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The Pulse of the Pharmaceutical Industry

Merck & Co. Dealt Another Setback as Its Ace Keytruda Comes Up Short in Head and Neck Cancer Study

Written by: | | Dated: Tuesday, July 25th, 2017


July 25, 2017
By Alex Keown, Breaking News Staff


KENILWORTH, N.J. – Merck (MRK)’s vaunted PD-1 inhibitor Keytruda suffered another setback this week when it failed to meet endpoints in a Phase III head and neck cancer study.

The company said Keytruda did not meet the pre-specified endpoint of overall survival in patients who had been previously treated for recurrent or metastatic head and neck squamous cell carcinoma. Despite the failure of the Phase III trial, Merck said the 2016 approval from the U.S. Food and Drug Administration for Keytruda for patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy remains unchanged. The company added that it will continue Phase III trials for Keytruda as a first-line treatment for recurrent or metastatic HNSCC. The Kaynote-048 trial, is another “shot on goal” for Merck to gain approval in head and neck cancer, Leerink’s Seamus Fernandez said in a note, as reported by Endpoints News.

Roger Dansey, Merck’s head of late-stage development in oncology, put a positive spin on the results, saying they remain encouraged by the positive effects Keytruda has had on cancer patients. He said the company is confident that Keytruda is an “important therapy” for patients with previously treated recurrent or metastatic head and neck cancer.

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). Merck said dosing of the 495 trial patients began in November 2014. Patients enrolled in the study had been previously treated with one or two platinum-containing systemic regimens. The company provided few details about the trial results, only noting that the trial failed to meet the primary endpoint of improving overall survival. 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 trial failure is the latest in setbacks for Keytruda. Earlier in July, the FDA placed a clinical hold on three clinical trials using Keytruda following the report of patient deaths in June. Merck said its Keynote-183, Keynote-185 and Keynote-023 trials were halted by the FDA after the Data Monitoring Committee discovered more patient deaths were observed in the Keytruda arm. Each of the trials is testing Merck’s drug as a combination treatment for the blood cancer multiple myeloma. In the trials, Keytruda was being tested in combination with drugs developed by Celgene (CELG), including Pomalyst and Revlimid.

Keytruda is a keystone drug for Merck. The PD-1 inhibitor has been approved to treat multiple types of cancer, including lung, bladder, melanoma and refractory classical Hodgkin lymphoma. In May, the FDA expanded Keytruda’s use by approving it for two new bladder cancer options. It was approved as a first-line treatment for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. Keytruda was also approved as a second-line treatment in locally advanced or metastatic urothelial carcinoma in patients who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

For some time, Merck’s Keytruda appeared to be the PD-1 inhibitor to beat, particularly after Bristol-Myers Squibb (BMY)’s Opdivo suffered its own setbacks, particularly in a late stage lung cancer trial. However, for head and neck cancers, Opdivo may be the leading PD-1 inhibitor. In April 2016, the FDA granted Opdivo Breakthrough Therapy Designation for the potential indication of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after platinum based therapy. 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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