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Regeneron reveals first data for bispecific antibody in multiple myeloma

Could be a pivotal treatment for patients who have exhausted options


Regeneron has made its first appearance on the BCMA scene, revealing data for its bispecific antibody candidate REGN5458 in multiple myeloma. 

The antibody targets BCMA, a protein that is typically over-expressed on multiple myeloma cells, by binding to it and the CD3 receptor on T-cells, bringing them together and activating T-cell killing of the cancer cells.

The much anticipated first results from the first two dose groups in the phase 1/2 trial of REGN5458 were presented at ASH 2019. The two doses studied were at 3mg and 6mg, administered weekly.

Patients had a median of seven lines of prior therapy, and has all failed CD38 antibody treatment. The results from treatment with REGN5458 were impressive – responses were observed in four of seven (57%) of patients, including three of four (75%) in the higher dosage group.

Also in the higher, 6mg dose group, two patients were minimal residue disease negative – this means that no cancer cells were detected in their bone marrow.

The safety profile of the antibody is encouraging – at the data cutoff, there had been no neurotoxicity, dose-limiting toxicities or treatment discontinuations due to adverse events.

There was, however, a number of reported adverse events, with the most common of these being lymphopenia, anaemia and thrombocytopenia and cytokine release syndrome.

Five patients experienced grade 3 or higher treatment-emergent adverse events, including lymphopenia, hypertension, anaemia, atrial fibrillation fatigue, febrile neutropenia, pain in extremity, septic shock and thrombocytopenia.

"We are encouraged to see promising, rapid clinical activity even at the initial two doses of REGN5458 in heavily pre-treated patients with multiple myeloma” said Israel Lowry, senior vice president and head of clinical and translational sciences for oncology at Regeneron.

“Two patients achieved the high bar of MRD negativity, and another patient attained a very good partial response despite entering the trial with difficult-to-treat plasmacytomas outside of the bone marrow," he added.

The BCMA protein has emerged as the most promising new target in multiple myeloma, and is being pursued by a host of competing pipeline candidates. This includes CAR-Ts from Celgene/Bluebird Bio, Celgene/Juno, J&J/Legend Biotech, a drug antibody conjugate from GSK and a bispecific antibody from Amgen.

At the beginning of the year, Sanofi updated its $2.17bn immuno-oncology deal with Regeneron, paying $462m to gain opt-in options for REGN5458 as well as REGN4018, a MUC16 CD3 targeting bispecific antibody.

Article by
Lucy Parsons

10th December 2019

From: Research



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