Merck claims its first pivotal sacituzumab win
Merck & Co has made a huge investment in its Kelun-originated TROP2-targeting ADC sacituzumab tirumotecan, and now it’s claimed its first global phase 3 win. On Monday Merck said the Trofuse-005 trial, testing sac-TMT versus chemo in post-PD-(L)1 and platinum endometrial cancer, had met its primary endpoints of progression-free and overall survival. Full results will be presented at a medical meeting. Gilead’s rival anti-TROP2 ADC Trodelvy is some way behind in the same setting, with the Ascent-Gyn-01 trial set to complete in 2029. Merck, meanwhile, has 17 global pivotal sac-TMT trials ongoing, including Trofuse-033 in first-line endometrial cancer, although that isn’t due to finish until 2032. The next Merck-sponsored trial to read out, according to the company’s 2025 ASCO presentation, could be Trofuse-15, in third-line-plus gastroesophageal cancer. Merck received a US commissioner’s national priority voucher (CNPV) for sac-TMT in December, although it’s unclear what indication is covered; Merck has only said the CNPV was given to a phase 3 study set to yield data in 2027. Meanwhile, sac-TMT is already approved in China for breast cancer and relapsed NSCLC; Kelun also claimed victory late last year in first-line NSCLC, with a Keytruda combo in the Optitrop-Lung05 study.
Merck-sponsored sacituzumab tirumotecan phase 3 trials
| Study | Setting | Design | Note |
|---|---|---|---|
| TroFuse-004 | 3rd-line EGFRm* non-squam NSCLC | Vs chemo | Data due Q2 2027 |
| TroFuse-005 | 2nd-line endometrial cancer (post-PD-(L)1 + chemo) | Vs chemo | Toplined positive May 2026 |
| TroFuse-007 | 1st-line PD-L1≥50% NSCLC | + Keytruda, vs Keytruda | Data due 2028 |
| TroFuse-009 | 2nd-line+ EGFR+ve non-squam NSCLC (post EGFR TKIs) | Vs chemo | Data due 2028 |
| TroFuse-010 | 2nd-line+ ER+ve HER2-ve breast cancer | +/- Keytruda, vs physician’s choice | Data due Q3 2027 |
| TroFuse-011 | 1st-line PD-L1<10% TNBC | +/- Keytruda, vs physician’s choice | Completes May 2030 |
| TroFuse-012 | Adjuvant TNBC | + Keytruda, vs Keytruda +/- chemo | Completes Dec 2030 |
| TroFuse-015 | 3rd-line+ gastroesophageal adenocarcinoma | Vs physician’s choice | Data due early 2027 |
| TroFuse-019 | Adjuvant stage II-IIIB NSCLC | + Keytruda, vs Keytruda | Completes Feb 2034 |
| TroFuse-020 | 2nd-line cervical cancer | Vs physician’s choice | Data due 2028 |
| TroFuse-021 | 1st-line ovarian cancer maintenance (non-HRD+ve) | +/- Avastin, vs Avastin | Completes Feb 2033 |
| TroFuse-022 | 2nd-line ovarian cancer maintenance (platinum-sensitive) | +/- Avastin, vs Avastin | Data due 2029 |
| TroFuse-023 | 1st-line squam NSCLC maintenance (post Keytruda + chemo) | + Keytruda, vs Keytruda | Data due 2029 |
| TroFuse-031 | 3rd-line bladder cancer | Vs chemo | Completes Jan 2029 |
| TroFuse-032 | Neoadjuvant TNBC or ER-low/HER2-ve breast cancer | + Keytruda + chemo, vs Keytruda + chemo | Completes Mar 2033 |
| TroFuse-033 | 1st-line pMMR endometrial cancer maintenance | + Keytruda, vs Keytruda | Completes May 2032 |
| TroFuse-036 | 1st-line cervical cancer maintenance | + Keytruda +/- Avastin, vs Keytruda +/- Avastin | Completes Oct 2031 |
Notes: *also includes NSCLC driven by mutations in ALK, ROS1, BRAF, NTRK, MET or RET; pMMR=mismatch repair proficient. Source: OncologyPipeline.
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