Afamitresgene autoleucel is under clinical development by Adaptimmune Therapeutics and currently in Phase II for Osteosarcoma. According to GlobalData, Phase II drugs for Osteosarcoma have a 13% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Afamitresgene autoleucel’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Afamitresgene autoleucel overview

Afamitresgene Autoleucel (Tecelra) is a melanoma-associated antigen A4 (MAGE-A4)-directed 13 genetically modified autologous T cell immunotherapy. It is formulated as a cell suspension for intravenous route of administration. Tecelra is 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, 6 or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen.

ADPA-2M4 is under development for the treatment of solid tumors including synovial sarcoma, myxoid/round cell liposarcoma, esophageal cancer (squamous and adenocarcinoma), esophagogastric junction cancer, melanoma, urothelial,  bladder, ovarian, squamous non-small cell lung, peripheral nerve sheath tumor (neurofibrosarcoma), neuroblastoma, osteosarcoma and gastric cancer. The therapeutic candidate constitutes autologous genetically modified T-cells expressing enhanced T cell receptors (TCRs) targeting MAGEA4. It is administered through parenteral and intravenous route. 

It was under development for the treatment of recurrent head and neck squamous cell carcinoma.

Adaptimmune Therapeutics overview

Adaptimmune Therapeutics (Adaptimmune) is a clinical-stage biopharmaceutical company that develops innovative T-cell therapy products for the treatment of cancer. The company product pipeline includes afami cel, ADP-A2M4CD8 and ADP-A2AFP. It treats synovial sarcoma, head and neck, urothelial, esophageal, EGJ cancer and hepatocellular carcinoma. Adaptimmune has collaborated with Alpine Immune Sciences, Cell and Gene Therapy Catapult, Center for Cancer ImmunTherapy, Genentech and MD Anderson Cancer Center, among others. The company has operations across the US and the UK. Adaptimmune is headquartered in Abingdon, Oxfordshire, the UK.

For a complete picture of Afamitresgene autoleucel’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 12 April 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.