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Clinical Trial
. 2022 Apr 15;128(8):1595-1604.
doi: 10.1002/cncr.34106. Epub 2022 Feb 14.

Ofatumumab plus HyperCVAD/HD-MA induction leads to high rates of minimal residual disease negativity in patients with newly diagnosed mantle cell lymphoma: Results of a phase 2 study

Pallawi Torka  1 , Othman S Akhtar  1 , Nishitha M Reddy  2 , Bora E Baysal  1 , Angela Kader  1 , Adrienne Groman  1 , Jenna Nichols  1 , Cory Mavis  1 , Joseph D Tario  1 , AnneMarie W Block  1 , Sheila N J Sait  1 , Paola Ghione  1 , Suchitra Sundaram  3 , Eugene R Przespolewski  1 , Alice Mohr  1 , Ian Lund  1 , Jessica Kostrewa  1 , Kenneth McWhite  1 , Joseph DeMarco  1 , Michael Johnson  1 , Andrea Darrall  1 , Rosh-Neke Thomas-Talley  1 , Paul K Wallace  1 , Vishala Neppalli  4 , Alan Hutson  1 , Francisco J Hernandez-Ilizaliturri  1
Affiliations
Clinical Trial

Ofatumumab plus HyperCVAD/HD-MA induction leads to high rates of minimal residual disease negativity in patients with newly diagnosed mantle cell lymphoma: Results of a phase 2 study

Pallawi Torka et al. Cancer. .

Abstract

Background: Ofatumumab is a humanized type 1 anti-CD20 monoclonal antibody. Preclinical studies show improved complement-mediated cytotoxicity (CMC) compared to rituximab in mantle cell lymphoma (MCL). This study evaluates the safety and efficacy of combining ofatumumab with HyperCVAD/MA (O-HyperCVAD) in newly diagnosed MCL.

Methods: In this single-arm phase 2 study, 37 patients were treated with the combination of O-HyperCVAD for 4 or 6 cycles, followed by high dose chemotherapy and autologous stem cell transplant. Primary objectives were overall response rate (ORR) and complete response (CR) rate at the end of therapy. Secondary objectives included minimal residual disease (MRD) negativity, progression-free survival (PFS), and overall survival (OS).

Results: Median age was 60 years; ORR was 86% and 73% achieved a CR by modified Cheson criteria. The MRD negativity rate was 78% after 2 cycles of therapy, increasing to 96% at the end of induction; median PFS and OS were 45.5 months and 56 months, respectively. Achieving a post-induction CR by both imaging and flow cytometry was associated with improved PFS and OS. Early MRD negativity (post-2 cycles) was also associated with an improved PFS but not OS. There were 3 deaths while on therapy, and grades 3 and 4 adverse events (AEs) were observed in 22% and 68% of the patients.

Conclusion: The addition of ofatumumab to HyperCVAD/HD-MA led to high rates of MRD negativity by flow cytometry in patients with newly diagnosed MCL. Achieving a CR post-induction by both imaging and flow cytometry is associated with improved overall survival.

Trial registration: ClinicalTrials.gov NCT01527149.

Keywords: CD20; MIPI score; monoclonal antibody; p53; survival outcomes.

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Figures

Figure 1:
Figure 1:
Trial design
Figure 2:
Figure 2:
Patient Disposition
Figure 3:
Figure 3:
Survival Outcomes; OS (A) and PFS (B) estimates for the cohort (n=37). Kaplan-Meier estimates of OS (C) and PFS (D) in patients who achieved a complete response by both high sensitivity flow cytometry and imaging criteria (HSFCM-CR) compared to those who did not.
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