Nearly 70% of those given approved myeloma therapy alive 5 years later
1-time treatment shown in trial to deliver long-term remission for half
Written by |
New data from a long-term clinical trial show 10 of 20 people with hard-to-treat multiple myeloma are alive and free from disease progression five years after receiving one-time treatment with the now-approved cell therapy Carvykti (ciltacabtagene autoleucel).
Overall, the five-year survival rate among participants in this small trial subgroup is nearly 70%, according to these data, announced by Johnson & Johnson, which markets Carvykti in collaboration with Legend Biotech. The patients in this subgroup did not receive any maintenance therapy, the company noted.
“These results add to the growing body of evidence suggesting that Carvykti may have curative potential for some patients, and reinforce the value of bringing highly effective therapies to patients earlier in their treatment journey,” Yusri Elsayed, MD, PhD, global therapeutic area head for oncology at Johnson & Johnson, said in a company press release.
“As we continue to advance a portfolio of complementary and combinable therapies, these findings reinforce our commitment to pursuing curative approaches and redefining what patients can expect from multiple myeloma treatment,” Elsayed added.
The mid-stage trial, dubbed CARTITUDE-2 (NCT04133636), is tracking treatment outcomes in more than 200 adults with myeloma across seven study groups. Its goal is to “generate long-term follow-up data on depth and durability of response” with Carvykti; the study is expected to wrap up in 2028.
Myeloma is a blood cancer in which plasma cells, a specific type of immune cell, grow out of control in the bone marrow, the spongy inside of some bones. Carvykti was approved in the U.S. in 2022 to treat adults with myeloma that is relapsed or refractory — meaning the cancer has failed to respond, or come back, following initial treatment.
The one-time treatment is specifically indicated for patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and who failed to respond to Revlimid (lenalidomide).
An earlier trial called CARTITUDE-1 tested the treatment in patients receiving later lines of therapy. The Phase 2 CARTITUDE-2 trial was designed to assess Carvykti among people in earlier lines of treatment.
Carvykti trial results highlight benefits of earlier treatment
Carvykti works by harnessing the cancer-killing capabilities of T-cells, a type of immune cell. The treatment involves collecting a patient’s T-cells, then equipping them in a lab with a chimeric antigen receptor (CAR), a human-made protein that directs the cells to attack BCMA, a protein expressed by plasma cells. After a round of chemotherapy, which kills existing T-cells to make room for the modified ones, the CAR T-cells are transfused back into the patient in a one-time procedure.
The new data come from CARTITUDE-2 — testing Carvykti in various settings for relapsed/refractory myeloma — specifically cover 20 patients who had received one to three prior lines of therapy, including a proteasome inhibitor, and whose cancer failed to respond to Revlimid.
Five years ago, treatment-free remissions of this duration were difficult to imagine for many patients with relapsed or refractory [hard-to-treat] multiple myeloma.
These participants have been followed for a median of 60.7 months, or slightly more than five years, during which half of the patients maintained remission the whole time — meaning their cancer didn’t progress or return, and they didn’t require additional treatments. The overall survival rate at five years was 69.2%, according to Johnson & Johnson.
“Five years ago, treatment-free remissions of this duration were difficult to imagine for many patients with relapsed or refractory multiple myeloma,” said Niels van de Donk, MD, PhD, a professor at University Medical Center in Amsterdam, who serves as a consultant to the company.
The researchers noted that, among the 10 patients who achieved long-term remission, five had at least one high-risk genetic marker, including four with two or more high-risk features.
“These new Carvykti findings provide additional evidence that when highly effective, established therapies are used earlier in the disease course, more patients may have the opportunity to achieve deep, durable remissions and long-term disease control without maintenance,” van de Donk said.
Leave a comment
Fill in the required fields to post. Your email address will not be published.