The U.S. Food and Drug Administration (FDA) has approved the combination of Tecvayli (teclistamab) and Darzalex Faspro (daratumumab and hyaluronidase-fihj) for treating certain people with multiple myeloma.
The approval specifically covers myeloma patients whose cancer didn’t respond to (refractory), or came back following (relapsed), at least one prior line of treatment. The milestone was announced by Johnson & Johnson (J&J), which markets both Tecvayli and Darzalex Faspro, and called the combo a “potential new standard of care” for myeloma in a company press release.
“As the leader in hematology, we have a proud history of transforming the treatment landscape for multiple myeloma,” said Imran Khan, MD, PhD, J&J’s vice president of U.S. hematology medical affairs. “This approval represents another pivotal milestone in improving outcomes for patients living with this disease, with a unique regimen accessible to patients across all practice settings.”
Khan added that the new FDA approval “adds a powerful new treatment option to our multiple myeloma portfolio, moving us closer to our ambition of one day curing this disease.”
Both therapies are given by subcutaneous, or under-the-skin, injection and are already FDA-approved as part of various regimens for myeloma treatment.
Tecvayli aims to trigger immune cells to kill myeloma cells by simultaneously binding to an immune cell protein called CD3 and a myeloma cell protein known as BCMA.
Darzalex Faspro, meanwhile, works by targeting a protein on myeloma cells called CD38. Darzalex Faspro is a subcutaneous formulation of the infusion therapy Darzalex; it was developed using drug-delivery technology from Halozyme Therapeutics.
“The newly approved Tecvayli plus Darzalex Faspro treatment regimen, in which both drugs are administered subcutaneously, offers patients with relapsed or refractory multiple myeloma a new, effective treatment option that can be administered across all treatment settings,” Helen Torley, resident and CEO of Halozyme, said in a separate press release announcing the approval.
Over 80% of patients given combo were still alive at 3 years
The FDA’s decision also converts Tecvayli to full approval as a monotherapy — as its name suggests, a treatment used on its own — for adults with relapsed or refractory multiple myeloma who have received at least four prior treatments. Tecvayli had received accelerated approval for this indication in 2022.
The regulatory agency’s approval of the combination therapy for relapsed/refractory myeloma was based primarily on data from the ongoing Phase 3 MajesTEC-3 trial (NCT05083169). The study enrolled more than 500 myeloma patients whose disease had failed to respond or had relapsed after one to three prior lines of treatment.
The trial’s participants were randomly assigned to receive Tecvayli plus Darzalex Faspro, or one of two previously-approved treatment combos that use Darzalex Faspro in tandem with steroids and other myeloma treatments.
The results showed that 83% of patients given Tecvayli plus Darzalex Faspro were still alive and free from disease progression after a median follow-up of approximately three years. By contrast, most patients given other regimens had experienced disease progression or died by the end of follow-up.
Overall survival rates at three years were 83.3% with the new combo and 65% with standard treatments. The novel combo also bested the other regimens at easing myeloma symptoms and improving patients’ quality of life, data indicated.
The option to use this regimen as early as second line is particularly important because patients with [relapsed/refractory multiple myeloma] often experience multiple relapses and reduced responsiveness to therapy over time, which makes earlier treatment with the most effective therapies critical.
Safety data from MajesTEC-3 showed that the Tecvayli/Darzalex Faspro combo had a safety profile overall comparable to that of the comparison regimens. Most patients reported some side effects; the most common serious side effects were low blood cell counts and infections. Safety issues leading to death were reported in 7.1% of patients on Tecvayli/Darzalex Faspro and 5.9% of those on other regimens.
“This new treatment option can redefine how we approach RRMM [relapsed/refractory multiple myeloma] treatment by giving healthcare providers a regimen with improvement in [disease progression and survival] and a well-characterized safety profile,” said Luciano J. Costa, MD, primary investigator of MajesTEC-3 study at the University of Alabama at Birmingham.
“The option to use this regimen as early as second line is particularly important because patients with RRMM often experience multiple relapses and reduced responsiveness to therapy over time, which makes earlier treatment with the most effective therapies critical. In addition, the steroid-sparing approach may reduce toxicity and improve tolerability,” Costa added.
Heather Ortner Cooper, president and CEO of the International Myeloma Foundation, said the new FDA approval “enhances the therapeutic landscape, giving oncologists diverse options to personalize treatment plans for each patient.”
J&J has also applied seeking approval of the Tecvayli/Darzalex Faspro regimen as a second-line myeloma treatment in Brazil and in the European Union.
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