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31 mei 2018: ASCO 2018

ASCO 2018

A.s. weekend start ASCO 2018 in Chicago. Hier een selectie van belangrijke abstracten gerelateerd aan nierkanker

Klik op de nummers voor de abstracten zelf. We zullen komende week zeker een aantal abstracten eruit kiezen om die wat uitgebreider te beschrijven maar hier alvast een voorselectie door dr. Eric Jonasch en dr. Monthy Pal die wij hebben overgenomen van ASCO POST:

Saturday, June 2, 8:00 AM–11:30 AM
Session: Genitourinary (Nonprostate) Cancer

4509 Pegilodecakin with nivolumab (nivo) or pembrolizumab (pembro) in patients (pts) with metastatic renal cell carcinoma (RCC). NM Tannir, A Naing, JR Infante, et al

Take-Home Message

  • This study included 38 patients with mRCC who were given pegilodecakin at 10 μg/kg (n = 6) or 20 μg/kg (n = 32) and nivolumab (n = 29) or pembrolizumab (n = 9). Patients had previously received at least one VEGFR-TKI. The combinations were well-tolerated, with commonly reported grade 3/4 treatment-related adverse events of anemia, thrombocytopenia, and hypertriglyceridemia. Reversible cytokine release syndrome was reported in 2 patients. Of 34 evaluable patients, there were 14 partial responses, 3 complete responses, and 15 patients had stable disease. The disease control rate was 81%, with an objective response rate of 53%. The 1-year overall survival was 89%.

  • These findings demonstrate that the combination of pegilodecakin with nivolumab or pembrolizumab is well-tolerated in patients with mRCC, with 10 μg/kg recommended for use in phase II studies.

4560 Lenvatinib + pembrolizumab in patients with renal cell carcinoma: Updated results. C-H Lee, V Makker, DW Rasco, et al

Take-Home Message

  • This multicenter, open-label study included 30 patients with metastatic ccRCC who received oral lenvatinib 20 mg daily plus pembrolizumab 200 mg IV every 3 weeks. Of these patients, 60% had at least one prior anticancer therapy, including 16 who had received at least one prior VEGF-targeted therapy. At a median follow-up of 13.8 months, the objective response rate at 24 weeks was 63.3% by investigator review per irRECIST and 66.7% by independent radiographic review using RECIST 1.1. Median progression-free survival was 17.7 months. Grade 3/4 adverse events were reported in 70% of patients, with 13% discontinuing treatment due to adverse events.

  • These results demonstrate manageable adverse events and promising activity of the combination of lenvatinib plus pembrolizumab in patients with metastatic ccRCC.

Sunday, June 3, 8:00 AM–11:00 AM
Session: Genitourinary (Nonprostate) Cancer

4500 Pembrolizumab monotherapy as first-line therapy in advanced clear cell renal cell carcinoma (accRCC): Results from cohort A of KEYNOTE-427. DF McDermott, J-L Lee, C Szczylik, et al

Take-Home Message

  • This study included 107 evaluable patients (median age, 64 years; 78% male) with histologically confirmed advanced ccRCC who had not received prior systemic therapy. Patients received the PD-1 inhibitor pembrolizumab 200 mg IV every 3 weeks for 2 years or until disease progression, unacceptable toxicity, or withdrawal from the study. After a median follow-up of 7.2 months, the objective response rate was 33.6%, including 1 complete and 35 partial responses. Treatment-related adverse events were reported in 73.6% of patients, with commonly reported (≥10%) events of fatigue, diarrhea, rash, pruritus, and arthralgia. Grade 3 to 5 treatment-related adverse events were reported in 18.2% of patients, including 1 patient with grade 5 pneumonitis.

  • PD-1 blockade in the front-line setting provides meaningful disease control without the side effects associated with combination PD-1 and CTLA-4 blockade.

4502 A randomized, open label, multicenter phase 2 study, to evaluate the efficacy of sorafenib (So) in patients (pts) with metastatic renal cell carcinoma (mRCC) after a radical resection of the metastases: RESORT trial. G Procopio, F Cognetti, R Miceli, et al

Take-Home Message

  • This study included 76 patients with mRCC who, after radical metastasectomy, were randomized to receive sorafenib (n = 32) or undergo observation (n = 36) for 52 weeks. The primary endpoint was recurrence-free survival. An interim analysis of 68 patients after a median follow-up of 21 months revealed no differences in median recurrence-free survival between the sorafenib and observation arms (29 months vs 35 months). Grade 3 adverse events were more common in the sorafenib arm vs the observation arm (22% vs 3%). Only 2 patients received the full dose of sorafenib.

  • Although sorafenib was found to be safe in patients with mRCC following radical metastasectomy, recurrence-free survival was not improved.

4511 Patient-reported outcomes (PROs) in IMmotion151: Atezolizumab (atezo) + bevacizumab (bev) vs sunitinib (sun) in treatment (tx) naive metastatic renal cell carcinoma (mRCC). B Escudier, RJ Motzer, BI Rini, et al

Take-Home Message

  • This secondary/exploratory analysis of the IMmotion151 study used data from patients who completed the MD Anderson Symptom Inventory (MDASI) and Functional Assessment of Cancer Therapy–Kidney Symptom Index 19 (FKSI-19) questionnaires during treatment and follow-up. In the intention-to-treat population, baseline completion was >80%, which remained ≥70% until week 57. Patients receiving atezolizumab plus bevacizumab reported better health-related quality of life, milder and more stable symptom severity, and less symptom-related interference with daily living compared with patients who received sunitinib. Time to deterioration in symptom-related interference was delayed for patients receiving atezolizumab plus bevacizumab vs sunitinib (11.3 vs 3.4 months, respectively).

  • These patient-reported outcomes suggest that daily functioning was maintained with minimal symptom interference with first-line atezolizumab plus bevacizumab in patients with mRCC.

Sunday, June 3, 1:00 PM–4:00 PM
Plenary Session

LBA3 CARMENA: Cytoreductive nephrectomy followed by sunitinib versus sunitinib alone in metastatic renal cell carcinoma—Results of a phase III noninferiority trial. A Mejean, B Escudier, S Thezenas, et al

Session: Genitourinary (Nonprostate) Cancer
Saturday June 2, 8:00 AM–11:30 AM

4516 Alterations in key clear cell renal cell carcinoma (RCC) genes to refine patient prognosis. D Bossé, W Xie, Y Ged, et al

Take-Home Message

  • In this study of 308 patients with clear cell mRCC treated with VEGF-TKI therapy in the first line, the researchers wanted to determine the prognostic value of genomic alterations leading to loss of function. Genomic alterations in BAP1 were significantly associated with a worse IMDC risk group and worse overall survival. Longer overall survival was significantly associated with genomic alterations in KDM5C and PBRM1. Significantly worse overall survival was reported in IMDC intermediate–risk patients with PBRM wild-type tumors that also harbored genomic alterations in BAP1.
  • The researchers suggest that genomic alteration assessment may be predictive of survival in IMDC intermediate–risk patients.

4517 Prospective phase II multi-center study of individualized axitinib (Axi) titration for metastatic renal cell carcinoma (mRCC) after treatment with PD-1 / PD-L1 inhibitors. MC Ornstein, SK Pal, LS Wood, et al

Take-Home Message

  • In this study, 38 patients with clear cell mRCC were given axitinib 5 mg twice daily with upward dose titration every 14 days in 1-mg twice-daily increments up to 10 mg. If grade 2 axitinib-related adverse events occurred, patients resumed the same dose after a 3-day break. In evaluable patients, the median progression-free survival is 9.2 months, with 54% of patients still taking axitinib. The objective response rate is 38.7%, with 38.7% partial response, 48.3% stable disease, and 12.9% progressive disease. Per patient, the median highest dose was 6 mg twice daily, with 44% of patients requiring dose reductions. No unexpected toxicities related to axitinib were reported.
  • These results demonstrate that axitinib treatment results in robust efficacy post immunotherapy therapy.

4518 Correlation of degree of tumor immune infiltration and insertion-and-deletion (indel) burden with outcome on programmed death 1 (PD1) therapy in advanced renal cell cancer (RCC). MH Voss, JB Novik, MD Hellmann, et al

Take-Home Message

  • Whole-exome sequencing data on 77 tumors from patients with RCC who received anti–PD-1 or TKI treatment and RNAseq data from 25 patients were evaluated to determine the predictive ability of mutation load and neoantigen burden. In patients who received anti–PD-1 therapy, increased immune infiltration, particularly by M2 macrophages, was favorably correlated with a durable clinical benefit. Neither mutation nor neoantigen burden significantly altered overall survival in patients who received anti–PD-1 therapy. A similar, but nonsignificant, correlation was observed in patients who received TKI therapy.
  • Baseline tumor infiltration of M2 macrophages was associated with a favorable outcome in patients with RCC who received anti–PD-1 therapy.

4519 Gut microbiome composition to predict resistance in renal cell carcinoma (RCC) patients on nivolumab. L Derosa, V Iebba, L Albiges, et al

Take-Home Message

  • In this study, fecal samples were collected from 69 patients treated with nivolumab to evaluate the potential influence of microbiome composition on outcomes. After 14 months of follow-up, 39% of patients were classified as primary resistant and 61% were non–primary resistant based on best response. Of the patients who received antibiotics , significantly more patients were primary resistant. Intra- and inter-sample diversity were not significantly different in patients who were primary resistant or non–primary resistant. Patients who were non–primary resistant had significantly more abundant Akkermansia muciniphila and Bacteroides salyersiae.
  • These findings suggest that gut microbiome composition may predict resistance to anti–PD-1 therapy in patients with RCC.

4565 Disease-free survival in patients at highest risk of recurrent renal cell carcinoma in S-TRAC. A Ravaud, DJ George, RJ Motzer, et al

Take-Home Message

  • In this study, 398 patients enrolled in S-TRAC were classified as highest risk for recurrent RCC, and disease-free survival analyses were conducted. In this group of patients, a significant treatment benefit with sunitinib on disease-free survival was determined by independent review, which was consistent with that reported in the S-TRAC trial for the overall population and patients with Fuhrman grade ≥2 and ECOG performance status ≥1 or T4 with any ECOG performance status or N+ with any T, any ECOG performance status. Similar rates of key adverse events in patients treated with sunitinib were reported in the highest risk group and in the overall population of study patients.
  • These results support sunitinib as adjuvant treatment in patients with RCC at high risk of recurrence.

4570 Patient-reported frustrations in renal cell carcinoma (RCC) care delivery: Results of a joint European Association of Urology (EAU)/KCCure survey. CD Bergerot, D Battle, PG Bergerot, et al 

Take-Home Message

  • An online survey was conducted to determine perceptions regarding adjuvant therapy among 450 patients with RCC. Of these patients, 56% were female, 85% were diagnosed with clear cell histology, and 73% had nonmetastatic disease. Common sources of frustration included poor communication, lack of confidence in diagnosis, fear of recurrence/progression, and financial issues. Patients who were older and had non–clear cell histology were more likely to report practical sources of frustration such as lack of information and financial issues. Female patients more commonly reported emotional sources of frustration.
  • These results highlight baseline characteristics that should be considered when considering care for patients with RCC to minimize patient frustration.

4579 Cabozantinib (Cabo) in advanced non-clear cell renal cell carcinoma (nccRCC): A retrospective multicenter analysis. NM Chanza, D Bossé, MA Bilen, et al

Take-Home Message

  • In this retrospective study, data from 80 patients with non-ccRCC were evaluated to characterize the toxicity and clinical activity of cabozantinib. Most patients were IMDC intermediate/poor risk (88%), and 53% received cabozantinib in the third line or later. Overall, 42% discontinued due to disease progression, and 5% discontinued due to toxicity. Frequently reported adverse events include fatigue and rash. Of 66 patients who remained on treatment for at least 8 weeks, the objective response rate was 27.3%. A durable clinical benefit of 6 months or longer was observed in 64% of patients. Median overall survival was 11 months, and time to treatment failure was 6.9 months. Of the 7 evaluable patients who had papillary RCC with MET alterations, 5 achieved clinical benefit.
  • These results demonstrate the safety and activity of cabozantinib in patients with non-ccRCC.

4583 Outcomes of patients (pts) with metastatic renal cell carcinoma (mRCC) and sarcomatoid dedifferentiation (sRCC) after treatment with immune checkpoint inhibitors (ICI): A single-institution retrospective study. JA Ross, BZ McCormick, J Gao, et al

Take-Home Message

  • In this retrospective study, data from 39 patients with metastatic RCC with sarcomatoid dedifferentiation (sRCC) who received immune checkpoint inhibitors were examined to determine treatment response. In all, 37 patients had IMDC intermediate- or poor-risk disease. Overall, 62% of patients responded to treatment, and, of these, 58% received first-line therapy. Of the 33 patients with ccRCC, 5 achieved complete response. Of the 6 patients with variant histology RCC, 5 did not respond to therapy. Median progression-free and overall survival were 8.3 months and not reached, respectively.
  • Immune checkpoint inhibitors have some efficacy in patients with ccRCC; however, patients with variant histology RCC continue to have poor prognoses.

TPS4597 PROSPER: A phase III randomized study comparing perioperative nivolumab (nivo) vs. observation in patients with localized renal cell carcinoma (RCC) undergoing nephrectomy (ECOG-ACRIN 8143). LC Harshman, M Puligandla, NB Haas, et al

Take-Home Message

  • This phase III study has a planned enrollment of 766 patients with clinical stage T2 or greater or node-positive M0 RCC of any histology. Patients will be randomized to receive two doses of nivolumab prior to surgery and adjuvant nivolumab for 9 months (investigational arm) or standard of care surgical resection and observation (control arm). The study is powered to detect 5-year recurrence-free survival and overall survival. Feasibility, safety, and quality of life endpoints will also be evaluated.
  • This study will evaluate the potential of perioperative nivolumab with radical or partial nephrectomy for increasing cures, time to recurrence, and survival in patients with high-risk localized and locally advanced RCC.

TPS4598 A phase 3, randomized, open-label study of nivolumab combined with cabozantinib vs sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC; CheckMate 9ER). TK Choueiri, AB Apolo, T Powles, et al

Take-Home Message

  • In this phase III study, 580 patients aged 18 years or older with measurable disease that has a clear cell component, no prior systemic therapy for RCC, and evaluable tumor biopsies will be enrolled. Patients will be randomized to receive nivolumab plus cabozantinib or sunitinib until disease progression or unacceptable toxicity. The primary endpoint is progression-free survival. Secondary endpoints will evaluate overall survival, objective response rate, and safety/tolerability.
  • These results will provide information related to the safety and efficacy of nivolumab plus cabozantinib vs sunitinib in previously untreated patients with advanced or metastatic RCC.

TPS4599 KEYNOTE-564: A phase 3, randomized, double blind, trial of pembrolizumab in the adjuvant treatment of renal cell carcinoma. TK Choueiri, DI Quinn, T Zhang, et al

Take-Home Message

  • In this randomized, double-blind study, approximately 950 patients with histologically confirmed ccRCC of intermediate/high risk, high risk, or M1 NED who have not previously received systemic therapy, have negative surgical margins, and ECOG performance status of 0-1 and tumor samples available for biomarker analyses will be enrolled. Patients will be randomized to pembrolizumab 200 mg or placebo until disease recurrence, discontinuation, or completion of 17 cycles. The primary and secondary endpoints are disease-free survival and overall survival, respectively. Exploratory analyses will investigate biomarkers associated with response.
  • These results will provide information related to the safety and efficacy of adjuvant pembrolizumab in patients with RCC after nephrectomy.

TPS4601 CANTATA: A randomized phase 2 study of CB-839 in combination with cabozantinib vs. placebo with cabozantinib in patients with advanced/metastatic renal cell carcinoma. NM Tannir, RJ Motzer, N Agarwal, et al

Take-Home Message

  • In this multicenter, double-blind study, approximately 300 patients with clear cell metastatic RCC will be enrolled. Patients will be randomized to receive CB-839, a first-in-class metabolic inhibitor, or placebo in combination with cabozantinib until disease progression or unacceptable toxicity. The primary endpoint is progression-free survival. Secondary endpoints will evaluate overall survival, quality of life, and safety.
  • The results will provide information related to the safety and efficacy of CB-839 plus cabozantinib in patients with metastatic RCC.

TPS4604 A phase 2, single-arm trial of neoadjuvant axitinb plus avelumab in patients (pts) with localized renal cell carcinoma (RCC) who are at high risk of relapse after nephrectomy (NeoAvAx). A Bex, JV Van Thienen, M Schrier, et al

Take-Home Message

In this neoadjuvant study, the combination of axitinib Plus avelumab followed by complete surgical resection will be evaluated in 40 patients with high-risk nonmetastatic ccRCC. Patients will be given axitinib 5 mg twice daily and escalated to 10 mg twice daily if tolerated and avelumab 10 mg/kg IV every 2 weeks for six cycles following acetaminophen and H1 blockers every 2 weeks. Patients who experience a tumor increase after the first 6 weeks or who do not exhibit change following dose escalation will be taken off trial and undergo surgery, whereas other patients will complete 3 months of treatment followed by resection. This study will determine partial response rates, disease-free survival, overall survival, recurrence rate, safety, and tolerability

This study will determine whether the combination of axitinib and avelumab should be used in this patient population.

Session: Genitourinary (Nonprostate) Cancer
Sunday June 3, 8:00 AM–11:00 AM

4500 Pembrolizumab monotherapy as first-line therapy in advanced clear cell renal cell carcinoma (accRCC): Results from cohort A of KEYNOTE-427. DF McDermott, J-L Lee, C Szczylik, et al

Take-Home Message

  • This study included 107 evaluable patients (median age, 64 years; 78% male) with histologically confirmed advanced ccRCC who had not received prior systemic therapy. Patients received pembrolizumab 200 mg IV every 3 weeks for 2 years or until progressive disease, unacceptable toxicity, or withdrawal from the study. After a median follow-up of 7.2 months, the objective response rate was 33.6%, including 1 complete and 35 partial responses. Treatment-related adverse events were reported in 73.6% of patients, with commonly reported events (≥10%) of fatigue, diarrhea, rash, pruritus, and arthralgia. Grade 3–5 treatment-related adverse events were reported in 18.2% of patients, including 1 patient with grade 5 pneumonitis.
  • The results demonstrate the safety and preliminary efficacy of pembrolizumab for patients with advanced ccRCC.

4502 A randomized, open label, multicenter phase 2 study, to evaluate the efficacy of sorafenib (So) in patients (pts) with metastatic renal cell carcinoma (mRCC) after a radical resection of the metastases: RESORT trial. G Procopio, F Cognetti, R Miceli, et al

Take-Home Message

  • This study included 76 patients with mRCC who were randomized after radical metastasectomy to receive sorafenib (n = 32) or to undergo observation (n = 36) for 52 weeks to evaluate recurrence-free survival. An interim analysis of 68 patients after a median follow-up of 21 months revealed no differences in median recurrence-free survival between the sorafenib and observation arms (29 months vs 35 months). Grade 3 adverse events were more common in the sorafenib arm vs the observation arm (22% vs 3%). Only 2 patients received the full dose of sorafenib.
  • The results show that sorafenib is safe in patients with mRCC following radical metastasectomy, but recurrence-free survival was not improved.

4511 Patient-reported outcomes (PROs) in IMmotion151: Atezolizumab (atezo) + bevacizumab (bev) vs sunitinib (sun) in treatment (tx) naive metastatic renal cell carcinoma (mRCC). B Escudier, RJ Motzer, BI Rini, et al

Take-Home Message

  • This secondary/exploratory analysis of the IMmotion 151 study used data from patients who completed the MD Anderson Symptom Inventory (MDASI) and Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (FKSI-19) questionnaires during treatment and follow-up. In the ITT population, baseline completion was >80%, which remained ≥70% until week 57. Patients receiving atezolizumab plus bevacizumab reported better HRQoL, milder and more stable symptom severity, and less symptom interference in daily functioning compared with patients who received sunitinib. Time to deterioration in daily functioning was delayed for patients receiving atezolizumab plus bevacizumab vs sunitinib (11.3 vs 3.4 months, respectively).
  • These results from patient-reported outcomes suggest that daily functioning was maintained with minimal symptom interference with atezolizumab plus bevacizumab in patients with mRCC.

Session: Plenary Session Including the Science of Oncology Award and Lecture
Sunday June 3, 1:00 PM–4:00 PM

LBA3 CARMENA: Cytoreductive nephrectomy followed by sunitinib versus sunitinib alone in metastatic renal cell carcinoma—Results of a phase III noninferiority trial. A Mejean, B Escudier, S Thezenas, et al


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