Opdivo plus chemo reduces death risk by 43% pre-surgery in NSCLC patients, leading to FDA approval, with broad patient eligibility regardless of PD-L1 levels.

Bristol Myers Squibb’s Opdivo, combined with chemotherapy, has been shown to reduce the risk of death by 43% when administered before surgery to patients with resectable non-small cell lung cancer (NSCLC). This significant finding from the phase 3 CheckMate-816 trial was part of the data that led to the FDA’s rapid approval of Opdivo for pre-surgical treatment in March. Although not yet statistically proven, a two-year follow-up indicated 83% survival for patients on the Opdivo-chemo regimen, compared to 71% for those on chemotherapy alone.

The FDA’s approval of Opdivo in the neoadjuvant setting for NSCLC is broad, covering patients with any level of tumor PD-L1 expression, provided their tumors are operable. This contrasts with other treatments like Roche’s Tecentriq, which is restricted to post-surgery use in patients with specific PD-L1 expression levels. While Opdivo’s effectiveness was more pronounced in patients with higher PD-L1 expression and advanced-stage disease, benefits were observed across all subgroups. Exploratory analyses suggested that Opdivo and chemo could significantly reduce the risk of event-free survival, particularly in patients with high PD-L1 levels.

The discussion now turns to the optimal use of PD-1/L1 inhibitors like Opdivo in treating NSCLC: pre-surgery, post-surgery, or both. The CheckMate-816 trial showed that achieving a pathological complete response—no sign of cancer in resected tissues—was associated with an 87% lower risk of disease progression or death. Ongoing and future clinical trials, including BMS’s CheckMate-77T and the National Cancer Institute’s ANVIL trial, aim to further clarify the role of treatments like Opdivo in both pre- and post-surgical contexts for various stages of NSCLC.

Read Full Article