TCR2 Therapeutics has reported positive interim results from its phase 1 part of the phase 1/2 clinical trial of its T-cell therapy candidate gavo-cel in mesothelin-expressing solid tumors.

The US-based clinical-stage cell therapy company said that as of the 30 June 2021 data cutoff, 17 patients, which include 12 mesothelioma, four ovarian cancer and one cholangiocarcinoma, had been given a single gavo-cel infusion in the dose escalation part of the gavo-cel phase 1 trial.

TCR2 Therapeutics said that clinical activity was observed in all the three mesothelin-expressing tumor types that were treated with gavo-cel.

The cell therapy company said that gavo-cel disease control rate (DCR) was 81% with tumor regression in 15 of 16 evaluable patients.

According to TCR2 Therapeutics, the overall response rate (ORR) was 31% in patients infused with gavo-cel following lymphodepletion. The company said that meaningful survival benefit was 11.2 months for patients suffering from refractory mesothelioma.

TCR2 Therapeutics said that the recommended phase 2 dose (RP2D) of the T-cell therapy candidate is being refined after identifying the maximum tolerated dose (MTD).

Alfonso Quintás-Cardama — Chief Medical Officer of TCR2 Therapeutics said: “We are very encouraged by the progression free survival and overall survival observed among patients with refractory mesothelioma treated so far with gavo-cel in the Phase 1 trial.

“Based on these data and the most recent patient experiencing a very mild safety profile at a cell dose of 3×108/m2, we believe the identification of the RP2D is close at hand.

“As we approach the Phase 2 expansion phase, our focus will shift to further optimizing outcomes for patients by studying combinations with immune checkpoint inhibitors, allowing gavo-cel re-treatment and evaluating different mesothelin expression thresholds.”

  Alfonso Quintás-Cardama, Cholangiocarcinoma, gavo-cel, mesothelioma, Ovarian Cancer, Solid tumors, TCR2 Therapeutics, USA