Merck Submits sBLA for Keytruda in Combination with Chemoradiotherapy for Newly Diagnosed High-Risk Locally Advanced Cervical Cancer

On September 20, MSD announced that the supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda, K drug) has been granted Priority Review by the FDA for the indication of combination with concurrent chemoradiotherapy to treat newly diagnosed high-risk locally advanced cervical cancer patients. The PDUFA date is January 20, 2024. If approved, Keytruda will become the first immunotherapy for this patient population.

This sBLA is primarily based on the positive results of the Phase III KEYNOTE-A18 study. The study is a randomized, double-blind, parallel-controlled Phase III clinical trial that enrolled 1060 previously untreated patients with high-risk (lymph node-positive IB2-IIB stage or III-IVA stage) locally advanced cervical cancer. It aims to evaluate the efficacy and safety of K drug combined with concurrent chemoradiotherapy compared to concurrent chemoradiotherapy alone. The primary endpoints of the study are progression-free survival (PFS) and overall survival (OS).

Patients in the experimental group need to receive 20 doses of K drug (the first 5 doses Q3W, the 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.

The results showed that the study met the primary endpoint of PFS. Additionally, there was a trend toward extended overall survival (OS), although the data were not yet mature.

Previously, K drug has been approved for the following indications in cervical cancer: 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 HPV vaccines have been launched globally, many eligible women still do not have the opportunity to get vaccinated. In clinical practice, there are only six drugs available for cervical cancer treatment: Keytruda (K药), Cadonilimab, Cemiplimab, Bevacizumab, Tisotumab Vedotin, and Sipulimab. Among them, only Pembrolizumab and Bevacizumab can be used as first-line treatments for cervical cancer.

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

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