Tisotumab vedotin, a new drug for cervical cancer ADC will apply for marketing!

Cervical cancer originates from the cells of the cervix. The disease is still one of the leading causes of cancer deaths in women worldwide. However. There are more than 311,000 female deaths each year in most developing countries.

Recently, the 2020 ESMO Virtual Conference announced the positive results of the ADC drug Tisotumab vedotin in the treatment of cervical cancer in the key phase II innovaTV 204 study. The drug has significant efficacy as a monotherapy and can provide clinically meaningful and durable objective relief. The total response rate (ORR) was 24%, DOR was 8.3 months, and safety was controllable.

Tisotumab vedotin international research data

innovaTV 204 is an ongoing single-arm, global, multi-center study. The 101 subjects have been received dual chemotherapy (with or without bevacizumab) with recurrent or metastatic cervical cancer. The study evaluated the efficacy and safety of the ADC drug Tisotumab vedotin (administered once every 3 weeks). The primary endpoint is the objective response rate (ORR) assessed by the blinded independent center review (BICR). The key secondary endpoints include duration of response (DOR), progression-free survival (PFS), overall survival (OS), safety, and tolerance.

The results showed that the ORR of Tisotumab vedotin treatment was 24% (95%CI: 15.9-33.3%). The complete response rate (CR) was 7% (7 cases), and the partial response rate (PR) was 17% (17 cases). The median follow-up was 10 months or, the median DOR was 8.3 months (95%CI: 4.2-not reached). The median time from initiation of treatment to remission was 1.4 months (range: 1.1-5.1).

Usually, treatment response was observed in the first 2 treatment cycles. Subgroup analysis showed that regardless of tumor histology, number of previously received therapies, response to previous systemic regimens, dual chemotherapy combined with bevacizumab as first-line treatment, the remission rate among the subgroups was generally consistent.

The median PFS was 4.2 months (95%CI: 3.0-4.4), and the 6-month PFS rate was 30% (95%CI: 20.8-40.1). The median OS was 12.1 months (95%CI: 9.6-13.9), and the 6-month OS rate was 79% (95%CI: 69.3-85.6). In the study, the most common treatment-related adverse events (≥20%) included hair loss, epistaxis, nausea, conjunctivitis, fatigue, and dry eye.

Tisotumab vedotin drug introduction

Drug name: Tisotumab vedotin

Developer: Seattle Genetics, Genmab

Tisotumab vedotin is an ADC drug under development that targets tissue factors (TF). The drug is designed to target the TF antigen on cancer cells and deliver the cytotoxic agent MMAE directly to cancer in the cell. In cancer biology, TF is a protein involved in tumor signal transduction and angiogenesis.

It is excessive in most cervical cancer patients and many other solid tumors (including ovarian, lung, pancreas, colorectal, and head and neck cancers). expression. Based on the high expression and rapid internalization of the TF factor in many solid tumors, TF has become an ideal target for the development of ADC drugs.