Express 90% chance of maintaining refractory tumor response for more than half a year! Pfizer's bispecific antibody was designated as a breakthrough therapy

Pfizer today announced that its cancer immunotherapy elranatamab has received Breakthrough Therapy Designation (BTD) from the U.
S.
FDA for the treatment of patients with
relapsed/refractory multiple myeloma (RRMM).
Elranatamab is a bispecific antibody
targeting B cell maturation antigen (BCMA) and CD3.

Multiple myeloma is a cancer of blood cells that is still incurable and mainly affects a type of cell
called plasma cells in the bone marrow.
When malignant, these plasma cells spread and replace normal cells
within the bone marrow.
Multiple myeloma is the second most common hematological cancer, affecting 1.
7 people per 100,000 people worldwide
.
In 2020, an estimated 176 000 people worldwide were diagnosed with multiple myeloma
.
Although a small number of patients have no obvious symptoms at the time of diagnosis, most patients will have fractures, pain, low red blood cell levels, fatigue, high calcium levels, kidney problems, infections, etc.
, and are diagnosed with multiple myeloma
.
It is still an incurable blood cancer and almost all patients relapse and require follow-up treatment
.
As the disease progresses, each recurrence becomes more aggressive, while the period of remission obtained with new therapies is gradually shortened
.

Elranatamab (PF-06863135) is a bispecific antibody
that targets B cell maturation antigens.
It binds to BCMA at one end and CD3 receptors on the surface of T cells at the other, thereby activating T cells to kill BCMA-expressing cancer cells
.
Elranatamab is treated with subcutaneous injection, which is more convenient than intravenous injection and may slow the occurrence
of potential side effects such as cytokine release syndrome (CRS).
Elranatamab is granted orphan drug designation by the U.
S.
FDA and the European Medicines Agency (EMA) for the treatment of multiple myeloma
.
and obtained Fast Track designation and Priority Drug Designation from the FDA and EMA, respectively, for the treatment of patients with
relapsed/refractory multiple myeloma.

Image source: 123RF

The breakthrough therapy designation is based on 6-month tracking data
from Cohort A (n=123) in the MagnetisMM-3 Phase 2 trial.
This trial examined the efficacy and safety
of elranatamab as monotherapy in patients with RRMM.
Data analysis showed that the overall response rate (ORR) of patients treated with 76 mg of subcutaneous injection of elranatamab per week was 61.
0%
during a median follow-up period of 6.
8 months.
In patients who respond, there is a 90.
4% chance that the response will be maintained for ≥ 6 months
.
Regardless of cause, the most common treatment associated adverse effects (TEAEs) were CRS (57.
9%), most of which were grade 1 (43.
2%) or grade 2 (14.
2%)
.

"By granting Elranatamab breakthrough therapy designation, the FDA recognizes the potential of this drug as an innovative therapy for the treatment of RRMM patients, a disease for which there has been no cure until now," said Chris Boshoff, Ph.
D
.
, Chief Development Officer, Global Product Development, Pfizer Oncology.
We look forward to working with the FDA to accelerate the development of
this therapy.
" ”