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In an interview with Pharmacy Times®, Sundar Jagannath, MD, MBBS, professor of medication—hematology and oncology at Mount Sinai Health System, mentioned key outcomes from the LINKER-MM1 trial of linvoseltamab (Lynozyfic; Regeneron), a BCMA-CD3 bispecific antibody accredited for the remedy of relapsed or refractory a number of myeloma (R/R MM). The agent demonstrated a excessive total response price, with roughly 50% reaching full remission or higher, even amongst sufferers who had exhausted normal therapies.
Jagannath emphasised the manageable security profile of linvoseltamab, highlighting a low price of neurotoxicity and largely gentle cytokine launch syndrome (CRS). Notably, linvoseltamab’s step-up dosing technique—with only a 24-hour hospitalization—makes it particularly appropriate for older adults, providing a sensible different to CAR T-cell remedy, Jagannath explains.
Pharmacy Times: Can you clarify the outcomes of the LINKER-MM1 trial?
Sundar Jagannath, MD, MBBS: Yes, this can be a bispecific antibody, and we participated within the LINKER-MM1 trial at our heart. I had firsthand expertise with it and had the prospect to current the outcomes at AACR in 2024. The outcomes at the moment are revealed in JCO. As a category, BCMA-CD3 bispecific antibodies have an total response price of round 70%, so we have been happy that linvoseltamab carried out very effectively. Most responses have been deep—50% achieved full remission or higher. I don’t recall the general MRD price, however at our heart, we carry out MRD testing, and I’ve sufferers who achieved MRD negativity, which is implausible for sufferers who had failed 3 or extra prior strains of remedy. These sufferers had been uncovered to the principle courses: proteasome inhibitors, IMiDs, and anti-CD38 monoclonal antibodies. Realistically, you may say they have been uncovered to quadruple remedy, as dexamethasone is included in all regimens. Importantly, there was an excellent proportion of high-risk sufferers on this trial—a couple of third—and so they all responded.
From a clinician’s perspective, linvoseltamab is effectively tolerated and efficient. What’s distinctive about it’s the step-up dosing. It’s administered as soon as per week with 24-hour hospitalization. This is particularly appreciated by aged sufferers who don’t need to be within the hospital for 7 days like another step-up regimens require. Some older adults expertise confusion or discomfort with extended hospitalization, so the 24-hour keep is an enormous plus. The step-up dosing is mild: beginning at 5 mg (1/20 of the complete dose), then 25 mg (about 1/8), after which the complete dose. CRS was noticed in about 46% of sufferers, however most of it was gentle—grade 1. That means over 50% didn’t get CRS, and when it did happen, it was manageable. In the trial, investigators may use tocilizumab (Actemra; Genentech) or dexamethasone. About 22% used tocilizumab, and one other 10–15% used dexamethasone. Neurotoxicity (ICANS) was low, at round 7.7%, with a balanced distribution throughout grades. Now that the drug is commercially obtainable, folks ask me if I’d use it. Absolutely. Especially for sufferers aged over 75, it’s an important choice. Many sufferers within the trial have been aged over 65 or 70 years, making it a really promising selection in comparison with chimeric antigen receptor (CAR) T-cell remedy, which is tougher to supply to older sufferers as a result of dangers and logistics. Linvoseltamab is a really palatable, accessible different.
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This web page was created programmatically, to learn the article in its authentic location you…
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This web page was created programmatically, to learn the article in its authentic location you…
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