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Merck’s Keytruda fails to improve survival in phase 3 head and neck cancer trial

PBR Staff Writer Published 26 July 2017

Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) failed to improve overall survival (OS) in a pivotal phase 3 trial in head and neck squamous cell carcinoma (HNSCC) patients compared to standard treatment.

The trial dubbed KEYNOTE-040 was held in patients who had previously undergone treatment for HNSCC and whose disease had recurred or is in a metastatic stage.

While the safety profile of keytruda was consistent in the phase 3 trial with those observed in previous trials, the anti-PD-1 therapy could not meet the pre-specified primary endpoint of OS.

The randomized, multi-center KEYNOTE-040 was conducted in 495 patients to study keytruda as a monotherapy against standard treatment comprising methotrexate, docetaxel or cetuximab for recurrent or metastatic HNSCC.

KEYNOTE-040’s secondary endpoints were progression-free survival (PFS) and overall response rate (ORR) among others.

Merck Research Laboratories senior vice president and oncology late-stage development therapeutic area head Roger Dansey said: “We are encouraged by the positive impact that KEYTRUDA has had on many cancer patients, including those with previously treated recurrent or metastatic head and neck cancer, and we remain confident that KEYTRUDA is an important therapy for this difficult-to-treat cancer.

Keytruda was approved by the US Food and Drug Administration (FDA) in August 2016 for treating patients with recurrent or metastatic HNSCC whose disease had progressed on or after receiving platinum-based chemotherapy.

Merck says that the current indication of keytruda remains intact and it will continue to go under clinical trials. Included in those is a phase 3 trial named as KEYNOTE-048 to assess keytruda as a first-line option for treating recurrent or metastatic HNSCC.


Image: Keytruda (pembrolizumab) Injection 100 mg. Photo: courtesy of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.