Clinical trial sees positive results for cervical cancer treatment

A clinical trial investigating the treatment TIVDAK for cervical cancer has shown positive results.

The topline results from the global Phase 3 innovaTV 301 study demonstrated a clinically meaningful improvement in overall survival with TIVDAK treatment for patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy.

According to the results, TIVDAK demonstrated a 45 per cent reduction in the risk of death compared to chemotherapy 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.

Median overall survival for patients treated with TIVDAK was not reached versus chemotherapy 10.7 months with a median follow-up of 11.5 months. Secondary endpoints of PFS and confirmed ORR also favoured treatment with TIVDAK compared to chemotherapy.

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, head of global research and development at Zai Lab, which carried out the trial.

“The consistent and positive results in the China subpopulation of the global Phase 3 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 tumours.”

“There are approximately 150,000 new cases of cervical cancer annually in China1, 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.”

In April 2024, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) granting full approval for TIVDAK® (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

The approval was based on results from the global, randomised, Phase 3 innovaTV 301 clinical trial (NCT04697628), which met its primary endpoint, demonstrating overall survival (OS) benefit in adult patients with previously treated recurrent or metastatic cervical cancer treated with TIVDAK compared to chemotherapy.

Based on the results, Zai Lab intends to submit an NDA for TIVDAK to China’s National Medical Products Administration (NMPA) in the first quarter of 2025.