Teclistamab is a bispecific antibody that binds the protein CD3 (expressed on the surface of cancer killing T-cells) to BCMA (a protein expressed at high levels of multiple myeloma cells).
This construct draws the cancer killer in direct contact with the cancerous myeloma cell to cause cell death of our cancer. The drug has been developed by Johnson & Johnson/Janssen, the marketers of both Darzalex and CARVYKTI (BCMA-targeting CAR-T). The company has presented several updates from their clinical trials in patients with relapsed/refractory multiple myeloma (RRMM) with at least three prior lines of therapy.
Data from the 165 the relapsed/refractory myeloma patients just treated with teclistamab can be summarized as follows:
Additional specifics can also be found in a recent short, and easily readable, article published in the New England Journal of Medicine.
Results from two clinical trials can be summarized as follows:
I am very comfortable making the statement that just about all of us, myeloma patients, have had our Quality of Life (QOL) impacted to various degrees in the course of our treatment journey. It is therefore heartening to see the publication of a study that monitored QOL of the patients enrolled in the teclistamab studies. Key conclusions are:
There are some patients who have relapsed after they have already been treated with novel anti-BCMA therapies [such as Blenrep, Abecma, Carvykti] either in clinical trials or in a regular clinical setting. The question arises whether such relapsed patients may find another lifeline with teclistamab. This study included a total of 40 relapsed patients.
“These patients had received a median of six prior lines of therapy, most (85 percent) were triple-class refractory and 35 percent were penta-drug refractory."
Key reported outcomes are:
Johnson & Johnson has two ongoing studies involving Darzalex Faspro:
In June 2021, Johnson & Johnson received “Breakthrough Therapy Designation” from FDA that expedites “the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition and is based on preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.”
In addition, the Company submitted its regulatory dossier to FDA in December 2021. Under the current procedures at FDA, it is reasonable to expect that teclistamab will be approved around mid-year of 2022, barring unforeseen regulatory or clinical circumstances. This product will give another treatment option AND additional hope to critically ill patients.
about the author
Paul Kleutghen
I am a patient diagnosed in 2014 with primary plasma cell leukemia (pPCL), a rare and aggressive variant of multiple myeloma and have been very fortunate to find successful treatment at the division of Cellular Therapy at the Duke University Cancer Institute. My wife, Vicki, and I have two adult children and two grandsons who are the ‘lights of our lives’. Successful treatment has allowed Vicki and I to do what we love best : traveling the world, albeit it with some extra precautions to keep infections away. My career in the pharmaceutical industry has given me insights that I am currently putting to use as an advocate to lower drug pricing, especially prices for anti-cancer drugs. I am a firm believer that staying mentally active, physically fit, compliant to our treatment regimen and taking an active interest in our disease are keys to successful treatment outcomes.
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