Positive topline results announced for Tivdak (tisotumab vedotin) in the China subpopulation of the phase III innovaTV 301 trial in patients with recurrent or metastatic cervical cancer.- Zai Lab

The China subpopulation results were consistent with those in the global population:

• i.   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 who had received prior standard systemic therapies, with more than half of this Chinese population having received prior anti-PD(L)1 therapy.
• ii..  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.
• iii.  Secondary endpoints of PFS and confirmed ORR also favored treatment with Tivdak compared to chemotherapy.
• iv,. The safety profile of Tivdak in the China subpopulation was manageable and consistent with the global profile.

“Recurrent or metastatic cervical cancer remains a significant challenge for patients, highlighting a critical unmet need for effective treatments that extend survival after relapse,” said Dr. Rafael Amado, President, Head of Global Research and Development at Zai Lab. “The consistent and positive results in the China subpopulation of the global Phase III study reinforce the potential for Tivdak, the only ADC therapy in this disease setting, to increase options in this therapeutically unmet clinical setting. If approved, we expect Tivdak to add to Zejula and augment our commercial franchise in women’s tumors.”

"There are approximately 150,000 new cases of cervical cancer annually in China and patients face limited treatment options once their cancer recurs or spreads after initial treatment,” said Dr. Lingying Wu, Professor of the Department of Gynecologic Oncology of National Cancer Center / Cancer Hospital Chinese Academy of Medical Sciences. “While the recent adoption of immunotherapy as a first-line treatment in China represents progress, there is a lack of effective options for patients following relapse. The promising results from TIVDAK, which demonstrated superior survival extension in patients whose disease progressed after initial treatments, including prior anti-PD(L)1 treatment, offer hope for addressing this critical unmet need.”