the safety and efficacy of aspacytarabine as a first-line treatment for AML patients unsuited for standard chemotherapy.
Oral Abstract Session: Pediatric Oncology I
Saturday, June 5, 2021; 10:00 AM–1:00 PM EDT
10004 Minimal residual disease at end of induction and consolidation remain important prognostic indicators for newly diagnosed children and young adults with very high-risk (VHR) B-lymphoblastic leukemia (B-ALL): Children’s Oncology Group AALL1131. WL Salzer, MJ Burke, M Devidas, et al
Take-Home Message
- The authors sought to determine whether survival is improved among children and young adults with very high–risk B-acute lymphoblastic leukemia who are minimal residual disease (MRD)–positive at the end of induction (EOI) and become MRD-negative at the end of consolidation (EOC) compared with those who remain MRD-positive at EOC.
- Among 823 patients, 4-year disease-free survival was significantly improved in those who were MRD-positive at EOI and MRD-negative at EOC compared with those who remained MRD-positive. The authors conclude that MRD is a strong prognostic indicator in very high–risk B-acute lymphoblastic leukemia.
Oral Abstract Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Monday, June 7, 2021; 11:30 AM–2:30 PM EDT
7501 Fixed-duration (FD) first-line treatment (tx) with ibrutinib (I) plus venetoclax (V) for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): Primary analysis of the FD cohort of the phase 2 captivate study. P Ghia, JN Allan, T Siddiqi, et al
Take-Home Message
- The authors report results for the fixed-duration cohort of the CAPTIVATE trial of first-line ibrutinib plus venetoclax for chronic lymphocytic leukemia (CLL). A total of 159 patients (median age, 60 years) with previously untreated CLL/small lymphocytic lymphoma (SLL) underwent 3 cycles of ibrutinib followed by 12 cycles of ibrutinib plus venetoclax; 55% achieved complete response (CR), a rate that was consistent for high-risk subgroups. Of these patients, 89% had CR ≥1 year. The overall response rate was 96%; the 24-month progression-free survival was 95%; 24-month overall survival was 98%. Most adverse events were grade 1 or 2.
- These results suggest that first-line ibrutinib plus venetoclax can produce durable responses in patients with CLL/SLL, including those in high-risk subgroups, with a safety profile consistent with that for each drug.
7502 First-in-human study of lisaftoclax (APG-2575), a novel BCL-2 inhibitor (BCL-2i), in patients (pts) with relapsed/refractory (R/R) CLL and other hematologic malignancies (HMs). S Ailawadhi, AAA Chanan-Khan, Z Chen, et al
Take-Home Message
- The authors of this phase I study investigated the efficacy, safety, pharmacokinetics, pharmacodynamics, and maximum tolerated dose/recommended phase II dose of lisaftoclax, a novel, orally administered, small-molecule selective BCL-2 inhibitor. In all, 35 patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or other hematologic malignancies were enrolled and received lisaftoclax daily in 28-day cycles at doses ranging from 20 mg to 1200 mg. The overall response rate was 85.7% for 12 of the 14 evaluable patients with relapsed/refractory CLL or small lymphocytic lymphoma, with a median of 3 cycles to response.
- The results indicate that lisaftoclax was well-tolerated. The maximum tolerated dose was not reached, and no tumor lysis syndrome occurred. Treatment-related adverse events greater than grade 2 were infrequent.
Poster Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Available Starting on Friday, June 4, 2021; 9:00 EDT
7544 Atezolizumab + obinutuzumab + venetoclax in patients with relapsed or refractory indolent non-Hodgkin’s lymphoma (R/R iNHL): Primary analysis of a phase 2 trial from LYSA. C Herbaux, H Ghesquieres, R Bouabdallah, et al
Take-Home Message
- This phase II trial of 78 patients with relapsed or refractory B-cell lymphomas evaluated the efficacy and safety of using atezolizumab, obinutuzumab, and venetoclax in combination therapy. As of January 8, 2021, 6% of study participants had not exhibited any relapse or progression of their disease. Grade 3–4 adverse events were experienced by 70.5% of participants, and 1 patient developed an adverse event that resulted in discontinuation of all drugs.
- The use of atezolizumab, obinutuzumab, and venetoclax combination therapy appears to provide overall response rates comparable with those associated with other innovative treatments for similar patient populations with no unexpected adverse events.
7560 Immune priming with nivolumab followed by nivolumab and rituximab in first-line treatment of follicular lymphoma: The phase 2 1st FLOR study. EA Hawkes, ST Lee, G Chong, et al
Take-Home Message
- This phase II study evaluated the efficacy and safety of using nivolumab followed by treatment with nivolumab plus rituximab for the first-line treatment of 39 patients with follicular lymphoma. The complete response to treatment was 54% (21 patients), and the overall response rate was 92% (36 patients). Incidence of ≥ grade 3 toxicity at the end of induction was 41% (16 patients).
- The use of using nivolumab followed by treatment with nivolumab plus rituximab may offer an effective and safe alternative treatment option to chemotherapy in the first-line treatment of patients with follicular lymphoma.
Poster Discussion Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Available Starting on Friday, June 4, 2021; 9:00 EDT
7511 Obinutuzumab (G)-atezolizumab (atezo)-lenalidomide (len) for the treatment of relapsed/refractory (R/R) follicular lymphoma (FL): Final analysis of a phase Ib/II trial. N Ghosh, GA Salles, IS Lossos, et al
Take-Home Message
- This phase Ib/II trial evaluated the treatment combination of obinutuzumab, atezolizumab, and lenalidomide in 38 patients with relapsed or refractory follicular lymphoma. At 36 months, progression-free survival was 64% (95% CI, 45‒79), overall survival was 85% (95% CI, 70‒93), and median duration of response was 38 months (95% CI, 35‒not evaluable). Grade 3 or 4 adverse events occurred in 84% of study participants (32 patients); the majority were hematologic in nature. Serious adverse events occurred in 47% of study participants (18 patients), and 13% (5 patients) developed an event that led to discontinuation of any drug. There were 2 fatal adverse events reported, which were both unrelated to any study medication.
- Patients with relapsed or refractory follicular lymphoma may experience improved outcomes when treated with the combination of obinutuzumab, atezolizumab, and lenalidomide. There were no significant differences in toxicities in the combination treatment when compared with the toxicities of each individual drug.
7513 Long-term analyses from L-MIND, a phase II study of tafasitamab (MOR208) combined with lenalidomide (LEN) in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). J Düll, KJ Maddocks, E Gonzalez-Barca, et al
Take-Home Message
- This is an updated efficacy analysis of the L-MIND phase II study of 80 patients with ≥35 months of follow-up (cut-off was October 30, 2020). Patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after one previous treatment and who were not candidates for transplant received tafasitamab and lenalidomide followed by tafasitamab monotherapy. There were 46 patients (57.5%) who demonstrated an overall response. This included 32 patients who exhibited a complete response (40%) and 14 patients who showed a partial response (17.5%) to treatment. There were no unexpected adverse effects, and no new safety signals were identified.
- Patients with relapsed or refractory DLBCL who are not candidates for transplant may gain an improved overall survival benefit and prolonged remission with the use of tafasitamab and lenalidomide followed by tafasitamab monotherapy.
7515 Outcomes in ZUMA-5 with axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory (R/R) indolent non-Hodgkin lymphoma (iNHL) who had the high-risk feature of progression within 24 months from initiation of first anti-CD20–containing chemoimmunotherapy (POD24). CA Jacobson, JC Chavez, A Sehgal, et al
Take-Home Message
- This study reports updated outcomes of the ZUMA-5 trial after ≥18 months of follow-up in 129 patients with relapsed/refractory indolent non-Hodgkin lymphoma (iNHL) after two or more previous lines of treatment. There were 81 patients who had the high-risk feature of progression within 24 months from initiation of first anti-CD20–containing chemoimmunotherapy (POD24); 48 patients did not have POD24. Study participants underwent leukapheresis followed by conditioning therapy and infusion. Efficacy-evaluable patients with POD24 (n = 61) and without POD24 (n = 37) demonstrated a 92% overall response rate. Complete response rates were 75% and 86%, respectively. Patients with and without POD24 demonstrated similar adverse events grade ≥3 (84% and 88%).
- Patients with POD24 iNHL exhibited a high degree of reliable response to treatment with axicabtagene ciloleucel. Rates of efficacy and adverse events were similar in patients with POD24 and patients without POD24 who received the treatment.
7516 Preliminary safety and efficacy of PBCAR0191, an allogeneic, off-the-shelf CD19-targeting CAR-T product, in relapsed/refractory (r/r) CD19+ NHL. BD Shah, CA Jacobson, S Solomon, et al
Take-Home Message
- This is an update to preliminary data for a study of 13 patients with relapsed/refractory CD19+ non-Hodgkin lymphoma treated with PBCAR0191, an off-the-shelf allogeneic CAR-T product. All patients were lymphodepleted with either standard (sLD) or enhanced (eLD) lymphodepletion prior to initiation of treatment with PBCAR0191. The overall response rate at day ≥28 was 77% (10 patients), which included 50% (3 patients) of the sLD cohort and 100% (7 patients) of the eLD cohort. The complete response rate at day ≥28 was 54% (7 patients), which included 33% (2 patients) of the sLD cohort and 71% (5 patients) of the eLD cohort. Most adverse events were mild, with PBCAR0191-related serious adverse events reported for 31% of patients (4/13). Death was reported in 1 patient due to febrile neutropenia. A higher frequency of infections and cytokine release–related adverse events was reported in the eLD cohort.
- Preliminary complete response rates with PBCAR0191 are comparable with those seen with autologous CAR T in this patient population. More time is needed to evaluate response durability.
7520 Promising tolerability and efficacy results from dose-escalation in an ongoing phase Ib/II study of mosunetuzumab (M) with polatuzumab vedotin (Pola) in patients (pts) with relapsed/refractory (R/R) B-cell non-Hodgkin’s lymphoma (B-NHL). LE Budde, N Ghosh, JC Chavez, et al
Take-Home Message
- This is a report of early clinical data from the phase Ib cohort of 22 patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma treated with a combination of mosunetuzumab and polatuzumab vedotin. As of November 17, 2020, the overall response rate was 68.2% (15/22), which included 63.2% of patients with aggressive non-Hodgkin’s lymphoma (12/19), 57.1% of patients with prior CAR-T therapy (4/7), and 100% of patients with follicular lymphoma (3/3). The complete response rate was 54.5% (12/22), which included 47.4% of patients with aggressive non-Hodgkin’s lymphoma (9/19), 28.6% of patients with prior CAR-T therapy (2/7), and 100% of patients with follicular lymphoma (3/3). Neutropenia was the most frequent treatment-related adverse event (45.4% of patients), as well as the most common grade ≥3 adverse event in 36.4% of patients (8/22) and the most common serious adverse event in 13.6% of patients (3/22). No neurotoxicity events were observed.
- Combination treatment with mosunetuzumab and polatuzumab vedotin had encouraging efficacy along with an acceptable toxicity profile in patients with aggressive relapsed or refractory non-Hodgkin’s lymphoma. The study is ongoing in an expansion cohort of patients with diffuse large B-cell lymphoma.
Oral Abstract Session Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Monday, June 7, 2021; 11:30 AM–2:30 PM EDT
7505 The combination of venetoclax, lenalidomide, and rituximab in patients with newly diagnosed mantle cell lymphoma induces high response rates and MRD undetectability. TJ Phillips, AV Danilov, DA Bond, et al
Take-Home Message
- This ongoing phase Ib study examines the safety and efficacy of the combination of lenalidomide, rituximab, and venetoclax in 28 patients with newly diagnosed mantle cell lymphoma. The overall response rate was 96% (27 patients) and MRD testing was negative in all patients. The most reported grade ≥3 treatment-emergent adverse events were neutropenia (68%) and thrombocytopenia (50%). At time of submission no patients had withdrawn or discontinued treatment due to treatment-emergent events.
- The combination treatment of lenalidomide, rituximab, and venetoclax in newly diagnosed patients with mantle cell lymphoma suggests high overall response with an acceptable safety profile comparable with the safety profile known for each individual drug.
Poster Discussion Session: Hematologic Malignancies—Plasma Cell Dyscrasia
Available Starting on Friday, June 4, 2021; 9:00 EDT
8009 MASS-FIX versus standard methods to predict for PFS and OS among multiple myeloma patients participating on the STAMINA trial. A Dispenzieri, AY Krishnan, B Arendt, et al
Take-Home Message
- This study of 575 patients with multiple myeloma was designed to test whether Mass-Fix, mass spectrometry of blood by matrix-assisted laser desorption/ionization, can predict survival outcomes better than other methodologies. The authors assessed four response parameters univariately: Mass-Fix, serum immunofixation, complete response, and minimal residual disease (MRD) by next-generation flow cytometry. At multiple testing points only MRD and Mass-Fix predicted PFS and OS, and only Mass-Fix predicted OS post induction. At 1 year post enrollment, MRS and Mass-Fix positivity both predicted inferior PFS and OS.
- The authors concluded that, despite the study’s limitations, Mass-Fix provides a useful, noninvasive way to predict outcomes in patients with multiple myeloma.
8010 Analysis of minimal residual disease in bone marrow by NGF and in peripheral blood by mass spectrometry in newly diagnosed multiple myeloma patients enrolled in the GEM2012MENOS65 clinical trial. N Puig, B Paiva, T Contreras, et al
Take-Home Message
- This study was designed to assess the clinical value of minimal residual disease (MRD) in the peripheral blood of patients with multiple myeloma. Sequential samples of MRD in bone marrow and serum from 184 newly diagnosed patients were analyzed by next-generation flow and by mass spectrometry, respectively, after induction of six cycles of bortezomib, lenalidomide, and dexamethasone (VRd); at day 100 after autologous stem cell transplantation; and following two further cycles of consolidation with VRd.
- Evaluation of MRD in serum by next-generation flow and in bone marrow as assessed by mass spectrometry showed significant agreement. Regarding progression-free survival, the two methods were associated with similar prognostic value at all measured time points.
8011 Interim analysis of a phase 2 minimal residual disease (MRD)-adaptive trial of elotuzumab, carfilzomib, lenalidomide, and dexamethasone (Elo-KRd) for newly diagnosed multiple myeloma (MM). BA Derman, JA Zonder, AJ Kansagra, et al
- The authors of this phase II study evaluated complete response (CR) and minimal residual disease (MRD) with regard to the addition of the monoclonal antibody elotuzumab (Elo) to the triplet induction regimen of carfilzomib, lenalidomide, and dexamethasone (KRd) for patients with multiple myeloma (MM) irrespective of their eligibility for autologous stem cell transplant. A total of 44 patients (median age, 62 years) from four MM Research Consortium sites were included, with 39 being evaluable for response. The primary endpoint was stringent CR or/and MRD negativity >50% after eight cycles.
- After eight cycles of Elo-KRd, 19 of 33 patients (58%) had met the statistical threshold for efficacy as per stringent CR or MRD as assessed by next-generation sequencing. At median follow-up of 2 years, estimated 2-year progression-free survival is 87%, and estimated 2-year overall survival is 89%. No patient who was MRD-negative after cycle 8 has progressed. Treatment-emergent adverse events occurred in 89% (pneumonia was most common, in 14%), and serious adverse events occurred in 68%, demonstrating tolerability that is consistent for these agents. Longer follow-up may show that an MRD-adaptive therapy regimen can reduce exposure while improving response in patients with MM.
8013 CARTITUDE-2: Efficacy and safety of ciltacabtagene autoleucel (cilta-cel), a BCMA-directed CAR T-cell therapy, in patients with progressive multiple myeloma (MM) after one to three prior lines of therapy. ME Agha, AD Cohen, D Madduri, et al
Take-Home Message
- The authors present initial results from cohort A in the phase II CARTITUDE-2 study of the safety, efficacy, and outpatient suitability of ciltacabtagene autoleucel (cilta-cel) for patients with progressive multiple myeloma after one to three previous lines of therapy. As of the data cutoff (median follow-up, 5.8 months), 20 patients who were refractory to lenalidomide and had not been exposed to BCMA-targeting agents had received a single infusion of cilta-cel 5 to 7 days after starting lymphodepletion (cyclophosphamide 300 mg/m2 and fludarabine 30 mg/m2 daily for 3 days). A single patient received treatment as an outpatient. The primary outcome was minimal residual disease (MRD) 10-5.
- The overall response rate was 95%, with a 1.0-month median time to first response and a 1.9-month median time to best response. Median duration of response was not reached. All 4 patients who had MRD-evaluable samples at 10-5 at the time of data cutoff were MRD-negative. The safety profile was manageable, including for the 1 patient treated as an outpatient. Findings for other cohorts in this study as well as in the CARTITUDE-4 study will add to the safety efficacy data and outpatient suitability of cilta-cel in this patient population.
8016 Idecabtagene vicleucel (ide-cel, bb2121), a BCMA-directed CAR T cell therapy, in relapsed and refractory multiple myeloma: Updated KarMMa results. LD Anderson, Jr, NC Munshi, N Shah, et al
Take-Home Message
- The authors present updated results from the pivotal KarMMa trial on the use of idecabtagene vicleucel (ide-cel), a BCMA-directed CAR T-cell therapy, for patients with relapsed/refractory multiple myeloma. Of 140 enrolled patients who had received three or more prior regimens and were refractory to their last regimen (per International Myeloma Working Group criteria), 128 received ide-cel following 3 days of lymphodepletion.
- With a median follow-up of 15.4 months, the overall response rate (ORR) was 73% and median progression-free survival (PFS) was 8.8 months, with both increasing at higher doses: ORR was 81% and PFS 12.2 months at the highest target dose of 450 × 106 CAR+ T cells. The 15-month event-free overall survival (OS) was 71%; median OS has not been reached. The updated data show that ide-cel continues to produce deep and durable responses in patients with relapsed/refractory multiple myeloma, with responses occurring in all patient subgroups.
8017 Updates from ICARIA-MM, a phase 3 study of isatuximab (Isa) plus pomalidomide and low-dose dexamethasone (Pd) versus Pd in relapsed and refractory multiple myeloma (RRMM). PG Richardson, A Perrot, JF San-Miguel, et al
Take-Home Message
- The authors report updated results of the phase III ICARIA study of the monoclonal antibody isatuximab (Isa) plus pomalidomide and low-dose dexamethasone (Pd) in patients with relapsed/refractory multiple myeloma who had received two or more (median, three) prior lines of therapy. In total, 27 patients (18%) in the Isa + Pd arm were still receiving treatment (median follow-up, 35.3 months) compared with 12 (8%) in the Pd-only arm, with 60% and 72%, respectively, having gone on to subsequent treatment.
- The addition of Isa to Pd produced significant improvement in two outcomes: Median time to next treatment was 15.5 months for the Isa + Pd arm and 8.9 months for the Pd-only arm (HR, 0.56; 95% CI, 0.42–0.74; P < .0001); and median time from randomization to disease progression on first subsequent therapy or death was 17.5 months in the Isa + Pd patients and 12.9 months in the Pd-only patients (HR, 0.76; 95% CI, 0.58–0.99; P = .0202). Median overall survival was 24.6 months for the Isa + Pd patients compared with 17.7 months for the Pd-only patients (HR ,0.76; 95% CI, 0.58–1.01; 1-sided P = .0280). No new safety signals were identified.
Poster Session: Hematologic Malignancies—Plasma Cell Dyscrasia
Available Starting on Friday, June 4, 2021; 9:00 EDT
8021 High-dose lenalidomide and melphalan as conditioning for autologous stem cell transplantation in relapsed or refractory multiple myeloma. AC Rossi, J Monge, R Niesvizky, et al
Take-Home Message
- The authors present the phase II data for the use of high-dose lenalidomide (HDLEN) plus high-dose melphalan (HDM) conditioning for autologous stem cell transplantation in multiple myeloma. A total of 50 heavily pretreated patients with relapsed/refractory multiple myeloma, including 68% with progressive disease at the time of enrollment, received oral HDLEN 350 mg daily on days −5 to −1 and HDM 100 mg/m2 on days −2 and −1.
- The overall response rate was 96% (80% had a very good partial response), median progression-free survival was 14.3 months, and overall survival was 68.2 months. Adverse events were mainly hematologic, gastrointestinal, and metabolic and were similar to those seen in historical controls receiving only HDM. The combination of HDLEN and HDM was well-tolerated and effective in this patient population and warrants further investigation. The use of HDLEN for patients with high-risk and progressing disease may be especially helpful.
8026 Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in elderly patients with relapsed multiple myeloma: IKEMA subgroup analysis. T Facon, P Moreau, TG Martin, et al
Take-Home Message
- The authors present a subgroup analysis of the phase III IKEMA study, which demonstrated significant improvement in progression-free survival (PFS) and a meaningful increase in complete response and minimal residual disease (MRD) negativity with isatuximab (Isa) plus carfilzomib (K) and dexamethasone (d) versus Kd for patients with relapsed multiple myeloma. Here, outcomes are compared between patients younger than 70 years (71.5%; representing 70.9% of the Isa + Kd arm and 72.4% of the Kd arm) and patients 70 years and older (28.5%; representing 29.1% of the Isa + Kd arm and 27.6% of the Kd arm).
- Regardless of age, PFS improved with the addition of Isa to Kd. Response rates and MRD negativity were higher with the combination, with response rates being similar in the two age groups and MRD negativity being 32.3% in the younger group and 23.1% in the older group. Adverse events ≥ grade 3 and serious treatment-emergency adverse events occurred more often in the older groups in both arms, but the safety profile was manageable and consistent with that seen for the study population as a whole. The combination of Isa and Kd may be a new treatment option for patients 70 years and older with relapsed multiple myeloma.
8029 Personalized, ctDNA analysis to detect minimal residual disease and identify patients at high risk of relapse with multiple myeloma. B Dhakal, S Sharma, S Shchegrova, et al
Take-Home Message
- To investigate the prognostic value of circulating tumor DNA (ctDNA) in multiple myeloma, the authors assessed ctDNA minimal residual disease (MRD) in blood samples after autologous stem cell transplantation (AHCT) from 28 multiple myeloma patients. There were 80 plasma timepoints available before and after AHCT. MRD was evaluated from bone marrow biopsy using multiparameter flow cytometry at the 10-4 level; individual bone marrow aspirates and matched normal blood were whole-exome sequenced; and somatic mutations were determined. MRD status was correlated with outcomes.
- ctDNA was identified in 70.8% of patients before AHCT, in 53.6% 3 months after AHCT, and in 39.2% in the surveillance period after AHCT. In all, 15 patients were ctDNA MRD–positive; of these, 14 relapsed during follow-up (HR, 5.64; 95% CI, 1.8–17; P = .0003). Progression-free survival was significantly improved for patients who were ctDNA-negative 3 months after AHCT (median PFS was 84 months compared with 31 months in those ctDNA-positive; P = .003). Prospective studies are warranted to further examine the prognostic benefit of ctDNA in patients with multiple myeloma at high risk of relapse.
8030 Cilta-cel versus conventional treatment in patients with relapse/refractory multiple myeloma. LJ Costa, Y Lin, TG Martin, et al
Take-Home Message
- Data from the CARTITUDE-1 trial on the use of ciltacabtagene autoleucel (cilta-cel) for heavily pretreated patients with relapsed/refractory multiple myeloma have been encouraging. The authors of the present study used the MAMMOTH dataset of patients with multiple myeloma refractory to anti-CD38 monoclonal antibody to compare conventional (non–CAR-T) treatment with cilta-cel.
- Patients in the CARTITUDE-1 intent-to-treat (ITT; underwent apheresis) and modified ITT (received cilta-cel at the recommended phase II dose) cohorts had greater overall response rates (84% vs 28% and 96% vs 30%, respectively), progression-free survival (12 months: 73% vs 12% and 79% vs 15%, respectively), and overall survival (12 months: 83% vs 39% and 88% vs 41%, respectively) compared with their matching MAMMOTH cohorts who received conventional therapy.
8035 Daratumumab (DARA) maintenance therapy following DARA + cyclophosphamide, bortezomib, and dexamethasone (CyBorD) induction therapy in multiple myeloma (MM): End-of-study analysis of LYRA. RM Rifkin, JM Melear, E Faber, et al
Take-Home Message
- The authors report the end-of-study analysis of LYRA, a community practice–based phase II study (N = 101) of daratumumab (DARA) plus cyclophosphamide, bortezomib, and dexamethasone (CyBorD) as an immunomodulatory drug–sparing regimen for patients with multiple myeloma (MM).
- The overall response rate was 97.4% in newly diagnosed patients who received autologous stem cell transplant (ASCT), 83% in those who did not, and 85.7% in patients with relapsed MM. The estimated 36-month progression-free survival was 69.3% in newly diagnosed MM patients who received ASCT (95% CI, 43.0–85.3), 72.6% in those who did not (95% CI, 54.0–84.7), and 31.7% in relapsed MM patients (95% CI, 5.6–63.4). Induction with DARA + CyBorD and maintenance with DARA monotherapy produced deep and durable responses in patients with newly diagnosed or relapsed MM, with no new safety signals identified with longer follow-up.
8041 LocoMMotion: A prospective, non-interventional, multinational study of real-life current standards of care in patients with relapsed/refractory multiple myeloma (RRMM) receiving ≥3 prior lines of therapy. M-V Mateos, K Weisel, V De Stefano, et al
Take-Home Message
- The authors present interim results from the prospective LocoMMotion study, designed to evaluate real-world standards of care in patients with multiple myeloma (MM) who progress after treatment with proteasome inhibitors, immunomodulatory drugs, and anti-CD38 monoclonal antibodies. This interim analysis included 225 patients (median age, 68 years; 55.1% male) from 75 sites in Europe (90.2%) and the US (9.8%), with a median follow-up of 3.7 months. In 121 patients, treatment is ongoing. All patients had received two or more prior lines of therapy (median, 4.0), with 92.4% being refractory to the last line of therapy. They were all triple-class exposed, with 73.8% being triple-class refractory. For the evaluable patients (n = 219), the overall response rate with real-world standard-of-care salvage therapy was 20.1%. Treatment-emergent adverse events (TEAEs) occurred in 65.8%, with 42.2% experiencing events of grade 3 or higher (most commonly anemia, neutropenia, and thrombocytopenia) and with 15 TEAE-related deaths.
- This real-world study shows that patients with relapsed/refractory MM continue to progress and often have poor outcomes. More therapies with novel mechanisms of action are needed to improve survival in this population.
8042 Isatuximab plus carfilzomib and dexamethasone in relapsed multiple myeloma patients with high-risk cytogenetics: IKEMA subgroup analysis. I Spicka, P Moreau, TG Martin, et al
Take-Home Message
- The authors report the results of a subgroup analysis of the phase III IKEMA study, which showed that progression-free survival (PFS) was significantly improved (P = .0007) in patients with relapsed multiple myeloma who received the addition of isatuximab (Isa) to carfilzomib (K) and dexamethasone (d) compared with those who received only Kd. This analysis concerned the safety and efficacy of Isa + Kd in patients with one to three prior lines of therapy and high-risk cytogenetics, defined as one or more of the following: del(17p)—50% cutoff; t(4;14) or t(14;16)—30% cutoff; assessment of gain(1q21) was prespecified as ≥3 copies—30% cutoff.
- The combination Isa + Kd improved progression-free survival in patients with one or more high-risk cytogenetic abnormality as well as standard-risk patients; disease response was greater in those with gain(1q21), either isolated or combined with high-risk cytogenetic abnormalities. Treatment-emergent adverse events occurred more often in the Isa + Kd arm; however, for high-risk patients the incidence of serious and fatal events was similar in the two arms. The data suggest that adding Isa to Kd may be a promising option for patients with relapsed multiple myeloma and high-risk cytogenetics.
8044 ISB 1342: A first-in-class CD38 T cell engager for the treatment of relapsed refractory multiple myeloma. M-A Doucey, B Pouleau, C Estoppey, et al
Take-Home Message
- ISB 1342, a heterodimeric bispecific antibody, is a first-in-class CD38 T-cell engager. With a fragment antigen–binding arm that recognizes CD38 and does not compete with daratumumab, it was engineered to overcome daratumumab resistance in patients with multiple myeloma and has shown encouraging target specificity in in vitro studies. When evaluated in vivo in a therapeutic model, weekly intravenous injection of ISB 1342 at 0.5 mg/kg induced complete tumor eradication. Assessment of the tumor environment 1 week after treatment demonstrated significantly increased release of TNF-α, granzyme A and B, and CXCL10 by ISB 1342 but not by daratumumab or the ISB 1342 control molecule.
- These data support the ongoing investigation of ISB 1342 in patients with relapsed multiple myeloma that is refractory to daratumumab, proteasome inhibitors, and immunomodulators.
8050 An animal model of MGUS/SMM to investigate the role of cellular senescence in progression to MM. H Zhang, OS Aljitawi, LX Zhang, et al
Take-Home Message
- To investigate the effect of cellular senescence on development of multiple myeloma (MM), the authors developed a novel mouse model derived from patients with the MM precursor stages of monoclonal gammopathy of undetermined significance (MGUS) and smoldering MM.
- The model demonstrated both a role for cellular senescence in the development of MM and a way to evaluate disease progression in patients with MGUS or smoldering MM, which have no approved therapies and for which research is currently limited due to lack of animal models.
Oral Abstract Session: Hematologic Malignancies—Plasma Cell Dyscrasia
Tuesday, June 8, 2021; 8:00 AM–11:00 AM EDT
8001 Depth of response and minimal residual disease status in ultra high-risk multiple myeloma and plasma cell leukemia treated with daratumumab, bortezomib, lenalidomide, cyclophosphamide and dexamethasone (Dara-CVRd): Results of the UK optimum/MUKnine trial. MF Kaiser, A Hall, K Walker, et al
Take-Home Message
- The authors report outcomes for patients with ultra high–risk newly diagnosed multiple myeloma (MM) and patients with plasma cell leukemia who were treated in the OPTIMUM/MUKnine study with up to six cycles of daratumumab, cyclophosphamide, bortezomib, lenalidomide, and dexamethasone (Dara-CVRd) induction; high-dose melphalan (HDMEL) and autologous stem cell transplant (ASCT) augmented with bortezomib; and then Dara-VR(d) consolidation for 18 cycles and Dara-R maintenance.
- In the intention-to-treat population at the end of induction, the overall response rate was 94% (which included 22% complete response and 58% very good partial response); at day 100 after ASCT, the overall response rate was 83% (which included 47% complete response and 32% very good partial response), with responses in patients with plasma cell leukemia being lower than in those with newly diagnosed MM. Toxicities were similar to those seen with similar induction regimens. Some early progressions were observed, underscoring the need to develop new therapies for this difficult-to-treat patient population.
8002 Carfilzomib-based induction/consolidation with or without autologous transplant (ASCT) followed by lenalidomide (R) or carfilzomib-lenalidomide (KR) maintenance: Efficacy in high-risk patients. F Gay, R Mina, D Rota-Scalabrini, et al
Take-Home Message
- To study the impact of treatment and cytogenetic abnormalities on progression-free survival, patients with multiple myeloma were randomized to receive either carfilzomib-lenalidomide-dexamethasone induction/consolidation with ASCT (KRd_ASCT), carfilzomib-cyclophosphamide-dexamethasone (KCd) with ASCT (KCd_ASCT), or KRd without ASCT (KRd12). Fluorescence in situ hybridization was used to analyze the impact of high-risk cytogenetic abnormalities, both individually and combined [del17p, t(4;14), t(14;16), del1p and 1q gain (3 copies) or amp1q (≥4 copies)]. Patients without these abnormalities were considered standard-risk.
- The results support the use of KRd_ASCT and KR maintenance for high-risk multiple myeloma patients. With KRd_ASCT, 4-year PFS from diagnosis was 62% for high-risk patients and 55% for double-hit (having two or more high-risk cytogenetic abnormalities) patients. With KR, the 3-year PFS from maintenance was 69% in high-risk patients and 67% in double-hit patients.
8004 Daratumumab (DARA) maintenance or observation (OBS) after treatment with bortezomib, thalidomide and dexamethasone (VTd) with or without DARA and autologous stem cell transplant (ASCT) in patients (pts) with newly diagnosed multiple myeloma (NDMM): CASSIOPEIA Part 2. P Moreau, P Sonneveld, for the CASSIOPEIA Study Investigators
Take-Home Message
- To compare maintenance with daratumumab (DARA) versus observation, 886 patients with newly diagnosed multiple myeloma who had achieved partial response or better after treatment with bortezomib, thalidomide, and dexamethasone (VTd) with or without DARA were randomized to receive either DARA maintenance for up to 2 years (n = 442) or undergo observation (n = 444) until progressive disease per International Myeloma Working Group criteria. The authors present the interim analysis after 281 PFS events.
- Median PFS was 46.7 months with observation and was not reached with DARA at a median follow-up of 35.4 months. For the DARA arm, ≥CR was 72.9% versus 60.8% in the observation arm (OR, 2.17; 95% CI, 1.54–3.07; P < .0001), and minimal residual disease negativity (in ≥CR pts at 10-5) was 58.6% versus 47.1% in the observation arm (OR, 1.80; 95% CI, 1.33–2.43; P = .0001). DARA was well-tolerated, and no new safety signals were identified.
8005 Ciltacabtagene autoleucel, a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy, in relapsed/refractory multiple myeloma (R/R MM): Updated results from CARTITUDE-1. SZ Usmani, JG Berdeja, D Madduri, et al
Take-Home Message
- The authors present updated efficacy and safety results in patients with longer follow-up (median, 12.4 months) enrolled in the phase Ib/II CARTITUDE-1 trial of ciltacabtagene autoleucel (cilta-cel). Patients with multiple myeloma had either undergone three or more prior lines of therapy (median, six) or were double-refractory to a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), and had received a PI, IMiD, and anti-CD38 antibody. A total of 97 patients received one infusion of cilta-cel 5 to 7 days after lymphodepletion.
- The median time to first response was 1 month, with an overall response rate of 97%; 67% achieved stringent complete response. The median time to complete response or better was 2 months. Median duration of response was not reached. The 12-month PFS was 77%, and overall survival was 89%, with median PFS not reached. The safety profile was manageable at the recommended phase II dose. Investigation of cilta-cel in various multiple myeloma patient populations is ongoing.
8007 Updated phase 1 results of teclistamab, a B-cell maturation antigen (BCMA) × CD3 bispecific antibody, in relapsed/refractory multiple myeloma (MM). AY Krishnan, AL Garfall, M-V Mateos, et al
Take-Home Message
- The authors report on patients given the recommended phase II dose (RP2D) of teclistamab, a BCMA × CD3 bispecific IgG4 antibody. A total of 156 patients with relapsed/refractory multiple myeloma received either intravenous or subcutaneous teclistamab. In total, 40 patients, who had undergone a median of five lines of prior therapy, received the RP2D dose: 1500 µg/kg weekly subcutaneously, with 60.0 µg/kg and 300 µg/kg step-up doses.
- The ORR in evaluable patients given the RP2D was 65%; median time to first response was 1 month; median duration of response was not reached. At a median follow-up of 5.3 months, 88% of the RP2D responders remained on treatment, with deepening responses. The dose was well-tolerated. Research on dosing strategies for teclistamab is ongoing.
8008 Updated results of a phase 1, first-in-human study of talquetamab, a G protein-coupled receptor family C group 5 member D (GPRC5D) × CD3 bispecific antibody, in relapsed/refractory multiple myeloma (MM). JG Berdeja, AY Krishnan, A Oriol, et al
Take-Home Message
- The authors report results concerning the recommended phaseII dose (RP2D) for talquetamab, a first-in-class bispecific IgG4 antibody that binds to CD3 and the novel target GPRC5D. A total of 174 patients with relapsed/refractory multiple myeloma or intolerance to standard therapies received either intravenous or subcutaneous talquetamab, with 28 receiving the RP2D (405 µg/kg subcutaneously weekly, with 10.0 µg/kg and 60.0 µg/kg step-up doses). Patients treated with the RP2D had received a median of 5.5 previous line of therapy, and 86% were refractory to the last line of therapy.
- In the 24 evaluable patients in the RP2D group, the ORR was 63%, with 50% very good partial response or better, and median time to first confirmed response was 1.0 month (range, 0.2–3.8 months), with durable and deepening responses (median follow-up, 6.2 months). These results along with a manageable safety profile support continued study of talquetamab.
Publication-Only Abstract Titles
Hematologic Malignancies—Plasma Cell Dyscrasia
E20005 Testing Mayo Clinic’s new 20/20/20 risk stratification model in another cohort of smoldering myeloma patients: A retrospective study. C Tessier, T Allard, JS Boudreault, et al
Take-Home Message
- In this retrospective, single-center study of 89 patients with smoldering multiple myeloma, the authors evaluated the ability of a newly proposed risk-stratification model from Mayo Clinic to identify the risk of progression to symptomatic MM. The model is based on the markers of bone marrow plasma cell percentage >20%, free light chain ratio >20, and serum M protein >20 g/L, with the presence of no, one, or two or more risk factors being associated with low, intermediate, or high risk of disease progression, respectively.
- The model as applied to this study population was able to predict the risk of progression to symptomatic MM at 2 years. The authors suggest that the model could be incorporated into research on various treatments for higher-risk smoldering MM.
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