Pembrolizumab fails to improve survival in head and neck squamous cell carcinoma

U.S. drugs regulator the FDA gave fast-track approval for use of Keytruda for this type of cancer a year ago.

In the Phase III Keynote-040 trial, Keytruda was being investigated as a monotherapy treatment against the standard of care treatments (methotrexate, docetaxel or cetuximab). The current indication remains unchanged and clinical trials continue, including KEYNOTE-048 (, NCT02358031), a phase 3 clinical trial of Keytruda in the first-line treatment of recurrent or metastatic HNSCC.

"There is significant need for new options that address the treatment gaps for patients in Europe with locally advanced or metastatic urothelial carcinoma, especially for those who have failed on prior platinum treatment or are ineligible for cisplatin-containing chemotherapy", noted Dr Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories.

At the same time that Merck announced the results of its Keynote-040 study, Bristol said the Food and Drug Administration had accepted its application to have Keytruda's rival, Opdivo, dosed at 480-milligrams every four weeks for 30 minutes. Patients enrolled in the study had been previously treated with 1-2 platinum-containing systemic regimens.

Keytruda (pembrolizumab) monotherapy failed to significantly improve overall survival (OS) compared to standard of care in the KEYNOTE-040 trial, which enrolled almost 500 participants with HNSCC who hadn't adequately responded to one or more platinum-containing systemic treatments. Dansey said the company will share the trial data at an upcoming conference, but did not specify which one.

Head and neck cancer is a catch-all for various cancers that develop in or around the throat, larynx, nose, sinuses and mouth.

The Keytruda clinical development program includes more than 30 tumor types in more than 500 clinical trials, including more than 300 trials that combine Keytruda with other cancer treatments. Earlier this month, Keytruda trials in the blood cancer multiple myeloma were stopped due to more deaths among those who received Keytruda along with standard combination therapy than those on standard treatment alone. In the trials, Keytruda was being tested in combination with drugs developed by Celgene (CELG), including Pomalyst and Revlimid.

It is a second rare setback for the medicine seen as the leading treatment among immunotherapies from the same class, known as PD-1 or PD-L1 inhibitors.

The pivotal phase 3 trial created to evaluate pembrolizumab for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma failed to meet its prespecified primary endpoint of OS, according to the drug's manufacturer. The designation was granted based on Phase III data that showed the drug succeeded in its endpoint of overall survival - the same endpoint that Merck's drug failed to hit.

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