Safety and efficacy of odronextamab in patients with relapsed or refractory follicular lymphoma
Tae Min Kim, Michał Taszner, Silvana Novelli, Seok‐Goo Cho, José C. Villasboas, Michele Merli, Ana Jiménez Ubieto, Benoît Tessoulin, Li Mei Poon, David Tucker, Jan Walewski, Shuhua Yi, Yue Song, Geoffrey Chong, Emmanuel Bachy, Stéphanie Guidez, Aránzazu Alonso, Deepa Jagadeesh, W. Zhang, Laura Magnano, Elżbieta Iskierka‐Jazdzewska, M. Tani, Biyi Shen, Amulya Uppala, Min Zhu, Salimah Z. Shariff, Jurriaan Brouwer‐Visser, Arvind Chaudhry, Hesham Mohamed, Srikanth Ambati, Stefano Luminari
Abstract
BACKGROUND: Odronextamab, a CD20×CD3 bispecific antibody that engages cytotoxic T cells to destroy malignant B cells, has demonstrated encouraging activity across multiple subtypes of relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma. PATIENTS AND METHODS: This phase II study (ELM-2; NCT03888105) evaluated odronextamab in patients with R/R follicular lymphoma after two or more lines of systemic therapy. Patients received intravenous odronextamab in 21-day cycles, with step-up dosing in cycle 1 to help mitigate the risk of cytokine release syndrome, until disease progression or unacceptable toxicity. The primary endpoint was objective response rate by independent central review. RESULTS: Among 128 patients evaluated, 95% completed cycle 1, and 85% completed four or more cycles. At 20.1 months' efficacy follow-up, objective response rate was 80.0% and complete response rate was 73.4%. Median duration of complete response was 25.1 months. Median progression-free survival was 20.7 months, and median overall survival was not reached. Discontinuation of odronextamab due to adverse events occurred in 16% of patients. The most common treatment-emergent adverse events were cytokine release syndrome [56%; grade ≥3 1.7% (1/60) with 0.7/4/20 mg step-up], neutropenia (39%), and pyrexia (38%). CONCLUSIONS: Odronextamab achieved high complete response rates with generally manageable safety in patients with heavily pretreated R/R follicular lymphoma.