Merck & Co – known as MSD outside the US and Canada – has shared positive phase 3 results for its Keytruda (pembrolizumab) in combination with chemoradiotherapy (CRT) in newly diagnosed patients with high-risk locally advanced cervical cancer.
The combination is the first immunotherapy-based regimen to demonstrate a statistically significant improvement in overall survival in this patient population.
According to the World Health Organization, cervical cancer is the fourth most common cancer in women globally, responsible for around 660,000 new cases and 350,000 deaths in 2022.
The KEYNOTE-A18 study evaluated Keytruda in combination with cisplatin and external beam radiotherapy followed by brachytherapy, compared to placebo, plus concurrent CRT in 1,060 newly diagnosed high-risk locally advanced cervical cancer patients, who had not received definitive surgery, radiation or systemic therapy for cervical cancer.
Results showed that Keytruda with concurrent CRT had a statistically significant and clinically meaningful improvement in overall survival in comparison to concurrent CRT alone and met its primary endpoint of progression-free survival.
In addition, Keytruda’s safety profile remained consistent with that observed in previous studies, with no new safety signals identified.
Dr Gursel Aktan, vice president, global clinical development, Merck Research Laboratories, said: “These results underscore our commitment to exploring the role of Keytruda across different types of cancers in earlier stages of disease” and “reinforce our research efforts in earlier stages of disease where there is a greater potential for better outcomes”.
The results from the study will be presented at an upcoming medical meeting and shared with regulatory authorities globally.
Keytruda works to enhance the immune system’s ability to detect and fight tumour cells and is currently indicated as the third approved therapy for the treatment of cervical cancer in the US.
Results from the study follow Merck’s announcement in January this year that Keytruda received approval from the US Food and Drug Administration for a new subset of cervical cancer patients with stage 3 to 4a disease.
The decision was based on previous results from the KEYNOTE-A18 study, which showed that Keytruda plus CRT reduced the risk of disease progression or death by 41% compared to placebo plus CRT.