Merck (MSD) has secured Chinese regulatory approval to use its PD‑1 inhibitor pembrolizumab, marketed in China as KeRuida (可瑞达®), in combination with carboplatin and paclitaxel as first‑line therapy for adults with primary advanced or recurrent endometrial cancer whose tumours show mismatch repair deficiency (dMMR). The approval also covers maintenance treatment with pembrolizumab alone after the initial chemo‑immunotherapy course. Chinese regulators authorised the new indication on the basis of data from the phase III study KEYNOTE‑868 (NRG‑GY018).
The change formalises a shift in treatment strategy for a molecularly defined subgroup of endometrial cancer. dMMR is a biomarker that signals defects in the tumour’s DNA repair machinery and is associated with a higher likelihood of response to immune checkpoint blockade. In practice, the new licence means clinicians in China can routinely combine pembrolizumab with the standard carboplatin‑paclitaxel backbone, then continue immunotherapy maintenance for sustained disease control in eligible patients.
For patients, the approval matters because it moves immunotherapy from a later‑line or experimental role into the front line for those with dMMR tumours. Carboplatin and paclitaxel have been the accepted first‑line chemotherapy for advanced or recurrent endometrial cancer; adding a PD‑1 inhibitor aims to both deepen and prolong responses. The regulatory decision follows international trials showing that dMMR tumours derive disproportionate benefit from checkpoint inhibitors compared with mismatch repair‑proficient disease.
The move also has clear commercial and policy implications. Merck’s pembrolizumab is already a cornerstone of modern oncology globally; bringing another labelled indication in China strengthens its position against a growing roster of domestic PD‑1/PD‑L1 competitors. It will also test China’s mechanisms for biomarker testing, reimbursement negotiations, and hospital adoption: successful rollout requires reliable MMR testing across hospitals and inclusion of the regimen in national or provincial formularies for affordability.
From a broader regulatory perspective, the approval reflects the continued alignment of China’s drug review process with international oncology evidence, with the NMPA increasingly granting indications based on global phase III data. Clinically, the decision should prompt guideline updates and encourage routine MMR testing at diagnosis of advanced endometrial cancer to identify patients eligible for chemo‑immunotherapy, while payers and hospitals weigh cost, capacity and real‑world effectiveness.
Looking ahead, the approval may encourage further trials of immunotherapy‑chemotherapy combinations and biomarker‑directed strategies in Chinese patient populations, and will intensify competition among PD‑1 agents on efficacy, safety in combination regimens, pricing and access. The immediate practical requirement will be to scale up MMR testing and create reimbursement pathways so that the potential patient benefit translates into real‑world outcomes across China’s hospitals.