By Fineline Cube 
Merck & Co. (MSD, NYSE: MRK) announced that Keytruda (pembrolizumab) has received its 20th indication approval in China, becoming the first PD‑1 inhibitor approved for first‑line treatment of mismatch repair‑deficient (dMMR) primary advanced or recurrent endometrial carcinoma. The approval expands Keytruda’s gynecologic cancer franchise in the world’s second‑largest pharmaceutical market.
Regulatory Milestone & Clinical Data
| Item | Detail |
|---|---|
| Company | Merck & Co. (NYSE: MRK) |
| Drug | Keytruda (pembrolizumab) |
| New Indication | dMMR primary advanced or recurrent endometrial carcinoma (first‑line) |
| Regulatory Body | National Medical Products Administration (NMPA) |
| Combination | Carboplatin + paclitaxel, followed by pembrolizumab monotherapy maintenance |
| Clinical Basis | Phase III KEYNOTE‑868 (NRG‑GY018) trial |
| China Approvals | 20 total indications |
| Strategic Significance | First PD‑1 inhibitor for first‑line endometrial cancer in China |
KEYNOTE-868 Trial Results
| Cohort | Treatment Group | Median PFS | Control Group | Median PFS | Hazard Ratio | P‑Value |
|---|---|---|---|---|---|---|
| dMMR | Keytruda + chemo | Not reached (95% CI: 30.7, NR) | Placebo + chemo | 6.5 months (95% CI: 6.4, 8.7) | HR: 0.30 (0.19–0.48) | p<0.0001 |
| pMMR | Keytruda + chemo | 11.1 months (95% CI: 8.7–13.5) | Placebo + chemo | 8.5 months (95% CI: 7.2, 8.8) | HR: 0.60 (0.46–0.78) | p<0.0001 |
Market Impact & Commercial Outlook
- China Gynecologic Cancer Market: Endometrial cancer affects ~70,000 new patients annually; dMMR subset represents 25–30% of cases
- First‑Mover Advantage: As first approved PD‑1 inhibitor for this indication, Keytruda secures premium positioning before competitors (including domestic PD‑1 inhibitors) enter market
- Revenue Potential: Analysts estimate ¥800 million–1.2 billion (US$110–170 million) peak annual sales for this indication in China
- Strategic Value: 20th approval reinforces Keytruda’s dominance in China immuno‑oncology; supports continued NRDL listing negotiations
- Global Alignment: Approval aligns with FDA and EMA approvals, enabling consistent global clinical practice
- Next Steps: Commercial launch expected Q2 2026; physician education programs targeting gynecologic oncologists to commence immediately
Forward‑Looking Statements
This brief contains forward‑looking statements regarding commercial launch timelines, market penetration, and revenue projections for Keytruda in China. Actual results may differ due to competitive dynamics, pricing negotiations, and market adoption rates.-Fineline Info & Tech