Cervical Cancer: Pembrolizumab Plus Chemoradiotherapy - Phase III Trial

KEYNOTE-A18 Phase III Trial Results

• July 19, 2023

On July 19, 2023, Merck announced results from KEYNOTE-A18/ENGOT-cx11/GOG-3047, a Phase III randomized trial evaluating pembrolizumab plus concurrent chemoradiotherapy versus placebo plus chemoradiotherapy in high-risk, locally advanced cervical cancer.

Trial Design

Patient Population: High-risk, locally advanced cervical cancer (newly diagnosed)

Treatment Arms:

• Pembrolizumab plus concurrent chemoradiotherapy
• Versus Placebo plus concurrent chemoradiotherapy

Primary Endpoints: Progression-free survival, overall survival

Secondary Endpoints: Complete response rate, objective response rate, safety

Key Interim Analysis Results

Progression-Free Survival: Pembrolizumab plus chemoradiotherapy demonstrated improved PFS versus placebo-chemoradiotherapy arm

Overall Survival: Interim data immature for final analysis

Safety Profile

Adverse events consistent with established immunotherapy and chemoradiotherapy safety data. No novel or unexpected toxicities identified.

Clinical Significance

According to Merck's Gursel Aktan: Pembrolizumab has established efficacy in recurrent/metastatic cervical cancer. KEYNOTE-A18 demonstrates pembrolizumab benefit extends to newly diagnosed, locally advanced cervical cancer, potentially expanding treatment paradigm to earlier disease stages.

Data Source

https://www.businesswire.com/news/home/20230719399142/en/

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