Truist Securities analyst Asthika Goonewardene in an investor note said data for anito-cel—particularly its safety profile—will help differentiate the CAR T therapy from Legend Biotech and J&J’s entrenched Carvykti in relapsed and refractory multiple myeloma.
Gilead Sciences and partner Arcellx on Tuesday provided a data preview for their investigational CAR-T therapy anitocabtagene autoleucel, demonstrating strong response rates and promising survival outcomes in patients with relapsed or refractory multiple myeloma.
Tuesday’s readout includes preliminary findings from the registrational Phase II iMMagine-1 trial, which showed that the CAR T therapy, also called anito-cel, elicited a 95% overall response rate in 58 patients who had been followed up for at least two months. The complete response or stringent complete response rate was 62% at this time point.
The companies are set to present these findings at the upcoming 2024 Annual Meeting of the American Society of Hematology (ASH 2024), being held Dec. 7–10 in San Diego.
In addition to response rates, early data from iMMagine-1 demonstrated a minimal residual disease rate of 92%, with six-month progression-free and overall survival rates of 90% and 95%, respectively.
In terms of safety, the trial found anito-cel to be well-tolerated, inducing no delayed neurotoxicities such as Guillain-Barré syndrome, Parkinson’s-like symptoms or cranial nerve palsies. Still, three patients died due to side effects, both related to the study treatment, according to the companies. These fatal toxicities included cytokine release syndrome, fungal infection and retroperitoneal hemorrhage.
BMO Capital Markets analyst Evan Seigerman said in a note to investors that while anito-cel’s efficacy represents “incremental” differentiation for the investigational CAR-T therapy, its safety remains “a key focus for commercialization,” and a superior safety profile will help it “overcome Carvykti’s lead in [relapsed or refractory multiple myeloma (RRMM)].”
“We view the anito-cel data as competitive vs Legend’s Carvykti – but we may need to see stronger or longer differentiation in terms of safety … to overcome competitive foothold, since anito-cel is notably behind,” Seigerman wrote.
By contrast, William Blair analyst Sami Corwin was more optimistic in her assessment of anito-cel, writing in a note that the findings “support best best-in-class profile” and demonstrate “superior benefit” versus Legend Biotech and Johnson & Johnson’s Carvykti.
“Anito-cel’s lack of delayed neurotoxicity events to date further suggests that anito-cel’s safety profile is differentiated from its competitors,” Corwin said, noting that the candidate’s “risk/benefit profile could not only make it a more appealing therapeutic option, but it could be more amenable for use in the outpatient treatment setting.”
Truist Securities analyst Asthika Goonewardene was similarly bullish on anito-cel’s commercial prospects. “If these data hold up, and go on anito-cel’s label, we think the prescribing community will view it as differentiated vs Carvykti,” he wrote in a note, adding that the firm continues “to view it as the better BMCA CAR-T.”
Also at ASH 2024, Gilead and Arcellx are set to present Phase I data for anito-cel in RRMM, showing a 100% overall response rate and a 79% complete response or strict complete response rate. As in the case of iMMagine-1, anito-cel was not associated with delayed neurotoxicities in this earlier-stage study.
