An Overview of Pipeline Indications for Current Commercially Approved CAR T Products

Pharmacy Times interviewed Craig Freyer, PharmD, BCOP, a clinical pharmacy specialist at Penn Medicine in the University of Pennsylvania Health System, and Andrew Lin, PharmD, BCOP, an oncology pharmacy specialist at Memorial Sloan-Kettering Cancer Center, to discuss their presentation at the recent ATOPP 2021 summit on re-examining the why, who, and where of chimeric antigen receptor (CAR) T-cell therapy.

Alana Hippensteele: What are some potential pipeline indications for the currently commercially approved CAR T products?

Andrew Lin: So, I think there are there's definitely exciting data coming out. I think most of our approved products also are looking to extend their indications, particularly if you look at tisagenlecleucel. It's probably going to go for an approval for relapse refractory acute lymphoblastic leukemia (ALL) in adults to mirror the approval that's already obtained in the patients who are under the age of 25. We'll also probably see some data coming out with looking at people who achieve a minimal residual disease positive complete remission in the same space.

We also see them probably pursuing an ALL approval, perhaps in that younger pediatric and young adult and adolescent group.

Then, like Craig mentioned to answer the first question about whether the CAR-T’s are going to move up beyond second line or after a second relapse for consolidation in first line therapy—that's an open question that we're going to get answered in ZUMA-7 and some similar studies for the other products as well.

And then axicabtagene ciloleucel is being pretty aggressive, and they're looking at a frontline treatment for patients with high risk disease in ZOOM-12. So, that's also already finished accrual, so we'll see some results probably early next year on that one. So, those are some exciting things on the horizon.

Alana Hippensteele: Great, great.

Craig Freyer: I think we also will look to see if maybe tisagenlecleucel will get an indication for more indolent lymphomas, such as follicular marginal zone lymphoma. There's some data coming out in the ELARA study that seems to have very high response rates exceeding 80%, with about 60% of those people having complete remissions following tisagenlecleucel. So that looks promising, as well as for a potential indication for lissacaptigine in the chronic lymphocytic leukemia space, which is being studied in the TRANSCEND-CLL-004 study, both as a monotherapy as well as in combination with ibrutinib.

In that scenario, we're seeing overall responses exceeding 80% to 90%, so it looks quite promising, particularly in people that have failed or who are intolerant to prior Bruton's tyrosine kinase inhibitor therapy.