First Bispecific Antibody, Teclistamab, Now FDA Approved in Multiple Myeloma

Posted: Oct 25, 2022

Treatment Advances

Today the FDA approved teclistamab, the first bispecific antibody to be used in relapsed or refractory multiple myeloma.

Teclistamab (brand named TECVAYLI™) was approved for patients who received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody.

Teclistamab is an off-the-shelf product given by subcutaneous injection (a shot) that links BCMA, a target on myeloma cells, with T cells to kill myeloma. The drug was approved based on results from the Phase II MajesTEC-1 clinical trial that included 110 patients.

The trial data included the following results for patients who had a median of 5 prior lines of therapy (78% of patients received four or more prior lines of therapy):

61.8% Overall Response Rate
58.8% of patietns had a very good partial response (VGPR) or better
28.2% achieved a complete response or better
Median duration of response was 18.4 months

Dr. Ajai Chari, MD at the Icahn School of Medicine at Mount Sinai said:

“In the pivotal teclistamab study, we have continued to observe positive results in heavily pretreated patients with relapsed or refractory multiple myeloma. As a clinician and researcher, I see first-hand the human toll of this incurable disease. The approval of teclistamab, as the first bispecific antibody in relapsed or refractory multiple myeloma, is a meaningful step in helping many of these hard-to-treat patients.”

The most common side effects in the Phase I/II study were:

Cytokine release syndrome (72% with .6% being Grade 3 and no Grade 4)
Neutropenia (64% Grade 3 or 4)
Anemia (55%, 37% Grade 4 or 4)
Infection (37% with respiratory tract infections being most common)
Patients receiving IVIG (39%)
Neurotoxic events were low grade (15% total with 14% being Grade 1 or 2)
ICANS (2.43% with Grade 3 or 4) Watch this video to better understand ICANS

Because there is a possiblity of of Cytokine Release Syndrome and neurological toxisity, the drug will include a Risk Evaluation and Mitigration Strategy (REMS) program.

Click here to review the initial results of the Phase I/II study published in the New England Journal of Medicine.

We look forward seeing this new BCMA-directed therapy used in the myeloma clinic that can be used by patients who many not be able to wait for CAR T therapy.

Additional Stories on Teclistamab

Updated Teclistamab Results in Multiple Myeloma

European Approval of Teclistamab Beats FDA to the Punch in Myeloma

ASCO 2021: FDA Grants Breakthrough Therapy Designation to Teclistamab in Mulitple Myeloma

FDA Expanded Access Program for Teclistamab

Guest Lecture: Teclistamab, Hans Lee, MD, MD Anderson Cancer Center

Myeloma Therapies: Bispecific Antibodies, CAR T and Antibody Drug Conjugates. How Do You Choose?