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Novartis' next-generation CAR-T therapy shows promise for multiple myeloma

More than 60% of patients with multiple myeloma — a bone marrow cancer that affects plasma cells — responded to Novartis AG's experimental treatment using engineered versions of their own cells to target the disease.

The Swiss company — which won U.S. approval for the first chimeric antigen receptor T-cell, or CAR-T cell, therapy this summer — is developing a variation of the white blood cell-modifying treatment to target a receptor known as B-cell maturation antigen, or BCMA, that tends to be highly prevalent in multiple myeloma.

In a study by the University of Pennsylvania that specifically targeted patients who had already tried a range of other treatments, 64% were observed to respond to the therapy.

All 15 participants in the trial were given a single dose of chemotherapy before being reinfused with their CART-BCMA cells. The extra chemotherapy step helped clear normal white blood cells to allow the "hunter" cells to multiply and attack cancerous ones, researchers from the university's Abramson Cancer Center said.

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In a high-dose grouping, one patient showed a complete response to the therapy, or no detectable signs of cancer. Others showed reduced signs of cancer, and the trial is ongoing with both high- and low-dose sections.

Yet, much like previous CAR-T therapy trials, the risks could be significant: 12 patients experienced cytokine-release syndrome, or CRS, a toxic reaction to the reinfused cells that can sometimes be deadly, as in Juno Therapeutics, Inc.'s trial for the now-scrapped JCAR015.

In Novartis' trial, researchers said that all 12 patients recovered, though one needed Roche Holding AG unit Genentech Inc.'s CRS antidote Actemra and another received Sylvant, a similar cytokine-blocking drug from Johnson & Johnson's Janssen Biotech, Inc. unit.

The university's previous study using CART-BCMA alone, without chemotherapy, showed a clinical benefit in six out of nine patients, Adam Cohen, the study's lead author and the director of Myeloma Immunotherapy at Abramson Cancer Center, said in a statement issued alongside the study.

CART-BCMA could be a significant next step on Novartis' CAR-T path, which began with Kymriah's August 2017 approval for pediatric acute lymphoblastic leukemia, or ALL. The company is looking to expand Kymriah to adult ALL, which can be particularly fatal, and the relatively more common blood cancer known as diffuse large B-cell lymphoma, or DLBCL.

Presentations in both areas are expected at the 59th Annual American Society of Hematology Meeting and Exposition in Atlanta, including a Dec. 11 presentation showing that Kymriah is as good at main rival Gilead Sciences Inc.'s Yescarta at fighting DLBCL.

A BCMA-targeting monoclonal antibody, GlaxoSmithKline plc's GSK2857916, showed a 60% response rate among similar patients who had relapsed or not responded to a range of other treatments. The detailed study will presented at the Atlanta meeting Dec. 12.