From the blog

Gavo-Cel Moving to Phase II Trial for Mesothelioma

Published: November 18, 2022

A study looking at T-cell therapy for mesothelioma is going to phase II of the clinical trial process. Researchers are trying to find out how effective the treatment is when combined with an approved immunotherapy combination. Researchers are looking at the relationship between gavocabtagene autoleucel (gavo-cel) with the combination of Opdivo and Yervoy. The combination was approved in 2020 by the FDA to treat mesothelioma. When the treatment was used alone, 93 percent of patients had tumor regression, meaning there is hope for mesothelioma patients. There are four cancers in the study including mesothelioma, non-small cell lung cancer, ovarian cancer, and cholangiocarcinoma. All patients need to have one of these cancers that also expresses mesothelin to be in the study.

The researchers are planning on having 75 patients in the mesothelioma section of the study. There will be 20 patients for the other cancers. The testing will occur at Memorial Sloan Kettering Cancer Center in New York City, National Cancer Institute in Bethesda, Maryland, Penn Medicine Abramson Cancer Center in Philadelphia, Sarah Cannon Research Institute in Nashville, Tennessee, University of California San Francisco Comprehensive Cancer Center, and University of Texas MD Anderson Cancer Center in Houston. The disease control rate was 77 percent in phase I of the study. The median progression free survival rate for the 23 mesothelioma patients was 11.2 months and the progression-free survival was 5.6 months. All the patients had been treated previously but their cancer returned.

The good news for patients is the gavo-cel treatment was well tolerated by patients in the study. There were side effects, but they were manageable. Patients in the mesothelioma section of the study will receive either gavo-cel alone, gavo-cel alongside Opdivo, or gavo-cel with Opdivo and Yervoy. Patients will be allowed to be treated multiple times. The success of gavo-cel is important because T-cell therapy usually does not have good results on solid tumors in advanced stages. Historically it has only been effective on blood cancers.  T-cell therapy was approved for leukemia in 2017.

T-cell therapy utilizes a patient’s own T cells to fight cancer. The white blood cells are separated from the blood outside the body using leukapheresis. It takes around four weeks for the T cells to be added back to the body. Once added, they target cancer cells that express the mesothelin protein. Patients need to have had one of five systemic standard of care therapies to be considered for the trial. Several patients have been treated in phase II, but more patients need to be recruited for the second phase of the study.

Caroline Seymore, “Gavo-cel Elicits Clinical Benefit in Solid Tumors, Including Ovarian Cancer and Mesothelioma” OncLive (September 28, 2022). [Link]
“Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer”c (April 19, 2019). [Link]
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