Aidixi (disitamab vedotin)

Studies evaluating ADCs (trastuzumab deruxtecan (T-DXd), sacituzumab govitecan (SG), MRG002, and RC48-ADC) in patients with HER2-low a/mBC were included. Future studies should focus on bringing ADCs into earlier lines of therapy in this population. This study was registered in PROSPERO (CRD42024452962).

The combination of RC48 with platinum+/- bevacizumab resulted in the highest ORR of 71.4% (5 out of 7 patients), with HER2 TKI following at a 50.0% ORR (4 out of 8 patients). RC48, particularly in combination regimens, demonstrates promising efficacy in advanced NSCLC with HER2 alterations. These findings underscore the need for further research to validate RC48's application in clinical practice.

RC48-ADC showcases promising efficacy and manageable safety in patients with both HER2-positive and HER2-low-expression mBC.

P1/2, N=35, Not yet recruiting, Zhejiang Cancer Hospital; Zhejiang Cancer Hospital

From gemtuzumab ozogamicin to trastuzumab emtansine (T-DM1), and now to third-generation agents such as trastuzumab deruxtecan (DS-8201) and disitamab vedotin (RC48), improvements have been made in target selectivity, potency, linker stability, and reduced off-target effects. ADCs represent a promising frontier in precision cancer treatment, with continued research enhancing their potential in breast cancer and beyond. This review provides a comprehensive exploration of ADCs' evolution in breast cancer therapy, offering a molecular perspective to inform clinical practice and update colleagues on this dynamic field.

Despite the unfavorable prognosis associated with advanced GC, the implementation of personalized treatment approaches may still prove beneficial for select patients. In patients with HER2-positive GC with extensive metastatic involvement, the use of the HER2-targeted combination with apatinib has demonstrated the potential to prolong both PFS and overall survival.

P1/2, N=72, Recruiting, Tianjin Medical University Second Hospital

P1, N=5, Recruiting, Second Xiangya Hospital of Central South University

Recently, the HER2-targeting antibody drug Disitamab vedotin (RC48) was approved and introduced primarily for gastric and bladder cancers, with minimal investigation in the field of lung cancer...In clinical specimens, heightened expressions of FOXA1 and HER2 correlate positively with clinical progression and poorer prognosis. These findings suggest that FOXA1 may serve as a potential biomarker or therapeutic target in future non-small cell lung cancer (NSCLC) treatments, and ongoing research may position RC48 as a transformative agent in lung cancer therapy.

P1/2, N=90, Recruiting, Zhejiang Cancer Hospital

P2, N=40, Not yet recruiting, RemeGen Co., Ltd.

Tumor progression occurred after six cycles of Tislelizumab combined with chemotherapy (gemcitabine and cisplatin) followed by five cycles of Tislelizumab monotherapy. The prognosis of advanced urothelial carcinoma with trophoblastic differentiation is unfavorable, and the available therapeutic options are limited. Combining Tislelizumab with Disitamab vedotin presents a promising anti-tumor strategy that warrants further investigation.

P2, N=40, Not yet recruiting, Fujian Medical University Union Hospital

The patient is still in remission at present. The current findings imply the potential efficacy of HER2-targeted ADCs for patients with HER2-low metastatic EC.

P2, N=36, Not yet recruiting, Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center

P1/2, N=35, Recruiting, Zhejiang Cancer Hospital

P2, N=0, Withdrawn, RemeGen Co., Ltd. | N=80 --> 0 | Not yet recruiting --> Withdrawn

P2, N=36, Not yet recruiting, Fudan University

P2, N=40, Recruiting, Tianjin Medical University Cancer Institute and Hospital

P2, N=39, Not yet recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

P2, N=332, Recruiting, Seagen Inc. | Trial completion date: Mar 2026 --> May 2028 | Trial primary completion date: Oct 2024 --> Nov 2026

P2, N=20, Completed, The First Affiliated Hospital of Army Medical University, PLA; The First Affiliated Hospital of Army Medical University, PLA | Not yet recruiting --> Completed

P4, N=39, Not yet recruiting, Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center

P2, N=30, Recruiting, Zhejiang Tumor Hospital; Zhejiang Tumor Hospital

P2, N=30, Not yet recruiting, Shandong First Medical University Affiliated Cancer Hospital; Shandong First Medical University Affiliated Cancer Hospital

P2, N=125, Not yet recruiting, Affiliated Hospital of Guangdong Medical University; Affiliated Hospital of Guangdong Medical University

P2, N=20, Not yet recruiting, Jiangxi Cancer Hospital; Jiangxi Cancer Hospital

P2, N=44, Not yet recruiting, Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center

P2, N=70, Not yet recruiting, Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center

P2, N=60, Not yet recruiting, Peking University First Hospital; Peking University First Hospital

P2, N=20, Recruiting, Fudan University | Not yet recruiting --> Recruiting

This patient received disitamab vedotin (an antibody-drug conjugate, targeting Her-2) combined with serplulimab as first-line treatment. Disitamab vedotin combined with immunotherapy demonstrated a long-term clinical benefit in advanced Her-2-positive EMPD. For rare solid tumors with Her-2 overexpression, disitamab vedotin combined with immunotherapy might offer a viable therapeutic choice.

P1/2, N=24, Recruiting, RemeGen Co., Ltd. | Not yet recruiting --> Recruiting

P2, N=20, Not yet recruiting, The First Affiliated Hospital of Zhengzhou University

P2, N=28, Recruiting, Wuhan Union Hospital, China

After experiencing disease progression following HER2-targeted therapy with RC48, the patient achieved noticeable partial remission through a therapeutic regimen that combined trastuzumab deruxtecan (DS8201) and tislelizumab. The data suggest a promising role for DS8201 in managing advanced stages of HER2-amplified metastatic breast cancer, especially in cases that demonstrate progression after initial HER2-directed therapies using ADCs. Furthermore, its combination with anti-PD-1 agents enhances therapeutic efficacy by augmenting the anti-tumoral immune response.

Surufatinib has demonstrated a progression-free survival (PFS) of no less than 14 months, and the patient's survival has endured for a duration of 33 months. This indicates the potential efficacy of surufatinib as a viable therapeutic alternative for adult patients afflicted with PB.

P2/3, N=130, Recruiting, RemeGen Co., Ltd. | N=60 --> 130

These initial studies led to FDA approval of two antibody-drug conjugates, enfortumab vedotin and sacituzumab govitecan...The combination of enfortumab vedotin and pembrolizumab was recently approved for first-line treatment of advanced urothelial carcinoma. Despite the great promise of these novel drugs, robust predictive biomarkers are needed to determine the patients who would maximally benefit. This review surveys the rationale and current state of the evidence for these new drugs and describes future directions actively being explored.

P2, N=40, Recruiting, RemeGen Co., Ltd. | Phase classification: P1 --> P2 | N=60 --> 40

P2, N=79, Recruiting, RemeGen Co., Ltd. | Not yet recruiting --> Recruiting

In particular, RC48 has low side effects and can be well tolerated by elderly patients after dose adjustment, providing them with treatment opportunities. It needs to be further discussed in the future research.