Axicabtagene ciloleucel showed a significant improvement in overall survival (OS) over standard of care in patients with relapsed or refractory large B-cell lymphoma (LBCL).
The announcement came from Kite about the results of the phase III ZUMA-7 study’s primary OS analysis.
The randomized, open-label, global, multicenter, phase III ZUMA-7 study is evaluating the safety and efficacy of axicabtagene ciloleucel versus standard of care for initial treatment of adults with relapsed or refractory LBCL within 12 months of first-line therapy.
ZUMA-7 included 359 patients from 77 centers who were randomized 1:1 to receive a single infusion of axicabtagene ciloleucel or historical standard-of-care second-line treatment. The historical standard of care included a platinum-based salvage combination chemoimmunotherapy regimen followed by high-dose therapy, and hematopoietic stem cell transplantation in patients who respond to salvage chemotherapy. Patients who received axicabtagene ciloleucel did not receive additional bridging chemotherapy.
The primary endpoint of ZUMA-7 is event-free survival (EFS), and secondary endpoints include objective response rate (ORR) and OS, which was “designated as a clinically important prespecified key secondary endpoint,” Kite officials said in the announcement. The prespecified primary OS analysis was to be conducted after 210 deaths or no later than five years after the first patient was randomized, according to Kite.
Of the patients who received axicabtagene ciloleucel, 40% were alive at two years and did not have cancer progression or a need for additional cancer treatment, compared with 16.3% of patients who received standard of care. Patients who received axicabtagene ciloleucel had a median EFS of 8.3 months, more than four times higher than the median EFS of two months in patients who received standard of care.
The ORR was 83% in patients who received axicabtagene ciloleucel, while it was 50% in those who received standard of care (odds ratio, 5.31; 95% CI, 3.1-8.9; P<.0001). The complete response rate was 65% in patients receiving axicabtagene ciloleucel, while it was 32% in those receiving standard of care.
The safety profile of axicabtagene ciloleucel was “consistent with previous studies,” Kite officials said. In the 168 patients who received axicabtagene ciloleucel and were evaluable for safety, grade ≥3 cytokine release syndrome occurred in 7%, and neurologic events were observed in 25% of patients.
Of the patients receiving standard of care, 83% had high grade events, which were mostly cytopenias, according to Kite.
The findings will be presented in full later this year at an upcoming scientific meeting, Kite officials said.
Source: Kite press release, March 2023