On October 25, 2021 TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from solid tumors, reported a clinical trial collaboration agreement with Bristol Myers Squibb (NYSE: BMY) to evaluate gavo-cel in combination with Opdivo (nivolumab) and Yervoy (ipilimumab) in its planned Phase 2 clinical trial in treatment refractory mesothelin-expressing solid tumors (Press release, TCR2 Therapeutics, OCT 25, 2021, View Source [SID1234591935]). The primary objective of the Phase 2 trial is to evaluate the efficacy of gavo-cel in patients with unresectable, metastatic or recurrent mesothelin-expressing cancers including non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma (MPM) and cholangiocarcinoma. TCR2 is sponsoring the Phase 2 trial.

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"We are very pleased to establish a collaboration agreement with Bristol Myers Squibb for our Phase 2 clinical trial as this enables us to evaluate the potential synergy between gavo-cel and immune checkpoint inhibitors," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "The new standard of care established by Opdivo in difficult-to-treat diseases is important for cancer patients around the world, including the recent approval of the combination of Opdivo and Yervoy as first-line treatment for adult patients with unresectable malignant pleural mesothelioma. We look forward to determining whether gavo-cel can provide additional clinical benefit to these patients."

The planned Phase 2 clinical trial will evaluate the antitumor activity and better characterize the safety of gavo-cel at the selected recommended Phase 2 dose (RP2D). Patients will receive gavo-cel at the RP2D and will be enrolled according to their cancer diagnosis to four distinct cohorts: NSCLC, ovarian cancer, MPM and cholangiocarcinoma. Patients with NSCLC, ovarian cancer, or cholangiocarcinoma will receive the combination of gavo-cel and Opdivo. Patients with MPM will be treated in three cohorts: the first will administer gavo-cel as a single agent, the second will treat patients with both gavo-cel and Opdivo, and the third will treat patients with gavo-cel, Opdivo and Yervoy.

Opdivo and Yervoy are trademarks of Bristol-Myers Squibb Company.