Dr Fenske on Assessing the Role of Auto-HCT in the Current MCL Treatment Paradigm

“We undertook this study, ECOG-ACRIN EA4151, to explore whether the autologous transplant does still offer benefit [to patients] in the current [MCL] treatment era.”

Timothy S. Fenske, MD, MS, section head of Hematologic Malignancies in the Division of Hematology/Oncology at the Medical College of Wisconsin, discussed the rationale for the phase 3 ECOG-ACRIN EA4151 trial (NCT-3267433) investigating autologous hematopoietic cell transplantation (auto-HCT) in patients with mantle cell lymphoma (MCL).

Patients with MCL are typically treated with auto-HCT once they have achieved complete remission (CR) with first-line therapy, Fenske began. However, with the advent of improved first-line treatment options for this patient population, the necessity of auto-HCT has come into question, he said.

Notably, the phase 3 TRIANGLE trial (NCT02858258) previously showed that auto-HCT did not provide added benefit when used in conjunction with induction and maintenance therapy regimens containing rituximab (Rituxan), ibrutinib (Imbruvica), and high-dose cytarabine in patients with MCL.

The ECOG-ACRIN EA4151 trial was designed to answer the question of whether auto-HCT is still beneficial in the context of this expanded treatment paradigm, according to Fenske. The study enrolled patients with MCL experiencing first deep CR with frontline rituximab-containing induction therapy, as measured by a minimal residual disease (MRD) assay. Overall survival served as the study’s primary end point. Progression-free survival and undetectable MRD conversion rates served as key secondary end points.

The trial assigned a total of 650 patients to 1 of 4 arms: auto-HCT plus rituximab in patients in MRD-negative CR (arm A; n = 257), rituximab alone in patients in MRD-negative CR (arm B; n = 259), auto-HCT plus rituximab in patients in partial response or MRD-positive CR (arm C; n = 49), and auto-HCT plus rituximab in patients with indeterminate MRD status (arm D; n = 85).

Disclosures: Fenske reported receiving honoraria from AbbVie, Adaptive Biotechnologies, ADC Therapeutics, AstraZeneca, Beigene, Janssen, Kite, Lilly, Ono Pharmaceuticals, SeaGen, and Bayer; performing speakers bureau roles with AstraZeneca, Beigene, Kite, and SeaGen; and performing consultancy roles for AbbVie, Adaptive Biotechnologies, ADC Therapeutics, AstraZeneca, Beigene, Janssen, Kite, Lilly, Ono Pharmaceuticals, SeaGen, and Bayer.