FDA News

FDA grants priority review to Keytruda for advanced liver cancer

The FDA granted priority review to pembrolizumab for previously treated patients with advanced hepatocellular carcinoma, the agent’s manufacturer announced.

Pembrolizumab (Keytruda, Merck) is an anti-PD1 injection therapy.

The priority review is based on the phase 2 KEYNOTE-224 clinical trial, which found that pembrolizumab produced a durable response among patients with advanced hepatocellular carcinoma.

As HemOnc Today previously reported, results of the trial were first presented at the Gastrointestinal Cancers Symposium and recently updated at the ASCO Annual Meeting.

Patients in the KEYNOTE-224 trial achieved a median PFS of 4.8 months (95% CI, 3.4-6.6) with pembrolizumab; the study’s secondary OS endpoint had not been reached. Nearly half (43.1%) of patients achieved 6-month PFS, and 77.9% achieved 6-month OS.

Overall response rate was 16.3% (95% CI, 9.8-24.9), and 94% of responders were estimated to have a response lasting at least 6 months.

“There continues to be a significant need for new options in the treatment of advanced hepatocellular carcinoma, which is the most common type of liver cancer,” Scot Ebbinghaus, MD, vice president of clinical research at Merck Research Laboratories, said in a press release. “The data supporting our application provide a clear rationale for the advancement of the Keytruda clinical program for hepatocellular carcinoma, and we are grateful for the opportunity to work with the FDA to potentially bring Keytruda to patients living with this difficult-to-treat cancer.”

In addition to the KEYNOTE-224 trial, Merck is conducting two ongoing phase 3 studies, KEYNOTE-240 and KEYNOTE-394, evaluating pembrolizumab monotherapy for second-line hepatocellular carcinoma.

The FDA granted priority review to pembrolizumab for previously treated patients with advanced hepatocellular carcinoma, the agent’s manufacturer announced.

Pembrolizumab (Keytruda, Merck) is an anti-PD1 injection therapy.

The priority review is based on the phase 2 KEYNOTE-224 clinical trial, which found that pembrolizumab produced a durable response among patients with advanced hepatocellular carcinoma.

As HemOnc Today previously reported, results of the trial were first presented at the Gastrointestinal Cancers Symposium and recently updated at the ASCO Annual Meeting.

Patients in the KEYNOTE-224 trial achieved a median PFS of 4.8 months (95% CI, 3.4-6.6) with pembrolizumab; the study’s secondary OS endpoint had not been reached. Nearly half (43.1%) of patients achieved 6-month PFS, and 77.9% achieved 6-month OS.

Overall response rate was 16.3% (95% CI, 9.8-24.9), and 94% of responders were estimated to have a response lasting at least 6 months.

“There continues to be a significant need for new options in the treatment of advanced hepatocellular carcinoma, which is the most common type of liver cancer,” Scot Ebbinghaus, MD, vice president of clinical research at Merck Research Laboratories, said in a press release. “The data supporting our application provide a clear rationale for the advancement of the Keytruda clinical program for hepatocellular carcinoma, and we are grateful for the opportunity to work with the FDA to potentially bring Keytruda to patients living with this difficult-to-treat cancer.”

In addition to the KEYNOTE-224 trial, Merck is conducting two ongoing phase 3 studies, KEYNOTE-240 and KEYNOTE-394, evaluating pembrolizumab monotherapy for second-line hepatocellular carcinoma.