Tango Therapeutics to start Phase 3 of vopimetostat plus daraxonrasib in pancreatic cancer in 2027
After FDA discussions and ESMO data showing an 82% response rate in later-line disease, Tango plans a front-line trial in MTAP-deleted pancreatic cancer in the first half of 2027.
Tango Therapeutics said on 9 November 2026 that it intends to begin a Phase 3 trial of vopimetostat combined with daraxonrasib in front-line pancreatic cancer with MTAP deletion. The company expects to start the study in the first half of 2027.
The company linked the plan to discussions with the US Food and Drug Administration and to data presented at ESMO. Those data showed an 82% objective response rate in patients with second- and third-line pancreatic cancer.
Tango also said it intends to discuss with regulators whether accelerated approval could be possible in second-line disease. The company did not indicate in the information available that any regulatory pathway has been agreed. Accelerated approval is a US mechanism that allows earlier authorisation on the basis of surrogate or intermediate endpoints, usually with confirmatory trials required afterwards.
The announcement came with the company's third-quarter results. Tango reported cash of $977.5 million as of 30 September 2026.
What it means for your team
- Regulatory teams tracking MTAP-deleted pancreatic cancer should note the planned first-half 2027 start of a front-line Phase 3 following FDA discussions.
- Any accelerated approval route in second-line disease remains only a topic for discussion with regulators, not an agreed pathway.
- Market-access teams may wish to follow the programme, since it targets a biomarker-defined population, but no pricing or reimbursement information was provided.
Company's press release (SEC filing): Tango Therapeutics, Inc. ↗
Article written by VigiEye from the official source (Tango Therapeutics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.