Regeneron Pharmaceuticals has presented positive data for odronextamab from Phase I ELM-1 and Phase II ELM-2 trials at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, US, from 9 to 12 December.

Odronextamab is a CD20xCD3 targeting bispecific antibody which is currently being evaluated by the US Food and Drug Administration (FDA) as a treatment for relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL) and r/r follicular lymphoma (FL). The agency has set a PDUFA date for odronextamab on 31 March 2024.

Regeneron has also disclosed updated Phase I/II LINKER-MM trial data for linvoseltamab as a treatment for r/r multiple myeloma (MM). Linvoseltamab is a B-cell maturation antigen (BCMA) and CD3-targeting bispecific antibody.

At eight months follow-up, the median duration of response (DoR) and median progression-free survival (PFS) have not been reached, said Dr. Hans Lee, LINKER-MM trial investigator, in an interview with Clinical Trials Arena.

Odronextamab trial data

The open-label Phase II ELM-2 trial (NCT03888105) investigating odronextamab enrolled patients with B-cell non-Hodgkin lymphoma who have received at least two prior lines of systemic therapy. The objective response rate (ORR) of 52% was observed in the 127 patients enrolled in the DLBCL cohort at 36 weeks of follow-up. The DoR was ten months, with 31% of the participants achieving complete response (CR).

The prespecified interim analysis occurred when the first 80 patients had at least 12 months of follow-up. The data showed an ORR of 80% among 128 patients in the FL cohort and DoR was 23 months, with 73% of the participants achieving CR.

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Median OS was not reached, and the median duration of CR was 24 months. The median PFS in complete responders was 28 months and 21 months for all patients.

The quality of life and functional measures were maintained in the FL cohort, said trial investigator Dr Benoît Tessoulin told Clinical Trials Arena. The FL cohort patients maintained moderate to high levels of functioning and health-related quality of life (HRQoL).

The most common adverse events observed in both groups were similar and included cytokine release syndrome (CRS), anaemia, pyrexia, and fatigue.

Linvoseltamab trial data

Patients enrolled in the Phase I/II LINKER-MM trial (NCT03761108), which investigated linvoseltamab, demonstrated an ORR of 69% at the median follow-up of eight months, said Lee. The ORR was similar to the data reported on 7 December, with patients who received the 200mg dose of linvoseltamab achieving an ORR of 71% at the median follow-up of 5.6 months.

Although median DoR and median PFS were not reached, the estimated nine-month DOR was 87% and the estimated nine-month PFS was 73%, Lee noted.

The most commonly observed adverse event was CRS, with 36% of the CRS episodes being Grade I and one Grade III CRS event. Most common Grade III and IV adverse events were haematologic in nature such as anaemia, neutropenia, and thrombocytopenia, he added.