Bristol Nabs Immunotherapy’s First FDA Nod for Small Cell Lung Cancer

Xconomy New York — 

Over the past few years, immunotherapy has rapidly begun to change how lung cancer is treated. But it hasn’t been an option for patients with a particularly aggressive form of the disease, small cell lung cancer (SCLC), until today.

The FDA on Friday approved Bristol-Myers Squibb’s (NYSE: BMY) immunotherapy, nivolumab (Opdivo), for SCLC patients who have failed at least two other treatments. The approval marks the first new treatment for SCLC in two decades.

The FDA gave Bristol an “accelerated” approval, on a thinner body of evidence than the agency typically requires. In a clinical study, 13 of 109 SCLC patients (12 percent) who failed two prior treatments responded to nivolumab for a median of 17.9 months. That’s a common theme with immunotherapy: Just a fraction of patients respond, but when they do, those responses can last, giving people at least a chance to live longer than previously thought possible. (To be clear, it’s not known if the Bristol drug will provide that benefit. Ongoing tests must confirm the results or nivolumab could be pulled from the market.)

The most common side effects seen in clinical testing were fatigue, decreased appetite, pain, difficulty breathing, nausea, diarrhea, constipation, and cough. Some cases of more severe side effects like pneumonia, lung inflammation, and a dangerous buildup of fluid in the lungs were also seen.

Lung cancer is still the leading cause of cancer death. But in recent years, immunotherapy has become a pillar of treatment along with chemotherapy—which for decades was the main option for patients with advanced lung cancer—and targeted therapies, which home in on genetic mutations like ALK and EGFR. Most patients don’t have the mutations necessary for targeted therapy. Immunotherapy has begun over the past few years to make its mark in the large remaining pool.

Much of immunotherapy’s impact so far, however, has been seen with non-small cell lung cancer, which accounts for about 85 percent of all lung cancer cases. Nivolumab, for instance, is already approved for patients with NSCLC. Up until today, there have been no approved immunotherapies for SCLC, a fast-moving lung cancer that accounts for about 10 to 15 percent of cases. About 2 percent of people with SCLC live five years after they are diagnosed, according to the American Cancer Society.

Carboplatin/etoposide chemotherapy has remained the standard of care for years, and other immunotherapy regimens, like a Bristol combination of ipilimumab (Yervoy) and chemo, have previously failed. Today’s approval could herald change, however. Other approaches from Merck and Bristol are in clinical testing, and a Roche regimen combining its immunotherapy atezolizumab (Tecentriq) with carboplatin/etoposide succeeded in a late-stage trial in June.

Here’s more on immunotherapy’s growing role in lung cancer, and how doctors are integrating the different regimens.