Clinical Responses Reported across Patient Subgroups with Adaptimmune's Cell Therapy, Afami-cel, Confirming Potential for People with Rare Sarcomas - BLA Submission On-Track
- Patients who responded to afami-cel had longer progression-free survival (median 58 weeks) compared to non-responders (median 12 weeks) -
- Responses occurred across subgroups, with greater response rates associated with lower baseline tumor burden, fewer prior lines of therapy, and higher MAGE-A4 expression -
- Afami-cel demonstrated a favorable benefit:risk profile -
Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - May 26, 2022) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a leader in cell therapy to treat cancer, presented 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) annual meeting.
"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 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
Adaptimmune is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.
This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Annual Report on Form 10-K filed with the Securities and Exchange Commission for the year ended December 31, 2021, our Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and other filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.
Sébastien Desprez - VP, Corporate Affairs and Communications
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Juli P. Miller, Ph.D. - VP, Investor Relations
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 Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator review; data cut-off for the Phase 1 trial with afami-cel is September 1, 2020, and October 11, 2021 for the pivotal trial SPEARHEAD-1
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