In a significant shift for non-small cell lung cancer (NSCLC) treatment, the integration of immunotherapy before and after surgery has emerged as a promising new approach. Following MSD’s Keytruda (pembrolizumab), Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) has now secured European Union (EU) approval for perioperative therapy. This development sets the stage for intensified competition in the early NSCLC treatment market.
Industry sources reported on Wednesday that BMS recently announced European Commission (EC) approval for Opdivo’s perioperative treatment strategy. This approach combines the PD-1 inhibitor with chemotherapy before surgery (neoadjuvant therapy) and continues as a standalone treatment after surgery (adjuvant therapy). The treatment targets adult patients with resectable high-risk NSCLC with a PD-L1 expression of 1% or higher.
The perioperative integrated therapy aims to shrink tumors by combining immunotherapy with chemotherapy before surgery, followed by monotherapy after surgery to prevent cancer recurrence. This expansion of immunotherapy into early-stage treatment marks a paradigm shift from its previous focus on advanced or metastatic cancers.
The EC decided based on BMS’s phase 3 clinical trial, CheckMate-77T. Results showed that the Opdivo-based integrated therapy improved event-free survival (EFS) by 42% compared to chemotherapy alone. Post 24 months of treatment, the event-free survival (EFS) rate was 65% in the Opdivo combination group compared to 44% in the control group, demonstrating superior long-term disease control. The therapy also showed significant improvements in secondary endpoints, including pathological complete response (pCR) and major pathological response (MPR).
This approval makes Opdivo the only PD-(L)1 inhibitor in Europe authorized for standalone neoadjuvant and perioperative integrated therapy. MSD’s Keytruda previously received EC approval for a similar perioperative strategy based on the KEYNOTE-671 trial in 2023, followed by approval for post-surgical monotherapy last year.
While Keytruda maintains its leading position in the global immunotherapy market, Opdivo’s recent approval suggests a potential shift in the early treatment landscape. Both drugs have already secured U.S. Food and Drug Administration (FDA) approval for this treatment strategy.
Experts anticipate that perioperative integrated therapy will soon become the new standard of care in NSCLC treatment. With Opdivo’s EC approval, competition among global pharmaceutical giants in the NSCLC treatment market is expected to intensify significantly.