BIO 2026: Realizing the promise of CAR-T cell therapies

“CAR-T cell therapies are remarkable drugs and are the gold standard for patients,” said Rachel Haurwitz, PhD, President & CEO of Caribou Biosciences.

These personalized immunotherapies have proven powerful enough to reprogram a patient’s immune system T cells to target and destroy things like cancer cells, and are useful for a variety of other autoimmune diseases, too. And we are understanding more about them every day.

And yet, only a fraction of eligible patients are getting access to CAR-Ts. For example, only 20-25% of eligible lymphoma patients have access to CAR-Ts, explained Haurwitz—shocking, given their life-saving potential.

For an industry Driven by Purpose, success doesn’t stop with scientific breakthroughs, it also has to ensure every eligible patient has the opportunity to benefit from them. So what is being done today to make sure that CAR-T can go mainstream and help as many patients as possible?

The challenges of CAR-T delivery

Experts on the final day of the 2026 BIO International Convention discussed barriers to access and adoption, and the need for empowered education. 

“There is no time like the present to expand into the community setting,” said Ryan Metheny, Head of U.S. Market Access at Kite Pharma.

“The journey from community to the academic circle is not amazing,” said Lynelle Hoch, President of Cell Therapy Organization at Bristol Myers Squibb.

“When we think about solving this, yes, you have to solve the general education problem and get it referred in, but the other problem to solve is that we’ve got to be able to bring this into the community,” she continued. “You can certainly educate more. You can certainly create more of a white-glove journey into the academic centers. But at the end of the day, if modality doesn’t make it into a community, you’re going to have a very small percentage of patients that are eligible to receive them.”

These two issues are compounded by the physical capacity of healthcare settings.

“We’re seeing limitations in capacity,” Metheny continued. “We’re hearing frequently from some of the larger centers that they’re starting to run low on capacity, and as they project out and look at the growth that CAR-T is expected to see in the coming five to seven years, they’re coming to us and saying, ‘We need greater capacity. We need the community to get involved.’ ”

“Patients want to be treated closer to home,” said Hoch. “They want to be surrounded by their family. They have an attachment to their community physicians, and they want to be treated closer to home.”

Another issue is coverage, Metheny noted. With new therapies come new questions, and sometimes even resistance to coverage.

“Predictability and sustainability in economics is a huge issue,” said Metheny. 

As Metheny noted, the traditional reimbursement model used for most products for a U.S. oncology physician is fairly straightforward, both in Medicare and commercially: delivery, approval, and reimbursement.

“Right now, in CAR-T, that’s not there,” Metheny continued. “As we think about the single case agreements and the negotiations that these sites have to go through, they’re not equipped like a traditional hospital with transplant experience to be able to work through those case negotiations in the way that a Stanford or an Emory or a large hospital would. So, I think getting to a point where we can have some economic reimbursement models that are more predictable, that are more similar to what they’ve experienced in that space would be a great start.”

How do we bring CAR-T to the masses?

“We’re all here because amazing scientists figured out that if you put this power construct into a T cell, you have the chance to provide curative intent therapy to a huge fraction of patients,” said Haurwitz. “That’s extraordinary.”

And, as was alluded to at the beginning of the conversation, education is an important first step. Patients need to be educated, clinicians need to be educated, and academia needs to be educated to effectively expand the use of CAR-T. 

But often, the panelists noted, patients are not educated in the right way. 

“We spend too much time educating patients about the complexity of CAR-T and not about the complexity of their life without CAR-T,” said Hoch. “I haven’t met a CAR-T patient yet who hasn’t said, ‘I would do it all over again‘—not even one.”

Reimbursement models also need to be addressed. 

“I think there are too many panels like this, quite frankly, where we talk about things, and then not enough action happens,” asserted Metheny. “And I think one of the big reasons is because the payers are not frequently enough at the table with us.”

How CAR-T can take off

There have been a number of steps that the U.S. Food and Drug Administration (FDA) has taken to maintain the momentum of CAR-Ts going mainstream.

“The FDA has taken a lot of heat lately, appropriately so, but I will say I have to pay them a huge compliment,” said Hoch. “There is significant momentum they created when they removed the REMS (Risk Evaluation and Mitigation Strategies) from auto CAR-Ts and reduced the patient burdens … Patients no longer have to be followed for four weeks at the academic centers, don’t have to not drive for eight weeks. Now, 96% of the talks about, and management of, CAR-Ts happen in the first two weeks, and patients typically are able to go back to their normal lives. After all, these patients do feel pretty quickly back to themselves and want to go back to their normal lives.”

But there are still steps that need to be taken. 

Hoch noted that it was worth the FDA revisiting the current 15-year follow-up requirement for patients. “We have now reams of data for almost two decades worth of CAR-T,” said Hoch, “that the risk of insertional immunogenesis is no different than the actual impact of the disease. And so, from our standpoint, we can’t keep these hurdles on a modality that are not data-driven anymore.”

Regardless of the challenges, the momentum of CAR-Ts is building. Now, the healthcare and regulatory community need to work together to pave the way for CAR-T to take off. 

Every eligible patient should be able to have the conversation about whether CAR-T is right for them, said Metheny. “I’m hopeful that in five years, we’re able to have that conversation with many more patients.”

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