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KN026-004 (Neo-Healer) — Anbenitamab + nab-docetaxel ± carboplatin vs THP ± carboplatin, neoadjuvant HER2+ early/locally advanced breast cancer

Abstract: LBA660 · Session: Breast Cancer — Local/Regional/Adjuvant (Oral Abstract Session), Sat May 30, 2026, 3:39–3:51 PM CT · Presenter: Zhimin Shao, MD, Fudan University Shanghai Cancer Center · Embargo: at presentation (May 30, 2026)

At a glance

  • Sponsor: Alphamab Oncology (anbenitamab/KN026); HB1801 nab-docetaxel co-developed with JMT-Bio (a CSPC subsidiary). (Research hint named Akeso/Hansoh — corrected to Alphamab/CSPC per sources.)
  • PI / presenter: Zhimin Shao, MD — Fudan University Shanghai Cancer Center
  • NCT ID: NCT06747338
  • Phase: III
  • Design: Randomized, controlled, open-label, multicenter; 1:1 to anbenitamab + HB1801 (nab-docetaxel) ± carboplatin vs trastuzumab + pertuzumab + docetaxel (THP) ± carboplatin; single-stage continuous 6-cycle neoadjuvant regimen
  • N: ~520 (randomized 1:1)
  • Primary endpoint(s): Total pathologic complete response (tpCR, ypT0/is ypN0) by blinded independent review committee (BIRC)
  • Comparator: THP / TCbHP — trastuzumab + pertuzumab + docetaxel ± carboplatin (standard neoadjuvant dual HER2 blockade)
  • Indication: HER2-positive early or locally advanced breast cancer
  • Line: Neoadjuvant (first-line, curative-intent)

Headline result

In the phase III Neo-Healer trial, neoadjuvant anbenitamab (KN026) plus albumin-bound docetaxel (HB1801) ± carboplatin significantly improved tpCR versus standard THP ± carboplatin, meeting the prespecified primary endpoint with both statistical and clinical significance. Per company and trade-press reports of the LBA660 oral presentation (OncLive/Docwire/CancerNetwork coverage), tpCR by blinded review was 62.4% vs 51.2% (absolute difference ~11.2 percentage points); investigator-assessed tpCR was 63.9% vs 51.2%, and breast pCR was 64.6% vs 55.0% (one-sided P = .0099). This is the first head-to-head phase III evidence that a single biparatopic HER2 bispecific can outperform the dual monoclonal-antibody backbone (trastuzumab + pertuzumab) in the neoadjuvant setting, with a reported manageable safety profile.

Mechanism / class

Anbenitamab (KN026) is an anti-HER2 biparatopic/bispecific antibody built on Alphamab's CRIB (Charge Repulsion Induced Bispecific) Fc-heterodimer platform. It simultaneously binds two non-overlapping HER2 epitopes (ECD subdomains II and IV) — the same domains targeted separately by pertuzumab (II) and trastuzumab (IV) — combining both binding regions in a single molecule for continuous, uninterrupted dual HER2 signal blockade, with enhanced receptor clustering, internalization, and ADCC. HB1801 is an albumin-bound (nab-) docetaxel. The 6-cycle single-stage regimen avoids drug switching/segmented dosing and allows surgery ~6 weeks earlier than the standard schedule. Anbenitamab is investigational and has no approval in breast cancer as of the presentation date; the comparator THP backbone is the established standard for neoadjuvant HER2+ disease.

Discussant takeaway

The control arm is the pre-DESTINY-Breast11 standard (THP). Commentators noted the result should be read against the evolving neoadjuvant landscape now reshaped by T-DXd → THP (DESTINY-Breast11), which is not the comparator here.

Practice-changing?

Pending. A positive head-to-head phase III against THP supports anbenitamab as a potential new, simpler single-agent neoadjuvant backbone in place of dual mAb HER2 blockade — if the tpCR gain and event-free/disease-free survival hold up. But the comparator predates T-DXd-based neoadjuvant data, the trial was conducted predominantly in China, and event-free/long-term outcomes are immature. Regulatory and broader practice impact awaits survival follow-up and ex-China data.

Sources

  • ASCO Meeting Library (abstract LBA660): https://meetings.asco.org/abstracts-presentations/search?q=LBA660
  • Alphamab Oncology — ASCO 2026 LBA preview (Apr 22, 2026): https://www.alphamabonc.com/en/html/news/2783.html
  • Alphamab Oncology — primary endpoint met topline (Apr 2026): https://www.alphamabonc.com/en/html/news/2778.html
  • PR Newswire — 2026 ASCO Preview, LBA oral selected: https://www.prnewswire.com/apac/news-releases/2026-asco-preview--results-from-phase-iii-study-of-anbenitamab-kn026-combined-with-hb1801-in-neoadjuvant-treatment-for-breast-cancer-selected-for-lba-oral-presentation-302749825.html
  • Docwire News — ASCO 2026 anbenitamab improves pCR: https://www.docwirenews.com/post/asco-2026-anbenitamab-improves-pathologic-complete-response-in-her2-positive-early-breast-cancer
  • OncLive — neoadjuvant anbenitamab plus docetaxel responses in HER2+ EBC: https://www.onclive.com/view/neoadjuvant-anbenitamab-plus-docetaxel-elicits-responses-in-her2-early-breast-cancer
  • CancerNetwork — anbenitamab combo meets pCR endpoint (NCT06747338, Neo-Healer): https://www.cancernetwork.com/view/anbenitamab-injection-combo-meets-pcr-end-point-in-her2-breast-cancer
  • OncoDaily — ASCO 2026 Day 2 highlights: https://oncodaily.com/not-to-miss/not-to-miss-asco-512178