FDA Commissioner’s National Priority Voucher (CNPV) granted by FDA for sacituzumab tirumotecan in 2L endometrial cancer  (EC) which could reduce review times from 10-12 months to as little as 1-2 months.

4 agosto 2026

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Merck stated that the FDA Commissioner’s National Priority Voucher (CNPV) for sacituzumab tirumotecan (sac-TMT, TROP2 ADC) will be used to support the initial regulatory submission for sac-TMT based on P3 TroFuse-005 for 2L EC pts. P3 TroFuse-005 is the first of 17 global P3 sac-TMT trials to read out positive data.

Key Highlights:

TroFuse-005 poses a direct competitive threat since sac-TMT is a key in-class competitor in 2L EC with a similar trial design.
- Positive topline results from the P3 TroFuse-005 were announced in May 2026 and is the first TROP2 ADC to show a statistically significant improvement in both OS and PFS versus chemotherapy in advanced/recurrent EC.
  - US approval for the TroFuse-005 regimen could occur as early as Q3 2026, with EU approval anticipated in Q2 2027.
Merck is guiding for detailed P3 TroFuse-005 data, likely an LBA at ESMO 2026.
- Merck also disclosed today that they will host an Investor Event at ESMO 2026 on Monday, October 26^th, 2026

TroFuse-005 study design:

P3 TroFuse-005 (NCT06132958): Sacituzumab tirumotecan in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)
- 2L EC pts: progressed after prior platinum chemo and PD-(L)1 immunotherapy
  - Pts were stratified by MMR status, TROP2 expression, number of prior LoTs, and disease status at baseline (RECIST1.1)
- N=710
- Sac-TMT dosing: 4 mg/kg Q2W
- 1EP: PFS, OS
- 2EP: ORR, DoR, QoL, safety/tolerability
- Closed to recruitment: Sep’25

List of P3 Sac-TMT studies initiated by Merck:

Trial	Setting	Design	N	Study Status
TroFuse-005	2L endometrial cancer	vs chemo	710	Active, not recruiting (Sept.’25)
TroFuse-020	2L cervical cancer	vs physician’s choice	686	Active, not recruiting (May’26)
TroFuse-021	1L maintenance in ovarian cancer	+/- bevacizumab, vs bevacizumab	900	Recruiting (initiated Feb.’26)
TroFuse-022	2L maintenance in platinum-sensitive ovarian cancer	+/- bevacizumab, vs bevacizumab	770	Recruiting (initiated Apr.’25)
TroFuse-036	1L maintenance in cervical cancer	pembrolizumab combo +/- bevacizumab, vs pembrolizumab +/- bevacizumab	1,023	Recruiting (initiated Jan.’26)
TroFuse-033	1L maintenance in pMMR EC	pembrolizumab combo, vs pembrolizumab	1,123	Recruiting (initiated May.’25)
TroFuse-010	2L+ ER+ve HER2-ve BC	+/- pembrolizumab, vs physician’s choice	1,200	Recruiting (initiated Apr.’24)
TroFuse-011	1L PD-L1 <10% TNBC	+/- pembrolizumab, vs physician’s choice	1,000	Recruiting (initiated May.’25)
TroFuse-012	Adjuvant TNBC	pembrolizumab combo, vs pembrolizumab +/- chemo	1,530	Recruiting (initiated Jun.’24)
TroFuse-032	Neoadjuvant high risk, early-stage TNBC and HR-low positive/HER2-negative BC	pembrolizumab combo, vs pembrolizumab +/- chemo	2,400	Recruiting (initiated Jun.’25)
TroFuse-004	2L+ EGFR+ve & other genetically altered* non-squamous NSCLC	vs pemetrexed or docetaxel	556	Active, not recruiting (initiated Nov.’23)
TroFuse-007	1L PD-L1 ≥50% NSCLC	pembrolizumab combo, vs pembrolizumab	614	Recruiting (initiated Dec.’23)
TroFuse-009	2L+ (post EGFR TKIs) EGFR+ve non-squamous NSCLC	vs pemetrexed + carboplatin	551	Active, not recruiting (May’26)
TroFuse-019	Adjuvant stage II-IIIB NSCLC	pembrolizumab combo, vs pembrolizumab	780	Recruiting (initiated Apr.’24)
TroFuse-023	1L maintenance in squamous NSCLC	pembrolizumab /chemo combo, vs pembrolizumab	851	Recruiting (initiated Jun.’24)
TroFuse-015	3L+ gastroesophageal adenocarcinoma	vs physician’s choice	450	Active, not recruiting (Feb.’26)
TroFuse-031	2-4L urothelial cancer (after enfortumab vedotin, PD-(L)1, platinum chemo)	vs non-platinum chemo	590	Recruiting (initiated Mar.’26)

Commissioner’s National Priority Voucher

Tags: sacituzumab tirumotecan sac-TMT 2L EC endometrial cancer

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FDA Commissioner’s National Priority Voucher (CNPV) granted by FDA for sacituzumab tirumotecan in 2L endometrial cancer  (EC) which could reduce review times from 10-12 months to as little as 1-2 months.

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FDA Commissioner’s National Priority Voucher (CNPV) granted by FDA for sacituzumab tirumotecan in 2L endometrial cancer (EC) which could reduce review times from 10-12 months to as little as 1-2 months.

Come giudichi questo contenuto?

FDA Commissioner’s National Priority Voucher (CNPV) granted by FDA for sacituzumab tirumotecan in 2L endometrial cancer  (EC) which could reduce review times from 10-12 months to as little as 1-2 months.