Bristol Myers Squibb's Opdivo Receives FDA Approval to Reduce Lung Cancer Recurrence Risk in Resectable NSCLC

Oct 04, 2024 07:40 CST Updated 07:40

Bristol-Myers Squibb

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Today, the U.S. FDA announced,Approval of Bristol Myers Squibb's重磅PD-1 inhibitor Opdivo (nivolumab) in combination with platinum-based chemotherapy as a neoadjuvant therapy before surgery, followed by monotherapy as an adjuvant treatment after surgery, for adult patients with resectable non-small cell lung cancer (NSCLC).These patients do not carryEGFROrALKGene mutation.

This approval is mainly based on the positive results of the randomized, double-blind, placebo-controlled Phase 3 clinical trial CHECKMATE-77T. In this study, 461 treatment-naïve patients with resectable NSCLC received either Opdivo or a placebo as neoadjuvant therapy in addition to platinum-based chemotherapy. After surgery, they received adjuvant therapy with either Opdivo or a placebo.

The primary efficacy endpoint of the trial was event-free survival (EFS), and the data showed,The median EFS for patients in the Opdivo group has not yet been reached (95% CI: 28.9, not estimable), while the median EFS in the chemotherapy group was 18.4 months (95% CI: 13.6, 28.1). Opdivo reduced the risk of disease progression by 42% (HR=0.58, 95% CI: 0.43, 0.78; p=0.00025).

The adverse events were similar to those observed in other clinical trials where Opdivo was used in combination with chemotherapy. Among patients receiving neoadjuvant treatment with Opdivo, 5.3% were unable to undergo surgery due to adverse events, compared to 3.5% in the placebo group. Additionally, 4.5% of patients receiving Opdivo neoadjuvant therapy experienced delays in surgery due to adverse events, while this figure was 3.9% in the placebo group.

Lung cancer is one of the leading causes of cancer-related deaths worldwide, with NSCLC being the most common type. In 60% of NSCLC patients, the cancer has not metastasized at the time of diagnosis, and half of these patients are eligible for surgical resection. Although many patients with non-metastatic NSCLC can be cured through surgery, 30% to 55% of them still experience disease recurrence and death. Neoadjuvant therapy before surgery and adjuvant therapy after surgery have the potential to improve long-term treatment outcomes for patients.

Opdivo is a PD-1 immune checkpoint inhibitor designed to help restore anti-tumor immune responses in the human body. Opdivo has become an important treatment option across multiple types of cancer, and to date, the Opdivo clinical development program has treated over 35,000 patients.

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References:

[1] FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer. Retrieved October 3, 2024, from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvantadjuvant-nivolumab-resectable-non-small-cell-lung-cancer

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