TRACON Pharmaceuticals (NASDAQ:TCON) Inc has said an initial independent data monitoring committee (IDMC) interim efficacy analysis of its ENVASARC pivotal trial is set to take place in 4Q following the enrollment of the 36th patient in the trial.
The trial, which began dosing in December 2020, is a multicenter, open-label, randomized, non-comparative, parallel cohort study targeting sarcoma being conducted at 30 top cancer centers in the United States and the United Kingdom.
TRACON said the initial IDMC interim efficacy analysis proceeds after the 36th patient has been enrolled for at least three months to permit two on study scans to determine the preliminary objective response rate.
READ: TRACON Pharmaceuticals says it is on track to release new efficacy data from ENVASARC protocol later this year
One objective response is required in each of the trial’s two cohorts to continue accrual in that cohort, according to the company. The first cohort includes the initial 18 patients who receive single agent envafolimab and the second cohort includes 18 patients who receive envafolimab with ipilimumab.
TRACON CEO Charles Theuer said the company was pleased to have accrued more than 36 patients in under six months since the US Food and Drug Administration (FDA) had approved its amended study protocol.
“As a result, we are currently ahead of the enrollment projection that would allow for full accrual of the 160 planned patients dosed with 600 mg of envafolimab before the end of 2023,” Theuer said. “We look forward to reporting the IDMC recommendations following the two interim safety analyses and interim efficacy analysis expected this year.”
The company noted that a second IDMC interim efficacy analysis was expected in 2023 following the enrollment of the 92nd patient in the trial.
TRACON is a clinical-stage biopharmaceutical company utilizing a cost-efficient, CRO-independent, product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies.
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