Merck Wins Approval for Keytruda in a few With Lung Cancer

Federal health officials have expanded approval of an innovative Merck drug to treat patients with an advanced form of the most common lung cancer.

The U.S. Food and Drug Administration today granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1.

After Parton underwent a full medical examination and a Connecticut scan, doctors discovered a form of non-small cell lung cancer that had spread all over his body. When it binds to another protein called PD-L1, PD-1 acts as an immune checkpoint, dampening the immune system’s T cells which otherwise could attack cancer cells, said Garon, who also is an associate professor of hematology-oncology at the David Geffen School of Medicine at UCLA.

The FDA speeded the drug’s approval. In people who responded to treatment, the average duration of response exceeded one year, a remarkable advance in this hard disease.

In regard to safety, the most common adverse events associated with pembrolizumab in these patients were fatigue, decreased appetite, dyspnea, and cough. Overall, the KEYNOTE-001 trial included 495 previously treated and treatment-naïve patients with advanced or metastatic NSCLC. Women who are pregnant or breastfeeding should not take Keytruda because it may cause harm to a developing fetus or newborn baby.

The accelerated approval is for use in patients with advanced non-small cell lung cancer (NSCLC) across all histologies whose disease has progressed on or after platinum-containing chemotherapy, as well as a targeted agent in epidermal growth factor receptor- or anaplastic lymphoma kinase-positive patients. Keytruda is approved for use with the PD-L1 IHC 22C3 pharmDx test, a companion diagnostic. The results showed that treatment with Keytruda shrank tumors in 41% of patients with the effect lasting as long as 9.1 months.

The American Cancer Society has more about non-small cell lung cancer.

“I think there’s going to be more and more interest on the part of oncologists in using PD-L1 expression in making decisions about how best to treat their lung-cancer patients”, Merck’s Dr. Perlmutter said.

However, in these trials, the response to nivolumab did not appear to correspond with increasing levels of PD-L1 expression.

Lung cancer is the No. 1 cancer killer, with 221,200 new cases and 158,000 deaths expected this year in the US, according to the National Cancer Institute.