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Regenerative Medicine Advanced Therapy designation was granted to an investigational CAR-T cell therapy for some patients with renal cell carcinoma.
The FDA granted Regenerative Medicine Advanced Therapy designation to the CAR-T cell therapy ALLO-316 for the treatment of adults with advanced or metastatic CD70-positive renal cell carcinoma, a type of kidney cancer.
The Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy designation to the CAR-T cell therapy ALLO-316 for the treatment of adults with advanced or metastatic CD70-positive renal cell carcinoma, a type of kidney cancer, who were previously treated with immune checkpoint inhibitor and VEGF-targeting therapy.
ALLO-316, according to a press release from Allogene Therapeutics, is a CAR-T cell therapy that targets CD70, which is a surface antigen that is often highly expressed in patients with renal cell carcinoma.
Per the FDA’s website, Regenerative Medicine Advanced Therapy designation is granted to drugs that are cell therapies intended to modify, treat, reverse or cure a serious or life-threatening disease or condition, and for which early clinical evidence demonstrates its potential to address an unmet medical need.
“The [Regenerative Medicine Advanced Therapy] designation for ALLO-316 highlights the transformative potential of our AlloCAR T platform to offer new hope for heavily pretreated patients with renal cell carcinoma who have exhausted standard treatment options,” Dr. Zachary Roberts, Executive Vice President of Research and Development and Chief Medical Officer of Allogene Therapeutics, said in the release. “This important milestone moves us closer to fulfilling the promise of ‘off-the-shelf’ CAR T therapy — delivering faster, more reliable and widely accessible treatments.”
Overall response rate: the percentage of patients with a positive response to treatment.
Partial response: a decrease in tumor size or extent of cancer in the body as a result of treatment.
Disease control rate: the percentage of patients with a positive response to treatment.
Cytokine release syndrome: a large, rapid release of cytokine in the blood from immune cells that may present with fever, headache, nausea, low blood pressure, rapid heartbeat and trouble breathing.
The receipt of the Regenerative Medicine Advanced Therapy designation from the FDA was based on findings from the phase 1 TRAVERSE trial. In particular, this trial is designed to evaluate the tolerability, safety and activity of ALLO-316 in advanced or metastatic renal cell carcinoma.
Preliminary findings from this trial were presented at an oncology conference in 2023. The results showed that treatment with ALLO-316 in patients with clear cell renal cell carcinoma demonstrated encouraging antitumor activity with a manageable safety profile.
“A single administration of ALLO-316 could be an effective treatment for [patients] with CD70-[positive] solid tumors, including [renal cell carcinoma], and hematologic malignancies,” the researchers wrote in the abstract presented at the American Association for Cancer Research Annual Meeting in 2023.
Of the 17 patients with clear cell renal cell carcinoma in this study treated with ALLO-316, three achieved best overall response of a partial response, with two patients having a partial response in subsequent visits. The overall response rate was 17% and the disease control rate was 89%. The confirmed overall response rate was 30% in the 10 patients with confirmed CD70-positive tumors, with a disease control rate of 100%.
Regarding side effects in this trial, 11 patients experienced cytokine release syndrome, all of which were low grade except for one patient with a grade 3 (severe) event. One patient experienced a dose-limiting toxicity related to an elevated liver function test, meaning that the patient had liver dysfunction.
The ongoing TRAVERSE trial, according to its ClinicalTrials.gov listing, is anticipated to enroll an estimated 120 patients with advanced or metastatic clear cell renal cell carcinoma. Researchers are aiming to complete the study by October 2025.
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