Tisotumab Vedotin Earns Hong Kong Approval in Recurrent Cervical Cancer

The Hong Kong Department of Health has approved tisotumab vedotin-tftv (Tivdak) as a treatment for adults with metastatic or recurrent cervical cancer who experienced disease progression on or after prior chemotherapy, according to a news release from the developer, Zai Lab Limited.¹

Previously, the FDA approved tisotumab for adults with recurrent or metastatic cervical cancer in April 2024.² According to the news release, China’s National Medical Products Administration is currently reviewing a biologics license application for tisotumab vedotin in the same patient population, which the agency accepted in March 2025.

“Today’s approval of [tisotumab vedotin] marks an important milestone for Zai Lab, further strengthening our women’s franchise in Greater China. Treatment options for patients with recurrent or metastatic cervical cancer after initial therapy are limited,” Andrew Zhu, chief commercial officer in Greater China at Zai Lab, stated in the news release.¹ “[Tisotumab vedotin], the first antibody-drug conjugate (ADC) therapy in cervical cancer, delivers a clinically meaningful survival benefit to patients.”

Data supporting tisotumab vedotin came from the phase 3 innovaTV 301 trial (NCT04697628), in which investigators evaluated the agent vs chemotherapy among 502 patients with metastatic or recurrent cervical cancer. Efficacy data released at the time of the FDA approval revealed a median overall survival (OS) of 11.5 months (95% CI, 9.8-14.9) with tisotumab vedotin compared with 9.5 months (95% CI, 7.9-10.7) with chemotherapy (HR, 0.70; 95% CI, 0.54-0.89; P = .0038).²

Other data from the innovaTV 301 trial showed a median progression-free survival (PFS) of 4.2 months (95% CI, 4.0-4.4) in the tisotumab vedotin arm and 2.9 months (95% CI, 2.6-3.1) in the chemotherapy arm (HR, 0.67; 95% CI, 0.54-0.82; P <.0001). Additionally, the confirmed objective response rate (ORR) was 17.8% (95% CI, 13.3%-23.1%) vs 5.2% (95% CI, 2.8%-8.8%) in each respective arm (P <.0001).

Common adverse effects associated with tisotumab vedotin included decreased hemoglobin, peripheral neuropathy, conjunctival adverse reactions, increased aspartate aminotransferase, increased alanine aminotransferase, nausea, fatigue, decreased sodium, constipation, and epistaxis.

In the open-label, multicenter innovaTV 301 trial, patients were randomly assigned 1:1 to receive tisotumab vedotin at 2 mg/kg intravenously every 3 weeks or the investigator’s choice of chemotherapy. In the comparator arm, patients received treatment with topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed.

The trial’s primary end point was OS.³ Secondary end points included PFS per investigator assessment, ORR per investigator assessment, time to response, duration of response, treatment-emergent adverse effects, and quality of life.

Patients 18 years or older with metastatic or recurrent cervical cancer harboring squamous cell, adenocarcinoma, or adenosquamous histology, as well as progression on or after treatment with standard-of-care chemotherapy doublet or platinum-containing therapy, were eligible for enrollment on the trial. Other eligibility criteria included having measurable disease per RECIST v1.1 guidelines, an ECOG performance status of 0 or 1, and a life expectancy of at least 3 months.

Those with primary neuroendocrine, lymphoid, or sarcomatoid histology; clinically significant bleeding issues or risks; or any prior intracerebral arteriovenous malformation, cerebral aneurysm, or stroke were ineligible for study entry. Patients were also ineligible to enroll if they had active ocular surface disease, major surgery within 4 weeks of study entry or minor surgery within 7 days of beginning study treatment, peripheral neuropathy of grade 2 or higher, or any prior treatment with monomethyl auristatin E–based agents.

In March 2025, tisotumab vedotin received approval for this cervical cancer population in Japan from the Ministry of Health, Labour and Welfare based on data from the innovaTV 301 trial.⁴

References

1. Zai Lab announces approval of TIVDAK® for patients with recurrent or metastatic cervical cancer in Hong Kong. News release. Zai Lab Limited. September 1, 2025. Accessed September 4, 2025. http://bit.ly/4neu48X
2. FDA approves tisotumab vedotin-tftv for recurrent or metastatic cervical cancer. News release. FDA. April 29, 2024. Accessed September 4, 2025. https://tinyurl.com/ets4ma4b
3. Tisotumab vedotin vs chemotherapy in recurrent or metastatic cervical cancer (innovaTV 301). ClinicalTrials.gov. Updated July 20, 2025. Accessed September 4, 2025. http://bit.ly/4lVKKRT
4. TIVDAK (tisotumab vedotin) approved by Japan Ministry of Health, Labour and Welfare for the treatment of advanced or recurrent cervical cancer that has progressed on or after chemotherapy. News release. Genmab. March 27, 2025. Accessed September 4, 2025. https://tinyurl.com/bdzn3hax