Teclistamab (Tecvayli, Johnson & Johnson), a first-in-class bispecific T-cell–engaging antibody, is approved to treat relapsed/refractory multiple myeloma in the US.
On February 20, teclistamab’s (Tecvayli; Johnson & Johnson) supplemental biologics license application was approved by the FDA, following additional positive data from the MajesTEC-1 study (NCT03145181 and NCT04557098), clearing way for subcutaneous biweekly dosing of the first-in-class bispecific antibody in patients who have relapsed/refractory multiple myeloma and have failed at least 4 prior lines of therapy. The move expanded the first-in-class agent’s original accelerated approval from October 2022.
In this final part of our interview with Imran Khan, MD, PhD, vice president, Hematology Medical Affairs, Johnson & Johnson—also check out part 1 and part 2—he looks to the future ongoing development of teclistamab and the potential ultimate goal of a cure.
“At the end of the day, every patient, every single patient, is an individual patient,” he emphasizes, “and we need to make sure that we are treating these patients and maximizing the opportunity and the potential to get these patients into meaningful remissions.”
Transcript
What are planned next steps in the clinical development of teclistamab?
We're really encouraged, number 1, by the efficacy and safety profile as we really continue to study Tecvayli [teclistamab] in patients with relapsed/refractory multiple myeloma. Having said that, we're also investigating the potential use of Tecvayli in several monotherapy and combination studies, including in earlier lines in the disease. That's through a comprehensive clinical development program. So as the first bispecific T-cell–engaging antibody approved in the US for the treatment of multiple myeloma, Tecvayli has the longest follow-up data, and that data demonstrate deep as well as sustained responses for patients with relapsed/refractory multiple myeloma and nearly 2 years of treatment across all patient types.
When I say these words, it's very profound when you think about this patient population in terms of not only the number of lines of therapy they've received, but, quite frankly, in terms of their prognosis. So it is quite transformational in that regard. And finally, Tecvayli also has the longest in-market experience, as I mentioned earlier, by physicians, and Johnson & Johnson really continues to invest in gathering new data on the patient experience and outcomes in a variety of settings, because that's equivalently important as well.
As an oncologist, this excites me so much, because at the end of the day, every patient, every single patient, is an individual patient, and we need to make sure that we are treating these patients and maximizing the opportunity and the potential to get these patients into meaningful remissions—not simply for the short term, but for the long term as well as much as possible. I think what I'm proud of is as an organization, our commitment to continue to develop a comprehensive portfolio to address the needs of each and every patient. And quite frankly, while I said earlier it's an incurable disease today, we are aiming for cure. That is something that's very much on our radar. It's not something we simply say, and hopefully that what you see is that what we're doing is really a commitment to that effort.
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