Merck & Co.'s Keytruda, chemoradiotherapy combo improves PFS in cervical cancer study
19 Jul 2023
Clinical ResultPhase 3
Merck & Co. announced on Wednesday that the use of Keytruda (pembrolizumab) with concurrent chemoradiotherapy demonstrated a significant and clinically meaningful improvement in progression-free survival (PFS) versus concurrent chemoradiotherapy alone in newly diagnosed patients with high-risk locally advanced cervical cancer. The results come from the Phase III KEYNOTE-A18 study.
"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," said Gursel Aktan, vice president of global clinical development at Merck Research Laboratories.
The trial, also known as ENGOT-cx11/GOG-3047, enrolled 1060 patients with newly diagnosed high-risk, locally advanced cervical cancer. Subjects were randomised to receive Keytruda in combination with external beam radiotherapy plus concurrent chemotherapy with cisplatin, followed by brachytherapy - also known as concurrent chemoradiotherapy - or placebo plus concurrent chemoradiotherapy. The study's primary endpoints are PFS and overall survival (OS), while secondary goals include complete response and objective response rates.
Favourable OS trend
Merck noted that while the PFS endpoint was met at the interim analysis, the OS data, which showed a "favourable trend" for the Keytruda arm, are not yet mature and follow-up will continue. The company added that the safety profile of the anti-PD-1 therapy was consistent with that observed in previously reported studies, with no new safety signals. Merck said that it plans to present the results at an upcoming medical meeting and submit them to regulatory authorities.
In the US, Keytruda is approved for use in combination with chemotherapy, with or without Roche's Avastin (bevacizumab), for the treatment of patients with persistent, recurrent or metastatic cervical cancer whose tumours express PD-L1, and as a monotherapy in patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumours express PD-L1.
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