Pfizer Inc. has paused a clinical trial of a drug for multiple myeloma (MM) after several patients treated with the agent have reportedly developed nerve damage. The decision was announced on May 4, 2021, in a statement from the company.
The drug, elranatamab, is a B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody being tested for treatment of relapsed or refractory MM in the phase 2 MagnetisMM-3 trial. The trial initiated in February 2021, but enrollment has been put on pause after three patients enrolled in a phase 1 trial of the drug developed peripheral neuropathy, or damage to the peripheral nerves.
In the phase 1 MagnetisMM-1 trial, treatment with elranatamab led to an 83% response rate in the thirty-patient cohort, with one third of patients achieving a complete response.
Enrollment will be halted as the company provides additional information regarding the occurrence of these side effects to the Food and Drug Administration (FDA), though patients who are showing beneficial response will continue to receive treatment.
“We have collected information about the cases, and the formal response package will be submitted to the FDA,” a Pfizer spokesperson told BioPharma Dive, noting that “various types of peripheral neuropathy have been reported in published literature” for other approved and investigational MM treatments.
— Nicolas Ferreyros (@nickcf) May 5, 2021
Important bit here with this pause as Pfizer really needs that pipeline working for them in areas where the path to market is easier (i.e. oncology vs immunology & inflammation where their JAK strategy is challenged)..
Elranatamab (PF-06863135) pic.twitter.com/Hi2NFag3Om
— John T. Bresnahan (@john_bresnahan) May 4, 2021