MiNK Therapeutics, Inc. announced the publication of a case report in Oncogene from its phase 1/2 study in patients with advanced solid tumors where one infusion of agenT-797 in gastric cancer refractory to anti-PD1 led to a durable confirmed partial response, highlighting the unique potential of iNKT cells to overcome resistance to immune checkpoint inhibitors (ICIs). Gastric cancer, the fifth most common malignancy globally, is incurable with only 12% responsive to ICIs. This phase study (NCT05108623) was designed to evaluate agenT-797, an unmodified iNKT cell therapy, in solid tumors refractory to ICIs.

Patients received a single dose of agenT-797, without lymphodepletion, either alone or in combination with pembrolizumab or nivolumab. This case report describes a durable response (by RECIST 1.1 criteria) in a patient with a challenging clinical profile?a PD-L1 positive, HER-2 negative, MSI-H adenocarcinoma with a high mutational burden (84 mut/MB). Prior treatments, including single-agent anti-PD-1 pembrolizumab, had failed to elicit a response, prompting a combination therapy approach involving chemotherapy (FOLFOX) and nivolumab.

However, even this combined regimen proved ineffective before the patient's enrollment in MiNK?s clinical trial. Following treatment with agenT-797, increased immune cell infiltration and proliferation were observed, which correlated with the radiographic partial response. A randomized phase 2 trial, led by Dr. Yelena Janjigian, Chief of Gastrointestinal Oncology at Memorial Sloan Kettering Cancer Center, is underway.