New knowledge from a part 1b/2 medical trial reveals {that a} particular protein known as CD47 will help predict how effectively the investigational drug evorpacept works for sufferers with metastatic breast most cancers, ALX Oncology Holdings Inc. introduced in a information launch.
The findings, derived from an exploratory evaluation of sufferers with HER2-positive most cancers that had unfold to different components of the physique, had been launched by the corporate to assist establish which people are more than likely to learn from this mixture remedy: By measuring CD47 expression ranges, researchers consider they’ll higher choose sufferers for evorpacept when used alongside the focused therapy Ziihera (zanidatamab-hrii).
Principal knowledge that help the findings
The latest exploratory evaluation revealed that the anti-tumor exercise of evorpacept is intently tied to the extent of CD47 expression present in a affected person’s most cancers. On this trial, optimistic responses had been largely restricted to sufferers with larger ranges of CD47 expression. This protein serves as a biomarker, a organic signpost that helps docs predict whether or not a affected person will reply to the therapy.
These breast most cancers findings reinforce earlier outcomes from the ASPEN-06 medical trial. That examine demonstrated that CD47 expression can be a predictive biomarker for sufferers with superior gastric most cancers that has retained HER2 expression.
Within the 9 sufferers with centrally confirmed HER2-positive metastatic breast most cancers, the mixture of evorpacept and Ziihera produced vital medical outcomes:
- Confirmed goal response price (cORR): 56% (5 out of 9 sufferers)
- Median progression-free survival (mPFS): 7.4 months
These outcomes are significantly notable as a result of the contributors had been closely pretreated, having obtained a median of six prior therapies, together with the remedy Enhertu (fam-trastuzumab deruxtecan-nxki), earlier than coming into the trial.
Trial particulars
The part 1b/2 trial is an open-label, multi-center examine evaluating the potential of evorpacept mixed with Ziihera. The trial included sufferers with beforehand handled, inoperable, regionally superior or metastatic HER2-expressing breast most cancers and different most cancers sorts.
The first outcomes of this trial had been first offered on the 2024 San Antonio Breast Most cancers Symposium (SABCS). Following that presentation, researchers carried out an extra exploratory evaluation particularly to establish biomarkers that might clarify why affected person responses fluctuate.
ALX Oncology can be transferring ahead with a part 2 trial known as ASPEN-09-Breast. The corporate acknowledged that the mixed knowledge from the present examine and the ASPEN-06 trial have elevated their confidence on this ongoing bigger examine. The whole biomarker evaluation from the part 1b/2 trial has been submitted for presentation at an upcoming scientific congress.
Security
The trial outcomes demonstrated that the mixture of evorpacept and Ziihera has a manageable security profile in sufferers who’ve already undergone in depth earlier remedies. Sustaining a manageable security profile is important for sufferers whose our bodies have already been affected by a number of rounds of earlier remedy.
By utilizing CD47 expression as a biomarker to information affected person choice, researchers hope to optimize the usage of the drug. This implies the remedy may be directed towards these more than likely to expertise a sturdy profit, doubtlessly avoiding pointless therapy for these whose most cancers biology might not reply to the mixture.
Evorpacept is designed as a foundational remedy for immuno-oncology and is at the moment being evaluated in a number of ongoing medical trials for a variety of most cancers indications. ALX Oncology’s second candidate, ALX2004, can be present process early-phase testing in sufferers with strong tumors, as the corporate continues to advance novel therapies designed to deal with most cancers and prolong sufferers’ lives.
References
- “New Knowledge Reveal CD47 Expression Stage Helps Predict Response to ALX Oncology’s Evorpacept in Mixture with Ziihera (zanidatamab-hrii) in Superior HER2-Constructive Breast Most cancers,” by ALX Oncology Holdings Inc. Information launch; Feb. 2, 2026.
Editor’s observe: This text is for informational functions solely and isn’t an alternative to skilled medical recommendation, as your personal expertise shall be distinctive. Use this text to information discussions along with your oncologist. Content material was generated with AI and reviewed by a human editor.
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