anvatabart opadotin (JNJ-0683) / Zhejiang Medicine, J&J - LARVOL DELTA

Screening or Early Detection of Brain Metastases and the Treatment in the Era of New Agents (GBCC 2025) - "Advances in systemic therapy have been greatest in HER2-positive breast cancer, where the current NCCN guidelines include a growing list of CNS-active regimens, such as tucatinib-capecitabine-trastuzumab, T-DXd, T-DM1, high dose trastuzumab and pertuzumab, neratinib-capecitabine, and lapatinib-capecitabine...There are a number of novel blood-brain-barrier (BBB) penetrant HER2-targeted tyrosine kinase inhibitors (e.g. ZN1041, IAM1363) in early-phase clinical trials. For patients with HER2-negative tumors, the data are more sparse; however, activity of chemotherapy drugs such as capecitabine, anthracyclines, platinums, and eribulin has been reported...Ongoing clinical trials are testing a wide variety of ADCs, such as patritumab deruxtecan, datopotamab deruxtecan, ARX788, and others...For example, the ELECTRA trial is testing the combination of elacestrant and abemaciclib. Overall, the expanding array of systemic options with clinically meaningful intracranial activity, as..."

Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2

Antibody-drug conjugates in elderly patients with breast cancer. (PubMed, Breast) - "This review explores the application of antibody-drug conjugates (ADCs), such as trastuzumab emtansine (T-DM1), trastuzumab deruxtecan (T-DXd) and sacituzumab govitecan (SG), in treating breast cancer among elderly populations. Emerging ADCs, including datopotamab deruxtecan and ARX-788, show promise but lack extensive geriatric-specific data. While the ADCs offer encouraging results in terms of efficacy and safety, with appropriate dose adjustments, further research is needed to optimize their use in elderly patients with breast cancer."

Journal • Review • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

ACE-Breast-02: a randomized phase III trial of ARX788 versus lapatinib plus capecitabine for HER2-positive advanced breast cancer. (PubMed, Signal Transduct Target Ther) - "This phase III trial aimed to compare ARX788, a site-specific, construct-homogeneous antibody-drug conjugate, with lapatinib plus capecitabine in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer (ABC) who had progressed on one line of trastuzumab based regimen. Six treatment-related deaths occurred, with three cases possibly related to ILD. ARX788 significantly improved PFS compared with LC in patients with HER2-positive ABC with a distinct toxicity profile, supporting it as a potential treatment option."

Clinical • Journal • P3 data • Breast Cancer • Dermatology • Dry Eye Disease • Gastrointestinal Disorder • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Interstitial Lung Disease • Oncology • Ophthalmology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • HER-2

ACE-BREAST-03: A phase 2 trial evaluating ARX788, an anti-HER2 antibody drug conjugate (ADC), for the treatment of HER2+ metastatic breast cancer (mBC) in patients who have been previously treated with trastuzumab deruxtecan (T-DXd) (SABCS 2024) - P2 | "The HER2-targeted ADC, T-DXd, improved PFS and OS vs T-DM1 as second- line treatment for HER2+ mBC and is now the preferred treatment option in this setting...A phase 2/3 study in China demonstrated that ARX788 had significantly improved PFS compared with the combination of lapatinib and capecitabine (HR 0.64 [0.49, 0.82], p = 0.0006) in patients treated with prior trastuzumab and taxane (ASCO 2024 Abstract 1020)...Tumor status is assessed every 9 weeks through 27 weeks and every 12 weeks thereafter. The study is currently enrolling in the US."

Clinical • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03) (clinicaltrials.gov) - P2 | N=71 | Recruiting | Sponsor: Ambrx, Inc. | Trial completion date: Dec 2026 ➔ Jun 2027 | Trial primary completion date: Jun 2025 ➔ Dec 2026

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

Evaluate the efficacy and safety of ARX788 given every 6 weeks in patients with HER2-positive advanced breast cancer (ChiCTR) - P2 | N=44 | Sponsor: He'nan Cancer Hospital; He'nan Cancer Hospital

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

Another HER2 antibody-drug conjugate, the Phase III clinical study data of ARX788 is released! [Google translation] (new.qq.com) - P2/3 | N=441 | ACE-Breast-02 (CTR20201708) | Sponsor: Zhejiang Medicine Co., Ltd./Zhejiang Xinma Biopharmaceutical Co., Ltd. | "The latest report on ARX788 comes from the 47th San Antonio Breast Cancer Symposium in 2024....The results of the study showed that for HER2-positive breast cancer patients who had previously been treated with the HER2-targeted drug trastuzumab and paclitaxel, ARX788 significantly prolonged the patients' progression-free survival time compared with the treatment regimen of lapatinib combined with capecitabine. The median progression-free survival time of ARX788 was 11.33 months, while the median progression-free survival time of the control group was 8.25 months. The median duration of remission of ARX788 was 12.45 months, while the median progression-free survival time of the control group was 8.34 months."

P3 data • HER2 Positive Breast Cancer

ARX788 for the treatment of HER2+ advanced breast cancer: clear efficacy and manageable toxicity [Google translation] (163.com) - P1b/2 | N=138 | ACE-Breast-08 (CTR20213419) | Sponsor: Zhejiang Medicine Co., Ltd. | "This phase I study explored the prospect of ARX788 as a third-line treatment for HER2+ advanced breast cancer...The results showed that ARX788 showed encouraging efficacy in patients with HER2-positive advanced breast cancer who had previously received trastuzumab and anti-HER2-TKI treatment: In the intention-to-treat population, the IRC-assessed cORR was 44.9% (95%CI: 36.5%-53.6%), including 3 complete responses (CR) and 59 partial responses (PR); The cORR assessed by the investigator was 42.0% (95%CI: 33.7%-50.7%), including 3 CRs and 55 PRs. The median follow-up time was 14.78 months, the progression-free survival (PFS) assessed by IRC was 5.68 months (95%CI: 5.49 months-8.25 months), and the PFS assessed by the investigator was 6.90 months (95%CI: 5.45 months-7.89 months)....The median overall survival (OS) has not yet been reached, and the 1-year OS rate is 81.3%."

P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

ARX788 for patients with HER2-positive advanced breast cancer: characterization, time course, and monitoring and management of adverse event from the phase III ACE-Breast-02 study (SABCS 2024) - P2/3 | " 441 eligible patients were randomized 1:1 to receive ARX788 or lapatinib plus capecitabine. ARX788 demonstrated a unique safety profile with less hematological and GI toxicities. Liver enzyme elevations were commonest with predominantly low grades, while ocular toxicity and ILD were common and manageable. The low rate of dose discontinuation suggested that, when with proactive monitoring and appropriately adequate management, these AEs did not pose a challenge to its clinical benefit."

Adverse events • Clinical • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

ACE-Breast-08: a phase I study of ARX788, a novel anti-HER2 antibody-drug conjugate, in patients with TKI pretreated HER2 positive advanced breast cancer. (SABCS 2024) - "ARX788 showed encouraging efficacy and manageable toxicities in patients with HER2-positive advanced breast cancer previously treated with trastuzumab and anti-HER2 TKI. *corresponding author: Zefei Jiang, jiangzf@hotmail.com"

Clinical • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

A case report of interstitial lung disease caused by HER2-positive breast cancer patient receiving two antibody-drug conjugate drugs successively. (PubMed, Transl Breast Cancer Res) - "The patient was treated with ADCs of ARX-788 for third-line treatment, she had ILD. After treatment of ILD, the patient was treated with ADCs of trastuzumab-DM1 (T-DM1) for fourth-line treatment and she had ILD again...Whether other anti-HER2 ADCs can be tried in the later lines is still being cautious. Whether there is a certain relationship between the side effects and efficacy of ADCs, there is no evidence-based data."

Journal • Breast Cancer • Gastrointestinal Disorder • HER2 Breast Cancer • HER2 Positive Breast Cancer • Interstitial Lung Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • HER-2

ARX788 for Treating Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Laura Huppert, MD, BA | Trial completion date: Feb 2028 ➔ Jun 2028 | Initiation date: Oct 2024 ➔ Jan 2025 | Trial primary completion date: Feb 2028 ➔ Jun 2028

Metastases • Trial completion date • Trial initiation date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

ARX788 in HER2-positive Metastatic Breast Cancer Patients (clinicaltrials.gov) - P2 | N=44 | Not yet recruiting | Sponsor: Henan Cancer Hospital

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

ARX788 for Treating Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Laura Huppert, MD, BA | Trial completion date: Nov 2028 ➔ Feb 2028 | Initiation date: Jul 2024 ➔ Oct 2024 | Trial primary completion date: Nov 2027 ➔ Feb 2028

Metastases • Trial completion date • Trial initiation date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd (clinicaltrials.gov) - P2 | N=44 | Not yet recruiting | Sponsor: Fudan University

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

A phase Ia/b trial of ARX788 combined with toripalimab for HER2-low advanced breast cancer (ABC) and other HER2-expressing solid tumors. (ASCO 2024) - "Background: ARX788 has been proved with superior PFS compared with a combination of capecitabine and lapatinib in the randomized phase Ⅱ/Ⅲ study for HER2-positive ABC (Ambrx, 2023). ARX788 with 1. 5mg/kg combined with toripalimab was shown acceptable safety profile with promising efficacy, no significant increase in adverse reactions or serious unexpected immune-related adverse reactions compared with ARX788 monotherapy, which supports further evaluation for HER2-low ABC in a larger sample in Ⅰb trial. Clinical trial information: CTR20222247."

Metastases • Alopecia • Breast Cancer • Cardiovascular • Dry Eye Disease • Hematological Disorders • Hepatology • HER2 Breast Cancer • HER2 Positive Breast Cancer • Immunology • Interstitial Lung Disease • Oncology • Ophthalmology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • HER-2

Zhejiang Medicine: The production arrangement of ARX-788 products of its subsidiary Xinma Bio will be determined based on regulatory compliance, commercialization progress and other factors [Google translation] (163.com) - "According to a report from the financial sector on July 19, an investor asked Zhejiang Medicine on an interactive platform : After the listing application of RX788 is approved, will the company produce it itself or entrust WuXi to produce it?....The company responded that the planned productions will be determined based on multiple considerations such as product regulatory compliance and commercialization progress. If the information on the project triggers disclosure obligations, the company will disclose it in a timely manner on the official website of the Shanghai Stock Exchange."

Commercial • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Positive Breast Cancer • Non Small Cell Lung Cancer • Oncology

ACE-Breast-02: A pivotal phase II/III trial of ARX788, a novel anti-HER2 antibody-drug conjugate (ADC), versus lapatinib plus capecitabine for HER2+ advanced breast cancer (ABC). (ASCO 2024) - "Research Funding: No funding sources reported. ARX788 significantly prolonged PFS comparing to LC in patients with HER2+ ABC previously treated with trastuzumab and taxane. While ocular toxicity and interstitial lung disease were common and manageable, its hematological and GI toxicities under no prophylactic premedication compared favorably with already available ADCs."

Metastases • P2/3 data • Breast Cancer • Dermatology • Dry Eye Disease • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Interstitial Lung Disease • Oncology • Ophthalmology • Pulmonary Disease • Respiratory Diseases • Solid Tumor

ACE-BREAST-03: A phase 2 trial evaluating ARX788, an anti-HER2 antibody drug conjugate (ADC), for the treatment of HER2+ metastatic breast cancer (mBC) in patients who have been previously treated with trastuzumab deruxtecan (T-DXd). (ASCO 2024) - P2 | "The HER2-targeted ADC, T-DXd, improved PFS and OS vs T-DM1 (trastuzumab emtansine) as second-line treatment for HER2+ mBC and is now the preferred treatment option in this setting. Tumor status is assessed every 9 weeks through 27 weeks and every 12 weeks thereafter. The study is currently enrolling in the US."

Clinical • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Preliminary safety and efficacy of TQB2930, a HER2-targeted bispecific antibody in patients with advanced breast cancer: Results from a phase 1b study. (ASCO 2024) - P1/2 | "Moreover, 5 pts achieved PR at 30mg/kg (ORR 41.7%), including one with prior exposure to trastuzumab, pyrotinib, tucatinib, ARX788, and the other one prior to trastuzumab, pertuzumab, lapatinib, MRG002. TQB2930 is well tolerated and has demonstrated promising single-agent anti-tumor activity in HER2-positive breast cancer who have failed standard anti-HER2 therapies, including multiple lines of prior HER2 targeted agents. These early signs of activity support the further exploration of combination therapy of TQB2930 and the study is ongoing."

Clinical • Metastases • P1 data • Anemia • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Leukopenia • Neutropenia • Oncology • Solid Tumor • CD4 • HER-2

Zhejiang Medicine: The ARX-788 project basically meets the conditions for new drug application, but has not yet met the technical and legal conditions for marketing application [Google translation] (163.com) - "According to the financial news on May 28, an investor asked Zhejiang Medicine on the interactive platform...The research and development of the ARX-788 project is still in progress, and the project has not failed; the ARX-788 project continues in accordance with the clinical trial plan and relevant regulatory requirements after the 2023-004 announcement....Regarding the ARX-788 project of the company's subsidiary, Xinma Bio, after the 2023-004 announcement, the clinical research conditions of the new drug application basically meet the new drug application conditions, but other aspects of the drug application, such as the production arrangement, do not meet the technical and legal conditions for the new drug application. Xinma Bio is making improvements to the parts that have not yet met the conditions, and has not yet submitted a new drug application."

Clinical • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology

A Study of ARX788 Combined With Pyrotinib Maleate Versus TCBHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients (clinicaltrials.gov) - P2/3 | N=136 | Active, not recruiting | Sponsor: Caigang Liu | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2026 ➔ Dec 2028

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

Comprehensive understanding of the mutant 'giant' Arthrospira platensis developed via ultraviolet mutagenesis. (PubMed, Front Plant Sci) - "NCB001, which was isolated from freshwater and owned by NCell Co., Ltd. Transcriptome analysis revealed that these morphological differences resulted from changes in cell wall formation mechanisms and increased cell division. Our results show that NCB002 has outstanding industrial value and provides a comprehensive understanding of it."

Journal

Zhejiang Pharmaceutical: The planned ARX788 production line of subsidiary Xinma Biotech is in progress [Google translation] (Sohu.com) - "According to AI News, an investor asked on the investor interactive platform: What is the current progress of the ARX788 production line built by the company, and when is it expected to be completed and put into production? How to control the risks of building a production line in advance before ARX788 submits a marketing application and is approved?....Zhejiang Pharmaceutical...stated on the investor interactive platform on March 4 that the ARX788 production line planned by the company's subsidiary Xinma Biotechnology is in progress. Xinma Biotechnology will carry out the construction project based on the overall product commercialization process and funding situation. Promote and adjust to ensure that project risks are controllable and profitability can meet expectations."

Clinical • Oncology • Solid Tumor

Johnson & Johnson Completes Acquisition of Ambrx (Businesswire) - "Johnson & Johnson...announced today it has successfully completed the acquisition of Ambrx Biopharma, Inc...in an all-cash merger transaction for a total equity value of approximately $2.0 billion, or $1.9 billion net of estimated cash acquired, as announced on January 8, 2024...'We’re pleased to welcome Ambrx’s talented scientific team and proprietary ADC platform to Johnson & Johnson. We look forward to continuing the development of ARX517, which represents a potential first- and best-in-class PSMA-targeting ADC for the treatment of metastatic castration-resistant prostate cancer.'....The acquisition presents a distinct opportunity for Johnson & Johnson to design, develop and commercialize targeted oncology therapeutics."

M&A • Breast Cancer • Castration-Resistant Prostate Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hematological Malignancies • HER2 Breast Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor