Asher Biotherapeutics announced a clinical trial collaboration and supply agreement with Amgen to evaluate etakafusp alfa (formerly known as AB248), Asher Bio?s investigational CD8+ T cell targeted interleukin-2 (IL-2) immunotherapy, in combination with IMDELLTRA (tarlatamab), Amgen?s DLL3-targeting Bispecific T-cell Engager (BiTE) therapy, in patients with extensive-stage small cell lung cancer (ES-SCLC). As part of this collaboration agreement, Amgen will sponsor and operationalize a global Phase 1b study to evaluate the safety and early efficacy of etakafusp alfa in combination with IMDELLTRA in patients with ES-SCLC. Asher Bio will retain full ownership of etakafusp alfa and will supply Amgen with etakafusp alfa at no cost.
SCLC is one of the most aggressive and devastating solid tumor malignancies, with a median survival of approximately 12 months following initial therapy and a 3% five-year relative survival rate for ES-SCLC. Current second-line treatments impart a short duration of response (median DoR: 3.3?5.3 months) and limited survival (median OS: 5.8-9.3 months), while current third-line treatments for SCLC, which consist primarily of chemotherapy, yield a short median DoR of 2.6 months and a median OS of 4.4-5.3 months. SCLC comprises 15% of the 2.4 million plus patients diagnosed with lung cancer worldwide each year.
Despite initial high response rates to first-line platinum-based chemotherapy, most patients quickly relapse within months and require subsequent treatment options.