Merck Announces Positive Phase III KEYNOTE-A18 Trial of Keytruda in First-Line Locally Advanced Cervical Cancer

On July 19, MSD announced that in the pre-specified interim analysis conducted by the Independent Data Monitoring Committee (IDMC), the Phase III KEYNOTE-A18 study of pembrolizumab (Keytruda, K drug) combined with concurrent chemoradiotherapy for newly diagnosed high-risk locally advanced cervical cancer patients met the primary endpoint of progression-free survival (PFS). Additionally, overall survival (OS) showed a trend toward extension, although the data are not yet mature.

KEYNOTE-A18 Study, also known as ENGOT-cx11/GOG-3047, is a randomized, double-blind, parallel-controlled Phase III clinical trial that enrolled 1,060 previously untreated patients with high-risk (lymph node-positive Stage IB2-IIB or Stage III-IVA) locally advanced cervical cancer. The study aims to evaluate the efficacy and safety of K drug combined with concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone. The primary endpoints are PFS and OS.

Patients in the experimental group need to receive 20 doses of K drug (first 5 doses Q3W, subsequent 15 doses Q6W) and concurrent chemoradiotherapy, plus external beam radiotherapy (EBRT), followed by concurrent chemoradiotherapy. Patients in the control group receive placebo treatment and concurrent chemoradiotherapy, plus EBRT, followed by concurrent chemoradiotherapy.

MSD stated that the data from the KEYNOTE-A18 study will be presented at an upcoming medical conference and will be submitted to regulatory authorities.

Previously, K drug has been approved for cervical cancer indications: ① monotherapy for PD-L1 positive recurrent or metastatic cervical cancer that has progressed after chemotherapy; ② in combination with bevacizumab and platinum-based chemotherapy for persistent, recurrent, or metastatic PD-L1 positive cervical cancer.

Cervical cancer is the fourth most common cancer among women globally, primarily caused by persistent infection with high-risk human papillomavirus (HPV). It is estimated that in 2023, there will be approximately 14,000 new cases of cervical cancer and 4,000 deaths in the United States. In 2020, China reported about 110,000 new cases of cervical cancer and approximately 60,000 deaths.

Vaccination against HPV is currently the most effective way to prevent HPV infection. However, although four types of HPV vaccines have been marketed globally, many eligible women still do not have the opportunity to be vaccinated. There are only six cervical cancer treatment drugs available clinically: Keytruda, Cadonilimab, Cemiplimab, Bevacizumab, Tisotumab vedotin, and Sipulimab. Among them, only Pembrolizumab and Bevacizumab can be used for first-line treatment of cervical cancer.

Among the Phase III drugs under research in China, Akeso's Cadonilimab, Hengrui's SHR-1701, CSPC's Enlibsucept, Qilu Pharmaceutical's PSB205, Yuheng Pharma's Siplinalimab, and Shanghai Pharma Biotech's Prolgolimab are conducting Phase III clinical trials for first-line treatment of cervical cancer.

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