First Immunotherapy Approved for Patients with Small Cell Lung Cancer
On August 17, 2018 the FDA approved the first immunotherapy – the checkpoint inhibitor nivolumab (Opdivo) – for patients with small cell lung cancer (SCLC).
This approval provides an important treatment option for patients with metastatic SCLC who have progressed after other treatments. The approval was based on the CheckMate-032 phase I/II clinical trial.
“This is exciting news because even though there have been new treatments for non-small cell lung cancer, there haven’t been any significant advancements for the treatment of small cell lung cancer,” said David M. Waterhouse, MD, MPH, co-director of research at OHC. “At OHC, we’ve have numerous patients with non-small cell who’ve been on Opdivo for 3 – 4 years and even longer and they are doing very well. Some tell us they forget they have lung cancer. Now we can offer it to this other group of patients with hopefully the same positive results.”
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. 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, MD, development lead for thoracic cancers at Bristol-Myers Squibb (BMS), when the FDA initially accepted this application.
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, PhD, 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.”
OHC has a number of open active trials in the treatment of lung cancer, including small cell lung cancer. For information, call 888-649-4800 or visit https://www.ohcare.com/patient-resources/clinical-trials/available-trials/.