Tango Therapeutics to Launch 300-Patient Vopimetostat Pancreatic Trial After FDA Support
Tango Therapeutics will launch this year a 300-patient randomized second-line pancreatic cancer trial of PRMT5 inhibitor vopimetostat with hierarchical PFS then OS endpoints across the US, Europe and Asia-Pacific after supportive FDA interactions. Combo cohorts with daraxonrasib and zoldonrasib have enrolled 14 and 16 patients, and the company expects data updates later this year.
1. Pivotal Trial Design
Tango Therapeutics confirmed a randomized 300-patient Phase 3 trial of vopimetostat in second-line pancreatic cancer with a hierarchical progression-free survival then overall survival endpoint, comparing against standard chemotherapy across sites in the US, Europe and Asia-Pacific and targeting launch this year.
2. FDA Interactions
The company engaged with regulators late last year to review trial design, statistical analysis plan, dose selection rationale and sample size calculations, receiving detailed guidance and what management described as significant support for the protocol.
3. Early Combination Cohorts
Initial combination studies with Revolution Medicines’ RAS inhibitors daraxonrasib and zoldonrasib have enrolled 14 and 16 patients respectively, with preclinical synergy noted and strong enrollment interest suggesting potential upside in comparator response benchmarks.
4. Broader Pipeline Outlook
Beyond vopimetostat, Tango’s CNS candidate TNG456 has begun dose escalation in glioblastoma and NSCLC cohorts, and a tumor-agnostic MTAP-deleted arm continues enrolling; the company anticipates data releases on monotherapy, combination and TNG456 programs later in the year.