ALX Oncology Holdings Inc. (ALXO, Financials) saw its stock price fall 15.8% to $1.52 as of 2:32 p.m. GMT-5 on Thursday, despite announcing positive updated results from its ASPEN-06 Phase 2 clinical trial.
Presenting at the 2025 American Society of Clinical Oncology Gastrointestinal tumors Symposium, the findings showed the potential of its experimental CD47-blocking therapy, evorpacept, to enhance outcomes for patients with HER2-positive stomach or gastroesophageal junction tumors.
Referred known as ETRP, the study assessed evorpacept versus a control group receiving trastuzumab, ramucirumab, and paclitaxel in combination. Evorpacept attained an overall response rate of 48.9%, almost tripling the 24.5% ORR seen in the control group among patients with verified HER2-positive expression. Median progression-free survival also increased to 7.5 months with evoracept from 6.7 months in the control group.
In those with verified HER2-positive expression, the therapy also showed a median duration of response of 15.7 months, much exceeding the 9.1 months attained by the control group. Safety records showed that evorpacept was typically well tolerated and that the adverse event profile matched the control schedule.
Presenting the results, Dr. Kohei Shitara highlighted the importance of evorpacept's effectiveness especially for patients who had already had HER2-targeted treatments. Chief Medical Officer of ALX Oncology, Dr. Alan Sandler, underlined the design of the treatment, which combines anti-HER2 antibodies efficiently to improve results.
For the second-line treatment of HER2-positive stomach and gastroesophageal junction tumors, the U.S. Food and Drug Administration has assigned Fast Track designation to evoracept. For this indication, the treatment also boasts Orphan Drug Designation from the FDA and the European Commission.
Confident in evorpacept's potential as a therapeutic choice for patients, ALX Oncology intends to engage regulatory talks with the FDA.
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