ESMO Congress 2026

Trastuzumab Deruxtecan Receives Conditional Tumor-Agnostic HER2 Approval in China

Trastuzumab deruxtecan (Enhertu) has received conditional approval in China as monotherapy for adults with unresectable or metastatic solid tumors expressing HER2 at IHC 3+ who have received prior treatment or have no satisfactory alternative options. The approval is based on four phase II trials: DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and DESTINY-PanTumor03, with full approval contingent on clinical benefit demonstrated in confirmatory trials.

Adjuvant Trastuzumab Deruxtecan Versus Trastuzumab Emtansine by Residual Cancer Burden in HER2-Positive Early Breast Cancer: A Decision Analysis

Trastuzumab 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.

Daiichi 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.

Nationwide HER2 Testing, Prospective Trastuzumab-Based Therapy, and Deep Visual Proteomics in Esophageal Squamous Cell Carcinoma

BL-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.

Trastuzumab 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.

FDA 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.

Response-Guided Bladder Preservation With Trastuzumab Rezetecan, Adebrelimab, and Concurrent Bladder Radiotherapy in HER2-Expressing Muscle-Invasive Bladder Cancer

Advances 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.

Multimodal Artificial Intelligence Predicts Pathological Response and Prognosis in HER2-Positive Early Breast Cancer Treated with Chemotherapy De-escalation Strategies: Analyses from PHERGain and PHERGain-2 Trials

FDA 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.

Tumor 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.

Trastuzumab/Pertuzumab With Fulvestrant and Kurmoxilil in HR+/HER2+ Early Breast Cancer

SHR-A1811 Versus Trastuzumab Plus Pertuzumab in ctDNA-Positive HER2-Positive Early Breast Cancer After Pathologic Complete Response

Evorpacept plus trastuzumab, ramucirumab and paclitaxel in HER2-positive gastric cancer: a randomized phase 2 trial.

Trastuzumab plus nivolumab with gemcitabine and cisplatin as first-line therapy for HER2-positive unresectable biliary tract cancer: a phase 1b/2 trial.

Evorpacept 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.

Trastuzumab 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.

Trastuzumab 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.

Super-antifouling electrochemical biosensor based on a biomimetic gemini zwitterionic interface for sensitive detection of therapeutic antibodies

NMPA 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%.

Read the @CD_AACR paper mentioned in Sarat Chandarlapaty's #AACR26 presentation on resistance to anti-HER2 ADCs: Trastuzumab Deruxtecan (...

In today’s Clinical Trials Plenary at #AACR26: