FDA grants fast track designation to ALX148 for two cancer indications
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The FDA granted fast track designation to ALX148 for the first-line treatment of patients with head and neck squamous cell carcinoma and second-line treatment of patients with HER2-positive gastric or gastroesophageal junction carcinoma, according to a press release from the drug’s manufacturer.
ALX148 (ALX Oncology) — a next-generation CD47 myeloid checkpoint inhibitor — is designed to maximize the clinical benefit of anticancer therapies for various tumor types.
The FDA based its decision, in part, on data from an open-label, multicenter phase 1 trial of ALX148 in combination with pembrolizumab (Keytruda, Merck) or trastuzumab (Herceptin, Genentech). Data showed a 40% objective response rate among checkpoint inhibitor-naive patients with HNSCC who progressed on prior platinum therapy, as well as a 21% ORR among patients with gastric or gastroesophageal junction carcinoma whose disease progressed on prior anti-HER2 therapy.
“FDA’s decision to grant fast track designation to ALX148 is an important recognition of ALX Oncology’s promising clinical data. This designation reflects the potential for ALX148 to be an important advancement in the treatment of patients with HNSCC and HER2-positive gastric/ gastroesophageal junction cancer,” Sophia Randolph, MD, PhD, chief medical officer of ALX Oncology, said in the press release. “We look forward to working closely with the FDA on the clinical development of ALX148 for patients with cancer.”