- Design
- Phase 3, randomised, open-label, multicentre (China)
- Population
- 885 patients with HER2-positive advanced breast cancer, first line
- Primary outcome
- Progression-free survival by blinded central review
- Effect
- 24-month PFS 58.5% vs 34.4%; HR 0.46 (95% CI 0.37–0.56)
HEALER was a phase 3, open-label trial in China that randomised 885 patients with HER2-positive advanced breast cancer to anbenitamab, a HER2-targeted bispecific antibody, with albumin-bound docetaxel, or to the established first-line combination of docetaxel, trastuzumab and pertuzumab.
At a prespecified interim analysis, with a median follow-up of 21 months, 24-month progression-free survival by blinded central review was 58.5% against 34.4% (HR 0.46). Responses were more frequent (87.6% vs 73.4%). Grade 3 or higher adverse events were more common with the bispecific (45.9% vs 34.4%), mainly neutropenia; two deaths from adverse events occurred in each arm. The trial was industry funded.
The progression-free survival gain is large, but overall survival data are not yet mature, the population was entirely Chinese, and the drug is not licensed outside China as far as this record shows. Docetaxel, trastuzumab and pertuzumab remains the first-line standard elsewhere for now.
- Keep docetaxel, trastuzumab and pertuzumab as first-line standard for HER2-positive advanced breast cancer.
- Note anbenitamab as a possible future option pending survival data and licensing.
- Expect more grade 3 neutropenia with the bispecific combination.
- Consider trial enrolment where available for patients with HER2-positive advanced disease.
Why it matters
A bispecific antibody has now challenged the first-line HER2 standard in a phase 3 trial.
Don't overread it
This is an interim progression-free survival result from an open-label trial in one country; overall survival is not yet shown.
The statistics, in plain English
An HR of 0.46 means the rate of progression or death was less than half that with standard therapy during follow-up. Interim analyses can overestimate effects, and progression-free survival does not always translate into longer life.
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