Seattle Cancer Care Alliance Research Leads to Fda Approval for Lung Cancer Treatment

SEATTLE — May 23, 2017 — Seattle Cancer Care Alliance reported today that the U.S. Food and Drug Administration has granted accelerated approval for a patient treatment for a specific type of lung cancer that combines immunotherapy with chemotherapy. Noted international lung cancer physician and researcher Dr. Renato Martins, Associate Medical Director of Solid Tumor Oncology at Seattle Cancer Care Alliance where he treats patients with head, neck or lung cancer and one of the authors of this study, led the clinical trial.

The drug has previously been approved to treat melanoma, head and neck cancer, lymphoma, and lung cancer in patients whose tumors have a high level of a protein called PD-L1. The KEYNOTE -021 clinical trial which began in 2015 and has concluded its enrollment period looked at overall response rate for patients with previously untreated metastatic non-squamous non-small cell lung cancer (NSCLC), when the drug pembrolizumab was combined with chemotherapy.

“FDA approval of this combination treatment will help about 80% of our patient population living with previously untreated metastatic non-squamous non-small cell lung cancer (NSCLC),” according to Dr. Martins.

Traditional treatment of lung cancer has relied on surgery, radiation and chemotherapy. This is the first time that immunotherapy has been combined with chemotherapy to treat lung cancer, with positive results.

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, and diagnosed for about 80 to 85% of all lung cancer cases, according to the American Cancer Society.

Approval was based on a cohort of 123 patients with locally advanced or metastatic non-squamous NSCLC and no prior systemic treatment for metastatic disease. Patients were randomized to receive either pembrolizumab, 200 mg every three weeks, in combination with pemetrexed and carboplatin (PC) for four cycles followed by pembrolizumab for a maximum of 24 months (n=60) compared to PC alone (n=63). Patients who received PC were eligible for pemetrexed maintenance.

Upon conclusion, the trial demonstrated an improvement in overall response rate and in progression-free survival for patients who received the combination treatment.

Among responders, the proportion of patients with response durations of six months or longer was 93% in the pembrolizumab-containing arm and 81% in the PC alone arm. Next, an additional study is required to confirm clinical benefit of pembrolizumab in combination with chemotherapy for this indication.

Seattle Cancer Care Alliance offers a range of testing, treatment and clinical trial options for lung cancer.

Media Contact:
Fred Hutch Media Team