Genmab, Seagen's Tivdak improves survival in confirmatory cervical cancer study

2023-09-05

临床结果临床3期抗体药物偶联物上市批准加速审批

Genmab and Seagen announced that the Phase III innovaTV 301 study of Tivdak (tisotumab vedotin) in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy met its primary endpoint of overall survival (OS). The companies added that the key secondary goals of progression-free survival and objective response rate also demonstrated statistical significance.

The antibody-drug conjugate (ADC) gained accelerated approval in the US in 2021 as monotherapy to treat adults with recurrent or metastatic cervical cancer who have experienced disease progression on or after chemotherapy. The clearance was based on tumour response and durability of response data from the Phase II innovaTV 204 trial, with innovaTV 301 serving as a confirmatory study.

The late-stage trial included 502 patients with recurrent or metastatic cervical cancer who received no more than two prior systemic regimens in the recurrent or metastatic setting. Subjects were randomised to receive Tivdak or investigator’s choice of chemotherapy alone, consisting of topotecan, vinorelbine, gemcitabine, irinotecan or pemetrexed.

Genmab and Seagen noted that the study's independent data monitoring committee determined that OS crossed the pre-specified efficacy boundary at an interim analysis. The drugmakers indicated that results from innovaTV 301 will be discussed with regulatory authorities and submitted for presentation at an upcoming medical congress.

"Demonstrating a survival benefit with the results of innovaTV 301 is a critical milestone in our efforts to ensure more adults living with advanced cervical cancer have an approved treatment option," remarked Roger Dansey, Seagen's chief medical officer. Tivdak, which is given by injection, is composed of Genmab's monoclonal antibody directed to tissue factor (TF) and Seagen's ADC technology that utilises a protease-cleavable linker to attach the cytotoxic agent MMAE to the antibody.