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Opdivo (nivolumab) Plus Yervoy (ipilimumab) with Two Cycles of Chemotherapy Demonstrates Durable Overall Survival vs. Chemotherapy at Two Years in First-Line Non-Small Cell Lung Cancer in Phase 3 CheckMate -9LA Trial

Published: 2021-05-19 21:00:00 ET
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Patients treated with Opdivo plus Yervoy with two cycles of chemotherapy showed sustained improvements in overall survival and progression-free survival and increased duration of response vs. chemotherapy at two years

Dual immunotherapy-based combination demonstrated clinical benefit across key subgroups of patients, regardless of PD-L1 expression level or histology

Data to be featured in an oral presentation during the 2021 American Society of Clinical Oncology Annual Meeting

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of chemotherapy showed a durable survival benefit compared to four cycles of chemotherapy alone after two years of follow-up in previously untreated patients with advanced non-small cell lung cancer (NSCLC). In the Phase 3 CheckMate -9LA trial, 38% of patients who received Opdivo plus Yervoy with two cycles of chemotherapy were alive at two years, compared to 26% of those who received chemotherapy alone. With additional follow-up, median overall survival (OS), the trial’s primary endpoint, was 15.8 months with the dual immunotherapy combination vs. 11.0 months with chemotherapy alone (Hazard Ratio [HR] 0.72; 95% Confidence Interval [CI]: 0.61 to 0.86).

The safety profile of Opdivo plus Yervoy with two cycles of chemotherapy reflected the established profiles of the immunotherapy and chemotherapy components in first-line NSCLC. These data will be featured in an oral presentation (Abstract #9000) at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting on June 4, 2021, from 1:00 to 4:00 p.m. EDT.

“Despite considerable advances made in the treatment of advanced non-small cell lung cancer, the majority of patients still do not survive long-term,” said Martin Reck, M.D., Ph.D., CheckMate -9LA study investigator, Lung Clinic Grosshansdorf, German Center of Lung Research. “The CheckMate -9LA trial was designed to bring together the proven durable benefits seen in other Phase 3 trials of nivolumab plus ipilimumab, with a short course of chemotherapy to help control the cancer early. Now, with two years of follow-up, we continue to see the promise of this approach, with sustained survival improvements for patients treated with nivolumab plus ipilimumab with chemotherapy compared to chemotherapy alone.”

With extended follow-up, the clinically meaningful efficacy of Opdivo plus Yervoy with two cycles of chemotherapy was maintained across key subgroups, including in patients with PD-L1 expression