First Patient Dosed With Drug Combo in Phase 2 Gastric Cancer Trial

A three-drug treatment combination has just been administered to the first patient in a phase 2 trial.

The first patient has been dosed in a phase 2 trial evaluating the treatment of botensilimab and balstilimab plus an allogeneic cell therapy for patients with refractory gastric cancer, according to a news release from Mink Therapeutics, the manufacturing company of the novel cell therapy.

This trial is important information for patients to know, especially because this novel treatment combination of an invariant natural killer T (iNKT) allogeneic cell therapy called agenT-797 with botensilimab and balstilimab may show promise for patients with refractory gastric cancer receiving the combination as second-line treatment.

Gastric (stomach) cancer is when cells in the stomach region grow out of control, turning into cancer, according to the American Cancer Society. Some main areas where gastric cancer can occur include the esophagus (tube after the throat), colon, stomach, liver, pancreas and rectum.

“This study is an important step in new treatment combinations to improve outcomes for patients with refractory gastric cancers, an incurable disease with limited response to available therapies,” Dr. Yelena Janjigian, Chief Gastrointestinal Oncology Service at Memorial Sloan Kettering Cancer Center, said in the release.

“AgenT-797, an off-the-shelf iNKT cell-based therapy, has shown the capacity to target cancerous cells in diseased tissues and is compatible with immune checkpoint inhibitors. This study builds upon the promising outcomes observed with iNKTs in gastric cancer and with botensilimab/balstilimab in GI cancers,” she said. “By harnessing the immune-enhancing potential of agenT-797, we aspire to improve outcomes for a greater number of patients facing challenging GI cancers."

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According to the news release, the phase 2 study aims to evaluate clinical safety and the efficacy of several drugs, including botensilimab, agenT-797, a novel fc-enhanced CTLA-4 inhibitor, balstilimab with Cyramza (ramucirumab) and paclitaxel for patients who have previously received treatment and have advanced esophageal, gastric or gastro-esophageal junction adenocarcinoma.

The researchers are also aiming to enroll 38 patients who have advanced, unresectable (surgically unremovable) or metastatic forms of these three cancers and have previously had disease progression (worsening or spreading) after initial treatment, the news release reported.

"We are thrilled to collaborate with GI cancer expert Dr. Yelena Janjigian on this phase 2 study, furthering the development of agenT-797 in refractory gastric cancer," stated Dr. Jennifer Buell, president and chief executive officer at Mink Therapeutics. "This study is designed to provide crucial insights into the clinical efficacy of agenT-797, while also assessing its potential synergies with chemotherapy and next-generation immune checkpoint inhibitors, botensilimab and balstilimab. This milestone underscores our unwavering commitment to advancing iNKT cell therapies to address the pressing unmet needs in cancer care and highlights the strength of our collaboration with Agenus to access these novel and exciting combinations to deliver meaningful benefits to our patients."

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The phase 2 trial is based on the findings from an earlier study, published in the journal Nature, which demonstrated that agenT-797 overcame resistance to immune checkpoint inhibitors and also showed durable disease stabilization and confirmed response in chemotherapy and anti-PD-1 refractory gastric cancer, according to the news release.

Researchers from the earlier study found that although immune checkpoint inhibitors help with therapeutic improvements, most patients with gastric cancer have tumor resistance to these drugs, which may lead to disease progression.

They established that patients with microsatellite instability-high advanced gastric cancer who previously had disease progression on standard chemotherapy and anti-PD-1 therapy had durable tumor responses after receiving agenT-797, according to the study.

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