Watch out, Gilead and Novartis: there's a new CAR-T in town.
Autolus is ready to hit the ground running after winning FDA approval for its Aucatzyl, a late entry to the heated CD19 CAR-T cell therapy arena.
The therapy was cleared to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-ALL) after showing complete remission in 63% of efficacy evaluable patients during Autolus’ FELIX study. 42% of patients achieved complete remission within three months and the median duration of response was 14.1 months, the company noted in its release.
While Gilead’s Tecartus and Novartis’ Kymriah also boast approvals in ALL, Autolus’ new med boasts a unique edge as the only CAR-T that doesn’t come with an FDA requirement for a Risk Evaluation Mitigation Strategy (REMS) program.
Aucatyzl will be manufactured at the drugmaker’s Stevenage, U.K. site dubbed “the Nucleus” with Cardinal Health serving as the U.S. commercial distribution partner. The company has wrapped up all pre-launch activities and will now move to finish the final steps involved in onboarding treatment centers, chief operating officer Chris Van said in a post-approval conference call Monday.
The 30 treatment centers Autolus is ready to authorize in the upcoming weeks should cover around 60% of the target population. Over the next 12 months, that number will swell to 60 centers that can reach 90% of patients, Van added.
As any cell therapy maker knows, initial supply can make or break a CAR-T roll out and has hindered others in the past. Autolus is confident in its supply chain after it was already been tested under “the most difficult circumstances” during its FELIX study over the peak of the COVID-19 pandemic. Currently, the product delivery team at the Nucleus is targeting an initial delivery turnaround time of 16 days, with room to improve in the future, according to Van.
Aucatzyl will go for $525,000, a list price that “reflects the clinical evidence and benefit” of the treatment. Competitors Gilead’s Tecartus, meanwhile, is priced lower at around $460,000, while Novartis’ Kymriah is priced at around $580,000 per treatment, William Blair analysts pointed out in a note to clients.
The “more tolerable” safety profile of Autolus’ option, however, stands to make the therapy the preferred option for ALL patients and eventually support majority market share, the analysts added. In the FELIX study, the treatment showed low levels of cytokine release syndrome (CRS) with 3% grade 3 events and no grade 4 or 5 events. Like other CAR-T products, Aucatzyl still comes with an FDA boxed warning for CRS, neurotoxicity and secondary T-cell malignancies.
A lack of REMS requirement could work to further support adoption by reducing burden for treatment centers, William Blair analysts noted. REMS is a reporting system that makes for an “ongoing obligation” and extra work for centers over years as much of the reporting involved in REMS is already reported through other registries, CEO Christian Itin, Ph.D., said on the call.
“It’s a big, I think relief, for centers to be able to simplify the approach there,” Itin said. “That’s where we see actually the biggest opportunity.”
As the U.K.-based drugmaker works on setting up treatment centers in the U.S., Aucatzyl is also under regulatory review in EU and the U.K. after both agencies accepted the applications earlier this year.