Bristol-Myers Squibb (BMS), the maker of the immunotherapy drug Odpivo® (nivolumab), announced yesterday that a phase III trial of the drug in patients with advanced non-small cell lung cancer (NSCLC) was being stopped ahead of schedule because preliminary results indicated that the study had met its endpoint—namely, superior overall survival in patients receiving Opdivo compared to the control arm, which consisted of standard chemotherapy.
BMS’s press release did not state what the survival advantage was (these data are not yet available), but it is significant that these patients had already been treated once with chemotherapy and had advanced disease. The favorable results mean that the drug could be considered soon for approval by the U.S. Food and Drug Administration (FDA).
The BMS trial, called Checkpoint-017, randomized 272 patients to receive either nivolumab intravenously every two weeks or the chemotherapy drug docetaxel intravenously every three weeks. The primary endpoint of the trial was overall survival. Secondary endpoints included objective response rate and progression free survival.
The trial is one of several that the company is conducting on nivolumab for lung cancer, both as first- and second-line therapy and in combination with other drugs.
Clinical trials are stopped early when results are so clear that it would be unethical to continue treating patients on the control arm with the less effective drug.
Nivolumab is already FDA-approved for the treatment of advanced melanoma—news that came just recently in December 2014. An approval for lung cancer would make it the first PD-1 checkpoint inhibitor approved for that condition.
Lung cancer is the leading cause of cancer-related deaths worldwide. More than 1.5 million people die each year of the disease, according the World Health Organization. NSCLC is the most common types of lung cancer, accounting for approximately 85 percent of cases. Once considered an unlikely target for immunotherapy, recent experience with PD-1 checkpoint inhibitors, of which Opdivo is one, have radically changed doctors’ views on the subject.
Immunotherapies like checkpoint inhibitors are not without toxicities or side effects. Serious adverse reactions occurred in 41% of patients receiving Opdivo in the trial, with most of these being immune-related and treatable with corticosteroids. The most common adverse reaction (≥20%) was rash (21%).
For a personal view of what nivolumab has meant to patients with lung cancer, check out Pam G.’s video on our patient-oriented site, TheAnswerToCancer.org.