Bristol Myers Squibb’s Opdivo achieved positive results in a Phase 3 clinical trial studying the drug in people with early-stage non-small cell lung cancer before and after surgery, a finding that could further support its use in less severely ill patients.
On Friday, Bristol Myers said the trial, dubbed CheckMate-77T, had met its primary goal by showing treatment with Opdivo rather than a placebo significantly improved “event-free survival,” or the amount of time a patient lives before their disease progresses or worsens.
The study evaluated pre-surgical, or neoadjuvant, Opdivo with chemotherapy, followed by surgery and post-surgical, or adjuvant, Opdivo given alone. The control arm was designed the same, only with a placebo in place of Opdivo.
Opdivo is what’s known as an anti-PD-1 immunotherapy; it helps the body recognize and attack cancer cells. The drug was one of the first in the class of immune checkpoint inhibitors to gain approval, and is authorized for use in a wide variety of cancers, including neoadjuvant and adjuvant settings. It’s is already approved as a neoadjuvant treatment in the patient population studied in CheckMate77T.
The trial specifically recruited participants with resectable stage IIA to IIIB non-small cell lung cancer, with total enrollment reaching 452. Bristol Myers made its announcement following an interim analysis that found a “statistically significant and clinically meaningful improvement” in event-free survival. More detailed data was not disclosed, but the company said full results will be shared at an upcoming unspecified medical conference.
“We’ve seen tremendous scientific advancements in the treatment of non-metastatic non-small cell lung cancer in recent years, and remain committed to researching new solutions that may help even more patients achieve better long-term outcomes,” said Abderrahim Oukessou, Bristol Myers’ global program lead for thoracic cancers, in a statement.
The new, positive data could support broader use of Opdivo. If approved again, the drug’s would expand into the adjuvant setting, meaning it’s given after tumor-removal surgery in an effort to kill any remaining cancer cells. While several other immunotherapies have been cleared for before and after surgical removal of tumors, lung cancer is still a large market, as at least a third of people with non-small cell lung cancer see their tumors return after surgical removal.
CheckMate-77T remains ongoing to evaluate its secondary endpoint of overall survival.
Merck & Co.’s PD-1 treatment Keytruda is approved for the same patients but in an adjuvant setting with chemotherapy.