Tecvayli, which was recently approved for pretreated relapsed/refractory myeloma, is a “much more convenient” treatment option than CAR-T cell therapy, one expert said.
With long wait times and manufacturing delays for CAR-T cell therapies, the Food and Drug Administration’s recent approval of Tecvayli (teclistamab-cqyv) for relapsed or refractory myeloma is a welcomed addition to the portfolio of drugs that are available to treat this disease, according to Dr. Omar Nadeem, the clinical director of the Myeloma Immune Effector Cell Therapy Program and Center for Prevention of Progression at the Dana-Farber Cancer Institute in Boston.
Tecvayli’s approval is for patients with relapsed/refractory myeloma who have undergone four or more lines of therapy — the same setting in which there are two FDA-approved CAR-T cell therapies for this patient population.
“If you are a patient or caregiver, you're probably familiar that there's been a long wait list over the last few years for these CAR-T products. We've been talking about them but are not necessarily able to offer it to all the patients who need it,” Nadeem said in an interview with CURE®. “So now having this approval come in the same space, and the fact that this is much more convenient and off the shelf and doesn't require manufacturing, is hopefully going to help a lot of those patients that have been waiting on these wait lists.”
Nadeem explained that the CAR-T process is lengthy: it involves taking blood from patients and then sending it off to be engineered to better fight cancer (a step at which there may be delays), before it is infused back into the patient. Also, there is limited supply of CAR-T cell products to begin with due to supply chain issues, Nadeem explained.
“In some circumstances, we have patients who want to get CAR-T cell therapy and we take them through the collection process and then the manufacture ring, which can sometimes take one to two months… so in that circumstance, sometimes, unfortunately, we missed the window to treat the patient,” Nadeem said.
Conversely, Tecvayli is an off-the-shelf product, meaning that it is not created with the use of individual patient cells. As such, clinicians can just order the drug for their patients, and can skip the blood collection and engineering steps that are seen with CAR-T cell therapy.
“Now, (with Tecvayli), that whole (care) gap is going to essentially be gone. We’re able to treat patients in real time, and hopefully we’re able to help more patients,” Nadeem said. “(Tecvayli) is a bispecific antibody. So basically, there is the same well of engaging the T cells to direct them toward myeloma, but doing it via a mechanism that does not require a whole manufacturing and cell collection.”
Nadeem also explained that research has shown lower instances and decreased severity of cytokine release syndrome and neurotoxicity — two common and potentially serious side effects of CAR-T cell therapy. Though he did admit that there is limited clinical experience with Tecvayli, and much more data for CAR-T cell therapies.
While Tecvayli may be a promising option for patients with pretreated, relapsed/refractory myeloma, Nadeem explained that more work is still needed in this space, especially when it comes to moving therapies out of the inpatient setting.
The rates of cytokine release syndrome — a dangerous side effect where the body releases too many inflammatory molecules called cytokines — may be lower with Tecvayli, but the FDA still mandates that patients are hospitalized during the initial doses of the therapy, so that clinicians can monitor for it.
“We’re sometimes having a hard time getting even our current CAR-T cell patients or transplant patients (in), and there's always, patients waiting in the emergency room waiting to be admitted,” Nadeem said. “So it really creates a crunch in terms of how many people how many myeloma patients in general can be treated in a hospital with all of our approved products.”
Nadeem is hoping that future trials will address how to administer Tecvayli in the outpatient setting, so that patients do not need to be admitted to the hospital, or how to give the therapy and get patients discharged faster.
“Since they are going to be the same patients … if you're either going to get one of the two CAR-T products (Tecvayli), then maybe we won't have to treat as many CAR-T cell patients,” Nadeem said. “So I think over time, it may balance each other out.”
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