Breakthrough Therapy designation for Adaptimmune’s NY-ESO-1-T cell therapy
Posted: 10 February 2016 | | No comments yet
The Breakthrough Therapy designation was based on the results of a Phase I/II trial in patients with unresectable, metastatic or recurrent synovial sarcoma…
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the Adaptimmune’s affinity enhanced T-cell therapy targeting NY-ESO in synovial sarcoma.
The designation is grant for HLA-A*201, HLAA*205 or HLA-A*206 allele-positive patients with inoperable or metastatic synovial sarcoma who have received prior chemotherapy and whose tumour expresses the NY-ESO-1 tumour antigen.
Commenting on the announcement, Dr Rafael Amado, Adaptimmune’s Chief Medical Officer, said: “We are committed to investigating the potential of our NY-ESO-1-T cell therapy across a variety of cancers. We are pleased that the FDA has granted Breakthrough Therapy designation for our T-cell therapy in synovial sarcoma, recognizing both the unmet need for patients suffering from this disease as well as the promise of these early data. We look forward to working closely with the FDA to expedite the clinical development of this therapeutic candidate.”
Designation based on results from a Phase I/II trial
The Breakthrough Therapy designation was based on the results of a Phase I/II trial in patients with unresectable, metastatic or recurrent synovial sarcoma who have received prior chemotherapy. Patients were treated with lymphodepleting chemotherapy followed by immunotherapy with T-cells engineered to recognise an HLA-A2 restricted NY-ESO-1 peptide. In the primary efficacy analysis, 60% of the 10 patients receiving the target dose of cells responded, and there was a 50% overall response rate in the 12 patients receiving any dose of cells. Nine out of ten of those patients who received the target dose and 75% of all patients were alive and on long term follow-up.
The most common adverse events included nausea, anaemia, pyrexia, lymphophenia and neutropenia. Cytokine release syndrome (CRS) was seen in four of twelve subjects, with grade 3 CRS observed in two subjects; no grade 4 CRS events were observed.
Adaptimmune recently announced that it will aim to initiate pivotal studies with its affinity enhanced Tcell therapy targeting NY-ESO in synovial sarcoma around year end 2016, and that it will also explore development in myxoid round cell liposarcoma. Studies with this therapy are also under way in myeloma, melanoma, ovarian cancer and non-small cell lung cancer.
