Following the positive results, the company now plans to start a global Phase III clinical trial evaluating the combination therapy of ASP-1929 and Keytruda as first-line therapy in recurrent HNSCC in the second half of this year. The study’s primary endpoint will be overall survival.
The results from the open-label Phase Ib/II study (NCT04305795) will be presented at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from 31 May to 4 June.
ASP-1929 is an antibody-dye conjugate comprising of an epidermal growth factor receptor (EGFR) antagonist antibody, cetuximab, and a light-activated dye, IRDue 700DX. The therapy is activated locally by inducing a photochemical reaction when illuminated with red light using a laser device system. This potentially causes membrane damage in cancer cells, leading to selective necrosis of cancer cells.
ASP-1929 received fast track designation from the US Food and Drug Administration (FDA) in 2018. It was approved as a treatment for unresectable locally advanced or recurrent head and neck cancer in Japan.
As of the data cut-off of 31 August 2023, 18 out of 19 patients received both therapies in the Phase Ib/II trial. Median overall survival and duration of response were not reached as of the data cut-off. The therapy had an objective response rate (ORR) of 35.3%, with four complete and two partial responses. At 24 months, the treatment had an estimated survival rate of 52.4%.
In March, Rakuten raised $119m in a Series E financing round to develop its Alluminox drug discovery platform and fund the Phase III ASP-1929 monotherapy trial (NCT03769506). The open-label Phase III study is expected to enrol approximately 275 participants with recurrent HNSCC who have received at least two prior lines of therapy.
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