Johnson & Johnson and Legend Biotech’s CAR-T cell therapy Carvykti reduced the risk of death by 45% compared to standard of care at almost three years for a portion of multiple myeloma patients, the companies said, marking the first time that a cell therapy has been shown to significantly extend life for patients with this blood cancer.
At a median of 34 months, 76.4% of patients who received Carvykti were alive, compared to 63.8% on standard of care, which consists of a combination of anti-cancer drugs (p=0.0009). The patients enrolled in the study received one to three prior lines of treatment.
“It’s a very significant development in the field,” said trial investigator Binod Dhakal, a hematologist at the Medical College of Wisconsin. “When you offer this therapy, or any other therapy, I think this kind of data would really help to decide and choose one versus another.”
The results were presented Friday at the International Myeloma Society annual meeting in Rio de Janeiro.
The presentation Friday also compared cohorts who received Carvykti across two studies: CARTITUDE-4 and CARTITUDE-1, which looked at multiple myeloma patients who received three or more previous lines of therapy. It suggested that patients who received Carvykti earlier had numerically higher survival rates.
In the CARTITUDE-4 trial, significantly more patients who received Carvykti had no measurable disease left compared to those who received standard care, according to Friday’s presentation.
The CARTITUDE-4 study served as the basis for the FDA’s April approval of Carvykti for multiple myeloma patients who had received at least one prior treatment regimen, making the therapy available to patients much earlier.
The FDA held an advisory committee in March for both Carvykti and 2seventy bio and Bristol Myers Squibb’s multiple myeloma cell therapy Abecma around concerns of higher rates of deaths in the first months of treatment among patients who received the cell therapies compared to those who received standard therapy.
Despite that, the advisory committee backed both cell therapies, saying their benefits outweighed the risks.
BMS reported in December that a study of Abecma after two lines of therapy suggested “a positive trend” in survival, but results weren’t statistically significant. Abecma was approved in that earlier-line setting in April.
Mark WildgustIn July, J&J and Legend teased the highly anticipated survival data on their CAR-T cell therapy, saying that the results were significant. J&J’s Mark Wildgust told Endpoints News on Thursday that the company will take the data to global regulators to update the therapy’s prescribing information, and it will also be using the results commercially “almost immediately.”
“If you see survival with an agent, it is unequivocal that it should be used over the current standard of care,” Wildgust said. “Knowing that many patients don’t make it from second line to third line and third line to fourth line, I think these data show that the earlier you use Carvykti, the better.”
Standard care in the study was either a combination of pomalidomide, bortezomib and dexamethasone, or Darzalex, pomalidomide, and dexamethasone.
J&J and Legend are also studying Carvykti in the frontline setting with two Phase 3 studies called CARTITUDE-5 and -6.