FDA’s Carvykti Approval Gives Patients Whose Myeloma Has ‘Failed Everything’ Another Chance to Attack the Disease

Patients with heavily pretreated relapsed/refractory multiple myeloma have traditionally had poor prognoses, and oftentimes run out of viable treatment options.

However, earlier this month, the Food and Drug Administration (FDA) approved Carvykti (cilta-cel) for the treatment of adults with relapsed/refractory myeloma who underwent four or more treatments.

In CARTITUDE-1, the clinical trial that supported the FDA’s approval decision, 98% of patients had their disease shrink as a result of Carvykti, a CAR-T cell therapy, while 78% had a stringent complete response, where no sign of cancer remains.

“On one hand (before the approval of Carvykti), you’re talking about hospice, and on the other hand, (with the use of Carvykti) the cancer has completely disappeared,” Dr. Sundar Jagannath, a professor of Medicine and director of the Multiple Myeloma Center of Excellence at the Tisch Cancer Institute in New York, said in an interview with CURE®.

Of note, Jagannath was an author on the study that led to Carvykti’s approval.

CAR-T cell therapy is unlike most other cancer treatments. It involves taking a patient’s blood and re-engineering the T cells to find and attack cancer cells — what Jagannath referred to as “killer T cells.” Once the cells are injected back into the patient’s body, they will continue to multiply while fighting myeloma.

Since Carvykti is a living therapy that will expand on its own, patients do not need to continuously come to the clinic for more cancer treatments.

“By the time patients come to receive (Carvykti), they have gone through a journey of receiving treatment constantly, month after month after month. Then, after you go through this (therapy), the cancer (may) disappear. Patients are feeling good, and they don’t need any more treatment. That’s incredible,” Jagannath said.

With prior standard of care, the average lifespan for this patient population is about nine months. But on the CARTITUDE-1 trial, more than half of the patients who received Carvykti were still alive two years later.

However, just because patients only need to receive Carvykti once, that does not mean that they can break ties with their oncology team completely. Clinician monitoring and follow-up is important, especially right after infusion, Jagannath stressed.

The T cells used in Carvykti treatment are engineered to produce cytokines, a protein molecule that is pivotal in cell signaling and inflammation. While cytokines help to fight the cancer, the rapid release of too many into the blood stream — a condition called cytokine release syndrome — can be dangerous and cause issues such as fever, drop in blood pressure or shortage of breath.

Patients should be carefully monitored by their health care team for the first two weeks after receiving Carvykti, as that is the most common time when cytokine release syndrome develops, Jagannath said. Then, for the first 100 days or so after infusion, they should also be weary of infections, since CAR-T cell therapy weakens the immune system.

“After the first 100 days, then they are monitored on a monthly (basis). Then, after one year, it could be much less because the results from (CARTITUDE-1) … showed that everybody who crossed the one-year (survival) mark, they’re all doing well, and nobody died after that one-year mark,” Jagannath said. “So that is when I can say that after the first year, the follow-up could be maybe once every three months or (so).”

Looking forward, Jagannath said that ongoing studies are looking at Carvykti in earlier treatment settings, meaning that patients would not have had to undergo four other therapies before getting CAR-T cell therapy.

“Every year, we will hear more and more, but the final word (on this topic) will take some time,” he concluded.

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