Adaptimmune Prepares for Next FDA Submission Following Success in Pivotal Sarcoma Study

Afami-cel Approval:
The FDA granted accelerated approval to afamitresgene autoleucel (afami-cel; Tecelra) for the treatment of adult patients with unresectable or metastatic synovial sarcoma who have received prior chemotherapy and meet specific immune and tumor criteria23.

Clinical Trial Results:
The approval was based on data from Cohort 1 of the phase 2 SPEARHEAD-1 trial, which showed an overall response rate (ORR) of 43% and a median duration of response (DOR) of 6 months in patients treated with afami-cel24.

Future Plans:
Adaptimmune is preparing to submit a rolling Biologics License Application (BLA) for lete-cel, another investigational treatment in their sarcoma franchise, next year23.

Market Potential:
Adaptimmune estimates that afami-cel and lete-cel combined could generate $400 million in peak yearly sales in the U.S. and potentially more if cleared in other geographies and sarcomas3.

Significance:
Afami-cel is the first engineered T-cell therapy to receive FDA approval for a solid tumor cancer, marking a significant advancement in the field of cell therapy34.

Sources:

2. https://www.onclive.com/view/fda-grants-accelerated-approval-to-afami-cel-for-advanced-synovial-sarcoma

3. https://finance.yahoo.com/news/first-kind-cell-therapy-approved-105400375.html

4. https://www.mskcc.org/news/immunotherapy-clinical-trial-shows-promise-for-treating-rare-sarcomas