Bristol Myers Squibb Receives FDA Approval for Perioperative Opdivo and Chemotherapy in Resectable Non-Small Cell Lung Cancer
Friday, October 04, 2024
Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo® (nivolumab) for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC) that is either 4 cm or larger or node-positive, excluding cases with known EGFR mutations or ALK rearrangements.
Lung cancer remains the top cause of cancer deaths in the U.S., with non-small cell lung cancer (NSCLC) making up 85% of cases. While early-stage NSCLC can sometimes be treated with surgery alone, up to 55% of patients may experience recurrence.
Opdivo is now the first PD-1 inhibitor to show statistically significant and clinically meaningful benefits in both neoadjuvant-only and perioperative regimens.
This approval is based on findings from the CheckMate-77T Phase 3 trial, which demonstrated improved outcomes with Opdivo compared to chemotherapy alone.
The treatment is to be administered before and after surgery in combination with platinum-doublet chemotherapy, followed by single-agent Opdivo as adjuvant therapy.
This underscores the need for pre-surgery (neoadjuvant) and post-surgery (adjuvant) treatments to improve survival rates, which vary based on the cancer's type and stage at diagnosis.
The approval addresses the high rates of disease recurrence in patients with resectable NSCLC, offering a new treatment option that targets micrometastasis and helps reduce the risk of cancer returning.
In the CheckMate-77T trial, patients receiving the perioperative Opdivo regimen (neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo) showed a 42% reduction in the risk of disease recurrence, progression, or death, compared to those who received chemotherapy and placebo.
The trial’s primary endpoint of event-free survival (EFS) was met, with a notable difference in 18-month EFS between the two groups—70% in the Opdivo group versus 50% in the chemotherapy and placebo group.
The secondary endpoint of pathologic complete response (pCR) was also achieved in 25% of patients in the Opdivo group, compared to just 4.7% in the comparator group.
Warnings associated with Opdivo include severe immune-mediated adverse reactions, such as pneumonitis, colitis, hepatitis, and endocrinopathies, among others. Treatment of patients with multiple myeloma using a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue and dexamethasone is not recommended outside of controlled clinical trials.
The approval builds on the FDA’s earlier endorsement of neoadjuvant Opdivo with chemotherapy for resectable NSCLC based on the CheckMate-816 trial. Opdivo-based treatments are now approved across four types of cancer, including lung, melanoma, bladder, and esophageal/gastroesophageal junction cancers.
Source: bms.com
