Merck (MSD) has reported that the Phase III KEYNOTE-A18 (ENGOT-cx11/GOG-3047) clinical trial of Keytruda plus chemoradiotherapy (CRT) in cervical cancer patients met the primary endpoint.
The double-blind, randomised trial is carried out by MSD in partnership with the European Network for Gynecological Oncology Trial (ENGOT) groups, and the GOG Foundation.
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The study compared Keytruda plus CRT comprising cisplatin and external beam radiotherapy (EBRT) followed by brachytherapy (BT) versus CRT with a placebo in 1,060 recently diagnosed patients with high-risk locally advanced cervical cancer.
Progression-free survival (PFS) and overall survival (OS) were the trial’s primary endpoints while secondary endpoints included complete response rate, safety and objective response rate.
The interim analysis by an independent Data Monitoring Committee revealed a significant improvement in OS for those treated with Keytruda and CRT, thereby meeting the primary endpoint of OS.
Keytruda’s safety profile in this study aligned with previous findings without any new safety concerns identified.
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By GlobalDataThe KEYNOTE-A18 trial had previously met its PFS endpoint last year, which led to the US Food and Drug Administration’s approval of Keytruda plus CRT in this patient group.
In the US, Keytruda is also approved for two indications in cervical cancer patients.
It is indicated for use with chemotherapy, with or without bevacizumab, for people with persistent, recurrent, or metastatic cervical cancer expressing PD-L1, as well as for usage as monotherapy in those with recurrent or metastatic cervical cancer with disease progression post-chemotherapy.
Merck Research Laboratories global clinical development vice-president Dr Gursel Aktan said: “This is the first Phase III trial in which an immunotherapy-based regimen has shown a statistically significant and clinically meaningful improvement in overall survival compared to chemoradiotherapy alone.
“Building on the positive progression-free survival findings from this study, these results underscore our commitment to exploring the role of Keytruda across different types of cancers in earlier stages of the disease, where there is a greater potential for better outcomes.”
The latest development comes after the company announced plans to commence two trials of a single-dose regimen of its multivalent human papillomavirus (HPV) vaccine, Gardasil 9 (recombinant Human Papillomavirus 9-valent).
