Merck: Phase 3 KEYTRUDA Trial Meets Primary Endpoint Of PFS In Advanced Cervical Cancer

(RTTNews) - Drug major Merck & Co., Inc. (MRK) announced on Wednesday that its Phase 3 KEYNOTE-A18 trial investigating KEYTRUDA (pembrolizumab) met one of its primary endpoints in patients with newly diagnosed high-risk locally advanced cervical cancer.

In the trial, KEYTRUDA, Merck's anti-PD-1 therapy, in conjunction with external beam radiotherapy plus concurrent chemotherapy, followed by brachytherapy, has met progression-free survival or PFS.

Merck also observed a favorable trend in overall survival or OS, the other primary endpoint in the trial, for KEYTRUDA plus concurrent chemoradiotherapy compared to concurrent chemoradiotherapy alone. However, these OS data were not mature at the time of the interim analysis. The Phase 3 trial is continuing and follow-up of OS is ongoing.

The safety profile of KEYTRUDA has been consistent in the trial with that observed in previously reported studies and no new safety signals were identified.

Merck plans to present the results at an upcoming medical meeting. It will also be submitted to regulatory authorities.

"The role of KEYTRUDA is already established in certain patients with persistent, recurrent or metastatic cervical cancer, and these results reinforce our research efforts in earlier stages of disease where there is a greater potential for better outcomes," commented Dr. Gursel Aktan, vice president, Merck Research Laboratories.

In the U.S., KEYTRUDA has two approved indications in cervical cancer, i.e., in combination with chemotherapy with or without bevacizumab for the treatment of persistent, recurrent, or metastatic cervical cancer; and as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

In pre-market activity, shares of Merck are trading at $107.00 up 0.99% or $1.05 on the New York Stock Exchange.