Alphamab Oncology (Stock Code: 9966.HK) announced that the IND application for a Phase II clinical study of JSKN033 (a proprietary high-concentration subcutaneous co-formulation consisting of HER2 bispecific antibody-drug conjugate (ADC) and PD-L1 immune checkpoint inhibitor) in combination with platinum-based chemotherapy with or without bevacizumab as first-line treatment of advanced cervical cancer (Study Number: JSKN033-202), has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).

Cervical cancer is the most common gynecological malignancy and the fourth leading cause of cancer-related deaths among women. Patients with early-stage disease often experience recurrence or metastasis within two years after treatment, while those with advanced disease have a poor prognosis, with a five-year survival rate of less than 20%. Currently, platinum-based (cisplatin or carboplatin) chemotherapy combined with bevacizumab represents the guideline-recommended first-line standard of care. Although immune checkpoint inhibitors have also achieved breakthrough progress, tumor heterogeneity in cervical cancer still leads to suboptimal responses in some patients, highlighting a clear unmet clinical need.

In recent years, multiple clinical studies have confirmed the synergistic potential of combining ADCs with immunotherapy and anti-angiogenic agents. As a first-in-class co-formulation of ADC and immune checkpoint inhibitor, JSKN033 leverages a dual mechanism of action, combining targeted tumor killing with immune activation. In early-stage clinical studies, JSKN033 monotherapy has demonstrated promising efficacy and a manageable safety profile in patients with cervical cancer who have failed standard therapies.

JSKN033-202 is an open-label, multicenter phase II clinical trial designed to evaluate the safety, efficiency and pharmacokinetics (PK)/pharmacodynamics (PD) of JSKN033 in combination with platinum-based chemotherapy, with or without bevacizumab, as first-line treatment for patients with advanced cervical cancer. All patients will receive treatment with JSKN033 plus either cisplatin or carboplatin, with or without bevacizumab, with the choice of platinum agent and the use of bevacizumab determined by the investigator based on individual patient circumstances. The initiation of this study is expected to provide an innovative and convenient treatment option for patients with advanced cervical cancer.