▎WuXiEdited by Kant Content Team

MSD announced today that its KEYNOTE-A18 Phase 3 clinical trial has met its primary endpoint. The combination of the重磅 PD-1 inhibitor Keytruda with chemoradiotherapy (CRT) significantly improved overall survival (OS) in newly diagnosed high-risk locally advanced cervical cancer patients. Detailed results of the trial will be presented at an upcoming medical conference.According to the press release, the combination of Keytruda and CRT is the first immunotherapy regimen to improve OS in this patient population.

KEYNOTE-A18 is a randomized, double-blind Phase 3 trial designed to evaluate the efficacy and safety of Keytruda in combination with external beam radiation therapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy (also known as chemoradiotherapy), in newly diagnosed high-risk locally advanced cervical cancer patients (IB2-IIB stage with positive lymph nodes, III-IVA stage).In a pre-specified interim analysis conducted by the Independent Data Monitoring Committee,Compared with placebo combined with CRT, patients receiving Keytruda in parallel with CRT showed statistically and clinically significant improvements in OS.

In the trialKeytrudaThe safety profile was consistent with previous observations in earlier trials; no new safety signals were identified.

It is worth mentioning that,KEYNOTE-A18 Trial Reached Another Primary Endpoint, Progression-Free Survival (PFS), in 2023.After a median follow-up of 17.9 months (range: 0.9-31.0), compared with patients who received concurrent chemoradiotherapy alone,The combination therapy of Keytruda with concurrent chemoradiotherapy reduced the risk of disease progression or death by 30% (HR=0.70, 95% CI: 0.55-0.89, p=0.0020).

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Keytruda is a humanized anti-PD-1 monoclonal antibody that blocks the binding of PD-1 to its ligands PD-L1 and PD-L2, thereby activating T lymphocytes.This effect may enhance the ability of the immune system to detect and combat tumor cells. In September 2014, Keytruda was first approved by the FDA for the treatment of advanced melanoma and was subsequently approved as a first-line therapy for patients with metastatic non-small cell lung cancer (NSCLC). In China, Keytruda has also been approved for multiple indications, covering melanoma, NSCLC, head and neck squamous cell carcinoma, colorectal cancer, esophageal cancer, liver cancer, and more.

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References:

[1] Merck’s KEYTRUDA® (pembrolizumab) Plus Chemoradiotherapy (CRT) Significantly Improved Overall Survival (OS) Versus CRT Alone in Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer. Retrieved March 15, 2024 from https://www.merck.com/news/mercks-keytruda-pembrolizumab-plus-chemoradiotherapy-crt-significantly-improved-overall-survival-os-versus-crt-alone-in-patients-with-newly-diagnosed-high-risk-locally-advanced-ce/

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