Dr Srour Highlights ALLO-316 Phase 1 Success in Advanced ccRCC

Samer A. Srour, MB ChB, MS, assistant professor, Department of Stem Cell Transplantation, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, discusses some of the updated results from the phase 1 TRAVERSE study (NCT04696731) of ALLO-316 in advanced clear cell renal cell carcinoma (ccRCC) study presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

In the phase 1b cohort of the TRAVERSE study, 20 heavily pretreated patients were included. Their median age was 56, and we patients up to age 65 years were included. Median prior lines of therapy were 4 and 32% of the patients had received 4 different classes of drugs in kidney cancer.

“The experts who treat kidney cancer know these patients have dismal prognosis with limited other options. And also, because of this allogeneic off-the-shelf product, we were able to treat patients from enrollment to treatment in just a median of 4 days. We had patients treated almost 1 day after enrollment. This is a great achievement compared to the autologous CAR T-cell products that are in the market,” explains Srour.

He explains that the safety profile of ALLO-316 was manageable and was consistent with what we see in other chimeric antigen receptor (CAR) T-cell products.

“In regard to cytopenias, for instance, cytokine release syndrome, 68% of our patients had grade 1 or 2 cytokine syndrome. Even neurotoxicity was very low-grade and transient. We didn't have any graft-vs-host disease incidence, for instance, in this product. Infections were also consistent with what we see in hematologic malignancies,” he shares.

Looking at the efficacy data, the confirmed objective response rate (ORR) was 25%. For patients with high CD70 scores, the ORR was a 31% objective response rate.

“What is more interesting, if we look at the data over time, most of these responses were actually durable. Only 1 of the 5 objective responses, for instance, has progressed, and the others, at the last time of follow-up, had durable responses, and some of them already passed the one-year mark,” Srour adds.

REFERENCE:

Srour S, Chahoud J, Drakaki A, et al. ALLO-316 in advanced clear cell renal cell carcinoma (ccRCC): Updated results from the phase 1 TRAVERSE study. J Clin Oncol. 2025;43(suppl 17):4508. doi:10.1200/JCO.2025.43.16_suppl.4508