CART T Elicits Strong Response for Multiple Myeloma

December 9, 2020 – For patients with heavily pretreated multiple myeloma, the strong responses seen with the new (CAR T-cell treatment ciltacabtagene autoleucel (cilta-cel) were also prolonged, according to researchers in the CARTITUDE-1 trial.

Among 97 patients with multiple myeloma whose cancer got worse during three or more types of treatment or after treatment with at least two types of therapy with a proteasome inhibitor and an immunomodulatory agent, the overall response rate was by 96.9%, reported Deepu Madduri, MD, of Mount Sinai Medical Center in New York City, and colleagues.

“We’ve seen how pre-treated these patients are, and seeing a single treatment get this kind of response rate is pretty exceptional. What is even more impressive is that 72% of these patients were still maintaining their response when the data was cut. She said in an oral summary presented at the American Society of Hematology Virtual Annual Meeting.

Cilta-cel is a CAR T.

It was granted a breakthrough therapy designation for relapsed / refractory multiple myeloma by the FDA in December 2019.

At the 2019 ASH Annual Meeting, Madduri reported on the Phase 1b results of the trial, which showed that for 29 patients with highly pre-treated, relapsed / refractory multiple myeloma, the overall response rate to 6-month median follow-up was 100%, of which 69% showed no signs of cancer, with 27 patients remaining without disease progression.

Security data

All patients had at least one hematologic side effect, of which 96 were more severe. Events include neutropenia, anemia, thrombocytopenia, leukopenia, and lymphopenia. The median time to recovery was 2 to 4 weeks.

Infections occurred in 57.7% of patients, including pneumonia in 8.2% and sepsis in 4.1%.

Cytokine release syndrome of any type occurred in 92 patients, but only 4 had a more severe case.

Neurotoxicity occurred in 20 patients, 10 of whom had more severe cases.

Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 16 patients, 2 of whom had more severe cases. The syndrome affects the central nervous system. Other neurotoxicities of all severity, many of which overlapped with ICANS, occurred in 12 patients, 9 of which were more severe.

The median time to onset of ICANS was 8 days, with a median time to recovery of 4 days. However, other neurotoxicities took longer to appear and resolve, with a median time to onset of 27 days and a median time to recovery of 75 days.

The study was sponsored by Janssen Research & Development and Legend Biotech. Madduri disclosed the fees, advice, and speakers bureau activities for these and other companies.

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Jothi Venkat

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