ASCO 2021: aanbevolen abstracten specifiek gerelateerd aan longkanker

Raadpleeg ook literatuurlijst niet-toxische middelen en behandelingen specifiek bij longkanker van arts-bioloog drs. engelbert Valstar.

13 juni 2021: Bron: ASCO 2021

Aanbevolen abstracten specifiek gerelateerd aan longkanker en mesothelioma - asbestkanker door artsen die of zelf voor ASCO werken of door ASCO zijn gevraagd naar hun tips voor belangrijke studies.

Deze abstracten worden aanbevolen door Jean-Yves Douillard MD, PhD

Oral Abstract Session: Lung Cancer—Non- Small Cell Metastatic
Friday, June 4, 2021; 1:00 PM–4:00 PM EDT

9000 First-line nivolumab (NIVO) plus ipilimumab (IPI) plus two cycles of chemotherapy (chemo) versus chemo alone (4 cycles) in patients with advanced non-small cell lung cancer (NSCLC): Two-year update from CheckMate 9LA. M Reck, TE Ciuleanu, M Cobo, et al

Take-Home Message

The authors report data with at least 2 years of follow-up from the randomized phase III CheckMate 9LA trial. Adults with stage IV or recurrent NSCLC received either four cycles of chemotherapy alone or two cycles of chemotherapy plus nivolumab (NIVO) and ipilimumab (IPI).
At minimum follow-up of 24.4 months, patients in the NIVO+IPI+chemo group had median OS of 15.8 months compared with 11.0 months for those in the chemo-only group. No new safety signals were observed.

9001 Outcomes of anti-PD-(L1) therapy in combination with chemotherapy versus immunotherapy (IO) alone for first-line (1L) treatment of advanced non-small cell lung cancer (NSCLC) with PD-L1 score 1-49%: FDA pooled analysis. O Akinboro, JJ Vallejo, PS Mishra-Kalyani, et al

Take-Home Message

The authors conducted a pooled analysis of eeight randomized controlled trials to evaluate the use of anti–PD-(L)1 therapy in patients with advanced NSCLC and PD-L1 scores of 1%–49% (2108 patients identified). Those who received immunotherapy plus chemotherapy (n = 639) had median PFS and OS of 7.7 months and 21.4 months, respectively; those who received immunotherapy alone (n = 529) had median PFS and OS of 4.2 months and 14.5 months, respectively (median follow-up, 12.1 months).
Immunotherapy plus chemotherapy may result in better patient outcomes than immunotherapy alone in this patient population.

9002 Pooled analyses of immune-related adverse events (irAEs) and efficacy from the phase 3 trials IMpower130, IMpower132, and IMpower150. MA Socinski, RM Jotte, F Cappuzzo, et al

Take-Home Message

To investigate the association between drug efficacy and immune-related adverse events (irAEs), the authors pooled data from three phase III trials (2503 patients) evaluating atezolizumab-containing treatments (atezo) as first-line therapy for treatment-naïve patients with nonsquamous stage IV NSCLC.
Baseline patient characteristics were generally similar between patients who experienced irAEs and those who did not. The most common irAEs were rash (28% in the atezo arm vs 18% in the control arm), hepatitis (15% in the atezo arm vs 10% in the control arm), and hypothyroidism (12% in the atezo arm vs 4% in the control arm); irAEs of any grade occurred in 48% of the atezo arm and 32% of controls. In the azeto arm, the OS hazard ratio for patients with irAEs versus those without was 0.69 (95% CI, 0.60–0.78); in the control arm, it was 0.82 (95% CI, 0.68–0.99).

9003 Overall survival and exploratory subgroup analyses from the phase 2 CodeBreaK 100 trial evaluating sotorasib in pretreated KRAS p.G12C mutated non-small cell lung cancer. F Skoulidis, BT Li, R Govindan, et al

Take-Home Message

In the phase II CodeBreaK 100 trial, sotorasib 960 mg was given orally once per day to patients with pretreated KRASG12C–mutated NSCLC. Next-generation sequencing of tissue samples was used to analyze mutant allele frequency and tumor mutational burden and to determine the mutational status of individual genes. The primary endpoint was ORR.
Sotorasib was found to be clinically beneficial across all patient subgroups, and response was independent of KRASG12C–mutant allele frequency (OR, 1.11; 95% CI, 0.88–1.39).

9006 Amivantamab in combination with lazertinib for the treatment of osimertinib-relapsed, chemotherapy-naïve EGFR mutant (EGFRm) non-small cell lung cancer (NSCLC) and potential biomarkers for response. J Bauml, BC Cho, K Park, et al

Take-Home Message

The authors present data from the CHRYSALIS study concerning the combination of 1050/1400 mg amivantamab and 240 mg lazertinib in 45 patients with osimertinib-relapsed, chemotherapy-naïve, EGFR-mutant NSCLC.
In total, 16 patients demonstrated a confirmed response (1 complete, 15 partial), with 11 of the 16 remaining in response (2.6–9.6 months). Among the patients who responded, immunohistochemistry testing for EGFR and MET expression identified a subgroup more likely to respond to the drug combination. Of the 45 patients, 20 were still on treatment at a median follow-up of 8.2 months. Median PFS was 4.9 months.

9007 Efficacy and safety of patritumab deruxtecan (HER3-DXd) in EGFR inhibitor-resistant, EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC). PA Janne, CS Baik, W-C Su, et al

Take-Home Message

The authors present data on the extended follow-up of 57 patients with locally advanced or metastatic EGFRm NSCLC and previous EGFR TKI therapy who received the recommended expansion dose of HER3-DXd, an antibody–drug conjugate (5.6 mg/kg IV every 3 weeks). The median duration of treatment was 5.5 months, and treatment was ongoing in 32% of patients. ORR was 39% (95% CI, 26.0%–52.4%); median duration of response was 6.9 months (95% CI, 3.1 months–not evaluable); median PFS was 8.2 months (95% CI, 4.4–8.3 months).
HER3-DXd at a dose of 5.6 mg/kg IV every 3 weeks showed efficacy in patients heavily pretreated for locally advanced or metastatic EGFRm NSCLC. No new safety signals were identified.

9008 Preliminary safety and efficacy results from phase 1 studies of DZD9008 in NSCLC patients with EGFR Exon20 insertion mutations. JC-H Yang, M Wang, P Mitchell et al

Take-Home Message

Two phase I/II studies are ongoing to investigate the safety, tolerability, pharmacokinetics, and preliminary antitumor efficacy of DZD9008, a rationally designed selective and irreversible EGFR exon20 insertion inhibitor. A total of 97 patients with NSCLC and EGFR or HER2 mutations received DZD9008 once daily (dose range, 50–400 mg).
At doses ≥100 mg, partial response was seen, and the objective response rate was 48.4% (15/31) and the disease control rate 90.3% (28/31) at the recommended phase II dose of 300 mg. DZD9008 was well-tolerated up to the 400-mg dose, with the most common treatment-emergent adverse events being diarrhea (5.2%) and rash (1%).

Oral Abstract Session: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Sunday, June 6, 2021; 8:00 AM–11:00 AM EDT

8500 IMpower010: Primary results of a phase III global study of atezolizumab versus best supportive care after adjuvant chemotherapy in resected stage IB-IIIA non-small cell lung cancer (NSCLC). HA Wakelee, NK Altorki, C Zhou, et al

Take-Home Message

The authors present the primary disease-free survival results from the interim analysis of Impower010, a randomized phase III study of adjuvant atezolizumab. A total of 1269 patients with completely resected stage IB–IIIA NSCLC and ECOG performance status 0–1 received 4 cycles of cisplatin-based chemotherapy, with 1005 of these patients randomized to also receive either 16 cycles of atezolizumab or best supportive care.
A statistically significant benefit in disease-free survival was observed for atezolizumab over best supportive care in patients with resected stage II–IIIA NSCLC, with notable benefit seen in the PD-L1 TC ≥1% subgroup. The safety profile was as expected from previous use of atezolizumab.

8501 Adjuvant gefitinib versus cisplatin/vinorelbine in Japanese patients with completely resected, EGFR-mutated, stage II-III non-small cell lung cancer (IMPACT, WJOG6410L): A randomized phase 3 trial. H Tada, T Mitsudomi, T Yamanaka, et al

Take-Home Message

The authors investigated the safety and efficacy of adjuvant gefitinib versus cisplatin-based adjuvant chemotherapy for treating patients with completely resected EGFR mutation–positive (exon 19 deletion or L858R), stage II–III NSCLC. Disease-free survival (DFS) was the primary endpoint. Median follow-up was 71 months.
Median DFS was 36 months in patients receiving gefitinib versus 25.2 months in those receiving cisplatin plus vinorelbine. However, by about 5 years after surgery, no significant difference in DFS was seen (HR, 0.92; 95% CI, 0.67–1.28; P = .63). Overall survival also did not significantly differ (median not reached in either arm). The 5-year survival rate for the gefitinib arm was 78.0% and for the cisplatin/vinorelbine arm was 74.6% (HR for death, 1.03; 95% CI, 0.65–1.65; P = .89). There were 3 treatment-related deaths in the cisplatin/vinorelbine arm, whereas none were reported in the gefitinib arm.

8502 CTONG1103: Final overall survival analysis of the randomized phase 2 trial of erlotinib versus gemcitabine plus cisplatin as neoadjuvant treatment of stage IIIA-N2 EGFR-mutant non–small cell lung cancer. Y-L Wu, W Zhong, K-N Chen et al

Take-Home Message

The authors present the final overall survival results from a phase II trial of neoadjuvant/adjuvant erlotinib versus gemcitabine + cisplatin chemotherapy in individuals with EGFR mutation–positive resectable stage IIIA (N2) NSCLC.
Median follow-up was 62.5 months. Median overall survival was 42.2 months in the erlotinib arm and 36.9 months in the gemcitabine + cisplatin arm (HR, 0.83; 95% CI, 0.47–1.47; P = .513). There were no significant differences among predefined subgroups in the two arms. No new safety signals were identified.

8503 Surgical outcomes from the phase 3 CheckMate 816 trial: Nivolumab (NIVO) + platinum-doublet chemotherapy (chemo) vs chemo alone as neoadjuvant treatment for patients with resectable non-small cell lung cancer (NSCLC). J Spicer, C Wang, F Tanaka, et al

Take-Home Message

The CheckMate 816 study, a randomized phase III trial comparing neoadjuvant nivolumab + chemotherapy with chemotherapy alone for resectable NSCLC, demonstrated previously that the nivolumab + chemotherapy combination (nivo arm) significantly improved pathologic complete response. Here, the authors present the key surgical outcomes.
In the nivo arm (n = 149), the definitive surgery rate was 83%; in the chemo arm (n = 135), it was 75%. Surgery was delayed due to adverse events for 6 patients in the nivo arm and 9 in the chemo arm, and surgery was cancelled due to disease progression for 12 patients in the nivo arm and 17 in the chemo arm. Rates of minimally invasive surgery were 30% and 22% for the nivo and chemo arms, respectively, with an 11% rate of conversion to open surgery for the nivo arm and 16% for the chemo arm. Rates of R0 resection and median residual viable tumor cells in the primary tumor bed were 83% and 10%, respectively, for the patients in the nivo arm and 78% and 74%, respectively, for patients in the chemo arm.

8507 A randomized phase II trial of oral vinorelbine as second-line therapy for patients with malignant pleural mesothelioma. DA Fennell, AC Casbard, C Porter, et al

Take-Home Message

In this multicenter randomized controlled phase II trial, 154 patients with malignant pleural mesothelioma who had progressed after first-line chemotherapy were randomized 2:1 to receive either vinorelbine plus active supportive care (ASC) or ASC only. The primary outcome was PFS.
The study’s primary endpoint was met. Median PFS was 4.2 months for the vinorelbine + ASC arm and 2.8 months for the ASC-only arm (HR, 0.59; 95% CI, 0.41–0.85; 1-sided P = .0017). Median OS was 9.3 months for the vinorelbine + ASC arm and 9.1 months for the ASC arm (HR, 0.79; 95% CI, 0.53–1.17; 2-sided P = .24). There were 108 deaths.

Abstracten aanbevolen door Sarah B. Goldberg MD, MPH

Poster Discussion Session: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Available Starting on Friday, June 4, 2021; 9:00 EDT

8511 Five-year survival outcomes with durvalumab after chemoradiotherapy in unresectable stage III NSCLC: An update from the PACIFIC trial. DR Spigel, C Faivre-Finn, IE Gray, et al

Take-Home Message

In this 5-year updated analysis of the PACIFIC trial in patients with unresectable stage III NSCLC who have not progressed on platinum-based concurrent chemotherapy, the survival benefits of adding durvalumab to concurrent chemotherapy were durable and maintained. The overall survival was 47 months with durvalumab (n=473) versus 29 months with placebo (n=236), and the progression-free survival was 17 months versus 5.6 months.

With a 43% overall survival rate for durvalumab at 60 months (vs 33% with placebo), these results highlight the continued benefit of durvalumab and extend the earlier results of the PACIFIC trial

Oral Abstract Session: Lung Cancer—Non-Small Cell Metastatic
Friday, June 4, 2021; 1:00 PM–4:00 PM EDT

Take-Home Message

The authors conducted a pooled analysis of eeight randomized controlled trials to evaluate the use of anti–PD-(L)1 therapy in patients with advanced NSCLC and PD-L1 scores of 1%–49% (2108 patients identified). Those who received immunotherapy plus chemotherapy (n = 639) had median PFS and OS of 7.7 months and 21.4 months, respectively; those who received immunotherapy alone (n = 529) had median PFS and OS of 4.2 months and 14.5 months, respectively (median follow-up, 12.1 months).

Immunotherapy plus chemotherapy may result in better patient outcomes than immunotherapy alone in this patient population.

9003 Overall survival and exploratory subgroup analyses from the phase 2 CodeBreaK 100 trial evaluating sotorasib in pretreated KRAS p.G12C mutated non-small cell lung cancer. F Skoulidis, BT Li, R Govindan, et al

Take-Home Message

In the phase II CodeBreaK 100 trial, sotorasib 960 mg was given orally once per day to patients with pretreated KRASG12C–mutated NSCLC. Next-generation sequencing of tissue samples was used to analyze mutant allele frequency and tumor mutational burden and to determine the mutational status of individual genes. The primary endpoint was ORR.

Sotorasib was found to be clinically beneficial across all patient subgroups, and response was independent of KRASG12C–mutant allele frequency (OR, 1.11; 95% CI, 0.88–1.39).

Take-Home Message

The authors present data from the CHRYSALIS study concerning the combination of 1050/1400 mg amivantamab and 240 mg lazertinib in 45 patients with osimertinib-relapsed, chemotherapy-naïve, EGFR-mutant NSCLC.

In total, 16 patients demonstrated a confirmed response (1 complete, 15 partial), with 11 of the 16 remaining in response (2.6–9.6 months). Among the patients who responded, immunohistochemistry testing for EGFR and MET expression identified a subgroup more likely to respond to the drug combination. Of the 45 patients, 20 were still on treatment at a median follow-up of 8.2 months. Median PFS was 4.9 months.

9007 Efficacy and safety of patritumab deruxtecan (HER3-DXd) in EGFR inhibitor-resistant, EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC). PA Janne, CS Baik, W-C Su, et al

Take-Home Message

The authors present data on the extended follow-up of 57 patients with locally advanced or metastatic EGFRm NSCLC and previous EGFR TKI therapy who received the recommended expansion dose of HER3-DXd, an antibody–drug conjugate (5.6 mg/kg IV every 3 weeks). The median duration of treatment was 5.5 months, and treatment was ongoing in 32% of patients. ORR was 39% (95% CI, 26.0%–52.4%); median duration of response was 6.9 months (95% CI, 3.1 months–not evaluable); median PFS was 8.2 months (95% CI, 4.4–8.3 months).

HER3-DXd at a dose of 5.6 mg/kg IV every 3 weeks showed efficacy in patients heavily pretreated for locally advanced or metastatic EGFRm NSCLC. No new safety signals were identified.

9008 Preliminary safety and efficacy results from phase 1 studies of DZD9008 in NSCLC patients with EGFR Exon20 insertion mutations. JC-H Yang, M Wang, P Mitchell, et al

Take-Home Message

Two phase I/II studies are ongoing to investigate the safety, tolerability, pharmacokinetics, and preliminary antitumor efficacy of DZD9008, a rationally designed selective and irreversible EGFR exon20 insertion inhibitor. A total of 97 patients with NSCLC and EGFR or HER2 mutations received DZD9008 once daily (dose range, 50–400 mg).

At doses ≥100 mg, partial response was seen, and the objective response rate was 48.4% (15/31) and the disease control rate 90.3% (28/31) at the recommended phase II dose of 300 mg. DZD9008 was well-tolerated up to the 400-mg dose, with the most common treatment-emergent adverse events being diarrhea (5.2%) and rash (1%).

Oral Abstract Session: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Sunday, June 6, 2021; 8:00 AM–11:00 AM EDT

Take-Home Message

The authors present the primary disease-free survival results from the interim analysis of Impower010, a randomized phase III study of adjuvant atezolizumab. A total of 1269 patients with completely resected stage IB–IIIA NSCLC and ECOG performance status 0–1 received 4 cycles of cisplatin-based chemotherapy, with 1005 of these patients randomized to also receive either 16 cycles of atezolizumab or best supportive care.

A statistically significant benefit in disease-free survival was observed for atezolizumab over best supportive care in patients with resected stage II–IIIA NSCLC, with notable benefit seen in the PD-L1 TC ≥1% subgroup. The safety profile was as expected from previous use of atezolizumab.

Take-Home Message

The CheckMate 816 study, a randomized phase III trial comparing neoadjuvant nivolumab + chemotherapy with chemotherapy alone for resectable NSCLC, demonstrated previously that the nivolumab + chemotherapy combination (nivo arm) significantly improved pathologic complete response. Here, the authors present the key surgical outcomes.

In the nivo arm (n = 149), the definitive surgery rate was 83%; in the chemo arm (n = 135), it was 75%. Surgery was delayed due to adverse events for 6 patients in the nivo arm and 9 in the chemo arm, and surgery was cancelled due to disease progression for 12 patients in the nivo arm and 17 in the chemo arm. Rates of minimally invasive surgery were 30% and 22% for the nivo and chemo arms, respectively, with an 11% rate of conversion to open surgery for the nivo arm and 16% for the chemo arm. Rates of R0 resection and median residual viable tumor cells in the primary tumor bed were 83% and 10%, respectively, for the patients in the nivo arm and 78% and 74%, respectively, for patients in the chemo arm.

ASCO 2021, aanbevolen abstracten, longkanker, chirurgie, operatie, immuuntherapie, anti-PD medicijnen, checkpointremmers