Bristol Myers Squibb announced results from three updated analyses from the CheckMate -77T, CheckMate -816, and CheckMate -9LA studies supporting Opdivo® (nivolumab) and Opdivo-based combinations in early stage and advanced non-small cell lung cancer (NSCLC). Data are being presented at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting from May 31 to June 4, 2024, in Chicago, IL. The immunotherapy analyses were presented as part of a larger collection of studies across the company?s lung cancer portfolio.

Other presentations include an updated analysis of the Phase 1/2 TRIDENT-1 study which shows Augtyro? (repotrectinib) continued to demonstrate durable responses in ROS1-positive TKI-naive NSCLC patients at a follow-up of approximately three years. Additionally, data from the Phase 3 KRYSTAL-12 study of KRAZATI® (adagrasib) showed a statistically significant improvement in progression-free survival (PFS) compared to docetaxel in patients with previously treated KRASG12C-mutated NSCLC.

CheckMate -77T Results . A late-breaking exploratory analysis from the Phase 3 CheckMate -77T study evaluating the perioperative regimen of neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo in patients with stage III resectable NSCLC was presented in an oral presentation (Abstract #LBA8007). In the analysis, the perioperative Opdivo regimen improved median event-free survival (EFS) regardless of nodal status, including in the N2 subgroup (30.2 vs.

10.0 months; HR, 0.46; 95% CI, 0.30?0.70) and non-N2 subgroup (NR vs. 17.0 months; HR, 0.60; 95% CI, 0.33-1.08) versus neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo. One-year EFS rates were higher in both subgroups with the perioperative Opdivo regimen (N2 70% vs.

45%, and non-N2 74% vs. 62%, respectively). Surgical feasibility was similar between patients with N2 and non-N2 disease and was also similar between the Opdivo and placebo arms (77% vs.

73% among patients with N2 status; 82% vs. 79% among patients with non-N2). After surgery, a higher proportion of patients in the Opdivo arm had a pathologic complete response compared with placebo in both N2 (28.6% vs.

7.6%) and non-N2 (31.1% vs. 6.7%) subgroups. Grade 3?4 treatment-related adverse events (TRAEs) occurred in 34% and 26% in patients with N2 disease and 29% and 21% of patients with non-N2 disease with the perioperative Opdivo regimen and placebo regimen, respectively.

These data represent a comprehensive analysis by nodal status among patients with stage III resectable NSCLC from a global Phase 3 study of perioperative immunotherapy. CheckMate -77T is the company?s second positive randomized Phase 3 trial with an immunotherapy-based combination for the treatment of resectable non-metastatic NSCLC. Data from CheckMate ?77T's primary analysis supported the regulatory filing acceptances for the perioperative Opdivo-based regimen by the U.S. Food and Drug Administration and European Medicines Agency in February 2024.

CheckMate -816 Results: Four-year survival data from the Phase 3 CheckMate -816 study, representing the longest follow-up among all global Phase 3 studies evaluating neoadjuvant or perioperative immunotherapy-based treatments for stage IB-IIIA resectable NSCLC, were also presented in a rapid oral session on June 2 (Abstract #LBA8010). With a median follow up of 57.6 months, neoadjuvant Opdivo with chemotherapy continued to improve EFS versus chemotherapy alone (median: 43.8 months vs. 18.4 months; HR, 0.66; 95% CI, 0.49 to 0.90).

Four-year EFS rates were higher in the neoadjuvant Opdivo with chemotherapy arm (49% vs. 38%). While overall survival (OS) did not meet statistical significance at this analysis, neoadjuvant Opdivo with chemotherapy continued to show a clinically important OS improvement trend over chemotherapy alone (HR, 0.71; 98.36% CI, 0.47 to 1.07).

At four years, 71% of patients treated with neoadjuvant Opdivo and chemotherapy were alive, compared to 58% with chemotherapy alone. OS will continue to be followed. An exploratory analysis of lung cancer-specific survival in this study also showed a consistent trend with OS, favoring neoadjuvant Opdivo with chemotherapy (HR, 0.62; 95% CI, 0.41-0.93).

No new safety signals were observed with neoadjuvant Opdivo with chemotherapy at the extended follow-up. CheckMate -9LA ResultsFinally, five-year follow-up results from the Phase 3 CheckMate -9LA study, showing durable, long-term survival benefits with Opdivo plus Yervoy® (ipilimumab) combined with two cycles of chemotherapy compared to chemotherapy alone as a first-line treatment in patients with metastatic NSCLC were presented. With a minimum follow-up of 57.3 months, the dual immunotherapy-based combination continued to improve OS, with 18% of patients treated with Opdivo plus Yervoy with two cycles of chemotherapy alive at five years compared to 11% of patients treated with chemotherapy alone (HR, 0.73, 95% CI, 0.62 to 0.85).

The five-year survival rate for patients with tumor PD-L1 <1% (a patient population with high unmet need) who were treated with Opdivo plus Yervoy with two cycles of chemotherapy was more pronounced at 22% compared to 8% for patients treated with chemotherapy alone (HR, 0.63; 95% CI, 0.49 to 0.83).