BCMA is a protein that is found in multiple myeloma cancer cells. CAR-T cell therapies such as Carvytki are engineered to home in on BCMA proteins.
According to a recent article from Fierce Biotech, patients will see trial results describing how Carvykti significantly outperformed the standard that is currently used.
The results are impressive. Carvykti reduced the risk of death or disease progression by 74% as compared to one of the most commonly used drug combinations that include Revlimid but in many cases is no longer effective.
The risk reduction is reported to be the largest to date in a Phase 3 study of a blood cancer treatment. The results will be presented at the ASCO annual meeting this month.
At closer review, the data affirm the potential for Carvykti to be used when Revlimid fails. This is a different scenario than only using the drug after several treatments fail. J&J will use its data in seeking expanded approval.
According to a recent article in BioPharmaDive, ASCO issued a statement by Oreofe Odejide, Oncologist at the Dana Farber Institute stating that the benefit of Carvykti compared to other options is that the drug can not only be used earlier but safely.
About CARTITUDE-4
CARTITUDE-4, J&J’s Phase 3 study, enrolled 419 multiple myeloma patients who were no longer responding to Revlimid. Several patients had been treated with other drugs after Revlimid before being treated with Carvykti. Once the patients were enrolled, half of the group was administered Carvykti while the second group received one of the three-drug cocktails.
In total, 84% of trial participants responded and saw their blood cancer counts recede. In comparison, these numbers compare to 67% of participants receiving standard treatment.
32 people could not receive the new treatment due to disease progression. A total of 176 people who did receive the new treatment showed a 99% response.
Achieving Minimal Residual Disease
Four times the number of people taking Carvykti received a response called “minimal residual disease” which indicates that there were no cancer cells found after treatment.
Mark Wildgust, J&J’s medical affairs for J&J’s Janssen unit, stated that one infusion of Carvykti prolongs progression-free survival as opposed to a substantially effective standard of care.
Dr. Binod Dhakal at Wisconsin’s Medical College is the lead investigator of the study. He described the new data in an ASCO press release referencing it as setting a higher efficacy bar in refractory and relapsed multiple myeloma.
Side Effects
Carvykti does have considerable side effects which include infections, neurological toxicity, low blood cell counts, and a dangerous immune reaction known as cytokine release syndrome (CRS).
Three-quarters of trial enrollees who were treated with Carvykti developed CRS. However, only two participants were listed with severe CRS adverse events.
CAR-T therapies are difficult to produce. They require an existing supply chain and intensive processing before being infused into patients. Also, some of the components used to make the therapies are difficult to obtain in larger quantities.
J&J is attempting to solve this problem by taking a phased approach to allocating supply to several growing treatment centers. Meredith Unger of Janssen’s U.S. CAR-T business was pleased to report that since the latter part of 2022, the CAR-T supply had increased significantly to approximately 50% per treatment slot.
Cell Therapy Potential
As part of their ASCO presentation, Legend and J&J included data from two earlier Carvykti studies and a third version of Carvykti given after a series of other treatments had failed.
Participants in one of the trials, LEGEND-2, lived an average of 56 months after receiving treatment. Additionally, data from CARTITUDE-1 evidenced no disease progression three years later.
Johnson & Johnson anticipates Carvykti to be in demand as a treatment for early-stage cancer cell therapy once data are presented giving a more detailed overview of Carvykti’s clinical trial results.
