Tango Therapeutics NASDAQ: TNGX said it plans to begin a global Phase III trial in the first half of 2027 evaluating vopimetostat in combination with daraxonrasib as a first-line treatment for patients with MTAP-deleted metastatic pancreatic ductal adenocarcinoma, or PDAC.
The company outlined the development plan after reporting updated early-stage clinical results for the combination ahead of a presentation at the European Society for Medical Oncology meeting. The data came from a Phase I dose-escalation study in previously treated patients with metastatic pancreatic cancer harboring both MTAP deletion and a RAS mutation.
Updated Pancreatic Cancer Results
According to Dr. Brian Wolpin, director of the Hale Family Center for Pancreatic Cancer Research at Dana-Farber Cancer Institute, 22 evaluable pancreatic cancer patients treated with vopimetostat plus daraxonrasib had a confirmed objective response rate of 82% and a disease control rate of 100%. The analysis included patients treated in the second- or third-line setting, with many participants receiving the regimen as a third-line therapy.
The median follow-up was approximately seven months. The company reported that median progression-free survival had not yet been reached and that the nine-month progression-free survival rate was nearly 90%, or 88% according to Tango’s presentation. Among seven second-line patients, no progression events had been observed at the time of the update.
Wolpin cautioned that comparisons across separate clinical trials are not straightforward, but said the durability observed so far appeared notable relative to prior treatment options in pancreatic cancer. Most patients remained on treatment at the time of the analysis.
The trial also included five patients with non-small cell lung cancer. Four of those five patients achieved an objective response, according to the company.
Safety Profile and Drug Interaction
Tango said the combination was generally well tolerated, with no Grade 4 or Grade 5 treatment-related adverse events reported. Most adverse events were Grade 1 or Grade 2. At the lower dose level, the company reported no Grade 3 or higher treatment-related rash or stomatitis events.
The regimen used 200 mg of vopimetostat once daily and 100 mg of daraxonrasib once daily at dose level 1. A second dose level evaluated 250 mg of vopimetostat with 100 mg of daraxonrasib. Grade 3 events at the first dose level were related to anemia and thrombocytopenia, Wolpin said.
Tango attributed part of the regimen’s profile to a drug-drug interaction. Adam Crystal, the company’s president of research and development, said vopimetostat is a moderate CYP3A4 inhibitor that increases daraxonrasib exposure by about threefold. Tango said 100 mg of daraxonrasib given with vopimetostat produced exposure similar to that of 300 mg daraxonrasib as a single agent.
Crystal said rates of rash, nausea, vomiting and diarrhea in the combination study were at least 20 percentage points lower than those previously reported for 300 mg daraxonrasib monotherapy, while acknowledging these were cross-trial comparisons with inherent limitations. The dose-reduction rate at dose level 1 was 20%, the company said.
Planned Registrational Strategy
Tango said recent discussions with the U.S. Food and Drug Administration supported a Phase III study design that is ready to begin operationally. The planned global, randomized trial will compare vopimetostat plus daraxonrasib with standard-of-care chemotherapy in first-line MTAP-deleted pancreatic cancer.
The study is expected to enroll 484 patients across the U.S., Europe and Asia-Pacific. Its dual primary endpoints will be objective response rate and progression-free survival, while overall survival will be a key secondary endpoint.
Malte Peters, Tango’s president and chief executive officer, said the company does not need additional first-line pancreatic cancer data before launching the Phase III trial. He characterized the remaining work as primarily operational, including coordinating a large multinational study.
Tango also plans to seek FDA guidance on a potential accelerated approval strategy in second-line pancreatic cancer. The company said such a pathway could involve a smaller Phase II study and could help assess the contribution of each component in the combination. Peters said detailed discussions on that potential study have not yet occurred.
The company currently has a supply agreement with Revolution Medicines for ongoing studies, but Peters said a supply agreement for the planned Phase III trial has not yet been finalized. Tango and Revolution Medicines are discussing the matter, he said.
Expanding Into MTAP Wild-Type Disease
Beyond MTAP-deleted tumors, Tango plans to test vopimetostat with a pan-RAS inhibitor in approximately 25 to 30 patients with MTAP wild-type pancreatic cancer in the second-line setting during the first half of 2027. The study is expected to be conducted through Tango’s collaboration with Erasca.
Crystal said preclinical testing across 12 MTAP wild-type, KRAS-mutant pancreatic cancer cell lines showed that vopimetostat enhanced the activity of daraxonrasib at clinically achievable concentrations. He said the company expects the benefit in MTAP wild-type disease could be more modest than the activity observed in MTAP-deleted tumors, but described the study as a capital-efficient test of the hypothesis.
Tango also said it expects to initiate its combination study with Erasca before the end of the year. The company plans to provide additional clinical data and development plans for vopimetostat and TNG456, its brain-penetrant PRMT5 inhibitor, at an investor conference in January 2027.
To concentrate resources on those programs, Tango said it has stopped certain preclinical and research activities and will focus its efforts on its PRMT5 portfolio.
About Tango Therapeutics (NASDAQ:TNGX)
Tango Therapeutics, Inc is a clinical-stage biotechnology company focused on discovering and developing medicines for cancer. The company uses functional genomics and genetic screening to identify vulnerabilities in tumor cells, including dependencies created by tumor-suppressor gene loss, and to develop targeted therapies designed to selectively attack cancer cells.
Tango's pipeline includes small-molecule programs for genetically defined solid tumors. Its lead program, TNG462, is an MTA-cooperative PRMT5 inhibitor being developed for cancers with MTAP gene deletions.
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