Rajat Bannerji, MD, PhD, hematologist/oncologist and chief of hematologic malignancies at the Rutgers Cancer Institute of New Jersey, discusses the toxicity profile of odronextamab (REGN1979) in non-Hodgkin lymphoma (NHL). 

During the 2020 ASH Annual Meeting & Exposition, the study schema of an ongoing phase 2 trial (NCT03888105) of odronextamab, a CD20 x CD3 bispecific antibody, in patients with relapsed/refractory B-cell NHL was presented virtually. Previously reported data demonstrated encouraging antitumor activity and manageable toxicity with odronextamab among this patient population. 

To date, safety signals with odronextamab include low-grade cytokine release syndrome and low-grade central nervous system toxicities, explains Bannerji. Notably, these toxicities tend to appear early in the treatment course. Other higher-grade toxicities, including infection, were observed and could present later, Bannerji says. However, very late-onset toxicities were not observed among patients who received odronextamab and remain in remission and off-treatment for over 1 year, concludes Bannerji.

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Rajat Bannerji, MD, PhD, discusses the toxicity profile of odronextamab in non-Hodgkin lymphoma.  



Dr. Bannerji on the Toxicity Profile of Odronextamab in Non-Hodgkin Lymphoma 

Rajat Bannerji, MD, PhD, hematologist/oncologist and chief of hematologic malignancies at the Rutgers Cancer Institute of New Jersey, discusses ongoing research with the bispecific antibody REGN1979 in non-Hodgkin lymphoma (NHL).

The dual CD3- and CD20-targeted bispecific antibody was evaluated in a phase I study in patients with relapsed/refractory NHL. The dose-escalation and dose-finding portion of the study has completed, says Bannerji. Investigators will continue to enroll to expansion cohorts to better define the activity of the agent in follicular lymphoma and in large cell lymphoma.

Based on the phase I experience, the sponsor has launched a phase II study, which will enroll patients with a number of B-cell lymphomas. Currently, it's open in follicular lymphoma, says Bannerji. In Europe, REGN1979 is being evaluated in combination with a checkpoint inhibitor. Moving forward, the drug will be evaluated as monotherapy and in various combinations to define its optimal role in the space, concludes Bannerji.

Dr. Bannerji on Ongoing Research With REGN1979 in Non-Hodgkin Lymphoma

Rajat Bannerji, MD, PhD, hematologist/oncologist and chief of hematologic malignancies at the Rutgers Cancer Institute of New Jersey, discusses the clinical activity of the bispecific antibody REGN1979 in patients with non-Hodgkin lymphoma (NHL).

Phase I safety and efficacy data regarding the human anti-CD20 x anti-CD3 bispecific IgG4 antibody were presented at the 2019 ASH Annual Meeting. Among the 22 patients with relapsed/refractory follicular lymphoma who received ≥5 mg of REGN1979, the overall response rate (ORR) was 95.5%, and the complete remission (CR) rate was 77.3%. At a median follow-up of 6.8 months, the median progression-free survival was 11.4 months in the relapsed/refractory follicular lymphoma cohort.

Among a subset of patients with relapsed/refractory diffuse large B-cell lymphoma who received ≥80 mg of REGN1979, the ORR rate was 57.9% and the CR rate was 42.1%. When broken down by prior CAR T-cell exposure, the ORR was 71.4% and the CR rate was 100% in patients who did not receive prior CAR T-cell therapy. In those who received prior CAR T-cell therapy, the ORR was 50% and the CR rate was 25%.

Patients with mantle cell lymphoma and marginal zone lymphoma were also included in the trial and experienced an ORR and CR rate of 67% and 33%, respectively.

Rajat Bannerji, MD, PhD

Articles

Dr. Bannerji on the Toxicity Profile of Odronextamab in Non-Hodgkin Lymphoma

Dr. Bannerji on Ongoing Research With REGN1979 in Non-Hodgkin Lymphoma

Dr. Bannerji on the Clinical Activity of the Bispecific Antibody REGN1979 in NHL