Kite Pharma's CAR-T Therapy Shows Promise in Advanced B-Cell Lymphoma Trial

Kite Pharma, a subsidiary of Gilead Sciences, has reported encouraging results from a phase 1a trial of its bicistronic CAR T-cell therapy, KITE-363, in patients with advanced B-cell lymphoma (BCL). The trial met its primary endpoint with no dose-limiting toxicities (DLTs) observed, while also demonstrating a high complete response rate in patients receiving the highest dose.

Safety Profile and Efficacy Results

The open-label trial evaluated 37 patients with relapsed or refractory BCL who had received at least two prior lines of therapy. Of these, 34 patients had large B-cell lymphoma (LBCL). The study's primary goal was met, with no DLTs recorded up to 28 days post-infusion.

Safety data revealed no grade 4 or 5 cases of cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS). One grade 3 CRS event was reported in a patient with nodular lymphocyte-predominant Hodgkin lymphoma, while three grade 3 ICANS cases were observed, two of which occurred in patients receiving the highest dose level.

Efficacy results were particularly promising, with an objective response rate (ORR) of 87% and a complete response (CR) rate of 78% in CAR-naive patients receiving the highest dose of KITE-363. The median duration of response had not been reached at the time of data cutoff, which occurred at a median follow-up of 7.3 months.

Potential for Outpatient Administration

Cindy Perettie, Executive Vice President and Global Head of Kite, highlighted the potential for KITE-363 to be administered in an outpatient setting, pending further safety profile improvements. "We're excited. We think this could be an outpatient drug," Perettie stated at the American Society of Clinical Oncology conference in Chicago.

The study revealed shorter resolution times for adverse events compared to current market products. ICANS events had a median duration of five days, while CRS events lasted a median of five days. Perettie noted, "Interestingly, ICANs today for the products on the market will take nine [or] 10 days, sometimes two weeks, to resolve. These resolved within one to five days."

Manufacturing and Future Developments

KITE-363 is an autologous, bicistronic therapy designed to express two different CARs simultaneously, targeting CD19 and CD20 costimulatory domains. The current manufacturing process takes five days, but Kite is exploring a three-day manufacturing method using more juvenile cells.

The company plans to decide in July which version of the therapy to advance into pivotal studies. Perettie expressed optimism about the therapy's potential, stating, "This, to me, is a community drug where we can reach more patients and provide more opportunity for a potential cure."

As Kite Pharma moves forward with KITE-363, the pharmaceutical industry will be watching closely to see if this promising CAR T-cell therapy can deliver on its early potential and potentially reshape the treatment landscape for advanced B-cell lymphomas.