Allogene Therapeutics Announces Positive Phase 1 Data Demonstrating the Potential of ALLO-316 in Heavily Pretreated Patients with Advanced Renal Cell Carcinoma at SITC and IKCS

Core Insights - The Phase 1 TRAVERSE trial demonstrated that a single infusion of ALLO-316 resulted in an Overall Response Rate (ORR) of 50% and a Confirmed Response Rate of 33% in patients with a CD70 Tumor Proportion Score (TPS) of greater than 50% [1][3] - ALLO-316 utilizes CD70 Dagger® technology, which promotes robust expansion and persistence of the CAR T cells, validating its potential as a next-generation allogeneic platform [1][2] - The safety profile of ALLO-316 was manageable, with a newly implemented diagnostic and management algorithm effectively reducing immune effector cell-associated neurotoxicity while preserving CAR T efficacy [1][7] Trial Details - The ongoing Phase 1 TRAVERSE trial is enrolling patients with advanced or metastatic renal cell carcinoma (RCC) who have progressed after treatment with immune checkpoint inhibitors and VEGF-targeting therapies [1][2] - As of October 14, 2024, 39 patients had been enrolled, with 26 confirmed to have CD70 positive RCC and evaluable for efficacy outcomes [2][3] - The trial includes a Phase 1b expansion cohort evaluating safety and efficacy at a dose level of 80 million CAR T cells following a standard lymphodepletion regimen [2][3] Efficacy Outcomes - Among patients with a TPS of ≥50%, 76% experienced a reduction in tumor burden, with two of six patients showing durable responses ongoing at four months [3][4] - The best overall response rate for CD70 positive patients was 27%, with a confirmed ORR of 19% across all patients evaluable for disease outcomes [4][5] Safety Profile - The most common adverse events included cytokine release syndrome (CRS) at 62%, fatigue at 59%, and neutropenia at 56%, with minimal incidence of immune effector cell-associated neurotoxicity [7][8] - Two dose-limiting toxicities (DLTs) were reported, including autoimmune hepatitis and cardiogenic shock, with three Grade 5 treatment-related adverse events [8][9] Regulatory Designation - The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-316, recognizing its potential to address unmet needs in advanced or metastatic RCC [1][10] - ALLO-316 also received Fast Track Designation from the FDA in March 2023, indicating its promising therapeutic potential [10] Company Overview - Allogene Therapeutics is a clinical-stage biotechnology company focused on developing allogeneic CAR T products for cancer and autoimmune diseases [11] - The company aims to provide "off-the-shelf" CAR T therapies that are readily available and scalable for patients [11]