trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma, Glenmark - LARVOL DELTA

Pyrotinib or placebo in combination with trastuzumab and docetaxel for untreated HER2-positive metastatic breast cancer: long-term survival results from the phase 3 PHILA study (SABCS 2025) - P3 | "Although cross-over was not allowed, the proportions of pts receiving pyrotinib, trastuzumab, pertuzumab, or anti-HER2 antibody-drug conjugate (incl. T-DM1, T-DXd, SHR-A1811) after study treatment discontinuation in each group were 18.5% vs. 51.9%, 26.3% vs. 25.6%, 15.5% vs. 14.0%, and 22.6% vs. 28.0%, respectively... The long-term analysis confirms that the previously observed improvements in OS and PFS with PyroHT compared to HT in the first-line treatment of HER2-positive metastatic breast cancer were maintained after 45.5 months of median follow-up. Notably, with PyroHT, 5-year OS rate remained at 66% and nearly 30% of pts remained progression-free at 5 years. PyroHT treatment delayed time to onset of brain metastasis."

Clinical • Combination therapy • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Clinical Study of SHR-A1811(sc) Subcutaneous Injection in Patients With Solid Tumor (clinicaltrials.gov) - P1 | N=107 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

New P1 trial • Solid Tumor

MA-UC-II-007: Phase II Study of Trastuzumab Rezetecan or in Combination With Adebrelimab in HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) (clinicaltrials.gov) - P2 | N=96 | Recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Oncology • Solid Tumor • Urothelial Cancer

A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer (clinicaltrials.gov) - P3 | N=650 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing (clinicaltrials.gov) - P2 | N=88 | Active, not recruiting | Sponsor: Fudan University | Recruiting ➔ Active, not recruiting

Enrollment closed • Non-Adenoid Cystic Carcinoma • Oncology • Salivary Gland Cancer • AR • HER-2

A Phase II Trial of SHR-A1811 in HER2-Expressing Recurrent/Metastatic Cervical Cancer (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Cervical Cancer • Oncology • Solid Tumor

SHR-A1811 Demonstrates Promising Efficacy and Safety in Neoadjuvant HER2+ Breast Cancer (Pharmacy Times) - "The data were presented at the European Society For Medical Oncology 2025 Congress.... SHR-A1811 demonstrated high tpCR rates in both monotherapy (72.4%) and combination therapy (77.1%) groups in early-stage HER2+ breast cancer. The trial included 64 female patients with stage 2-3 HER2+ breast cancer, showing promising antitumor activity and manageable safety. No new safety signals were identified..."

P2 data • HER2 Positive Breast Cancer

A Phase II Clinical Study of Trastuzumab Rezetecan (SHR-A1811) or in Combination With Adebrelimab (SHR-1316) for HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) (ChiCTR) - P2 | N=96 | Recruiting | Sponsor: Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center

New P2 trial • Oncology • Solid Tumor • Urothelial Cancer • HER-2 • PD-L1

A Multicenter, Open-Label Phase II Clinical Study Evaluating the Safety, Tolerability, and Efficacy of SHR2554 Tablets in Combination with Other Antitumor Therapies in Patients with Locally Advanced Unresectable or Metastatic Gastric or Gastro-oesophageal Junction Adenocarcinoma (ChiCTR) - P2 | N=366 | Recruiting | Sponsor: Harbin Medical University Cancer Hospital; Harbin Medical University Cancer Hospital

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18 • HER-2 • PD-L1

Single arm, multicenter, exploratory phase II clinical study of new adjuvant therapy with Trastuzumab Deruxtecan for Injection for injection for early or locally advanced HR positive/HER2 low expression breast cancer with poor efficacy of dalpiciclib combined with endocrine therapy (ChiCTR) - P4 | N=30 | Not yet recruiting | Sponsor: Anyang Tumor Hospital; Anyang Tumor Hospital

New P4 trial • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

A Phase III Study of SHR-A1811 in Combination With Chemotherapy and Adebrelimab in Previously Untreated Patients With Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P3 | N=600 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

New P3 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

A Phase III Study of SHR-A1811 in Combination With Chemotherapy and Adebrelimab in Previously Untreated Patients With Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P3 | N=600 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

A prospective clinical study of SHR-A1811 monotherapy or combined with pertuzumab in the treatment of HER2-positive advanced breast cancer with brain metastases after progression with pyrotinib (ChiCTR) - P4 | N=40 | Not yet recruiting | Sponsor: Changde First People's Hospital; Changde First People's Hospital

Monotherapy • New P4 trial • Brain Cancer • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Phase I/II clinical study of SHR-A1811 combined regimen for injection in treatment of platinum-sensitive recurrent ovarian cancer (ChiCTR) - P1/2 | N=42 | Recruiting | Sponsor: Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology; Tongji Hospital, Tongji Medical College ,Huazhong University o

New P1/2 trial • Platinum sensitive • Breast Cancer • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • BRCA • BRCA1 • BRCA2 • HER-2 • HRD • MUC16

Trastuzumab Rezetecan: First Approval. (PubMed, Drugs) - "In May 2025, it was approved by the National Medical Products Administration of China for the treatment of adults with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have human epidermal growth factor receptor 2 (HER2) [ERBB2]-activating mutations and have received ≥ 1 previous systemic treatment. This article summarizes the milestones in the development of trastuzumab rezetecan leading to this first approval."

Journal • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

SHR-A1811 combined with adebrelimab in HR-/HR-low, HER2-low metastatic breast cancer: Preliminary results from an open-label, single-arm, phase II trial (ESMO 2025) - P2 | "The HER2-directed Antibody-Drug Conjugate (ADC) drug T-DXd has shown significant benefits in the entire HER-2 low MBC population, including those with HR- or low HR expression. 10 pts (41.67%) experienced grade ≥3 TEAEs. Conclusions Preliminary results of SHR-A1811 combined with Adebrelimab in HR-negative/HR-low, HER2-low MBC pts yields promising antitumor efficacy with manageable toxicity."

Clinical • IO biomarker • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • ER • HER-2

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

SHR-A1811 versus pyrotinib plus capecitabine in human epidermal growth factor receptor 2-positive (HER2+) advanced/metastatic breast cancer (BC): A multicenter, open-label, randomized, phase III study (HORIZON-Breast01) (ESMO 2025) - P3 | "Methods Taxane- and trastuzumab-pretreated patients (pts) with HER2+ advanced/metastatic BC were randomized (1:1) to receive intravenous SHR-A1811 or oral pyrotinib plus capecitabine...Results As of Jun 30, 2025, 287 pts were randomized (SHR-A1811, n=142; pyrotinib plus capecitabine, n=145; IHC 3+: 76.1% vs. 71.7%; HR+: 47.9% vs. 47.6%; median lines of prior systemic treatments: 1 vs.1; prior pertuzumab: 71.8% vs. 72.4%), with median follow-up of 15.9 months (95% CI 14.6–17.1) for SHR-A1811, and 15.3 months (95% CI 14.3–16.6) for pyrotinib plus capecitabine...b 1-sided c. assessed in treated pts. Conclusions SHR-A1811 exhibited significant PFS benefit and strong trend in OS benefit versus pyrotinib plus capecitabine in the second-line therapy in HER2+ advanced/metastatic BC, with favorable safety profile of low ILD occurrence."

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

Live from ESMO | Hengrui Debuts Exhibition Booth with Landmark Data Showcasing Pharma’s Emerging Innovation Power (The Manila Times) - "This year, the company unveiled 46 studies across 14 innovative therapeutic programs, including nine oral presentations, two mini oral sessions, and four late-breaking abstracts (LBAs), underscoring its global R&D strength. These data highlight the company's commitment to multi-cancer coverage and multi-mechanism innovation in oncology."

Clinical data • Gastrointestinal Cancer • Head and Neck Cancer • HER2 Positive Breast Cancer • Non Small Cell Lung Cancer • Small Cell Lung Cancer

Jiangsu Hengrui Secures NMPA Approval to Launch Phase III Trial of Trastuzumab Rezetecan in HER2‑Positive Breast Cancer (flcube.com) - "The study will compare Trastuzumab rezetecan monotherapy with the standard neoadjuvant regimen of docetaxel + carboplatin + trastuzumab + pertuzumab in patients with previously untreated, early or locally advanced HER2‑positive breast cancer....Enrollment to begin Q4‑2025 with first results expected in 2027."

New P3 trial • HER2 Positive Breast Cancer

Neoadjuvant SHR-A1811 with or without pyrotinib in HER2-positive breast cancer (MUKDEN 07): A multi-cohort, multicenter, phase II clinical trial (ESMO 2025) - P2 | "No treatment-related deaths occurred in this study. Conclusions SHR-A1811, as neoadjuvant therapy for early-stage HER2+ BC, demonstrated encouraging antitumor activity and acceptable safety, supporting its further evaluation in randomized trials."

Clinical • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Trastuzumab Rezetecan Improves PFS Vs SOC in HER2+ Breast Cancer (Targeted Oncology) - "...Findings from the phase 3 HORIZON-Breast01 trial (NCT05424835) presented at the 2025 ESMO Annual Congress....At an overall median follow-up of about 15.5 months, the median progression-free survival (PFS) by blinded independent central review (BICR) was 30.6 months (95% CI, 16.8–not reached) in the trastuzumab rezetecan arm compared with 8.3 months (95% CI, 6.9–11.0) in the combination arm (HR, 0.22; 95% CI, 0.15–0.34; P <.0001). The 12-month PFS rates were 84.7% vs 35.5%, respectively."

P3 data • HER2 Positive Breast Cancer

Application and Progress of Antibody-Drug Conjugates (ADCs) in the Treatment of Metastatic Triple-Negative Breast Cancer. (PubMed, Oncol Ther) - "Antibody-drug conjugates (ADCs) have emerged as a leading therapeutic strategy: sacituzumab govitecan extended mPFS to 5.6 months (ASCENT trial), SKB264 to 6.7 months, and datopotamab deruxtecan achieved an ORR of 79%. In Human epidermal growth factor receptor 2 (HER2)-low TNBC, trastuzumab deruxtecan prolonged OS to 18.2 months, while disitamab vedotin and SHR-A1811 achieved ORRs of 26% and 60%, respectively...Bispecific ADCs, linker optimization, and combination regimens (ICI, PARPi) are under investigation. Future efforts will focus on targeting epidermal growth factor receptor (EGFR) and FRα and on developing multimodal immunovascular strategies to sustain clinical benefit."

Journal • Review • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ERBB3 • FOLR1 • HER-2 • NECTIN4

The Efficacy and Safety of Trastuzumab Rezetecan (SHR-A1811) in HER2-Low Unresectable/Metastatic Breast Cancer Patients With Visceral Crisis (clinicaltrials.gov) - P2 | N=184 | Not yet recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

New P2 trial • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor

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. | N=50 ➔ 150

Enrollment change • Platinum sensitive • Oncology • Ovarian Cancer • Solid Tumor