Shanghai and Cambridge, Mass. — Zai Lab Limited said China’s National Medical Products Administration has approved TIVDAK, or tisotumab vedotin for injection, for the treatment of adult patients with recurrent or metastatic cervical cancer whose disease has progressed on or after chemotherapy.
The company said TIVDAK is the first antibody-drug conjugate approved in China for previously treated recurrent or metastatic cervical cancer.
The approval is based on results from the global, randomized Phase 3 innovaTV 301 clinical trial, which met its primary endpoint by showing an overall survival benefit in adult patients with previously treated recurrent or metastatic cervical cancer treated with TIVDAK compared with chemotherapy. Zai Lab said the benefit was also seen in an exploratory subpopulation of patients in China.
The China approval follows previous regulatory approvals in the United States, Japan, the European Union, the United Kingdom, Macau and Hong Kong. Zai Lab said the indication statement for TIVDAK differs slightly by region.
“Cervical cancer remains one of the leading causes of cancer death in women in China. Antibody-drug conjugates have proven to be novel and effective treatments for many types of cancer, and we are pleased to bring this innovative therapeutic class to patients in China with cervical cancer,” said Rafael G. Amado, M.D., President and Head of Global Research and Development at Zai Lab. “Coupled with the previous global approvals of TIVDAK for this disease, the China BLA approval further validates the robust global evidence of clinical benefit for this population of advanced patients with limited therapeutic options.”
In the global study, TIVDAK met the primary endpoint of overall survival in the intention-to-treat population, with a hazard ratio of 0.70, a 95% confidence interval of 0.54 to 0.89 and a two-sided p value of 0.0038. The China subpopulation showed consistent results, with a clinically meaningful improvement in overall survival and a hazard ratio of 0.55, corresponding to a 45% reduction in the risk of death compared with chemotherapy.
Zai Lab said 54.1% of patients in the China subpopulation had received prior anti-PD(L)1 therapy, the current standard of care for second-line cervical cancer treatment. TIVDAK showed consistent overall survival benefit trends regardless of prior immunotherapy exposure.
The company said no new safety signals were identified among patients in the China subpopulation who received TIVDAK. The most common Grade 3 or higher treatment-emergent adverse events in the global study were anemia, urinary tract infection and abdominal pain. In the China subpopulation, the most common Grade 3 or higher treatment-emergent adverse events were anemia, cough and malaise.
“Treatment options are very limited for cervical cancer patients once recurrence or metastasis occurs,” said Dr. Lingying Wu, Ph.D., China Leading Principal Investigator of the innovaTV 301 Study and Professor of the Department of Gynecologic Oncology of National Cancer Center / Cancer Hospital Chinese Academy of Medical Sciences. “Consistent with findings from the global innovaTV 301 trial, the China subpopulation data demonstrate that TIVDAK offers significant clinical benefits to these patients, irrespective of prior PD-(L)1 inhibitor therapy.”
Zai Lab said it plans to use its experience and presence in China’s gynecologic oncology market, along with commercial synergies with its ZEJULA team, to bring TIVDAK to patients in China.
