Bristol Myers Squibb Showcases New Analyses on Opdivo at 2024 ASCO for Early and Advanced NSCLC

Bristol Myers Squibb has announced significant findings from three updated analyses from the CheckMate studies -77T, -816, and -9LA, showcasing the efficacy of Opdivo® (nivolumab) and its combinations in early-stage and advanced non-small cell lung cancer (NSCLC). These findings were presented at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting.

CheckMate -77T Study Findings

The Phase 3 CheckMate -77T study evaluated a perioperative regimen involving neoadjuvant Opdivo with chemotherapy, followed by surgery and adjuvant Opdivo, in patients with stage III resectable NSCLC. The late-breaking exploratory analysis revealed that this regimen significantly improved median event-free survival (EFS) regardless of nodal status, including the N2 subgroup (30.2 vs. 10.0 months) and non-N2 subgroup (NR vs. 17.0 months), compared to neoadjuvant chemotherapy and placebo. One-year EFS rates were higher with the perioperative Opdivo regimen in both subgroups. Additionally, a higher proportion of patients in the Opdivo arm achieved a pathologic complete response post-surgery compared to the placebo arm 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) were reported in 34% of patients with N2 disease and 29% in non-N2 with the perioperative Opdivo regimen.

CheckMate -816 Study Findings

The CheckMate -816 study, evaluating neoadjuvant Opdivo with chemotherapy versus chemotherapy alone in stage IB-IIIA resectable NSCLC, presented four-year survival data. With a median follow-up of 57.6 months, the combination of neoadjuvant Opdivo with chemotherapy continued to show improved EFS (43.8 vs. 18.4 months) compared to chemotherapy alone. The four-year EFS rates were 49% for the Opdivo and chemotherapy arm, compared to 38% for chemotherapy alone. Although overall survival (OS) did not reach statistical significance, a trend toward improved OS was noted (71% vs. 58%). No new safety issues emerged with the extended follow-up.

CheckMate -9LA Study Findings

The CheckMate -9LA study, with a five-year follow-up, highlighted the benefits of Opdivo plus Yervoy® (ipilimumab) combined with two cycles of chemotherapy versus chemotherapy alone as a first-line treatment for metastatic NSCLC. The dual immunotherapy combination showed a sustained improvement in OS, with 18% of patients on the combination alive at five years versus 11% on chemotherapy alone. Notably, patients with tumor PD-L1 <1% had a pronounced survival benefit, with a five-year survival rate of 22% compared to 8% for chemotherapy alone. The combination treatment also demonstrated more durable responses and maintained benefits across all secondary endpoints and subgroups. No new safety concerns were observed.

Broader Implications and Future Prospects

These findings highlight the growing body of evidence supporting the use of Opdivo and its combinations in various stages of NSCLC. The results from these studies reinforce the potential of immunotherapy to offer new treatment options and improve survival outcomes for patients with both early-stage resectable and advanced metastatic NSCLC. Bristol Myers Squibb’s continued focus on innovative immunotherapy approaches and targeted treatments aims to address the unmet needs of NSCLC patients and enhance long-term outcomes. The company remains committed to advancing cancer care through rigorous research, clinical trials, and the development of therapies that harness the body’s immune system to fight cancer effectively.

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