The fifth annual CAR-TCR Summit will kick off in Boston Tuesday with a focus on advancements in immunotherapies targeting various cancers, as well as challenges that face the field.
Over a four-day period, the summit will feature more than 150 speakers and presenters who will lead discussions, workshops and more interactive events focused on the realities and difficulties of bringing CAR-T and TCR therapies to market. The annual summit brings together some of the biggest names working with CAR-T and TCR (T-cell receptor) programs. So far, in the United States, there have been two approved CAR-T therapies – Novartis’ Kymriah, the first CAR-T treatment approved in the United States, and Kite’s (now Gilead’s) Yescarta, approved two months later. Both drugs were approved by the U.S. Food and Drug Administration in 2017 for types of B-cell blood cancers.
CAR-T treatments have been more successful with blood cancers and T-cell receptor therapies could be a key immunotherapy treatment for solid tumors – a much wider target for drugmakers. Companies in this space, such as Celgene, will certainly show off some of its latest data. Celgene, which is being acquired by Bristol-Myers Squibb, has a significant presence in both the CAR-T field due to its acquisition of Juno Therapeutics and TCR therapies. Other companies in this space include Adaptive Biotechnologies and Genentech, which earlier this year forged a deal that could be worth up to $2 billion to develop and commercialize novel neoantigen directed T-cell therapies for the individualized treatment of a broad range of cancers.
Despite those approvals of the rather revolutionary CAR-T treatments, neither drug has gained significant traction in the United States or in Europe, where they have also been approved. On its website, the CAR-TCR Summit points to some reasons why the CAR-T therapies have not been more widely prescribed relate to “challenges in manufacturing scale-up, the ability to meet patient demands alongside payers and healthcare providers who are unable to make this therapy widely available”
However, safety concerns may also have played a significant role in why some prescribers are not opting to use CAR-T therapies. Particular risks to the treatment are cytokine release syndrome and neurological toxicities. However, Kite Pharma, a subsidiary of Gilead Sciences, presented data earlier this summer at the American Society of Clinical Oncology that showed a method to mitigate those concerns. Data from the ZUMA-1 trial that showed introducing a regimen of steroids to CAR-T patients who show early signs of neurologic events reduces the safety concerns associated the CAR-T treatment. The study showed that early steroid interventions may reduce the incidence of severe CRS and neurologic events associated with Yescarta without impacting the efficacy of the drug.
The summit is intended to provide participants with a breakdown of strategies to “optimize the durability, persistence and targeting of approved and novel therapies to reduce relapse rates and overcome toxicity, as well as how to streamline process development and logistics supply chains for affordable and accessible CAR-TCR therapeutics.”
Some of the programs that will be part of the summit include a panel hosted by Aleta Biotherapeutics and Endocyte over the construct design of CAR-T and TCR therapies to enhance potency and multi-targeting therapy. Kite will also host a discussion on the mechanisms of product and treatment failure of CAR-T programs. Dan Farber Cancer Institute will conduct a seminar on setting up the necessary infrastructure to run effective CAR-T trials and supply chain coordination discussions will also be on the agenda. Other programs include looks at off-target toxicity concerns, supply chain management and the scaling needed for successful manufacture. Finally, a seminar aimed at providing insight into the Centers for Medicare’s view on the value of these therapies to ensure they are accessible to patients.
Patient success stories will also be highlighted over the four-day summit. Several stories have already been posted on the summit’s website, such as Nicole Gularte. She sought treatment from CAR-T therapies for several years. She was finally able to receive treatment from Kymriah in a clinical program in 2016 a year before the FDA granted approval. Before that treatment, Nicole had six relapses over the course of six years. Today, the Summit notes that she is an active patient advocate and keynote speaker.
Another success story is Dough Olson, who was diagnosed with chronic lymphocytic leukemia in 1996. For six years he received no treatment but was watched carefully to see if his cancer progressed. Then, in 2002, he underwent chemotherapy. After that, he was in remission for five years but in 2009 his cancer returned and did not respond to treatment. In 2010, Olson became one of the first patients to take part in a CAR-T clinical program. Nine years later he continues to share his story and the success of the treatment.
These stories and a lot more will take center stage throughout the CAR-TCR Summit in Boston this week.
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