USA – The U.S. Food and Drug Administration (FDA) has approved Bristol Myers Squibb’s (BMS) immunotherapy drug, Opdivo (nivolumab), for a new indication in non-small cell lung cancer (NSCLC).
This approval marks a significant expansion in treatment options for patients with resectable NSCLC, offering a combination therapy approach that includes both pre-surgery (neoadjuvant) and post-surgery (adjuvant) treatment.
Opdivo’s role in lung cancer treatment
Opdivo, a PD-1 inhibitor, has been approved by the FDA to be used with platinum-doublet chemotherapy before surgery and as a monotherapy after surgery.
This regimen is specifically for patients with resectable NSCLC who do not have epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
The new approval is expected to benefit thousands of patients, as NSCLC accounts for up to 85% of all lung cancer cases in the U.S.
More than 200,000 Americans are diagnosed with lung cancer annually, making this new treatment option a significant development in the fight against this deadly disease.
Clinical Evidence: CheckMate-77T Trial
The FDA’s decision was based on positive results from the Phase III CheckMate-77T trial, which demonstrated that the Opdivo-based regimen significantly improves event-free survival (EFS) in patients with NSCLC.
The trial showed that patients who received Opdivo plus chemotherapy had a 42% reduced risk of disease recurrence, progression, or death compared to those who received chemotherapy and a placebo.
At a median follow-up of 25.4 months, 70% of patients in the Opdivo arm achieved event-free survival at 18 months, compared to 50% in the control group.
Moreover, 25% of patients in the Opdivo group reached a pathologic complete response, a significant improvement over the 4.7% in the placebo group.
A unique advantage in the treatment landscape
This new approval makes Opdivo the only PD-1 inhibitor approved for resectable NSCLC in both the neoadjuvant (pre-surgery) and perioperative (before and after surgery) settings.
Competing drugs like AstraZeneca’s Imfinzi and Merck’s Keytruda have also been approved for early-stage NSCLC but lack the flexibility of Opdivo’s dual-role treatment regimen.
Wendy Short Bartie, Senior Vice President of U.S. Oncology and Hematology at BMS, emphasized the significance of the approval: “This milestone expands the role of Opdivo-based treatments and builds upon the foundation set by the FDA approval of neoadjuvant-only Opdivo plus chemotherapy in resectable NSCLC based on the CheckMate-816 trial.”
Opdivo’s long-standing impact
Opdivo has been a key player in cancer immunotherapy since its initial approval ten years ago. In 2023, the drug generated US $9 billion in worldwide sales, making it one of BMS’s most important assets.
Despite recent challenges, such as a dip in net income in the second quarter of 2024, Opdivo continues to drive revenue and expand its indications, helping to improve patient outcomes in various cancers.
With this latest FDA approval, BMS is poised to further its commitment to lung cancer treatment.
“With this new Opdivo-based regimen, we are reinforcing our commitment to helping improve patient outcomes and expanding our thoracic portfolio in early-stage disease,” added Bartie.
As Opdivo enters the perioperative treatment landscape, it joins a competitive field that includes AstraZeneca’s Imfinzi, approved in August 2024, and Merck’s Keytruda, which secured approval for a similar use case in October 2023.
