Occupier News
13 December 2024
First patient treated with Adaptimmune’s TECELRA(R) (afamitresgene autoleucel)
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Dosing marks a milestone for first engineered cell therapy approved in the US for a solid tumour cancer, synovial sarcoma.
Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company working to redefine the treatment of solid tumour cancers with cell therapy, with its research base at Milton Park, has announced that the first patient has been treated with TECELRA® (afamitresgene autoleucel).
TECELRA is the first engineered cell therapy for a solid tumour cancer approved in the US and the first new therapy option in more than a decade for synovial sarcoma, a rare, soft tissue cancer that most commonly impacts young adults. The patient was treated at Moffitt Cancer Centre, one of Adaptimmune’s Authorised Treatment Centres (ATCs) and a leader in sarcoma research and treatment.
In August 2024, the US Food and Drug Administration (FDA) granted accelerated approval of TECELRA for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumour expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer:
“Dosing our first commercial TECELRA patient, in partnership with one of the top cancer centres in the US, is an incredible milestone for the sarcoma community and for Adaptimmune.“We are focused now on reaching as many eligible synovial sarcoma patients as possible with this one-time infusion treatment as well as advancing our broader sarcoma franchise as we aim to ultimately redefine the way cancer is treated.”
Mihaela Druta, MD, Medical Oncologist and Vice Chair of the Sarcoma Department, Sarcoma Medical Oncology at Moffitt Cancer Centre; SPEARHEAD-1 Trial Investigator:
“Synovial sarcoma is a particularly devastating type of cancer, affecting many patients in the primes of their lives with poor prognosis for those who fail first-line treatment.“Despite this outlook, in the last decade we have seen no new, effective treatments become available to patients. TECELRA’s one-time infusion treatment provides a much-needed option to patients with unresectable or metastatic synovial sarcoma, offering a novel therapeutic approach to treatment as well as a newfound sense of hope for patients and their loved ones.”
Several Authorised Treatment Centres (ATCs) are accepting referrals across the US where patients and healthcare providers can initiate the TECELRA treatment journey.
Adaptimmune is confident the full ATC network of approximately 30 ATCs will be active by the end of 2025, covering an estimated 80% of patients treated in sarcoma centres of excellence. Healthcare providers anywhere in the country can get patients tested for the biomarkers. In addition, an integrated support programme, AdaptimmuneAssist, is available to enable a seamless and personalised experience through the treatment journey.
About Synovial Sarcoma
There are more than 50 different types of soft tissue sarcomas which are categorised by tumours that appear in fat, muscle, nerves, fibrous tissues, blood vessels, or deep skin tissues.1 Synovial sarcoma accounts for approximately 5 to 10% of all soft tissue sarcomas (there are approximately 13,400 new soft tissue cases in the US each year).2,3
One third of patients with synovial sarcoma will be diagnosed under the age of 30.3
The five-year survival rate for people with metastatic disease is approximately 20% and most people undergoing standard of care treatment for advanced disease experience recurrence and go through multiple lines of therapy, often exhausting all options.4
About TECELRA
TECELRA® (afamitresgene autoleucel) is a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumour expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.
This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Please see important safety information including contraindication and full Prescribing Information, including Boxed Warning and Medication Guide, here.
1. “What is a Soft Tissue Sarcoma?” American Cancer Society. https://www.cancer.org/cancer/types/soft-tissue-sarcoma/about/soft-tissue-sarcoma.html. Accessed June 24, 2024.
2. “Soft Tissue Sarcoma.” Cleveland Clinic. https://my.clevelandclinic.org/health/diseases/21732-soft-tissue-sarcoma. Accessed June 6, 2024.
3. “Synovial Sarcoma.” National Cancer Institute. https://www.cancer.gov/pediatric-adult-rare-tumor/rare-tumors/rare-soft-tissue-tumors/synovial-sarcoma. Accessed June 5, 2024.
4. Aytekin MN, Öztürk R, Amer K, et al. Epidemiology, incidence, and survival of synovial sarcoma subtypes: SEER database analysis. J Orthop Surg (Hong Kong). 2020;28(2):1-12.
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