Tango plans pivotal trial of vopimetostat for pancreatic cancer
Focus of new study will be on patients already given one line of therapy
Following new, positive data from a Phase 1/2 clinical study, Tango Therapeutics is planning to launch a pivotal trial to test its therapy candidate vopimetostat (TNG462) in people with pancreatic cancer.
The upcoming trial is expected to enroll approximately 300 people with this cancer type who harbor a specific mutation called MTAP-del. To be eligible, patients will need to have received at least one prior line of therapy. Under the company’s current plans, participants in the upcoming study will be randomly assigned to treatment with daily oral vopimetostat or with one of four standard chemotherapy regimens.
If the results are positive, Tango hopes to use the findings as a basis to apply for regulatory approvals of vopimetostat as a pancreatic cancer treatment, according to a company press release.
Tango is planning to meet with the U.S. Food and Drug Administration (FDA) in the coming months to discuss these plans, including the testing dose. Pending feedback from the agency, the company is hoping to get the trial up and running in 2026.
“With FDA alignment on the go-forward dose of 250 mg … we anticipate that this study will enroll rapidly, underscoring the potential for vopimetostat to be the first [MTAP-specific treatment] to market,” said Barbara Weber, MD, president and CEO of Tango.
According to Tango, about 35% of pancreatic cancers harbor the MTAP-del mutation, which makes the cancer cells unable to produce an enzyme called methylthioadenosine phosphorylase. This mutation often occurs due to genetic changes that help cancer cells grow faster, but it also leads to a buildup of certain byproduct molecules that can impair the activity of another protein called PRMT5 (protein arginine methyltransferase 5).
Vopimetostat is designed to inhibit PRMT5, which studies have shown can kill cancer cells with the MTAP-del mutation. Weber said that the therapy “has the potential to be a turning point for treatment of multiple difficult-to-treat MTAP-del cancers, beginning with pancreatic cancer.”
Developer reports positive data from Phase 1/2 trial testing vopimetostat
Tango is now running a Phase 1/2 clinical trial (NCT05732831) that’s testing vopimetostat in people with various types of solid tumors harboring MTAP-del mutations. The trial is being run at sites in the U.S., France, and Spain, and as of earlier this year, it was still recruiting participants.
A total of 64 people with pancreatic cancer were enrolled in the study as of early September. Among them, 39 received an active dose of vopimetostat and have been followed for at least six months. Data show that 15% of these patients showed an objective response to vopimetostat, essentially meaning their tumor got smaller following treatment.
Among the individuals who’d previously received one line of therapy, the objective response rate (ORR) was somewhat higher at 25%, and the median progression-free survival (PFS) was 7.2 months. PFS refers to the time that patients are alive without their cancer worsening. Among those who’d received two or more treatments prior to entering the trial, the median PFS was markedly lower at 4.1 months.
Weber called these results “a substantive dataset on … vopimetosta.”
In [already treated] MTAP-deleted pancreatic cancer [patients], the median [progression-free survival] is 7.2 months and the [objective response rate] is 25%, more than double that observed in historical control studies, supporting our decision to initiate a pivotal trial in this patient population in 2026.
Because the best results were seen in patients given one prior line of therapy, the upcoming pivotal trial plans to specifically focus on this population.
“In [second-line] MTAP-deleted pancreatic cancer, the median PFS is 7.2 months and the ORR is 25%, more than double that observed in historical control studies, supporting our decision to initiate a pivotal trial in this patient population in 2026,” Weber said.
Tango is also running a separate Phase 1/2 study (NCT06922591) testing vopimetostat in combination with other therapies in people with MTAP-del pancreatic cancer or lung cancer whose cancer is still progressing after at least one prior treatment. That study is still recruiting participants at its six sites in the U.S.
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