Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422) announced that a new indication application for sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) has been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. The application seeks approval of sac-TMT in combination with MSD’s anti-PD-1 monoclonal antibody pembrolizumab (KEYTRUDA) as first-line treatment for adult patients with locally advanced or metastatic non-squamous NSCLC whose tumors have a PD-L1 tumor proportion score (TPS) <1% and are EGFR-negative and ALK-negative. This marks the seventh indication application for sac-TMT accepted for review by the NMPA.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | CDE, NMPA (China) |
| Action | New indication application accepted for review |
| Product | Sacituzumab tirumotecan (sac-TMT; SKB264/MK-2870), TROP2-directed ADC |
| Regimen | Sac-TMT + pembrolizumab (KEYTRUDA, MSD) |
| Proposed Indication | First-line locally advanced or metastatic non-squamous NSCLC, PD-L1 TPS <1%, EGFR-negative, ALK-negative |
| Pivotal Evidence | Phase 3 registrational OptiTROP-Lung06 study |
| Milestone | Seventh sac-TMT indication application accepted by the NMPA |
| Review Timeline | Not disclosed |
Drug Profile & Commercial Status
- Modality: Sac-TMT is a trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC).
- Approved Indications in China: Four indications have been approved and marketed, covering triple-negative breast cancer (TNBC), third-line and second-line EGFR mutant-positive non-squamous NSCLC, and HR+/HER2- breast cancer.
- Global Partnership: In May 2022, Kelun Pharma licensed MSD the exclusive rights to develop, use, manufacture and commercialize sac-TMT in all territories outside Greater China (Mainland China, Hong Kong, Macao and Taiwan).
Clinical Evidence – OptiTROP-Lung06 Phase 3 Study
| Endpoint | Result | Comparator | Assessment |
|---|---|---|---|
| Progression-Free Survival (PFS, primary) | Statistically significant and clinically meaningful improvement | Pembrolizumab + pemetrexed + platinum-based chemotherapy | Blinded independent central review (BICR) |
| Overall Survival (OS, secondary) | Positive trend observed | Same comparator | Data not disclosed |
The registrational OptiTROP-Lung06 study demonstrated that sac-TMT plus pembrolizumab achieved a statistically significant and clinically meaningful improvement in the primary endpoint of PFS by BICR versus the standard-of-care chemoimmunotherapy regimen, with a positive trend also observed in the secondary endpoint of OS.
Market Impact & Outlook
- Front-Line Lung Cancer Push: The application advances sac-TMT from later-line settings into the first-line non-squamous NSCLC market — one of oncology’s largest commercial segments — specifically in the PD-L1 TPS <1% population where chemoimmunotherapy outcomes remain suboptimal.
- ADC–IO Combination Strategy: Pairing a TROP2 ADC with a PD-1 inhibitor reflects a broader industry bet that ADC–immunotherapy combinations can outperform chemotherapy-backbone regimens in first-line lung cancer.
- Portfolio Velocity: With seven indication applications accepted and four approvals already marketed in China, sac-TMT has become one of the most rapidly expanding ADC franchises in the Chinese market.
- Global Upside: Through the 2022 license, MSD holds ex–Greater China rights, linking the program’s international trajectory to Kelun’s domestic momentum; global regulatory plans were not disclosed.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the CDE review outcome, potential approval and commercialization of sac-TMT in first-line non-squamous NSCLC, and ongoing global development by MSD. Actual results may differ materially due to risks including regulatory review decisions, confirmatory clinical data, competitive dynamics in ADC and immuno-oncology markets, and partnership execution.-Fineline Info & Tech
