Samer A. Srour, MD, discusses the results of the phase 1 TRAVERSE trial of ALLO-316 in patients with advanced renal cell carcinoma.
Samer A. Srour, MD, assistant professor in the department of stem cell transplantation, division of cancer medicine at The University of Texas MD Anderson Cancer Center, Houston, TX, discusses the results of the phase 1 TRAVERSE trial (NCT04696731) of ALLO-316 in patients with advanced renal cell carcinoma (RCC).
ALLO-316 is an allogeneic chimeric antigen receptor (CAR) T-cell therapy. Patients who previously received a checkpoint inhibitor and VEGF inhibitor for advanced or metastatic RCC were enrolled in the TRAVERSE trial to investigate safety and efficacy of ALLO-316.
Srour says that 19 of 20 enrolled patients have received ALLO-316 and there have been no new safety signals. Most adverse events (AEs) were similar to those experienced with autologous CAR T-cell therapies.
Although most of the patients were treated at the lowest 2 dose levels investigated, there was promising efficacy in the trial. Among patients who expressed CD70, which is targeted by ALLO-316, there was a 100% disease control rate and a 30% objective response rate, which is encouraging in these pretreated patients with RCC. Srour says the trial continues to accrue patients and is planning to expand further toward the end of 2023.
0:08 | We enrolled so far 20 patients, and 19 of them have been infused with ALLO-316. If you look at the safety data, we did not see any unexpected safety signals. Most of the [adverse events] we saw were similar to the ones we see with autologous CAR T-cell products.
0:32 | For the efficacy, although this is a secondary objective, we were encouraged to see that at very low dose levels—most of these patients are treated at dose level 1 or 2 on this study—so even at those low dose levels, we were able to see very promising and encouraging responses. If you take patients who have CD70-positive expression—this ALLO-316 targets CD70—we have a 100% disease control rate, and we have a 30% objective response rate, which means patients responded with significant shrinkage of their tumors. These in the context of the phase 1 clinical trial at low dose levels, are very encouraging. To that extent, we continue to accrue, and we are planning to expand further, hopefully, towards the end of this year.