Introduction
In a significant milestone for lung cancer treatment, the FDA has approved nivolumab, in combination with platinum-doublet chemotherapy, as a neoadjuvant therapy for resectable non-small cell lung cancer (NSCLC). Following surgery, nivolumab is administered as a single-agent adjuvant treatment. This approval is specifically for adults with tumors ≥4 cm and/or node-positive NSCLC without EGFR mutations or ALK rearrangements. The decision represents a step forward in the ongoing evolution of cancer immunotherapies.
Current Regulatory Status
Nivolumab’s approval under the FDA’s Project Orbis allows for concurrent regulatory submission and review among international partners, including Australia, Brazil, Canada, and Israel. This global collaboration aims to expedite access to promising oncology treatments. While the FDA has granted its approval, reviews are ongoing with other regulatory bodies.
Drug and Technology Overview
Nivolumab, marketed as Opdivo by Bristol Myers Squibb, is a PD-1 immune checkpoint inhibitor that enhances the immune system’s ability to detect and fight cancer cells. Administered in conjunction with platinum-doublet chemotherapy as a neoadjuvant, it is then followed by nivolumab alone as an adjuvant post-surgery. This dual-phase approach addresses both pre- and post-surgical cancer control, with a dosing regimen of 360 mg every 3 weeks in the neoadjuvant phase and 480 mg every 4 weeks during the adjuvant phase.
Trial Details
The efficacy of nivolumab was demonstrated in the CHECKMATE-77T trial, a randomized, double-blind, placebo-controlled study with 461 participants suffering from untreated, resectable NSCLC (Stage IIA to select stage IIIB). Participants were given either nivolumab or a placebo with platinum-based chemotherapy for up to 4 cycles, followed by either nivolumab or placebo alone for up to 13 cycles post-surgery.
The study’s primary endpoint was event-free survival (EFS), with the median EFS not reached in the nivolumab group, compared to 18.4 months in the placebo group. This translated to a hazard ratio of 0.58, significantly favoring nivolumab. Although overall survival (OS) was not formally tested during the interim analysis, no adverse survival trends were observed.
Indication and Disease Details
Non-small cell lung cancer (NSCLC) remains one of the leading causes of cancer-related deaths globally. This approval targets patients with resectable NSCLC, a subset where surgery alone may not be sufficient. By integrating nivolumab in both pre- and post-surgical settings, the treatment aims to improve surgical outcomes and long-term survival for patients without specific EGFR or ALK mutations.
Conclusion
The approval of nivolumab for neoadjuvant and adjuvant use in resectable NSCLC offers a novel therapeutic approach, aiming to improve long-term outcomes in lung cancer treatment. With promising data from the CHECKMATE-77T trial and international regulatory collaboration, nivolumab’s availability marks a key advance in cancer immunotherapy. Healthcare providers and patients alike can look forward to more personalized, effective treatment pathways in lung cancer care.
Dr. Vinoth Khandelwal, Ph.D.
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