TRACON Pharmaceuticals (NASDAQ:TCON) Inc has said that the Independent Data Monitoring Committee for the ENVASARC pivotal trial of potential cancer drug envafolimab has recommended that the trial proceed as planned after reviewing the 12-week safety data from more than 20 patients enrolled in the study as of May 2021.
The San Diego company said the safety data reviewed included information and 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.
“Envafolimab continues to be well tolerated as a single agent and when combined with Yervoy in refractory sarcoma patients who are enrolled in the ENVASARC trial,” TRACON chief medical officer James Freddo said in a statement. “We remain on track for the Independent Data Monitoring Committee to review interim efficacy data in the fourth quarter of this year.”
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The ENVASARC trial is a multi-center, open-label, randomized, non-comparative, parallel cohort study at around 25 top cancer centers in the US that began dosing in December 2020.
TRACON expects the trial to enroll 160 patients with undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (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 overall response rate (ORR) by blinded independent central review with the duration of response a key secondary endpoint.
In July 2021, TRACON upsized a bought deal offering of its stock to $15 million to support the continued clinical development of potential cancer drug envafolimab.
Envafolimab is a novel, single-domain PD-L1 antibody that is administered by subcutaneous injection without the need for an adjuvant. Envafolimab is currently dosing in the ENVASARC pivotal Phase 2 trial in the US, sponsored by TRACON and has been accepted for priority review by the Chinese National Medical Products Administration for the treatment of High levels of MicroSatellite Instability (MSI-H) cancer patients.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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