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Two Nature Medicine reports advance HER2-targeted treatment. In the randomized ASPEN-06 trial, adding the CD47 inhibitor evorpacept to trastuzumab, ramucirumab and paclitaxel produced a higher objective response rate than the trastuzumab-ramucirumab-paclitaxel combination alone in HER2-positive advanced gastric cancer that had progressed on anti-HER2 treatment, with response linked to CD47 and HER2 expression. Separately, a trial tested trastuzumab plus nivolumab, gemcitabine and cisplatin as first-line therapy for HER2-positive unresectable biliary tract cancer, reporting encouraging response rates and an association between HER2 expression and clinical benefit. Both findings support HER2 status as a treatment-guiding marker. Confirmation in larger trials and broader validation in biliary tract cancer remain open questions.
Written by a model from the reports
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- mp.weixin.qq.comPickTrastuzumab Deruxtecan Gains Conditional Tumor-Agnostic HER2-Positive Approval in China
Daiichi Sankyo's trastuzumab deruxtecan (Enhertu) has been approved in China for adult patients with unresectable or metastatic solid tumors expressing HER2 IHC 3+ who have received prior treatment or have no satisfactory alternative options. The approval, granted conditionally by the NMPA, covers a tumor-agnostic indication.
- mp.weixin.qq.comPickDaiichi Sankyo and AstraZeneca's Trastuzumab Deruxtecan Wins Tumor-Agnostic Indication in China
On October 22, Daiichi Sankyo and AstraZeneca's trastuzumab deruxtecan received approval in China for a new tumor-agnostic indication: adults with unresectable or metastatic HER2 IHC 3+ solid tumors who have received prior treatment or have no satisfactory alternative options. The CDE had granted the indication priority review. Since its first approval in December 2019, the drug has expanded across breast cancer, gastric cancer and non-small cell lung cancer, among other tumor types.
- clinicaltrials.govBL-M07D1 (Trastuzumab Brengitecan T-bren) vs Standard of Care Platinum-based Chemotherapy (PBC) for HER2-expressing Metastatic Urothelial Cancer After Progression on Anti-PD-(L)1-based Therapy
A newly registered phase 3 trial (NCT07869836) will randomize 520 participants with HER2-expressing metastatic urothelial cancer progressing on or after anti-PD-(L)1-based therapy to BL-M07D1 (trastuzumab brengitecan, T-bren) at one of two dose levels versus gemcitabine plus platinum-based chemotherapy (cisplatin or carboplatin). Sponsored by SystImmune, it is recruiting with a planned start in September 2026 and will evaluate efficacy and safety.
- biorxiv.orgPickTrastuzumab deruxtecan kills skin and uveal melanoma in vivo by HER2-independent payload release
Trastuzumab deruxtecan (T-DXd) inhibited all subcutaneous melanoma PDXs and outperformed trastuzumab emtansine (T-DM1), which had limited activity, while liver models were less sensitive. Parental and ERBB2-knockout xenografts responded similarly at first, though knockout tumors regrew earlier, and melanoma cells resisted both ADCs in vitro with little trastuzumab uptake. Tumor-derived cathepsin L found outside melanoma cells suggests payload release can occur extracellularly, independent of HER2.
- mp.weixin.qq.comPickFDA Approves Pfizer's TUKYSA Plus Trastuzumab and Pertuzumab for First-Line HER2+ Breast Cancer Maintenance
The FDA approved Pfizer's TUKYSA (tucatinib) combined with trastuzumab and pertuzumab as maintenance therapy after induction treatment for adults with unresectable locally advanced or metastatic HER2-positive breast cancer. The approval extends TUKYSA into the first-line setting and offers a chemotherapy-free maintenance option. According to Pfizer, the regimen reduced the risk of death by 35.9% compared with trastuzumab alone.
- N Engl J MedAdvances in Systemic Treatment of Breast Cancer.
A New England Journal of Medicine review traces systemic therapy for breast cancer since 2020, covering targeted therapies, antibody-drug conjugates and immunotherapy across biologic subtypes. CDK4/6 inhibitors remain foundational in hormone-receptor-positive, HER2-negative disease, trastuzumab deruxtecan is reshaping HER2-positive treatment, and immune checkpoint inhibitors have improved outcomes in triple-negative breast cancer. Unresolved issues include treatment sequencing, predictive biomarkers, circulating tumor DNA analysis and equitable access to high-cost therapies.
- fda.govPickFDA approves tucatinib with trastuzumab and pertuzumab for the maintenance treatment of HER2-positive breast cancer
The FDA approved tucatinib (Tukysa, Seagen, a Pfizer subsidiary) with trastuzumab and pertuzumab on October 7, 2026, for maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer after induction therapy. In the 654-patient HER2CLIMB-05 trial, median progression-free survival was 24.9 months with tucatinib 300 mg twice daily versus 16.3 months with placebo (HR 0.64, p<0.0001). The label carries a boxed warning for hepatotoxicity; overall survival data were immature.
- medicalxpress.comPickTumor markers reveal which HER2+ breast cancer patients may respond to less intensive chemotherapy
In the CompassHER2-pCR trial, 43.8% of 2,141 early-stage HER2-positive breast cancer patients achieved a pathologic complete response after 12 weeks of neoadjuvant taxane, trastuzumab and pertuzumab, rising to 63.7% in ER-negative disease. The HER2DX test, analyzed in 569 participants, showed pCR rates of 68% with high scores versus 19% with low scores, an association that held after adjustment for clinical factors. The results support using tumor markers to select patients for less intensive chemotherapy.
- Nature MedicinePickEvorpacept plus trastuzumab, ramucirumab and paclitaxel in HER2-positive gastric cancer: a randomized phase 2 trial
Adding the CD47 inhibitor evorpacept to trastuzumab, ramucirumab and paclitaxel (TRP) produced a higher objective response rate than TRP alone in patients with HER2-positive advanced gastric cancer that had progressed on anti-HER2 treatment. The finding comes from the phase 2 part of the randomized ASPEN-06 trial. Response was associated with CD47 and HER2 expression.
- Nature MedicinePickTrastuzumab plus nivolumab with gemcitabine and cisplatin as first-line therapy for HER2-positive unresectable biliary tract cancer: a phase 1b/2 trial
A phase 1b/2 trial tested trastuzumab combined with nivolumab, gemcitabine and cisplatin as first-line therapy for HER2-positive unresectable biliary tract cancer. The regimen showed encouraging clinical response rates, and HER2 expression was associated with clinical benefit. The results support HER2 status as a marker guiding trastuzumab-based treatment in this population.
- mp.weixin.qq.comPickTrastuzumab Deruxtecan Extends Median PFS to 14.3 Months as First-Line Therapy in HER2-Mutant Advanced NSCLC
In the phase III DESTINY-Lung04 trial, first-line trastuzumab deruxtecan (Enhertu) gave a median progression-free survival of 14.3 months in patients with HER2-mutant advanced non-small cell lung cancer, versus 8.3 months with pembrolizumab plus chemotherapy. It is the first HER2-targeted therapy to show superiority over standard treatment in this setting.
- mp.weixin.qq.comPickNMPA Approves Hengrui HER2 ADC Ruikang Trastuzumab for HER2-Positive Colorectal Cancer
NMPA approved a new indication for Hengrui Medicine's HER2 ADC ruikang trastuzumab (Aivida) on August 6 for adults with HER2-positive colorectal cancer who failed prior oxaliplatin, fluorouracil and irinotecan treatment. It becomes China's first targeted therapy specifically for HER2-positive colorectal cancer. The pivotal study showed nearly doubled progression-free survival and an overall response rate of 40.7%.
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