ALX Oncology has announced new data from a Phase Ib/II clinical trial of its cluster of differentiation 47 (CD47)-inhibitor, evorpacept, combined with Jazz Pharmaceuticals’ Ziihera (zanidatamab-hrii) in heavily pretreated patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (mBC).
The findings show that among these patients, CD47 expression acts as a predictive biomarker for evorpacept activity.
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The multi-centre, open-label trial assessed evorpacept in combination with zanidatamab for previously treated, inoperable, locally advanced or metastatic HER2-expressing breast cancer and other cancers.
Primary results presented at the 2024 San Antonio Breast Cancer Symposium showed encouraging anti-tumour activity and a manageable safety profile in patients who had received a median of six prior therapies, including Enhertu.
In nine patients with centrally confirmed HER2-positive breast cancer who received the investigational combination, researchers observed a confirmed objective response rate of 56%, and a median progression-free survival of 7.4 months.
Further exploratory analysis aiming to identify biomarkers for response indicated that therapeutic benefit was seen primarily among patients exhibiting higher CD47 expression.
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By GlobalDataALX Oncology chief medical officer Barbara Klencke said: “These new findings support a CD47-dependent, HER2-driven biology for evorpacept. Going forward, we believe that a biomarker-driven approach incorporating CD47 expression may optimise patient selection for evorpacept combinations with HER2-targeted agents.
“Additionally, taken together, the data from this trial and the ASPEN-06 clinical trial reinforce our confidence in the ongoing ASPEN-09-Breast Phase II trial.”
In 2024, ALX Oncology revealed topline data from its Phase II ASPEN-06 clinical trial, indicating that evorpacept, in combination with standard therapies, enhanced tumour response in patients with HER2-positive gastric or gastroesophageal junction (GEJ) cancer.
