A combination of Tango Therapeutics’ vopimetostat and Revolution Medicines’ recently approved Rasonque led to a response rate of 82% in an ongoing Phase 1/2 trial—a drop from 92% that was reported in June in fewer patients.
Tango Therapeutics was trading down on Friday after updated results from a mid-stage study of its pancreatic cancer candidate combined with Revolution Medicines’ recently approved Rasonque showed a lower response rate than previously reported.
Tango announced updated results from the ongoing Phase 1/2 study of its investigational PRMT5 inhibitor vopimetostat combined with daraxonrasib—greenlit by the FDA as Rasonque for second-line pancreatic cancer—that show an 82% objective response rate in 22 evaluable patients. Median progression-free survival (PFS) has not yet been reached in the study, but PFS was 88% in patients with second- or third-line pancreatic cancer, Tango said. The data will be presented this weekend at the European Society of Medical Oncology meeting in Madrid.
Tango previously revealed data in June from 12 patients in the trial, showing a 92% response rate and PFS of 90% at six months. The results received much fanfare.
“WOW!” Leerink Partners wrote in a note to investors at the time, predicting the biotech’s stock would at least double on the data. Sure enough, shares of Tango rose 43% at market open on June 8 to $28.94. As of publication on Friday, the company was down nearly 18% from the previous day’s close, trading at $22.91.
Analysts, however, did not appear too concerned with the less-stunning results. The updated data are “supportive of the highly synergistic effect of the combination,” William Blair analysts said in a Thursday note.
The data met Jefferies’ expectations, with the analysts expressing confidence in a Thursday note that the response rate would reach or exceed 70%—a bar the combo more than cleared.
As for safety, the combination was generally well-tolerated in 25 patients with pancreatic cancer or non-small cell lung cancer who received dose level 1— 200 mg of vopimetostat and 600 mg of daraxonrasib every day—with no dose-limiting toxicities (DLTs). Dose level 2— 250 mg and 600 mg, respectively, “was not well-tolerated,” according to Tango’s release, with three of four patients experiencing DLTs.
Tango plans to seek the FDA’s guidance regarding a possible accelerated approval path for vopimetostat plus daraxonrasib in the second-line pancreatic cancer setting, Tango CEO Malte Peters said during a Friday morning conference call to discuss the data.
Tango also plans to launch a Phase 3 trial of the combo in patients with front-line (1L) pancreatic cancer with MTAP deletions in the first half of 2027, Peters said in a prepared statement on Friday. Approximately 40% of patients with pancreatic cancer have an MTAP deletion, the executive added. The company will move forward with dose level 1 and compare the combination against standard of care chemotherapy.
“It is encouraging to see that the clinical activity and tolerability observed in our initial June 2026 dataset has been confirmed with longer follow-up and in a larger patient population, affirming our belief that the response rate and durability observed with vopimetostat plus daraxonrasib surpass any published PDAC [pancreatic ductal adenocarcinoma] datasets, even in front-line settings,” Peters said.
Notably, William Blair said that “it is too difficult to draw real conclusions on the 1L trend,” with only two evaluable patients—one of whom did not respond to the combo.
RevMed is also looking to move Rasonque into the first line setting for pancreatic cancer. The FDA granted Breakthrough Therapy Designation for the drug in that setting in September, weeks after its second-line approval. The designation was based on data from patients with treatment-naive RAS mutant metastatic pancreatic cancer treated with RevMed’s drug in the open-label Phase 1/2 RMC-GI-102 trial. In this study, daraxonrasib combined with a standard of care chemotherapy regimen showed “encouraging preliminary antitumor activity” and a manageable safety profile, according to the biotech’s announcement.
The ongoing RASolute 303 trial is now studying daraxonrasib as a monotherapy and in combination with this chemo regimen versus chemotherapy alone in patients with previously untreated metastatic PDAC.
On Tango’s call Friday morning, Peters said that “executing against our pivotal study in frontline pancreatic cancer is our primary goal.” He added that the biotech aims for vopimetastat to become “a PRMT5 combination partner of choice for any RAS inhibitor.”
To achieve the goal, Tango is deprioritizing novel target discovery, according to a Friday SEC filing. The company intends to reduce its workforce by 14%, “with the majority of the headcount reductions from the company’s research group.”
Tango had 97 R&D employees and 137 full-time staffers in total as of Dec. 31, 2025, per an end-of-year SEC filing, meaning that around 19 people are losing their jobs at the biotech.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.