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The FDA approved as neoadjuvant treatment for adults with resectable non-small cell lung cancer (NSCLC), Bristol Myers Squibb announced.

According to the company, the approval marks the first for an immunotherapy-based treatment prior to surgery in NSCLC, and was granted for use irrespective of patients' PD-L1 status based on findings from the trial.

"Given the rates of disease recurrence in patients with resectable NSCLC, additional treatment options are needed that can be given before surgery to help improve the chance of successful surgical treatment and support the goal of reducing the risk of cancer returning," said trial investigator Mark Awad, MD, PhD, of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute, in a release.

"The approval of nivolumab with platinum-doublet chemotherapy marks a turning point in how we treat resectable NSCLC and it enables us to use immunotherapy and chemotherapy as neoadjuvant treatment for patients before surgery," he added. "Today's announcement reinforces the need to increase the rates of NSCLC screening and early detection, and for patients to discuss treatment options with their providers."

In CheckMate-816, 358 patients with resectable NSCLC (tumors ≥4 cm or node positive) were randomized 1:1 to receive either nivolumab combined with platinum-doublet chemotherapy or platinum-doublet chemotherapy alone before surgery.

Investigators found that the immunotherapy-based combination resulted in a statistically significant improvement in event-free survival (EFS), with a 37% reduction in the risk of progression, recurrence, or death (HR 0.63, 95% CI 0.45-0.87, P=0.0052) compared with chemotherapy alone.

The nivolumab group had a median EFS of 31.6 months (95% CI 30.2-not reached) compared with 20.8 months (95% CI 14.0 to 26.7) for patients treated with chemotherapy alone. In addition, a pathologic complete response rate of 24% was observed in the nivolumab group compared with 2.2% with chemotherapy alone (P<0.0001).

A prespecified interim analysis for overall survival resulted in an HR of 0.57 (95% CI 0.38-0.87), which Bristol Myers Squibb noted "did not cross the boundary for statistical significance." Data from the trial are expected to be presented at the American Association for Cancer Research meeting in April.

As for safety, serious adverse reactions occurred in 30% of patients receiving nivolumab plus chemotherapy. Serious adverse reactions occurring in more than 2% of patients included pneumonia and vomiting, with no fatal adverse reactions occurring in patients who received the combination therapy.

The most common adverse reactions included nausea (38%), constipation (34%), fatigue (26%), decreased appetite (20%), and rash (20%).

Adverse reactions leading to the discontinuation of the combination therapy occurred in 10% of patients, and 30% had at least one treatment withheld for an adverse reaction.

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