AiWeiDa (trastuzumab rezetecan) / Jiangsu Hengrui Pharma, Glenmark - LARVOL DELTA

SHR-A1811 ± adebrelimab (Adebre) for HER2-overexpressing advanced NSCLC: results from a phase 1b/2 study (ESMO 2026) - No abstract available

Metastases • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

Updated results of SHR-A1811 plus pertuzumab in human epidermal growth factor receptor 2-positive (HER2+) unresectable/metastatic breast cancer: a phase 1b/2 study (ESMO 2026) - No abstract available

Metastases • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Trastuzumab rezetecan (SHR-A1811) in HER2-low advanced breast cancer (BC): a randomized, phase 3 study (HORIZON-Breast06) (ESMO 2026) - No abstract available

Clinical • Late-breaking abstract • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Comprehensive Evaluation of the Efficacy and Safety of HER2-Targeted Therapies in Biliary Tract Cancer: Systematic Review and Network Meta-Analysis (ACG 2026) - "A total of twelve early-phase clinical trials involving 400 patients with biliary tract cancer were included in the analysis. Across the available HER2-directed regimens, trastuzumab plus chemotherapy was evaluated in 2 trials (124 patients) and demonstrated an ORR of 43.2% (95% CI 19.4â68.8) with a DCR of 80.0% (95% CI 72.3â86.7). Trastuzumab plus pertuzumab, assessed in 2 trials (45 patients), showed an ORR of 20.9% (95% CI 9.1â35.3) and a DCR of 53.4% (95% CI 37.8â68.8)."

Retrospective data • Review • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

NeoTRECAMCT-01：A prospective, non-randomized controlled clinical study of SHR-A1811 plus camrelizumab in perioperative combination or sequential chemotherapy for ER(-)/ER(1-10%), HER2-low expressing early or locally advanced breast cancer (ChiCTR) - P2 | N=74 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Xi'an Jiaotong University; The First Affiliated Hospital of Xi'an Jiaotong University

New P2 trial • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Innovative Therapies for HER2-altered Non-Small Cell Lung Cancer: a Narrative Review. (PubMed, Crit Rev Oncol Hematol) - "Combination strategies with immune checkpoint inhibitors, such as platinum-based chemotherapy plus PD-L1 inhibitors, are also being actively investigated, although overlapping toxicities, particularly pulmonary adverse events, remain a key concern. This narrative review summarizes the clinicopathological features of HER2-altered NSCLC, critically evaluates emerging HER2-targeted therapies, and discusses future treatment directions."

IO biomarker • Journal • Review • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

HER2-Targeted AIE Nanotheranostics Overcome SHR-A1811 Resistance via Immunogenic Pyroptosis and Tumor-Associated Macrophage Reprogramming in Breast Cancer. (PubMed, Small) - "AIE780-A1811 NPs demonstrate potent antitumor efficacy across SHR-A1811-resistant cell lines, patient-derived organoids, and mouse xenografts, achieving near-complete tumor regression with negligible systemic toxicity. This multimodal strategy integrating targeted chemotherapy, photothermal therapy, and immunomodulation offers a promising translational approach to overcome ADC resistance in refractory HER2-positive breast cancer."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Immunology • Oncology • Solid Tumor • CD8 • HER-2 • NLRP3

Trastuzumab Rezetecan and Adebrelimab, Alone or in Combination, After Chemoradiotherapy for HER2-Altered Unresectable Stage III Lung Cancer (clinicaltrials.gov) - P2 | N=105 | Not yet recruiting | Sponsor: Ming Chen

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

Plasma cfDNA Methylation Defines Progression-Associated Epigenetic States in Multiple Myeloma (IMS 2026) - "Peripheral blood samples from healthy donors (n = 20), Smoldering MM (SMM, n = 20), Newly Diagnosed MM (NDMM, n = 24), and Relapsed/Refractory MM (RRMM, n = 20) patients underwent cfDNA methylation profiling using the Avida Methyl 3400 DMR Cancer Panel (Agilent)... Plasma cfDNA methylation profiling reveals progressive promoter-centered epigenetic remodeling across MM evolution and identifies clinically aggressive NDMM epigenetic states beyond conventional tumor burden assessment, supporting the use of cfDNA methylation for minimally invasive identification of aggressive MM progression states."

cfDNA • IO biomarker • Hematological Malignancies • Multiple Myeloma • BMI1 • CBX2 • JARID2 • PAX6 • SUZ12

Safety, tolerability, pharmacokinetics, and antitumor activity of SHR-A1811 in HER2-expressing/mutated advanced solid tumors: A global phase 1, multi-center, first-in-human study (AACR 2023) - "Background: SHR-A1811 is an ADC comprised of a humanized anti-HER2 monoclonal antibody (trastuzumab), a cleavable linker, and a DNA topoisomerase I inhibitor payload. SHR-A1811 was well-tolerated and showed promising antitumor activity in heavily pretreated advanced solid tumors.Table 1. Subgroup analyses of ORRNo. of prior treatment lines in metastatic setting in all pts (N=250)HER2 positive BC (N=108)HER2-low BC (N=77)Other tumor types (N=65)≤381.8% (45/55)58.7% (27/46)36.7% (18/49)>381.1% (43/53)51.6% (16/31)31.3% (5/16)Prior anti-HER2 therapies in pts with BC (N=185)*HER2 positive BC (N=108)HER2-low BC (N=77)All BC (N=185)Any82.2% (88/107, 73.7-89.0)68.8% (11/16, 41.3-89.0)80.5% (99/123, 72.4-87.1)Trastuzumab81.9% (86/105, 73.2-88.7)75.0% (9/12, 42.8-94.5)81.2% (95/117, 72.9-87.8)Pertuzumab83.0% (39/47, 69.2-92.4)100% (5/5, 47.8-100)84.6% (44/52, 71.9-93.1)Pyrotinib86.9% (53/61, 75.8-94.1)71.4% (5/7, 29.0-96.3)85.3% (58/68, 74.6-92.7)Lapatinib80.0% (28/35,..."

Clinical • Metastases • P1 data • PK/PD data • Biliary Cancer • Biliary Tract Cancer • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • HER-2

Phase II Study of Trastuzumab Rezetecan Combined With Retlirafusp Alfa With or Without CAPOX as Perioperative Therapy for Resectable Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New P2 trial • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

Iparomlimab and Tuvonralimab in Combination with Trastuzumab Rezetecan for the Treatment of HER2-low Advanced Breast Cancer: A Single-arm, Multicenter, Phase II Clinical Study (ChiCTR) - P2 | N=42 | Not yet recruiting | Sponsor: Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital ＆Institute); Shandong First Medical University an

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • HER-2

Efficacy and safety of neoadjuvant SHR-A1811 with or without pyrotinib in women with locally advanced or early HER2-positive breast cancer: a randomized, open-label, phase 2 trial. (PubMed, Ann Oncol) - P2 | "This is the first study to report the efficacy and safety of third-generation HER2-directed ADC in the neoadjuvant setting for HER2-positive breast cancer. SHR-A1811 showed robust activity, with a tolerable safety profile. (ClinicalTrials.gov, NCT05582499)."

Journal • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Interstitial Lung Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • HER-2

Clinical outcomes and genomic landscape of anti-HER2 antibody-drug conjugates in HER2-positive and HER2-low metastatic breast cancer. (PubMed, Ther Adv Med Oncol) - "Patients with HER2-positive or HER2-low MBC who received anti-HER2 ADCs (T-DXd, SHR-A1811, RC48, or T-DM1) between September 1, 2020, and September 1, 2024, were enrolled. Distinct genomic alterations, especially MYC amplification, were associated with poorer outcomes, underscoring the need for biomarker-driven strategies. These descriptive findings should be interpreted with caution and require prospective validation."

Clinical data • Journal • Breast Cancer • Fatigue • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pneumonia • Solid Tumor • CCND1 • FGF19 • MYC • TP53

SHR-A1811 plus pertuzumab in human epidermal growth factor receptor 2-positive (HER2+) unresectable/metastatic breast cancer: Results from a phase Ib/II study (ESMO 2025) - P2 | "Background SHR-A1811 is a HER2-targeted antibody-drug conjugate combining trastuzumab linked to a topoisomerase I inhibitor payload via a cleavable linker, with substantial single agent antitumor activity for heavily pretreated HER2+ advanced/metastatic breast cancer patients (pts), as shown in a global phase 1 trial ( Yao H et al; SGBCC 2025 ). The most common TRAE was decreased neutrophil count (86.7%, [54.7%, ≥G3]), no deaths or interstitial lung disease were reported. Table: 536MO Efficacy summary Phase 2 SHR-A1811 + pertuzumab Total (phase 1b + phase 2 N=75) 3.2 mg/kg (N=11) 4.8 mg/kg (N=22) 6.4 mg/kg (N=32) ORR, n (%, 95% CI) 7 (63.6, 30.8-89.1) 19 (86.4, 65.1-97.1) 27 (84.4, 67.2-94.7) 58 (77.3, 66.2-86.2) median PFS, months (95% CI) 27.8 (16.6-NR) NR (22.3-NR) NR (NR-NR) NR (22.9-NR) 12-months PFS rate, % (95% CI) 100.0 (100.0-100.0) 90.5 (67.0-97.5) 96.4 (77.2-99.5) 91.0 (81.0-95.8) Conclusions SHR-A1811 plus pertuzumab demonstrated favorable efficacy and..."

Metastases • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer (clinicaltrials.gov) - P1/2 | N=150 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Trial completion date: Jul 2026 ➔ Dec 2026 | Trial primary completion date: May 2026 ➔ Dec 2026

Platinum sensitive • Trial completion date • Trial primary completion date • Oncology • Ovarian Cancer • Solid Tumor

Safety, Efficacy, and Pharmacokinetics of SHR-A1811, a Human Epidermal Growth Factor Receptor 2-Directed Antibody-Drug Conjugate, in Human Epidermal Growth Factor Receptor 2-Expressing or Mutated Advanced Solid Tumors: A Global Phase I Trial. (PubMed, J Clin Oncol) - "SHR-A1811 exhibited acceptable tolerability, promising antitumor activity, and a favorable pharmacokinetic profile in heavily pretreated advanced solid tumors. The recommended phase II dose of 4.8 or 6.4 mg/kg was selected for various tumor types."

Journal • Metastases • P1 data • PK/PD data • Breast Cancer • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Immunology • Interstitial Lung Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • HER-2

SHR-A1811-307: A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer (clinicaltrials.gov) - P3 | N=868 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Trial primary completion date: Oct 2027 ➔ Jul 2026

Trial primary completion date • Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Impact of bevacizumab on the efficacy of antibody–drug conjugates as later-line treatment of basal-like immune-suppressed triple-negative breast cancer. (ASCO 2026) - P2 | "In arm C, patients received either SHR-A1811 (anti-HER2 ADC, 4.8 mg/kg IV q3w) alone (C1) or with bevacizumab (15 mg/kg IV q3w) (C2). In arm D, patients received either SHR-A1921 (Trop2-targeted ADC, 3.0 mg/kg IV q3w) alone (D1) or with bevacizumab (7.5 mg/kg IV q3w) (D2)... This study provides preliminary evidence of synergy between bevacizumab and ADCs, supporting a promising new strategy—especially for basal-like, immune-suppressed TNBC. Phase III trials are ongoing to confirm the efficacy and safety of this combination. The efficacy table."

ADC • Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Phase 3 trial of trastuzumab rezetecan vs standard of care (SOC) for chemotherapy-refractory, HER2-positive, advanced colorectal cancer (CRC). (ASCO 2026) - P3 | " In this randomized, open-label, multicenter, phase 3 trial, pts with HER2-positive, RAS and RAF wild-type, advanced CRC who have progressed after standard 2nd-line therapy were randomized 2:1 to receive trastuzumab rezetecan (4.8 mg/kg, d1, iv, q3w) or SOC (TAS-102 [35 mg/m2, bid, d1-5 and d8-12], fruquintinib [5 mg, qd, d1-21], or regorafenib [160 mg, qd, d1-21]; po, q4w). Compared with SOC, trastuzumab rezetecan achieved prolonged PFS and improved ORR in chemotherapy-refractory HER2-positive advanced CRC, with a tolerable safety profile. Efficacy. Data are median (95% CI), or n (%; 95% CI), unless otherwise stated."

Metastases • P3 data • Breast Cancer • Colorectal Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Septic Shock • Solid Tumor • HER-2

A Study of Trastuzumab Rezetecan in Combination With Adebrelimab Versus Investigator's Choice of Therapy in Subjects With Residual Triple Negative Breast Cancer (clinicaltrials.gov) - P3 | N=1000 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Trastuzumab rezetecan versus pyrotinib plus capecitabine for patients with HER2-positive metastatic breast cancer (HORIZON-Breast01): interim analysis of a multicentre, open-label, randomised, controlled, phase 3 trial. (PubMed, Lancet Oncol) - P3 | "Trastuzumab rezetecan improved progression-free survival versus pyrotinib plus capecitabine and showed a distinct safety profile in patients with HER2-positive breast cancer, presenting as a potential new treatment option."

Journal • P3 data • P3 data: top line • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Interstitial Lung Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Septic Shock • Solid Tumor • HER-2

HER2-Directed Antibody-Drug Conjugate SHR-A1811 in the Neoadjuvant Treatment of HER2-positive Early Breast Cancer: a Prospective, Randomized, Open-label, Phase 2 Trial. (SABCS 2024) - P2 | "Patients were randomly assigned (1:1:1) to receive nab-paclitaxel (100mg/m2 i.v. day 1, day 8, and day 21 in a 28-day per cycle) combined with carboplatin(AUC 1.5 i.v. day 1, day 8, and day 21 in a 28-day per cycle), trastuzumab(initial dose 8mg/kg, subsequent dose 6mg/kg i.v. every 3weeks), and pertuzumab (initial dose 840mg, subsequent dose 420mg i.v. every 3weeks) for 6 cycles (PCbHP), SHR-A1811 monotherapy (4.8mg/kg i.v. day 1 every 3weeks) for 8 cycles, or SHRA1811 with pyrotinib (240mg orally once a day daily) for 8 cycles. Interpretation This is the first study to report the efficacy of third generation HER2-directed ADC in the neoadjuvant setting of HER2 positive breast cancer. SHR-A1811 exhibited promising antitumor activity and acceptable tolerability, with monotherapy pCR rate up to 63%."

Clinical • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

HORIZON-CRC221: A Global Trial of Trastuzumab Rezetecan (SHR-A1811) in Combination With Chemotherapy and Bevacizumab as First-Line Treatment in Patients With Advanced Colorectal Cancer Expressing HER2 (clinicaltrials.gov) - P2 | N=48 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P2 trial • Colorectal Cancer • Gastric Cancer • Oncology • Solid Tumor • BRAF • HER-2 • MSI

A Clinical Study of SHR-A1811 in Combination With Chemotherapy and Bevacizumab Versus Standard Therapy as First-Line Treatment for Advanced Colorectal Cancer (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Oncology • Solid Tumor