Soon after the FDA granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC), it approved Opdivo (nivolumab) for an expanded use – to treat patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy.
Soon after FDA granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC), it approved Opdivo (nivolumab) for an expanded use – to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease progressed during or after platinum-based chemotherapy.
Earlier this year, FDA approved Opdivo, manufactured by Bristol-Myers Squibb in Princeton, N.J., to treat patients with advanced squamous NSCLC. The October 9 approval expands the use of Opdivo to also treat patients with non-squamous NSCLC.
Keytruda, marketed by Merck & Co., in Whitehouse Station, N.J., is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, the first test designed to detect PD-L1 expression in non-small cell lung tumors. The PD-L1 IHC 22C3 pharmDx diagnostic test is marketed by Dako North America Inc. in Carpinteria, Calif.
Opdivo also works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body’s immune cells and some cancer cells). By blocking this pathway, Opdivo may help the body’s immune system fight the cancer cells, according to the FDA.
“There is still a lot to learn about the PD-1/PD-L1 pathway and its effects in lung cancer, as well as other tumor types,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. “While Opdivo showed an overall survival benefit in certain non-small cell lung cancer patients, it appears that higher expression of PD-L1 in a patient’s tumor predicts those most likely to benefit.”
The safety and effectiveness of Opdivo for this use was demonstrated in an international, open-label, randomized study of 582 participants with advanced NSCLC whose disease progressed during or after treatment with platinum-based chemotherapy and appropriate biologic therapy.
Participants were treated with Opdivo or docetaxel. The primary endpoint was overall survival, and the secondary endpoint was objective response rate (the percentage of patients who experienced complete or partial shrinkage of their tumors). Those treated with Opdivo lived an average of 12.2 months, compared to 9.4 months in those treated with docetaxel.
Additionally, 19% of those treated with Opdivo experienced a complete or partial shrinkage of their tumors, an effect that lasted an average of 17 months, compared to 12% among those taking docetaxel, which lasted an average of 6 months.
While patients who received Opdivo lived longer than those who received docetaxel across the study, an evaluation of samples from a subgroup of patients’ tumors suggests that the level of PD-L1 expression in NSCLC tumors may help identify patients who are more likely to live longer due to treatment with Opdivo.
As a result, FDA also approved Dako North America’s PD-L1 IHC 28-8 pharmDx test to detect PD-L1 protein expression levels and help physicians determine which patients may benefit most from treatment with Opdivo.
The most common side effects of Opdivo are fatigue, musculoskeletal pain, decreased appetite, cough and constipation. Opdivo also has the potential to cause severe immune-mediated side effects that involve healthy organs, including the lung, colon, liver, kidneys, hormone-producing glands and the brain.