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

SHR-A1811, a novel anti-HER2 antibody-drug conjugate with optimal drug-to-antibody ratio, efficient tumor killing potency, and favorable safety profiles. (PubMed, PLoS One) - "HER2-targeting antibody-drug conjugates (ADCs), especially trastuzumab deruxtecan (T-DXd), have revolutionized the treatment landscape of HER2-expressing or mutant cancers. The above results suggested that SHR-A1811 is a potential best-in-class anti-HER2 ADC with a highly permeable payload, optimized DAR, great potency and better safety profiles. Currently SHR-A1811 has entered phase II and phase III clinical studies for breast cancer, gastric cancer, colorectal cancer, and NSCLC."

Journal • Breast Cancer • Colorectal Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

SHR-A1811 Plus Pertuzumab in the Neoadjuvant Treatment of HER2 Positive BC (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Henan Cancer Hospital | Not yet recruiting ➔ Recruiting

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

Enhanced efficacy of inavolisib combined with anti-PD-1 or anti-HER2 antibody in treating brain metastases from breast cancer. (ASCO 2025) - "Alpelisib is the only approved PI3K inhibitor for treating PIK3CA mutation-positive breast cancer...In addition to the Inavolisib monotherapy and vehicle control groups, Inavolisib was combined with a PD-1 antibody or albumin-bound paclitaxel in the triple-negative model...However, overall, the combination with trastuzumab achieved unexpectedly good results, which were comparable to SHR-A1811 and superior to Tucatinib... Our findings suggest that the combination of the PI3K inhibitor Inavolisib with anti-PD-1 or anti-HER2 antibody therapy may offer an effective strategy for treating brain metastases in breast cancer. This discovery provides new insights and possibilities for improving treatment options in breast cancer brain metastasis. Further research is needed to validate the efficacy and safety of this combination therapy."

Clinical • IO biomarker • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • PIK3CA • PTEN

SHR-A1811 Combination Regimen for the Treatment of Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov) - P1/2 | N=100 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Cervical Cancer • Oncology • Solid Tumor

Hengrui Pharma Showcases Global Impact at the 2025 ASCO: 72 Study Results Highlight Chinese Cancer Innovation (The Manila Times) - "The 2025 ASCO Annual Meeting successfully concluded in Chicago on June 3 (local time). Hengrui Pharma delivered a strong international presence, featuring 15 innovative drugs and 72 research outcomes. These included 4 oral presentations, 5 rapid oral presentations, 27 poster presentations, and 36 online publications. Multiple groundbreaking research advances has elicited widespread discussion among global experts."

Clinical data • Breast Cancer • Cholangiocarcinoma • Hepatocellular Cancer • Non Small Cell Lung Cancer • Pancreatic Cancer

SHR-A1811 as neoadjuvant therapy for HR-positive, HER2-low breast cancer: A single-arm, phase II clinical study. (ASCO 2025) - P2 | "As a neoadjuvant treatment, SHR-A1811 achieves a significant improvement in ORR and brings both pCR and RCB 0-I benefits in patients with HR+/HER2-low breast cancer. These outcomes support further exploration of SHR-A1811 in this patient population."

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

A phase II study to evaluate the safety and efficacy of BB-1701 in subjects with HER2 expression locally advanced/metastatic breast cancer previously treated with HER2-ADC containing TOP-I inhibitor. (ASCO 2025) - P | "Funded by No funding sources reported Clinical Trial Registration Number: CTR20241422 Background: BB-1701 is an HER2-targeting antibody-drug conjugate (ADC) containing eribulin...Among 8 HER2 low-expressioning (IHC 1+) patients, 3 patients achieved PR (2 patients received prior trastuzumab deruxtecan and 1 patient received prior SHR-A1811) and 4 patients had SD with DCR of 87.5%. BB-1701 shows promising antitumor activity and a manageable safety profile in HER2 expressing breast cancer patients who had previously been treated with HER2-ADC (containing TOP-I inhibitor)."

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

HER2-ADC trastuzumab rezetecan (SHR-A1811) in HER2-positive breast cancer with brain metastases: Update results from REIN trial. (ASCO 2025) - P2 | "Funded by No funding sources reported Clinical Trial Registration Number: NCT05769010 Background: HER2-directed antibody-drug conjugates (ADCs) have been demonstrated to be of intracranial activity in patients with HER2+ breast cancer (BC) with brain metastases (BM). Our findings showed that SHR-A1811 6.4 mg/kg solely or SHR-A1811 4.8 mg/kg combined with bevacizumab both can attain high intracranial remission rates, while the lower-dose combination regimen might exhibit a better safety profile. The long-term outcomes will continue to be followed up."

Anemia • Brain Cancer • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

SHR-A1811 plus adebrelimab in unresectable or metastatic triple-negative breast cancer: Results from a phase 1b/2 expansion cohort. (ASCO 2025) - P2 | "We evaluated SHR-A1811 in combination with adebrelimab (anti-PD-L1 antibody), pyrotinib (irreversible, pan-HER receptor tyrosine kinase inhibitor), pertuzumab, or albumin-bound paclitaxel in unresectable or metastatic breast cancer in an open-label, dose-finding and efficacy expansion phase 1b/2 study... SHR-A1811 plus adebrelimab had a good safety and tolerability profile. The combination showed encouraging antitumor activity in unresectable or metastatic TNBC, irrespective of HER2 or PD-L1 expression status. Phase 2 preliminary efficacy summary.11HER2 and PD-L1 results were based on central lab assessment."

IO biomarker • Metastases • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

SHR-A1811 in patients (pts) with HER2-expressing advanced gynecological cancers (Gynecol C): A phase 2 study. (ASCO 2025) - P2 | "SHR-A1811 showed encouraging activity and manageable safety profile in pts with HER2-expressing advanced Gynecol C. Antitumor activity.Data are n (%), median (95% CI), or otherwise indicated. aIn pts with baseline and at least one post-baseline assessments; N was 41, 26, 33, 100, 37, 25, 31, and 93. bIn pts with confirmed CR or PR; N was 23, 13, 21, 57, 21, 13, 19, and 53."

Clinical • Metastases • P2 data • Anemia • Cervical Cancer • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • HER-2

SHR-A1811 in HER2-expressing salivary gland cancers: Preliminary efficacy and safety results. (ASCO 2025) - P2 | "SHR-A1811 demonstrated promising efficacy in both HER2-positive and HER2-low advanced salivary gland cancers, achieving high ORRs and DCRs with an acceptable toxicity profile. Baseline characteristics."

Clinical • Anemia • Interstitial Lung Disease • Leukopenia • Neutropenia • Oncology • Pulmonary Disease • Respiratory Diseases • Salivary Gland Cancer • HER-2

SHR - A1811 Versus Chemotherapy for Platinum-resistant Recurrent Epithelial Ovarian Cancer (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Tongji Hospital

New P3 trial • Platinum resistant • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Trastuzumab Rezetecan Yields High Intracranial Remission Rates in HER2-Positive BC With Brain Metastases (DocWire) - P2 | N=125 | REIN (NCT05769010) | "Trastuzumab rezetecan (SHR-A1811) as a 6.4 mg/kg dose alone or 4.8 mg/kg dose combined with bevacizumab both yield high intracranial remission rates in patients with HER2-positive breast cancer (BC) with brain metastases (BM)...according to updated results from the REIN trial presented as an abstract at the 2025 American Society for Clinical Oncology Annual Meeting....As of June 3, 2024, the study has enrolled 58 patients, 33 in the trastuzumab rezetecan alone arm and 25 in the trastuzumab rezetecan-bevacizumab combination arm. Most patients (96.6%) previously received anti-HER2 therapy, and the median number of prior systemic therapies in the advanced setting was 2 (range, 0-9). Among 54 patients who received one or more efficacy assessments, the confirmed ORR-IC was 84.4% (27/32) in the trastuzumab rezetecan alone arm and 72.7% (16/22) in the trastuzumab rezetecan-bevacizumab combination arm."

P2 data • HER2 Positive Breast Cancer

China's HER2-Targeted ADC Trastuzumab Rezetecan Gains NMPA Approval for HER2-Mutant NSCLC (PRNewswire) - "The National Medical Products Administration has recently granted approval for Trastuzumab rezetecan, China's first domestically developed antibody-drug conjugate (ADC), for treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating HER2 (ERBB2) mutations who have previously received at least one systemic therapy. The approval of Trastuzumab rezetecan was based on the pivotal HORIZON-Lung study....The trial achieved a median follow-up of 14.2 months, an IRC-confirmed objective response rate (ORR) of 74.5%, and a median progression-free survival (mPFS) of 11.5 months-thereby doubling the efficacy of conventional treatments."

China approval • Non Small Cell Lung Cancer

SHR - A1811 Injection in the Treatment of Platinum-sensitive Recurrent Ovarian Cancer (clinicaltrials.gov) - P1/2 | N=90 | Not yet recruiting | Sponsor: Tongji Hospital

New P1/2 trial • Platinum sensitive • Oncology • Ovarian Cancer • Solid Tumor

A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing (clinicaltrials.gov) - P2 | N=88 | Recruiting | Sponsor: Fudan University | Trial completion date: Sep 2026 ➔ Dec 2026 | Trial primary completion date: Sep 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Oncology • Salivary Gland Cancer • AR • HER-2

A Phase II Study of SHR-A1811 Combined With Radiotherapy in HER2-positive and HER2-low Breast Cancer Brain Metastases (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Wuhan Union Hospital, China

New P2 trial • Brain Cancer • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

SHR-A1811 and THPy in First or Second Line for HER2 Positive Advanced Breast Cancer Brain Metastases (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Wuhan Union Hospital, China

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

Trastuzumab rezetecan in HER2-expressing advanced gastric cancer or gastroesophageal junction adenocarcinoma and colorectal cancer (IGCC 2025) - "Trastuzumab rezetecan showed tolerable safety and preliminary efficacy in HER2-expressing advanced GC/GEJ and CRC."

Metastases • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

HER2-DM-NACT: This Study Aims to Optimize Neoadjuvant Therapy for HER2-positive Breast Cancer by Implementing a Dynamic Monitoring-guided Treatment Strategy. (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Hebei Medical University Fourth Hospital

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive 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=50 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

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

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=864 | 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 • HER-2

SHR-A1811-305: A Phase III, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy (clinicaltrials.gov) - P3 | N=1600 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting | N=1200 ➔ 1600

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

2025 AACR Oral Report | Hengrui's innovative drug rezetecan Trastuzumab for the treatment of advanced HER2-mutated non-small cell lung cancer study results disclosed [Google translation] (Jiangsu Hengrui Press Release) - P1/2 | N=157 | HORIZON-Lung (NCT04818333) | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | "At this AACR conference, Professor Lu Shun from the Department of Oncology, Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong University, gave an oral presentation on the latest results of the Phase II clinical study (HORIZON-Lung study) of the innovative HER2-targeted antibody-drug conjugate (ADC) trastuzumab (SHR-A1811) in patients with advanced HER2-mutated non-small cell lung cancer (NSCLC)....The ORR based on IRC assessment was 74.5% (95% CI: 64.4-82.9), the DCR was 98.9% (95% CI: 94.2-100.0), and the median duration of response (DoR) was 9.8 months (95% CI: 8.3-13.9). In subgroup analysis, the efficacy of trastuzumab was consistent in different subgroups of patients, regardless of whether the patient had received anti-HER2 TKI treatment or whether there were baseline brain metastases."

P2 data • Non Small Cell Lung Cancer

SHR-A1811, a HER2-directed antibody-drug conjugate (ADC), in advanced HER2-mutant non-small cell lung cancer (NSCLC): Updated phase 2 results from HORIZON-Lung (AACR 2025) - "At the updated analysis, SHR-A1811 continued to show clinically meaningful efficacy with a manageable safety profile in pts with previously treated HER2-mutant NSCLC, supporting it as a potential new treatment option for this population.Table 1. Efficacy summaryPatients (n=94)IRCINVORR, % (n/N; 95% CI)74.5 (70/94; 64.4-82.9)68.1 (64/94; 57.7-77.3)Median DoR, mo (95% CI)9.8 (8.3-13.9)9.9 (7.2-11.5)DCR, % (n/N; 95% CI)98.9 (93/94; 94.2-100.0)96.8 (91/94; 91.0-99.3)Median PFS, mo (95% CI)11.5 (9.7-15.2)12.5 (9.9-15.1)PFS by baseline subgroup, mo (95% CI)BM (n=24)11.3 (9.5-NR)-No BM (n=70)11.5 (8.5-15.2)-1 line of prior therapy (n=43)9.9 (8.1-NR)-≥2 lines of prior therapy (n=51)13.9 (9.7-16.8)-Prior anti-HER2 TKI (n=22)9.7 (8.3-16.8)-No prior anti-HER2 TKI (n=72)11.5 (9.9-NR)-A775_G776insYVMA (n=68)15.2 (10.6-16.8)-Other mutations (n=26)9.6 (7.1-11.1)-BM, brain metastases; DCR, disease control rate; DoR, duration of response; INV, investigator; IRC, independent review..."

IO biomarker • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor