Zai Lab's TIVDAK: A Beacon of Hope in the Fight Against Cervical Cancer in China

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) has announced positive topline results from the China subpopulation of the global Phase 3 innovaTV 301 trial, demonstrating a clinically meaningful improvement in overall survival (OS) with TIVDAK treatment for patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy. The results, consistent with those in the global population, have significant implications for the treatment landscape in China, where cervical cancer remains a substantial health burden.

Cervical cancer is a leading cause of cancer-related deaths among women in China, with approximately 150,000 new cases annually. Despite advancements in treatment options, patients face limited alternatives once their cancer recurs or spreads after initial treatment. The recent adoption of immunotherapy as a first-line treatment in China has left a critical unmet need for effective options following relapse. TIVDAK's promising results offer hope for addressing this challenge and extending survival for patients with recurrent or metastatic cervical cancer.

TIVDAK demonstrated a 45% reduction in the risk of death compared to chemotherapy (HR: 0.55 [95% CI: 0.27-1.15]) in the China subpopulation, with more than half of this Chinese population having received prior anti-PD(L)1 therapy. Median OS for patients treated with TIVDAK was not reached versus chemotherapy 10.7 months [95% CI: 6.0-not reached] with a median follow-up of 11.5 months. Secondary endpoints of progression-free survival (PFS) and confirmed objective response rate (ORR) also favored treatment with TIVDAK compared to chemotherapy. The safety profile of TIVDAK in the China subpopulation was manageable and consistent with the global profile.

The positive results in the China subpopulation, particularly in patients with prior anti-PD(L)1 therapy, have significant implications for the treatment of recurrent or metastatic cervical cancer. Over half of the Chinese study population in the innovaTV 301 trial had received prior anti-PD(L)1 therapy, reflecting real-world treatment patterns. The positive results in this subgroup suggest that TIVDAK could be an effective treatment option for patients whose disease has progressed after initial treatments, including immunotherapy. This is particularly relevant given the recent adoption of immunotherapy as a first-line treatment in China, which leaves a lack of effective options for patients following relapse.

Zai Lab intends to submit a New Drug Application (NDA) to China's National Medical Products Administration (NMPA) in the first quarter of 2025, leveraging its commercial footprint of ZEJULA in women's cancer to bring the medicine to patients in China if approved. With approximately 150,000 new cervical cancer cases annually in China, TIVDAK could provide a much-needed treatment option for patients with alternatives after initial treatment failure.

In conclusion, Zai Lab's TIVDAK has shown promising results in the China subpopulation of the global Phase 3 innovaTV 301 trial, demonstrating a clinically meaningful improvement in overall survival compared to chemotherapy. The positive results in patients with prior anti-PD(L)1 therapy have significant implications for the treatment of recurrent or metastatic cervical cancer in China, where cervical cancer remains a substantial health burden. If approved, TIVDAK could provide a much-needed treatment option for patients with alternatives after initial treatment failure, potentially extending survival and improving quality of life.