Results from a phase 3 and a phase 1b/2 clinical trial found that patients with recurrent or metastatic cervical cancer treated with tisotumab vedotin experienced clinically meaningful and durable anti-tumor activity.

In September 2021, the US Food and Drug Administration (FDA) granted tisotumab vedotin accelerated approval for the treatment of recurrent or metastatic cervical cancer patients with disease progression.

Primary results from the ongoing randomized, open-label trials were presented at the 2023 ESMO Gynecological Cancers Congress by lead author Marta Bini, MD, IRCCS National Cancer Institute Foundation, Milan, Italy.

The phase 3 innovaTV-301/ENGOTcx12/GOG-30xx trial aims to assess the efficacy of tisotumab vedotin alone vs the investigator’s choice of chemotherapy in second- or third-line recurrent or metastatic cervical cancer, while the phase 1b/2 ENGOT Cx8/GOG 3024/innovaTV-205 trial is testing the tisotumab vedotin alone and in combination with (1) bevacizumab, (2) carboplatin, (3) pembrolizumab, and (4) pembrolizumab plus carboplatin with or without bevacizumab. Dr Bini explained, “The preliminary data highlighted the feasibility of the combination due to a good toxicity profile” and the suggestion of good clinical activity.”

The innovaTV-204/ GO30xx/ENGOT-cx6 trial found that tisotumab vedotin monotherapy resulted in an objective response rate (ORR) of 24% (7% complete responses; 17% partial responses). Comparatively, preliminary data from the innovaTV- ENGOT Cx8/GOG 3024/innovaTV-205 trial found that among the 482 enrolled participants, treatment with tisotumab vedotin in combination with carboplatin had an ORR of 55%. Additionally, for patients who received a combination of tisotumab vedotin and pembrolizumab the ORR was 41%. Treatment with tisotumab vedotin plus pembrolizumab and carboplatin with or without bevacizumab is still being evaluated.

“Although the phase III randomized controlled trial (ENGOT-cx12/GOG-3057/innovaTV-301) is still enrolling, the available evidence from phase II studies supports the adoption of [tisotumab vedotin in pre-treated recurrent or metastatic cervical cancer patients,” Dr Bini concluded.

Source:

Dini M. “Tisotumab vedotin in recurrent or metastatic cervical cancer.” Presented at ESMO Gynecological Cancers Congress; February 23-25, 2023; Barcelona, Spain. Abstract 12P