On May 26, 2022 Adaptimmune Therapeutics plc (NASDAQ: ADAP), a leader in cell therapy to treat cancer, reported that pooled analyses from its Phase 1 and pivotal trials with afami-cel for synovial sarcoma and myxoid/round cell liposarcoma (MRCLS) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting (Press release, Adaptimmune, MAY 26, 2022, View Source [SID1234615189]).

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"People with sarcoma struggle with limited treatment options that are often ineffective and toxic," said Brandi Felser, Chief Executive Officer of the Sarcoma Foundation of America. "New and innovative treatments are long overdue for people with sarcoma."

"Our cell therapy, afami-cel, has produced impressive clinical responses in heavily pre-treated patients with late-stage, rare sarcomas – a patient population with a high unmet medical need," said Elliot Norry, Adaptimmune’s Chief Medical Officer. "Obtaining commercial approval for afami-cel for the treatment of synovial sarcoma is a top priority, and the pivotal trial, SPEARHEAD-1, met its primary endpoint for efficacy last year. These data provide evidence of the benefits of afami-cel across patient sub-groups, and further inform SPEAR T-cell development strategies for the treatment of solid tumors."

Data support the potential of afami-cel as a treatment option for people with rare sarcomas

Afami-cel is a cell therapy that uses a patient’s own T-cells to express an engineered T-cell receptor (TCR) designed to kill cancer cells in solid tumors expressing a protein called MAGE-A4
Pooled data were analyzed[1] from 69 patients with synovial sarcoma or MRCLS who received afami-cel in the Phase 1 trial or Cohort 1 of the SPEARHEAD-1 trial
The overall response rate was 36% in heavily pre-treated patients across both types of sarcomas (41% in synovial sarcoma and 10% for MRCLS), with a median duration of response of 52 weeks
Responses occurred across subgroups (i.e., age, gender, number of prior lines of therapy, tumor burden, and MAGE-A4 expression level)
Lower baseline tumor burden, fewer prior lines of prior therapy, and higher MAGE-A4 expression were associated with greater response rates
Among patients with clinical responses, median progression-free survival (PFS) was 58 weeks compared to 12 weeks in non-responders
Patients who received 2 or fewer prior lines of therapy had a response rate of 49% compared to 24% for patients who received 3 or more
As reported last year, the pivotal trial SPEARHEAD-1 met its primary endpoint for efficacy and the benefit:risk profile of afami-cel has been favorable with mainly low-grade cytokine release syndrome and tolerable/reversible hematologic toxicities
Adaptimmune is on-track for BLA submission to FDA in Q4 2022 and planned commercial launch in 2023