ORLANDO, Fla.—The leader of Gilead Sciences' Kite Pharma is sure that anito-cel, the biotech’s next-generation multiple myeloma CAR-T challenger to Carvykti, is ready for prime time—and that the company is ready to bring CAR-T to the masses.
“As we improve on safety and physicians are getting more confidence using CAR-T, we're really seeing it move into the community,” Cindy Perettie, executive vice president and global head of Kite, told Fierce Biotech at the American Society of Hematology (ASH) annual meeting in Orlando, Florida.
Anito-cel, along with other next-generation CAR-Ts still in phase 1, are meant to become “outpatient community-ready” one-and-done therapies, she said.
Perettie’s confidence stems from data shared at ASH on Dec. 6, when Kite revealed that patients treated with the Arcellx-partnered autologous therapy achieved a 96% overall response rate at the 15.9 month mark, with 74% of patients’ cancer disappearing completely.
“We've moved from the high 60 percentages to 74% complete response in these patients,” Perettie explained. “That's, in my mind, durability.”
That durability is coupled with what Perettie called anito-cel’s “pristine safety profile,” long considered a strong suit for the therapy in comparison to Johnson & Johnson and Legend Biotech’s Carvykti.
Of the 117 relapsed or refractory myeloma patients treated with anito-cel in the phase 2 iMMagine-1trial, 83% had no or grade 1 cytokine release syndrome, which consists of a fever only, Kite announced in a Dec. 6 release. The rate of immune-cell-associated neurotoxicity syndrome was 8%, with one grade 3 case and the rest grade 2 or lower.
And, with Kite already experienced at manufacturing approved CAR-Ts like Yescarta (axi-cel), the turnaround time for crafting a patient’s anito-cel treatment sits at a comparable 14 to 17 days, Perettie said.
“We think the entire experience for the physicians, the patients and their caregivers and the centers, is going to be improved with anito,” she added. “We’re excited to launch it next year.”
Analysts from Leerink Partners were similarly pleased with the data drop, writing in a Dec. 7 note that anito-cel continues to show a best-in-class profile.
The cell therapy’s progression-free survival and overall survival “are trending slightly better than competitor product” Carvykti’s results from its Cartitude-1 study, the analysts wrote. Combined with anito-cel’s superior manufacturing and safety profile, “these competitive outcomes are sufficient to drive physician enthusiasm and uptake in the U.S.,” they added.
While iMMagine-1’s focus is late-line patients, Kite is also studying anito-cel in second-line multiple myeloma in iMMagine-3 and in newly diagnosed patients in a small study that just finished enrollment, Perettie said.
Kite also let loose new data at ASH from the phase 1 trial of KITE-363 and KITE-753 in relapsed and/or refractory B-cell lymphoma. Both are CAR-T therapies similarly designed to engineer T cells to target both CD19 and CD20.
“Today, with axi-cel or the current therapies on the market, we can cure about 50% of those late-stage patients,” Perettie explained. Though KITE-363 and KITE-753 are still in their early days, “we were able to show complete responses of 71%,” with a safety profile similar to anito-cel’s.
The safety of Kite’s next-gen CAR-Ts is critical for Perettie’s mission of bringing them to outpatient facilities within communities, rather than relegating the treatment to large hospitals and specialized treatment centers.
“That's a therapy that can be delivered in the community, that's a therapy that allows the patient to go home fairly quickly,” she said. “We're excited because this is the opportunity to reach patients where they are.”
While Kite is committed to expanding the availability of traditional autologous CAR-T, where T cells are removed from patients, genetically engineered in the lab and then reinfused back into the patient, the Gilead unit has been pushing ahead with in vivo approaches as well. In vivo CAR-T involves using gene therapy to tweak T cells while they’re still in the patient, potentially offering much simpler treatment.
In August, Gilead bought in vivo CAR-T outfit Interius BioTherapeutics for $350 million, with the goal of integrating the company’s platform into Kite. And, in October, Kite paid $120 million upfront to develop in vivo therapies with Chinese company Pregene.
“We've been looking for off-the-shelf options,” including allogeneic approaches that use T cells from a donor rather than the patient, Perettie said, “and we really haven't seen the depth or durability of response pan out” in oncology.
“For in vivo, you have an off-the shelf-product, and for the first time, we're seeing autologous-like efficacy, with really good safety,” she added.