Аdaptimmune has announced that its pivotal Phase II trial of lete-cel, an investigational T cell therapy, has met its primary endpoint, positioning the company for its second FDA approval for sarcoma treatments.
The UK-based biotech plans to submit a rolling Biologics License Application (BLA) to the US Food and Drug Administration (FDA) by the end of 2025. The application will seek approval for lete-cel to treat advanced or metastatic synovial sarcoma and myxoid/round cell liposarcoma (MRCLS).
Promising Phase II Results for Adaptimmune
Data from the Phase II IGNYTE-ESO trial (NCT03967223) revealed that 42% of patients treated with lete-cel achieved a response. Median response duration was 18.3 months for synovial sarcoma and 12.2 months for MRCLS. While all patients experienced treatment-emergent adverse events (TEAEs) — including cytopenia, cytokine release syndrome, and rash — the safety profile aligned with prior data and showed no unexpected issues.
The primary analysis involved 64 patients with either synovial sarcoma or MRCLS. More detailed trial results will be presented at the Connective Tissue Oncology Society (CTOS) annual meeting on November 16, 2024, in San Diego, California.
Synovial sarcoma and MRCLS are rare and aggressive cancers with limited treatment options. Synovial sarcoma, a soft tissue cancer, typically affects the limbs of young adults, while MRCLS, a subtype of liposarcoma, is challenging to treat with standard methods like surgery, chemotherapy, or radiotherapy.
Аdaptimmune – Building a Sarcoma Portfolio
Adaptimmune is steadily expanding its presence in the sarcoma treatment landscape. In August 2024, the company achieved its first FDA approval with Tecelra (afami-cel), a T cell receptor (TCR) therapy for metastatic synovial sarcoma. Tecelra marked a milestone as the first engineered cell therapy for solid tumors and the first new treatment for synovial sarcoma in over a decade.
The approval of lete-cel could significantly increase Adaptimmune’s addressable market in the US. According to GlobalData, the market could grow 2.5 times, from 400 patients annually with Tecelra to 1,000 with lete-cel. These therapies could also be combined or used sequentially, as lete-cel targets a different antigen than Tecelra.
Strategic Partnerships Strengthening Position
Adaptimmune has engaged in strategic collaborations to enhance its cell therapy pipeline. In 2021, it partnered with Genentech, a Roche subsidiary, in a five-year T cell therapy development deal valued at over $3 billion. Although Genentech exited the partnership in April 2024, Adaptimmune quickly secured a $665 million agreement with Galapagos, including a $100 million upfront payment for rights to uza-cel, another MAGE-A4 T cell therapy.
The company has also collaborated with Agilent Technologies to develop the FDA-approved MAGE-A4 ICH 1F9 pharmDx companion diagnostic. In addition, Thermo Fisher Scientific has included Tecelra in the labeling of its SeCore CDx HLA-A Locus Sequencing System.
With lete-cel on track for regulatory submission and multiple strategic collaborations, Adaptimmune is poised to strengthen its position as a leader in T cell therapies for sarcoma. The company’s progress underscores the potential of engineered cell therapies to address unmet needs in rare and aggressive cancers.
Recourse: pharmaceutical-technology.com
Official press release: adaptimmune.com
