New CAR T-cell therapy shows promise in tough myeloma cases
Trial results show arlo-cel may help control relapsed or refractory disease
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Bristol Myers Squibb‘s experimental cell therapy arlocabtagene autoleucel (arlo-cel) may help control myeloma that has returned or failed to respond after at least four prior lines of therapy, according to results from a Phase 2 clinical trial.
“These topline results support arlo-cel’s potential benefit for patients while showing a safety profile consistent with expectations,” Lynelle B. Hoch, president of Bristol Myers Squibb’s cell therapy organization, said in a company press release.
Myeloma is a type of blood cancer marked by the uncontrolled growth of certain immune cells in the bone marrow. Available myeloma treatments include targeted agents, immunotherapies, and chemotherapy.
CAR T-cell therapies involve collecting cancer-killing immune cells from a patient, then engineering them with a human-made molecular receptor (a chimeric antigen receptor, or CAR) that directs the immune cells to attack a specific target expressed by cancer cells. Patients undergo chemotherapy to eliminate existing immune cells and make room for the modified cells, after which the therapeutic immune cells are infused into the body to target cancer cells.
Several CAR T-cell therapies for myeloma are approved; most of them target a specific myeloma protein called BCMA. Arlo-cel (also known as BMS-986393) is a CAR T-cell therapy designed to target a different myeloma protein, GPRC5D.
Combination treatments
The Phase 2 QUINTESSENTIAL (NCT06297226) trial tested arlo-cel in more than 200 people with myeloma that was relapsed or refractory, meaning the cancer had come back or failed to respond after prior lines of treatment. All study participants had previously received at least three lines of treatment with at least four types of therapies, including a proteasome inhibitor, an immunomodulatory agent, an anti-CD38 antibody, and a BCMA-targeting therapy.
“As combination treatment regimens are now frequently used in earlier lines of therapy, an increasing number of people with multiple myeloma are quadruple-class exposed and resistant to currently available therapies earlier in the treatment journey, creating a critical need for new therapeutic approaches,” Hoch said.
The QUINTESSENTIAL study’s main goal was to assess response rates — the number of patients whose cancer burden decreased following therapy — in the subset of patients who had received four or more prior lines of treatment. Bristol Myers Squibb said the results showed a “statistically significant and clinically meaningful overall response rate” in these patients, with some patients achieving a complete response — meaning they had no detectable cancer.
Overall and complete response rates were also seen in the broader study population, according to Bristol Myers Squibb. The company said detailed results will be presented at an upcoming scientific meeting.
Hoch said the results “underscore our continued innovation in multiple myeloma and highlight the value of targeting alternative proteins, like GPRC5D, with the power of cell therapy to transform outcomes, laying the foundation for arlo-cel to become an important treatment option for this emerging group of patients who have been exposed to prior BCMA-targeted therapies.”
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