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Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell–Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial

Catherine Thieblemont , MD, PhD; Tycel Phillips, MD; Herve Ghesquieres , MD, PhD; Chan Y. Cheah, MBBS, DMSc; Michael Roost Clausen, MD, PhD; David Cunningham, MD; Young Rok Do, MD, PhD; Tatyana Feldman, MD; Robin Gasiorowski, MBBS, PhD; Wojciech Jurczak, MD, PhD; Tae Min Kim, MD, PhD; David John Lewis, MD; Marjolein van der Poel, MD, PhD; Michelle Limei Poon, MD; Mariana Cota Stirner, MD, PhD; Nurgul Kilavuz, MSc; Christopher Chiu , PhD17; Menghui Chen, PhD; Mariana Sacchi, MD; Brian Elliott, MD; Tahamtan Ahmadi, MD, PhD; Martin Hutchings, MD, PhD; and Pieternella J. Lugtenburg, MD, PhD

Journal of Clinical Oncology

December 22, 2022

PATIENTS AND METHODS

In the dose-expansion cohort of a phase I/II study (ClinicalTrials.gov identifier: NCT03625037), adults with relapsed or refractory CD20+ large B-cell lymphoma and at least two prior therapy lines (including anti-CD20 therapies) received subcutaneous epcoritamab in 28-day cycles (once weekly step-up doses in weeks 1-3 of cycle 1, then full doses once weekly through cycle 3, once every 2 weeks in cycles 4-9, and once every 4 weeks in cycle 10 and thereafter) until disease progression or unacceptable toxicity. The primary end point was overall response rate by the independent review committee.

RESULTS

As of January 31, 2022, 157 patients were treated (median age, 64 years [range, 20‐83]; median of three [range, 2-11] prior therapy lines; primary refractory disease: 61.1%; prior chimeric antigen receptor (CAR) T-cell exposure: 38.9%). At a median follow-up of 10.7 months, the overall response rate was 63.1% (95% CI, 55.0 to 70.6) and the complete response rate was 38.9% (95% CI, 31.2 to 46.9). The median duration of response was 12.0 months (among complete responders: not reached). Overall and complete response rates were similar across key prespecified subgroups. The most common treatment-emergent adverse events were cytokine release syndrome (49.7%; grade 1 or 2: 47.1%; grade 3: 2.5%), pyrexia (23.6%), and fatigue (22.9%). Immune effector cell–associated neurotoxicity syndrome occurred in 6.4% of patients with one fatal event.

CONCLUSION

Subcutaneous epcoritamab resulted in deep and durable responses and manageable safety in highly refractory patients with large B-cell lymphoma, including those with prior CAR T-cell exposure.

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