FDA Grants Merck's Keytruda Priority Review for Cervical Cancer

The U.S. Food and Drug Administration (FDA) accepted Merck & Company’s supplemental Biologics License Application and granted Priority Review for Keytruda (pembrolizumab) in advanced cervical cancer.

The application is partly based on data from the Phase II KEYNOTE-158 clinical trial that is evaluating Keytruda in patients with multiple advanced solid tumor types, including cervical cancer. The application is for patients with advanced cervical cancer with disease progression on or after chemotherapy.

The company notes that this is the first filing and Priority Review given for an anti-PD-1 therapy in cervical cancer. It is also the 14th Keytruda-related submission accepted by the FDA.

The PDUFA date for this application is June 28, 2018. Keytruda is currently involved in more than 700 clinical trials across various cancers and treatment settings.

"Advanced cervical cancer is an illness with a poor prognosis and a high unmet medical need," said Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories, in a statement. "We look forward to working with the FDA on the review of this application to help bring Keytruda to previously-treated patients with advanced cervical cancer."

Last year, about 12,820 cases of cervical cancer were diagnosed in the U.S. The five-year survival rate of patients with stage IV cervical cancer is estimated at 15 to 16 percent. It is most likely to be diagnosed in women between the ages of 35 and 44.

This news comes at the same time the agency placed a clinical hold on a combination therapy of Advaxis, Inc.’ axalimogene filolisbac with AstraZeneca Pharmaceuticals LP’s approved PD-L1 compound, Imfinzi, after a patient death in a Phase I/II clinical trial in patients with HPV-triggered head-and-neck and cervical cancer. The patient died from respiratory failure after the sixth treatment cycle.

John Carroll, with Endpoints News, writes, "While trial deaths in studies using CAR-T drugs are not unusual, the checkpoints have been going into hundreds of combination studies without raising a lot of safety issues—aside from combos using Celgene’s Revlimid and Pomalyst with Merck’s Keytruda, where an imbalance in patient deaths triggered concern. That caused a blanket pullback involving similar checkpoint combos, but after the FDA determined there likely was no class effect involved, most of those studies were allowed to get back into the clinic."

Keytruda has been approved so far to treat melanoma, lung cancer, head and neck cancer, classical Hodgkin Lymphoma, urothelial carcinoma, microsatellite instability-high (MI-H) cancer, and gastric cancer.

Last week, Merck inked a deal with Eisai Inc. to evaluate the company’s Lenvima (lenvatinib mesylate) with Keytruda. Merck paid $300 million upfront and a potential $5 billion in milestones. They will develop Lenvima as a monotherapy and in combination with Keytruda, splitting development costs. They will also work on a pipeline for endometrial cancer, non-small cell lung cancer, hepatocellular carcinoma, head and neck cancer, bladder cancer and melanoma, and a basket trial for multiple cancer types.

"Together with Eisai, we aim to maximize the value of Lenvima for its current indications while jointly pursuing additional approvals in combination with Keytruda across a wide range of cancers," said Roger Perlmutter, Merck’s head of R&D, in a statement. "There is strong scientific evidence supporting synergistic effects of Keytruda when used in combination with Lenvima, and the companies have already received Breakthrough Therapy Designation from the U.S. FDA for the Keytruda/Lenvima combination in renal cell carcinoma. Through this collaboration, we will both broaden our oncology portfolio and have the opportunity to help even more cancer patients around the world."

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