Peptide News Digest

#Her2-Targeted-Adc

2 stories

Regulatory · View digest

NICE Issues Final Draft Guidance Recommending Enhertu (Trastuzumab Deruxtecan) for Routine NHS Use in HER2-Low Advanced or Metastatic Breast Cancer After Chemotherapy Progression

The UK's National Institute for Health and Care Excellence (NICE) issued Thursday September 17, 2026 final draft guidance recommending Daiichi Sankyo and AstraZeneca's Enhertu (trastuzumab deruxtecan, HER2-targeted antibody-drug conjugate combining an anti-HER2 antibody with a topoisomerase I inhibitor payload via a cleavable linker) for routine National Health Service use in adults with HER2-low advanced or metastatic breast cancer whose disease has progressed after prior chemotherapy. The NICE recommendation is based on DESTINY-Breast04 Phase 3 data documenting a 6.4-month improvement in median progression-free survival and a 6.6-month improvement in median overall survival versus physician's choice chemotherapy in HER2-low mBC. This is one of the last major geographies to add routine HER2-low mBC coverage for Enhertu, which has been approved by the FDA (August 2022 HER2-low, January 2025 HER2-ultralow) and the EMA. The NICE reversal follows an earlier draft rejection based on cost-effectiveness concerns; the final recommendation reflects updated commercial arrangements with AstraZeneca-Daiichi Sankyo through the NHS.

Research · View digest

Sichuan Kelun-Biotech Publishes Phase 3 HER2-Targeted Antibody-Drug Conjugate Trastuzumab Botidotin vs T-DM1 Data in Journal of Clinical Oncology: 11.1 vs 4.4 Months Median Progression-Free Survival

Sichuan Kelun-Biotech Biopharmaceutical (HKEX: 6990) announced Monday September 14, 2026 that Phase 3 registrational study results for trastuzumab botidotin — a novel HER2-targeted antibody-drug conjugate — versus T-DM1 (Roche's Kadcyla, trastuzumab emtansine) in HER2-positive unresectable or metastatic breast cancer have been published in the Journal of Clinical Oncology. Trastuzumab botidotin produced 11.1 months median progression-free survival versus 4.4 months on T-DM1, a hazard ratio of 0.39 (61% reduction in risk of progression or death). Co-senior authors: Professors Xichun Hu and Hongxia Wang of Fudan University Shanghai Cancer Center, and Dr. Junyou Ge. The NMPA approved trastuzumab botidotin in October 2025 for adults with unresectable or metastatic HER2-positive breast cancer who had received at least one prior anti-HER2 therapy. The T-DM1 comparator (approved 2013) has historically been the standard of care in this second-line setting, though Daiichi Sankyo/AstraZeneca's Enhertu (trastuzumab deruxtecan) has since taken market share on stronger DESTINY-Breast trial data. Kelun-Biotech has opened a Phase 2 study of trastuzumab botidotin in patients who previously received a topoisomerase inhibitor payload ADC (which includes Enhertu-treated patients). The Phase 3 result strengthens the case for global development beyond China.