Drugs

Allogene Reports Encouraging CAR-T Therapy Data

Allogene Therapeutics is reporting encouraging response rate data for its investigational ALLO-316 in advanced renal cell carcinoma (RCC), but the results also showed three patient deaths (Grade 5 adverse events). The results are from the Phase 1 TRAVERSE trial of ALLO-316’s potential as an “off-the-shelf” CAR-T therapy for solid tumors.

The trial is evaluating ALLO-316 in patients with advanced RCC who have not responded to previous treatments. Allogene says the therapy is designed to target CD70, a protein commonly expressed in certain cancer cells, including those in RCC. So far, 39 patients have been enrolled in the trial, with 26 having CD70-positive tumors eligible for efficacy evaluation.

Among the findings, the company says patients with a CD70 Tumor Proportion Score of 50% or higher — representing a large portion of the advanced RCC population — experienced the most notable response. In this subgroup, 76% (16 of 21 patients) showed a reduction in tumor size, with a 50% overall response rate and a confirmed response rate of 33%. Furthermore, Allogene says two patients in this group demonstrated durable responses lasting over four months, an encouraging sign of treatment resilience.

Allogene says the three Grade 5 treatment-related adverse events involved: 1) cardiogenic shock, which was one of two dose-limiting toxicity; 2) sepsis from multi-drug resistant Klebsiella pneumoniae; and 3) “failure to thrive” in a participant 16 months after treatment with ALLO-316.

Additional data are expected in mid-2025, and Allogene says it is optimistic that ALLO-316 could signal a new era in CAR-T cell therapies for solid tumors, potentially offering hope to RCC patients who have exhausted other treatment options.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome