The primary overall survival analysis of the phase 3 ZUMA-7 trial favors axicabtagene ciloleucel over standard of care therapy.
Compared with standard-of-care (SOC) therapy, axicabtagene ciloleucel (axi-cel; Yescarta) significantly boosted overall survival (OS) in patients with relapsed/refractory large B-cell lymphoma (LBCL), according to data from the primary OS analysis of the phase 3 ZUMA-7 trial (NCT03391466).1
Investigators plan to present full results from the OS analysis at an upcoming medical meeting.
Prior data from ZUMA-7 supported the FDA approval of axi-cel for the treatment of adult patients with LBCL that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy in April 2022.2
Findings for the primary end point of event-free survival (EFS) showed that at a median follow-up of 24.9 months, axi-cel generated an estimated median EFS of 8.3 months (95% CI, 4.5-15.8) compared with 2.0 months (95% CI, 1.6-2.8) with SOC treatment (HR, 0.40; 95% CI, 0.31-0.51; P <.0001). The estimated 18-month EFS rates in the experimental and control arms were 41.5% (95% CI, 34.2%-48.6%) and 17.0% (95% CI, 11.8%-23.0%), respectively.
Additionally, axi-cel elicited an objective response rate (ORR) of 83% (95% CI, 77%-88%) vs 50% (95% CI, 43%-58%) for SOC.
The randomized, open-label, global, multicenter, phase 3 ZUMA-7 study enrolled 359 patients with relapsed/refractory LBCL within 12 months of first-line therapy.3 First-line treatment needed to consist of an anti-CD20 monoclonal antibody, unless the investigator determined that tumor was CD20 negative, and an anthracycline-containing chemotherapy regimen.
Patients were excluded from the trial if they had a history of malignancy other than non-melanoma skin cancer or carcinoma in situ unless they were disease free for at least 3 years; received more than 1 line of therapy for LBCL; or had a history of autologous or allogeneic stem cell transplant.
Patients were randomly assigned 1:1 to a single infusion of axi-cel or SOC treatment with platinum-containing salvage chemotherapy followed by high-dose therapy and autologous stem cell transplant in responders.
Along with the primary end point of EFS, OS was designated as a clinically important prespecified key secondary end point. Other secondary end points included ORR, patient-reported outcomes, and safety.1
Regarding safety, findings from ZUMA-7 showed that axi-cel displayed a safety profile consistent with previous studies. Among the 168 patients evaluable for safety who received axi-cel, grade 3 or higher cytokine release syndrome was reported in 7% of patients, and neurologic events occurred in 25% of patients. In the SOC arm, 83% of patients had high-grade adverse effects, mostly consisting of cytopenias.
References
Acalabrutinib Plus Chemoimmunotherapy Improves PFS in Mantle Cell Lymphoma
May 6th 2024Patients with untreated mantle cell lymphoma treated with acalabrutinib plus bendamustine and rituximab had significant improvements in progression-free survival compared with bendamustine and rituximab alone.