Following strong treatment response data for Adaptimmune’s lete-cel, the biotech is planning to initiate a rolling BLA submission to the FDA, set to start by the end of 2025.
Adaptimmune Therapeutics on Wednesday revealed primary findings from a pivotal Phase II study demonstrating that its investigational TCR T cell therapy lete-cel elicited high rates of treatment response in patients with advanced or metastatic synovial sarcoma or myxoid/round cell liposarcoma.
The results of the IGNYTE-ESO study, to be presented during the 2024 Annual Meeting of the Connective Tissue Oncology Society in San Diego, showed that of the 64 treated patients, 42% responded to lete-cel, including six who achieved complete response and 21 who reached partial response. Median duration of response was 12.2 months overall, 18.3 months in synovial sarcoma and 12.2 months in myxoid/round cell liposarcoma (MRCLS).
Progression-free survival at the time of the analysis was 5.3 months in the overall evaluable study sample, according to Adaptimmune’s announcement.
As for safety, lete-cel’s adverse events were consistent with what had been established in prior studies and were manageable overall. Common side effects included rashes, cytopenia and cytokine release syndrome. The biotech in its press release called lete-cel’s benefit-to-risk profile “acceptable.”
“These data underscore lete-cel’s potential to transform the lives of people with these cancers who have a poor prognosis and few treatment options,” CMO Elliot Norry said in the announcement.
With these pivotal findings, Adaptimmune will initiate a rolling Biologics License Application by the end of 2025, seeking approval for lete-cel in synovial sarcoma or MRCLS.
To help support this regulatory effort—and the commercialization of lete-cel, if approved—the biotech on Thursday also announced a sweeping reprioritization initiative that will include downsizing its workforce by 33% to reduce total operating expenses by 25% in the first year of implementation.
Overall, the cost-cutting campaign will help Adaptimmune generate around $300 million in aggregate savings from 2025 to 2028, excluding one-time costs. With these savings, Adaptimmune will be able to prioritize its R&D programs “with highest potential for return on invested capital and transformational benefit to patients,” according to its announcement.
Alongside the layoffs, the biotech will also terminate enrollment into the Phase II SURPASS-3 study of its other TCR T cell therapy uza-cel for platinum-resistant ovarian cancer.
Adaptimmune gained 7.7% in after-hours trading on Wednesday, jumping to $0.83 from $0.77 at the previous market close.
In August 2024, Adaptimmune won the FDA’s nod for Tecelra (afamitresgene autoleucel) for unresectable or metastatic synovial sarcoma, making it the first approved engineered cell therapy for solid tumors—and the first new treatment for synovialsarcoma in more than a decade. CEO Adrian Rawcliffe said in Wednesday’s business update that Tecelra’s launch has been “encouraging,” with nine authorized treatment centers active and one patient already having been apheresed during the third quarter.
Currently, the company projects peak sales of $400 million Tecelra and lete-cel, pending the latter’s approval.
