US regulators have further expanded the scope of Bristol Myers Squibb’s Opdivo, approving its use for a previously treated small cell lung cancer.
The immunotherapy is now the first and only immuno-oncology treatment option for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy.
Clearance for this indication was granted by the US Food and Drug Administration under the regulator’s accelerated approval pathway based on overall response rate (ORR) and duration of response (DOR) data, so continued approval may be contingent upon verification of clinical benefit in confirmatory trials.
Data from the SCLC cohort of the ongoing Phase I/II CheckMate-032 study showed that of 109 patients receiving Opdivo (nivolumab) after platinum-based chemotherapy and at least one other prior line of therapy, 12 percent responded to treatment, regardless of PD-L1 expression.
Twelve patients (11 percent) had a partial response, and one patient had a complete response (0.9 percent). Also of note, among responders the median DOR was 17.9 months.
On the safety side, Opdivo was discontinued in 10 percent of patients, and one dose was withheld in 25 percent of patients for an adverse reaction. Serious adverse reactions occurred in 45 percent of patients, BMS said.
“While Immuno-Oncology innovations have dramatically changed how oncologists approach certain cancers, we have had limited progress for patients with small cell lung cancer,” said Leora Horn, associate professor of medicine, Ingram associate professor of cancer research, director of the thoracic oncology program and assistant vice chairman for faculty development, Vanderbilt University Medical Center.
The approval of Opdivo “is particularly exciting considering it is the first checkpoint inhibitor approved for these specific patients, and now we can finally treat this devastating disease from a different angle.”
Opdivo is already approved for various indications across melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), classical Hodgkin lymphoma (cHL), squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma, microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) and hepatocellular carcinoma (HCC).