Dr Srour on Next Steps Planned for the Investigation of ALLO-316 in Advanced Clear Cell RCC

Samer A. Srour, MB ChB, MS, assistant professor, Department of Stem Cell Transplantation and Cellular Therapy, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses planned next steps and future avenues of investigation for the novel CD70-targeted agent ALLO-316 in patients with advanced or metastatic clear cell renal cell carcinoma (RCC).

ALLO-316 was investigated in the first-in-human phase 1 TRAVERSE study (NCT04696731). The dose-escalation portion of the study was designed to examine the off-the-shelf CAR T-cell therapy at 4 dose levels of 40 x 10⁶, 80 x 10⁶, 120 x 10⁶, and 240 x 10⁶ CAR+ cells.

Initial dose-escalation findings from this trial were presented at the 2023 AACR Annual Meeting, and showed that the agent had encouraging clinical activity and safety in patients with clear cell RCC who were heavily pretreated and experienced disease progression on standard therapies, Srour states. The agent produced an overall response rate of 17% and a disease control rate (DCR) of 89% in the efficacy-evaluable population (n = 18). Notably, patients with CD70-positive RCC (n = 10) achieved a partial response rate of 30% with the agent, and a DCR of 100%.

For the current analysis, only 2 patients in the study population (n = 19) received the agent at the third dose level. The data that were presented were primarily from patients who received the CAR T-cell therapy at dose levels 1 and 2, Srour notes. Based on these results, the trial will continue to accrue patients from multiple centers, and to administer ALLO-316 at the 2 higher dose levels, he says. Provided that patient outcomes with ALLO-216 continue to be positive, a phase 2 trial could be conducted, Srour continues. Future investigations of this agent will expand to other CD70-expressing solid tumors, he adds.

Although preliminary, these findings renew the hope that CAR T-cell therapy could be an effective option for patients with solid tumors, according to Srour. Therefore, research in RCC and other solid tumors should continue to evaluate the utility of CAR T-cell products such as ALLO-316, he says. These agents have the potential to induce longer, durable remissions for patients with historically poor prognosis, and may eventually lead to a cure for solid tumors, Srour states. Community oncologists are encouraged to refer patients to clinical trials involving this novel strategy, he concludes.

Disclosures: Dr Srour reported receiving honorarium for consulting/speaking for Novartis Pharmaceuticals.