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.
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.
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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.
ALX 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.
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