TCR² Therapeutics Announces Positive Interim Results from Ongoing Phase 1/2 Trial of Gavo-cel for Treatment Refractory Mesothelin-Expressing Solid Tumors
Excerpt from the Press Release:
– Clinical activity observed in all three mesothelin-expressing tumor types treated
– Gavo-cel disease control rate (DCR) 81% with tumor regression in 15 of 16 evaluable patients
– Overall response rate (ORR) 31% in patients infused with gavo-cel following lymphodepletion
– Meaningful survival benefit at 11.2 months for patients with refractory mesothelioma
– Recommended Phase 2 Dose (RP2D) being refined after identification of the Maximum Tolerated Dose (MTD)
– TCR2 to host a conference call on Friday, September 17 at 9:00a.m. ET
CAMBRIDGE, Mass., Sept. 17, 2021 (GLOBE NEWSWIRE) — TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from cancer, today announced positive interim results from the ongoing Phase 1 portion of the gavo-cel Phase 1/2 clinical trial for mesothelin-expressing solid tumors. A dataset will also be featured in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2021 on September 17 at 14:20 CEST (8:20am EST) (Presentation #959O) and is part of the official ESMO Press Programme.
As of the June 30, 2021 data cutoff, 17 patients (12 mesothelioma, 4 ovarian cancer and 1 cholangiocarcinoma) had received a single gavo-cel infusion in the dose escalation portion of the gavo-cel Phase 1 clinical trial. The median number of prior lines of therapy was 5, including immune checkpoint inhibitors (n=11) and mesothelin-directed therapies (n=5). Gavo-cel was administered up to dose level 5 (DL5) (5×108/m2 following lymphodepletion). Two dose limiting toxicities were reported: one Grade 3 pneumonitis at DL1 that resolved with supportive measures, which permitted the continuation of dose escalation, and one Grade 5 bronchoalveolar hemorrhage at DL5, which along with the development of severe CRS in all 3 patients treated at this dose level, led the Safety Review Team to declare 5×108/m2 as the MTD. Following identification of the MTD, one patient has received gavo-cel at 3×108/m2 after lymphodepletion using a split dosing approach to refine the RP2D and an additional patient has been treated at DL3 (1×108/m2 following lymphodepletion). In both cases gavo-cel was well tolerated with only Grade 1 non-hematological toxicities being reported.
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