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AACR Annual Meeting 2026

April 17–22, 2026 · San Diego · 2418 items

← Next-generation ADCs: payload innovation

trastuzumab

Clinical trial

23 people · 23 posts · 4 abstracts

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Records
Drug / trialReadoutSetting
T-DXd + pertuzumabtrastuzumabHER2#BREASTCANCERPFS 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.

Other cases in this chapter

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.

Records
Drug / trialReadoutSetting
T-DXd + pertuzumabtrastuzumabHER2#BREASTCANCERPFS HR 0.56; ILD ~12%, including 2 grade 5DESTINY-Breast09 · 1L HER2+
Other cases in this chapter
Evidence
2968
EGFR S442 mutation confers cetuximab resistance that can be overcome by ERBB2 blockade by trastuzumab-deruxtecan.

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

Read the abstract →
CT011
Genomic HER2 amplification predicts for complete clinical response in a phase II study of induction tucatinib and trastuzumab combined with chemotherapy in locally advanced rectal adenocarcinoma

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

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ALTER: A randomized Phase II trial evaluating an upfront alternating regimen of sacituzumab-govitecan and trastuzumab-deruxtecan versus sacituzumab-govitecan alone in HER2-low metastatic triple-negative breast cancer (NCT07151586)

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

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Floor
TodayOct 23Fri
Oct 22Thu
  1. mp.weixin.qq.com89

    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.

  2. mp.weixin.qq.com83

    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.

    No engagement yet
Oct 21Wed
Oct 14Wed
  1. clinicaltrials.gov35

    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.

Oct 13Tue
  1. bioRxiv Cancer Biology51

    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.

    trastuzumabderuxtecanHER2No engagement yet
Oct 9Fri
  1. mp.weixin.qq.com67

    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 yet
Oct 8Thu
  1. N Engl J Med40

    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 yet
  2. FDA Drugs80

    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.

Oct 7Wed
  1. medicalxpress.com60

    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
Oct 6Tue
Oct 4Sun
Sep 24Thu
  1. Nature Medicine56

    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.

Sep 22Tue
  1. Nature Medicine52

    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.

Sep 14Mon
  1. mp.weixin.qq.com74

    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.

Aug 24Mon
Aug 8Sat
  1. mp.weixin.qq.com78

    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.

Apr 22Wed
Apr 20Mon
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