Jason Romancik, MD, discusses the design and key results from the phase 2 PILOT study.
Jason Romancik, MD, assistant professor, Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, discusses the design and key results from the phase 2 PILOT study (NCT03483103).
The single-arm study evaluated the efficacy and safety of lisocabtagene maraleucel (liso-cel, Breyanzi) in the second-line setting for transplant-ineligible patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL). The study had no comparison to current standard of care, Romancik states.
Patients included in the study population were predominantly high-risk and had generally poor prognosis, Romancik continues. The median age of participants was 74 years, and a majority of patients had medical comorbidities that made them ineligible for hematopoietic stem cell transplantation (HSCT). Patients with poor performance status were also eligible for enrollment, and 26% of patients had an ECOG performance status of 2. Furthermore, most patients relapsed within 1 year of first-line therapy. Researchers also utilized the HCT comorbidity index (HCT-CI) to evaluate and predict treatment-related mortality, and 44% of patients had an HCT-CI score greater than 3.
Results from the PILOT study showed an overall survival response of 80% and a complete response rate of 54%. Although median progression-free survival was capped at 9 months, the tail end of the Kaplan-Meier survival curve started to plateau at this cut-off, indicating that some patients may experience long-term benefit or long-term remission from this treatment, Romancik concludes.