A combination therapy led by ALX Oncology Holdings Inc. (NASDAQ: ALXO) demonstrated a 100 percent response rate in a subset of patients with advanced HER2-positive breast cancer, validating the company's biomarker-driven approach and boosting confidence in its lead drug candidate, evorpacept.
"We are encouraged by the data presented yesterday at the ESMO Breast Cancer 2026 congress, which reinforce the potential of our CD47-inhibitor evorpacept to provide durable responses in patients with HER2-positive cancers that express high levels of CD47,” said Jason Lettmann, Chief Executive Officer at ALX Oncology.
The data, from a Phase 1b/2 trial, showed that all five patients with confirmed HER2-positive metastatic breast cancer and high CD47 expression had a confirmed objective response. This group also saw a median progression-free survival of 22.1 months and a median duration of response of 20.2 months. In contrast, patients with low CD47 expression had a 25 percent response rate and a median progression-free survival of just 3.4 months. These findings, presented at the ESMO Breast Cancer 2026 congress, build on similar results from the ASPEN-06 trial in gastric cancer, strengthening the hypothesis that CD47 expression is a key predictive biomarker for evorpacept's effectiveness.
The positive clinical results provide a significant tailwind for ALX Oncology as it navigates a competitive immuno-oncology market. The data de-risks the ongoing Phase 2 ASPEN-09-Breast trial, which is evaluating evorpacept with trastuzumab and chemotherapy, with topline data expected in mid-2027. The company's pipeline also includes ALX2004, an EGFR-targeted antibody-drug conjugate, which is on track to report safety data in the second half of 2026.
ALX Oncology reported a net loss of $17.9 million, or $0.17 per share, for the first quarter of 2026. This represents a significant narrowing from the $30.8 million net loss, or $0.58 per share, reported in the same period of 2025. Research and development expenses were nearly halved to $13.6 million from $23.9 million year-over-year.
The company ended the quarter with $169.1 million in cash, cash equivalents, and investments, which it stated is sufficient to fund operations through key clinical data readouts into mid-2027. The company also strengthened its leadership by appointing Jeff Knight as Chief Development and Operating Officer.
ALX Oncology will host a webcast on May 8, 2026, at 8:30 a.m. ET to discuss the financial results and the new clinical data. The call will feature Dr. Sara Hurvitz, a leading breast cancer expert from the Fred Hutchinson Cancer Center, who will provide perspective on the trial findings.
This article is for informational purposes only and does not constitute investment advice.
