Pivotal Merck/Kelun TROP2 studies seek nearly 10,000 patients
As if Merck & Co’s desire to take on Daiichi Sankyo/AstraZeneca in the TROP2-targeting ADC space was in any doubt, yet another phase 3 study of sacituzumab tirumotecan has just been listed on clinical trials registries. This will test the Kelun-originated anti-TROP2 ADC as maintenance after Keytruda plus chemo in first-line squamous NSCLC, and seeks to recruit 851 patients. It takes the number of Merck-sponsored pivotal trials of the project to nine, versus Kelun’s five, and the total number of patients to be enrolled into these efforts now stands at a remarkable 9,367. That’s an enormous bet to put on an asset for which Merck paid Kelun just $47m two years ago. For their part, Daiichi/Astra have so far taken datopotamab deruxtecan into 12 phase 3 studies, and two settings are already before the FDA: the agency is to rule on approval for second-line non-squamous NSCLC (Tropion-Lung01 study) in December, and on use in second-line ER-positive HER2-negative breast cancer (Tropion-Breast01) in February 2025.
Pivotal trials of sacituzumab tirumotecan
| Study | Setting | Design | Primary endpoints | Enrolment |
|---|---|---|---|---|
| Global studies sponsored by Merck... | ||||
| MK-2870-019 | Adjuvant stage II-IIIB NSCLC | Keytruda combo, vs Keytruda | DFS | 780 |
| MK-2870-007 | 1L PD-L1 ≥50% NSCLC | Keytruda combo, vs Keytruda | OS | 614 |
| MK-2870-023 | 1L maintenance in squamous NSCLC | Keytruda/chemo combo, vs Keytruda | OS | 851 |
| MK-2870-004 | 2L+ EGFR+ve & other genetically altered* non-squamous NSCLC | Vs pemetrexed or docetaxel | PFS & OS | 556 |
| MK-2870-009 | 2L+ (post EGFR TKIs) EGFR+ve non-squamous NSCLC | Vs pemetrexed + carboplatin | PFS & OS | 520 |
| MK-2870-012 | Adjuvant TNBC | Keytruda combo, vs Keytruda +/- chemo | iDFS | 1,530 |
| MK-2870-010 | 2L+ ER+ve HER2-ve breast cancer | +/- Keytruda, vs physician’s choice | PFS | 1,200 |
| MK-2870-005 | 2L endometrial cancer | Vs chemo | PFS & OS | 710 |
| MK-2870-015 | 3L+ gastroesophageal adenocarcinoma | Vs physician’s choice | OS | 450 |
| ...and those with an Asia focus, sponsored by Kelun | ||||
| SKB264-III-12 | 1L PD-L1 ≥1% NSCLC | Keytruda combo, vs Keytruda | PFS | 646 |
| SKB264-III-09 | 2L+ (post EGFR TKIs) EGFR+ve non-squamous NSCLC | Vs pemetrexed + carboplatin | PFS | 356 |
| SKB264-III-11 | 1L TNBC | Vs chemo | PFS & OS | 524 |
| SKB264-III-10 | 2L+ ER+ve HER2-ve breast cancer | Vs physician’s choice | PFS | 376 |
| SKB264-III-03/ OptiTROP-Breast01 | 3L+ TNBC | Vs physician’s choice | PFS | 254 |
Note: *includes NSCLC driven by mutations in ALK, ROS1, BRAF, NTRK, MET or RET. Source: OncologyPipeline.
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