Mogamulizumab Combo Significantly Improves PFS in Elderly Patients with Aggressive ATL

A combination therapy of the anti-CCR4 antibody mogamulizumab (Moga) with biweekly cyclophosphamide, doxorubicin, vincristine, and prednisone (Moga-CHOP-14) significantly improved progression-free survival (PFS) in elderly patients with aggressive adult T-cell leukemia/lymphoma (ATL) who were who were not candidates for allogeneic hematopoietic stem cell transplantation (HSCT).

Results from the phase II trial conducted at 21 centers in Japan were presented at the 2023 American Society of Clinical Oncology Annual Meeting by Ilseung Choi, MD, in the Department of Hematology and Cell therapy in the National Hospital Organization Kyushu Cancer Center in Fukuoka, Japan and colleagues.

Among the 48 evaluable patients, the median age was 74 years (interquartile range [IQR], 70-78). ATL subtypes included 31, nine, and eight patients with acute, lymphoma, and unfavorable chronic types, respectively. ATL-PI included nine, 31, and eight patients with high, intermediate, and low risk, respectively.

Patients received six cycles of Moga-CHOP-14, followed by two cycles of Moga monotherapy. The primary endpoint was one-year PFS, defined as the time from enrollment to the progression or relapse of ATL or death due to any cause, whichever occurred first. Secondary endpoints were complete response rate (CR), overall response rate (ORR), overall survival (OS), one-year event-free survival (EFS), and the incidence of adverse events.

With a median follow-up of 1.6 years (IQR, 0.7-2.4), 1-year PFS was 36.2% (90% confidence interval (CI), 24.9-47.6), and a median PFS was 0.7 years (95% CI, 0.5-1.0). CR and ORR were noted in 64.6% (95%CI, 49.5-77.8), and 91.7% (95% CI, 80.0-97.7), respectively. One-year OS was 66.0% (95% CI, 50.6-77.6) and median OS was 1.6 years (95%CI, 1.1-2.8). One-year EFS was 29.9% (95% CI, 17.6-43.2) and median EFS was 0.5 years (95%CI, 0.4-0.7).

The most frequent AEs grades 3 or 4, which occurred in >10% of patients were lymphocytopenia (97.9%), leukopenia (93.8%), neutropenia (89.6%), febrile neutropenia (64.8%), anemia (58.3%), thrombocytopenia (45.8%), infection (27.1%), skin rash (20.8%), and hyperglycemia (20.8%). Relative dose intensity (RDI) was calculated for each drug: the mean RDI for Moga was 82.1%, for cyclophosphamide 71.7%, for doxorubicin 72.7%, for vincristine 72.0%, and for prednisone 77.3%.

“This study demonstrated that Moga-CHOP-14 significantly improved PFS in elderly patients with aggressive CCR4-positive ATL who were ineligible for [allogeneic] HSCT,” the authors wrote. “Moga-CHOP-14 is now considered for the preferred first-line treatment in those patients.”

Reference

Choi I, Yoshimitsu M, Kusumoto S, et al. A phase 2 trial of CHOP with anti-CCR4 antibody mogamulizumab for elderly patients with CCR4-positive adult T-cell leukemia/lymphoma. Abstract #7504. Presented at the 2023 American Society of Clinical Oncology Annual Meeting; June 2-6, 2023; Chicago, Illinois.