Zai Lab Reports Positive Phase 3 Results for TIVDAK in Chinese Cervical Cancer Patients

Zai Lab Limited has revealed encouraging results from the China segment of the global Phase 3 innovaTV 301 clinical study, indicating significant progress in the treatment of recurrent or metastatic cervical cancer. The trial focused on assessing the efficacy of TIVDAK, an antibody-drug conjugate, in comparison to standard chemotherapy. TIVDAK displayed a substantial reduction in the risk of mortality among the participants, aligning with the outcomes observed in the broader global study.

In the Chinese participants, TIVDAK achieved a 45% decrease in the risk of death when compared to chemotherapy, specifically in patients who had previously undergone standard systemic therapies. A notable finding was that over half of these patients had received prior anti-PD(L)1 therapy. While the median overall survival (OS) for those treated with TIVDAK was not yet reached, it significantly surpassed the median OS of 10.7 months for chemotherapy, with a median follow-up duration of 11.5 months. Secondary endpoints, including progression-free survival (PFS) and confirmed objective response rate (ORR), also favored TIVDAK over chemotherapy. Additionally, the safety profile of TIVDAK in this Chinese cohort was manageable and consistent with that observed globally.

Dr. Rafael Amado, President and Head of Global Research and Development at Zai Lab, highlighted the persistent challenge posed by recurrent or metastatic cervical cancer and emphasized the unmet need for therapies that enhance survival rates post-relapse. He noted that the consistent positive results in the China subpopulation reinforce TIVDAK’s potential as a promising therapeutic option in this challenging clinical space.

Dr. Lingying Wu, a Professor at the National Cancer Center in China, underscored the limited treatment options available to Chinese cervical cancer patients once the disease recurs or progresses. Although the adoption of immunotherapy as a first-line treatment marks progress, the lack of effective solutions following relapse remains a critical issue. The promising outcomes of TIVDAK offer hope by extending survival for patients whose disease progressed after initial treatments, including after anti-PD(L)1 therapies.

In April 2024, the U.S. Food and Drug Administration (FDA) granted full approval to TIVDAK for treating patients with recurrent or metastatic cervical cancer who had experienced disease progression following chemotherapy. This approval stemmed from the global findings of the Phase 3 innovaTV 301 trial, which demonstrated a significant improvement in overall survival for patients treated with TIVDAK compared to chemotherapy.

The trial design of innovaTV 301 involved a global, randomized, open-label study comparing TIVDAK to an investigator's choice of single-agent chemotherapy in patients with recurrent or metastatic cervical cancer. The primary endpoint was overall survival, with progression-free survival and objective response rate as key secondary outcomes. Conducted by Seagen, later acquired by Pfizer, in collaboration with Genmab and other international oncology groups, the trial aimed to address the limitations of existing therapies for this patient population.

Cervical cancer remains a leading cause of cancer-related deaths among women globally, including in China, where an estimated 150,000 new cases are reported annually. For patients with recurrent or metastatic disease, treatment options are limited, making the introduction of effective therapies like TIVDAK vital. TIVDAK's development and potential approval in China are poised to offer a new avenue for addressing this critical unmet need.

Zai Lab, an innovative biopharmaceutical company operating in China and the United States, is committed to advancing medical treatments in areas with significant unmet needs. The company aims to submit a New Drug Application for TIVDAK to China's National Medical Products Administration in the first quarter of 2025, leveraging its established presence in women's cancer treatments to make this therapy available to patients if approved.