On Friday, August 17, the FDA approved the first immunotherapy—the checkpoint inhibitor nivolumab (Opdivo®, Bristol-Myers Squibb)—for patients with small cell lung cancer (SCLC).
This approval, which was based on the CheckMate-032 phase I/II clinical trial, provides an important treatment option for patients with metastatic SCLC who have progressed after prior treatment with platinum-containing chemotherapy and at least one other systemic therapy.
In the pivotal trial, 109 patients with metastatic SCLC were treated with nivolumab, which targets the PD-1 immune checkpoint pathway. Thirteen (12%) of those patients experienced responses, with the median response lasting nearly a year and a half (17.9 months). With respect to side effects, 45% of the patients experienced serious adverse reactions, 25% had to skip a dose, and 10% were forced to discontinue.
“Small cell lung cancer is a highly aggressive disease, one where most patients experience relapse within a year of diagnosis. The overall prognosis for this cancer remains poor, and there have been no new treatment advances in nearly 20 years,” said Sabine Maier, M.D., development lead for thoracic cancers at Bristol-Myers Squibb (BMS), when the FDA initially accepted this application.
“This approval builds on our heritage of bringing immuno-oncology therapies to patients with other types of thoracic cancers. It also reinforces our commitment to bringing transformative treatments to patients in urgent need of effective new options,” Maier added in a press release after the approval.
Each year, an estimated 29,000 people in the United Stated are diagnosed with SCLC, which comprises 10-15% of all lung cancer cases. While there have been several immunotherapy approvals in the past few years for patients with advanced non-small cell lung cancer (NSCLC), the most common form of lung cancer, there has been little progress in treatments—of any type—for advanced SCLC.
The approval of nivolumab in this indication “marks a major milestone for the patients touched by this unrelenting disease and may motivate them to pursue further treatment where there previously were no other approved options,” said Andrea Ferris, president and chairman of LUNGevity Foundation, in the BMS press release.
“In addition to providing potential relief for patients with this aggressive form of lung cancer, this approval further demonstrates immunotherapy’s ability to help patients with all types of cancers, including those that have traditionally been hard-to-treat,” noted Jill O’Donnell-Tormey, Ph.D., chief executive officer and director of scientific affairs at the Cancer Research Institute. “While there’s still much work to do, advances like these provide hope that with the power of the immune system at our disposal, no cancer is beyond our reach.”
Read about the small cell lung cancer patient experience with immunotherapy in our interview with Gloria.