Neeraj Joshi, Sarah J. Harmych, Hidenori Tanaka, Galina Bogatcheva, Marisol A. Ramirez, Ramona Graves-Deal, Claiborne W. Tydings, Claudia C. Wahoski, Chelsie K. Sievers, Maria Johnson Irudayam, James N. Higginbotham, Frank L. Revetta, Zhiguo Zhao, Jeffrey L. Franklin, Binyam Yilma, Tina M. O'Grady, Stamatina Fragkogianni, Metamia Ciampricotti, M Kay Washington, Xingyi Guo, Allison S. Walker, Jens Meiler, Qi Liu, Robert J. Coffey, Eben L. Rosenthal, Bhuminder Singh
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AACR Annual Meeting 2026
April 17–22, 2026 · San Diego · 2418 items
← Next-generation ADCs: payload innovation
trastuzumab
Clinical trial23 people · 23 posts · 4 abstracts
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| Drug / trial | Readout | Setting |
|---|---|---|
| T-DXd + pertuzumabtrastuzumabHER2#BREASTCANCER | PFS HR 0.56 (40.7 vs 26.9 mo) | DESTINY-Breast09 · 1L HER2+ mBC · Phase 3 |
T-DXd is already rewriting the first-line standard.
- olaparib + T-DXdConfirmed PR 42.9%, mDOR 11.2 mo (n=28)
- risvutatugB7-H3 ADC, floor ORR ~47%
- zanidatamab 新辅助No-chemo pCR 30%, HER2 down 56%
- AVA6103 / pan-RAS ADCTricomplex pan-RAS as payload
zanidatamab binds two HER2 domains at once (the trastuzumab and pertuzumab sites) and does not lean on chemo cytotoxicity. T-DXd is the other pole: an ADC payload pushing the first-line standard up, at the cost of interstitial lung disease.
| Drug / trial | Readout | Setting |
|---|---|---|
| T-DXd + pertuzumabtrastuzumabHER2#BREASTCANCER | PFS HR 0.56; ILD ~12%, including 2 grade 5 | DESTINY-Breast09 · 1L HER2+ |
- zanidatamabNo-chemo neoadjuvant pCR 30%
- pumitamigTNBC cORR 61.5%
- NSABP-B-59ctDNA predicted non-pCR and distant recurrence
Mailin Li, Xen Ping Hoi, Jenying Deng, Junjun Zheng, Rabia Hashmani, Recep Bayraktar, Wei Qian, Jianying Zhou, Jian Guan, Kai Sun, Hanh Mai, Tiffany Sheu, Susan Haley, Mary Schwartz, Sunil Mathur, Stephen T. Wong, Fotis Nikolo, Keith Syson Chan, Polly Niravath, Jenny C. Chang
Read the abstract →Michael B. Foote, Jinru Shia, Callahan Wilde, Marinela Capanu, Joanne Chou, Vetri Sudar Jayaprakasam, Marc Gollub, Miteshkumar Patel, Mina Ito, Leonard B. Saltz, Devika Rao, Neil Segal, Maliha Nusrat, Karuna Ganesh, Paul Romesser, Julio Garcia-Aguilar, Martin Weiser, Rona Yaeger, Luis A. Diaz, Andrea Cercek
Read the abstract →Alexandre de Nonneville, Jean-Marie Boher, Jean-Sébastien Frenel, Gerald Bagoe, Olivier Tredan, Marie-Ange Mouret-Reynier, Chayma Bousrih, Vincent Massard, Julien Grenier, Marie Robert, Florence Lerebours, Delphine Loriat, Florence Dalenc, Christelle Jouannaud, Stéphanie Becourt, Philippe Follana, Sylvain Ladoire, William Jacot, Bogdan-Valentin Popescu, Maxime Brunet, George Emile, Jerôme Lemmonier, Sylvie Mijonnet, Anthony Gonçalves, François Bertucci
Read the abstract →mp.weixin.qq.comPickScore8989 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.
Why it matters: Four phase II studies provide cross-tumor ORR, survival and ILD safety data for weighing benefit, risk and evidence limits.
mp.weixin.qq.comPickScore8383 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.
Why it matters: Trastuzumab deruxtecan's HER2 IHC 3+ tumor-agnostic approval in China allows comparison of review timing and covered populations with analogous global approvals.
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clinicaltrials.govScore3535 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.
bioRxiv Cancer BiologyPickScore5151 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.
Why it matters: Suggests T-DXd may work in melanoma through HER2-independent payload cleavage, widening its potential use beyond HER2-positive tumors.
mp.weixin.qq.comPickScore6767 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.
Why it matters: FDA approval moves Pfizer's TUKYSA into first-line HER2+ breast cancer maintenance with a 35.9% death-risk reduction.
HER2No engagement yetclinicaltrials.govScore2929 Response-Guided Bladder Preservation With Trastuzumab Rezetecan, Adebrelimab, and Concurrent Bladder Radiotherapy in HER2-Expressing Muscle-Invasive Bladder Cancer
N Engl J MedScore4040 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.
No engagement yetmedRxiv OncologyScore4545 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
HER2No engagement yetFDA DrugsPickScore8080 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.
Why it matters: FDA approval extends tucatinib to first-line maintenance, with PFS results from a randomized phase 3 trial.
medicalxpress.comPickScore6060 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.
Why it matters: It identifies predictors of response to de-escalated chemotherapy in early-stage HER2+ breast cancer.
HER2No engagement yet
clinicaltrials.govScore2727 Trastuzumab/Pertuzumab With Fulvestrant and Kurmoxilil in HR+/HER2+ Early Breast Cancer
Nat Med Evorpacept plus trastuzumab, ramucirumab and paclitaxel in HER2-positive gastric cancer: a randomized phase 2 trial.
Nat Med Trastuzumab plus nivolumab with gemcitabine and cisplatin as first-line therapy for HER2-positive unresectable biliary tract cancer: a phase 1b/2 trial.
Nature MedicinePickScore5656 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.
Why it matters: It tests CD47 blockade as a way to overcome resistance to anti-HER2 therapy in gastric cancer.
Nature MedicinePickScore5252 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.
Why it matters: First data on adding trastuzumab and nivolumab to standard gemcitabine-cisplatin in HER2-positive biliary tract cancer.
mp.weixin.qq.comPickScore7474 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.
Why it matters: First HER2-targeted therapy to beat standard first-line care in HER2-mutant advanced NSCLC in phase III.
pubmed.ncbi.nlm.nih.govScore4040 Super-antifouling electrochemical biosensor based on a biomimetic gemini zwitterionic interface for sensitive detection of therapeutic antibodies
Same topic trastuzumab · 23 peopleNo engagement yet
mp.weixin.qq.comPickScore7878 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%.
Why it matters: First approved targeted therapy for HER2-positive colorectal cancer in China, from a pivotal study readout.
Dana-Farber News@DanaFarberNewsScore6060 In today’s Clinical Trials Plenary at #AACR26: