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The US Food and Drug Administration (FDA) has granted a Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-316, a CAR T-cell therapy for patients with advanced or metastatic kidney cancer that is positive for the CD70 biomarker and who have already been treated with immunotherapy and a VEGF-tyrosine kinase inhibitor (TKI).
ALLO-316 was previously granted a fast track designation by the FDA in March 2022. ALLO-316 is a novel off-the-shelf, CD70-targeting chimeric antigen receptor T-cell (CAR T-cell) treatment.
An RMAT designation is granted to products that are designed to treat, modify, reverse, or cure serious or life-threatening diseases and have clinical data suggesting that it can address an unmet medical need. Under the RMAT designation, the development of ALLO-316 could be accelerated in the USA.
The RMAT designation is supported by data from an ongoing phase 1 clinical trial, called TRAVERSE.
TRAVERSE is a first-in-human, dose-finding study of ALLO-316. All patients included in the trial had advanced or metastatic clear cell renal cell carcinoma (RCC) and had previously been treated with immunotherapy and VEGF-TKI. The primary end point for the study is safety (side effects), assessed at 28 days following infusion with ALLO-316.
In total, 19 patients with clear cell kidney cancer were enrolled in the study at the time of the data cut-off, of whom 18 were included in the efficacy analysis. Among these patients, the disease control rate was 89%, and the overall response rate was 17%. Ten of these patients had the CD70 biomarker. For these 10 patients, the disease control rate was 100%, and the overall response rate was 30%. The longest response lasted 8 months. In these 10 patients, the average time to when the treatment stopped working and the cancer started growing again (progression-free survival) was 5 months. Some patients are showing deepening responses over time.
The treatment was well tolerated, with only one patient needing to limit their dose due to side effects.
