J&J's 'Tec-Dara' combo shines in multiple myeloma study
A two-drug regimen from Johnson & Johnson showed an unprecedented tumor-progression benefit compared to the standard of care for patients with relapsed or refractory multiple myeloma, according to results from a Phase 3 study presented today.
In a study called MajesTEC-3, the two J&J drugs, Tecvayli and Darzalex, reduced the risk of tumor progression by 83% compared to standard multi-drug treatment — achieving the study's primary efficacy goal. At three years, 83% of the patients treated J&J's "Tec-Dara" regimen were still alive without disease worsening compared to 30% of patients in the control arms.
The study enrolled 587 patients with multiple myeloma who had experienced between 1 and 3 prior lines of therapy.
"I think this is the best [risk reduction] we've seen in a Phase 3 clinical trial in multiple myeloma," said María-Victoria Mateos, a cancer researcher and physician at the University of Salamanca in Spain who presented the study.
The combination also improved overall survival, reducing the risk of death by 55% in the study.
Serious infections were reported in 54% of patients on the Tec-Dara combination, worrisome enough to warrant investigators to add new mitigation measures in the middle of the trial.
Tecvayli is a bispecific antibody that works by engaging a plasma cell protein called BCMA on one end and T cells on the other, helping the immune system find and attack myeloma cells. Darzalex is an antibody that targets the protein CD-38, which is also found on myeloma cells.
"We're seeing potential cures for multiple myeloma, and I hope we can realize that soon with all the therapies coming, including this one," said Surbhi Sidana, a hematologist-oncologist at Stanford who was also an investigator on the trial.
One limitation of the study was that patients were ineligible for participation if they had already received Darzalex as part of their first-line treatment. This could raise questions about using Darzalex again when patients relapse, especially given the availability of a CAR-T therapy for these patients.
CDC cuts impact sickle-cell data collection program
Cuts at the Centers for Disease Control and Prevention have cast uncertainty over a decade-old effort to track sickle cell disease, leaving researchers without specialized federal support.
The CDC established the Sickle Cell Data Collection (SCDC) program to address a lack of research on the disease, which is the most commonly inherited blood disorder. Since its launch, the CDC has partnered with and funded states to collect data that can inform patient care and guide state and federal policy.
That program was thrown into disarray on April 1, when all but two employees from the CDC's Division of Blood Disorders and Public Health Genomics were placed on administrative leave, including all staff who oversaw the SCDC program.
In 16 states, teams continue collecting data on patients with sickle cell disease, but they are doing so with far less coordination from the CDC.
"We're all taking responsibility for different chunks of the work that CDC used to do, and trying to do our best to bridge that gap," Sarah Reeves, principal investigator for the Michigan SCDC program, told STAT on the sidelines of the ASH meeting.
Reeves' team has produced a quantitative report that includes where people with sickle cell disease live, how many are seeing hematologists, immunizations gaps, and preventative care rates. They are partnering with the Michigan Department of Health and Human Services, which is making a five-year strategic plan for sickle cell treatment in the state.
But Reeves worries the SCDC program may have lost some of its potential for broader-reaching impact, since the CDC staff was their main connection to external partners and policymakers at the national level. Future funding beyond this year also remains uncertain.
"Without having that coordination, we're doing our best, but we don't know all the players," Reeves said, adding that future funding is also uncertain.
No comments