TRACON Pharmaceuticals Inc (NASDAQ:TCON) says the Independent Data Monitoring Committee for the ENVASARC pivotal trial has recommended that the trial will proceed as planned following the review of safety data from more than 20 patients enrolled so far.
The company said the safety data reviewed included data from more than 10 patients enrolled into cohort A of treatment with single-agent envafolimab and more than 10 patients enrolled into cohort B of treatment with envafolimab and Yervoy (ipilimumab) for sarcoma, a rare group of cancers that arise in the bones and connective tissue.
“We are pleased with the recommendation of the Data Monitoring Committee to continue the ENVASARC pivotal trial as planned,” said Dr James Freddo, chief medical officer, in a statement.
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“Envafolimab has been well tolerated as a single agent and when combined with Yervoy in these patients with refractory sarcoma who are enrolled in the ENVASARC trial. Based on the current accrual rate, we expect the Data Monitoring Committee to review additional safety data in the third quarter and to review interim efficacy data in the fourth quarter of this year,” Dr Freddo added.
The ENVASARC trial is a multi-center, open-label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the US that began dosing in December 2020.
TRACON expects the trial to enroll 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into cohort A of treatment with single-agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy.
The primary endpoint is ORR by blinded independent central review with the duration of response a key secondary endpoint.
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