No Lack of Enthusiasm for CAR-T Development, Experts Say

Robert H. Carlson, MBA

Disclosures

November 30, 2016

In This Article

When Novartis announced in late August that it was dissolving its cell and gene therapies unit, some observers thought that might mean a setback for chimeric antigen receptor T-cell (CAR-T) research there and elsewhere.

Novartis said that it's not scaling back on CAR-T research, but Medscape Oncology asked a spectrum of researchers in the field to speculate on the implications of the company's decision to reintegrate cell therapy into its oncology unit.

Forging Ahead

In essence, the experts' take is that CAR-T development is forging ahead at Novartis and other companies, and that CAR-T, checkpoint inhibitors, and other immunotherapies will each have a place in the clinic, most likely in combination with each other and with standard chemotherapy and radiation therapy.

"I don't think [Novartis' decision] has mitigated enthusiasm for CAR; in fact, it's sort of strengthened the community to address some of the challenges, such as neurotoxicity," said Cassian Yee, MD, a professor in the Department of Immunology and director of Solid Tumor Cell Therapy at the University of Texas MD Anderson Cancer Center.

"And it opens new opportunities for all these other alternative CAR approaches and other T-cell approaches, because CAR is only one T-cell therapy modality out of at least three or four," Dr Yee said, in a phone interview during a break at the International Cancer Immunotherapy Conference. The conference, sponsored by the Cancer Research Institute, Association for Cancer Immunotherapy, European Academy of Tumor Immunology, and American Association for Cancer Research, took place September 25-28 in New York.

Dr Yee says that there are many different ways to target the surface molecules using the CAR-T platform, and there is no lack of interest, certainly, in applying innovative approaches to provide a measure of safety or increase efficacy. "The consensus is that there are bound to be setbacks," Dr Yee continued. "Some of these may be due to overexuberance with some of the technologies."

That has been the case of CAR-T, he said, as attempts to extend it to other cancers have not always been so straightforward.

"I don't believe the field should be influenced by incidents where there's a resetting of opinion or a perception of how successful a therapy should be; the field moves in fits and starts," Dr Yee said. "I do believe the role of T-cell therapy is becoming more dominant in terms of the technologies and ambitiousness of trials addressing specific areas in which new checkpoint or cytokine or immunomodulatory therapy can be challenging."

Novartis is definitely not downplaying cell therapy, said Stephan Grupp, MD, director of the Cancer Immunotherapy Frontier Program and director of translational research at the Center for Childhood Cancer Research at Children's Hospital of Philadelphia, who has worked on clinical trials for Novartis.

Dr Grupp said that in his personal opinion, not speaking in any way for Novartis, he sees the company "moving full-court press" in planning for a US Food and Drug Administration submission in January 2017 for CTL-019, an engineered cell therapy product for pediatric acute lymphocytic leukemia. "They're delivering cell products for cell therapy trials across the world—literally executing on global cell therapy logistics—so to say that they are exiting the field is just not accurate," he said.

Dr Grupp believes that the company's reintegration of cell therapy into its oncology unit and loss of 120 positions with the closing of its cell and gene therapies unit has nothing to do with checkpoint inhibitors.

"It does have a lot to do with the cycle of how large pharmaceutical companies do things," Dr Grupp said.

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