Tisotumab forvedotin-tftv is approved for recurrent or metastatic cervical cancer

October 2021: The FDA has given tisotumab vedotin-tftv (Tivdak, Seagen Inc.), a tissue factor-directed antibody and microtubule inhibitor combination, rapid approval for adult patients with recurrent or metastatic cervical cancer who are progressing on or after chemotherapy.

InnovaTV 204, an open-label, multicenter, single-arm clinical trial, was used to gain approval (NCT03438396). In 101 patients with recurrent or metastatic cervical cancer who had had no more than two prior systemic regimens in the recurrent or metastatic context, including at least one prior platinum-based chemotherapy treatment, efficacy was assessed. Sixty-nine percent of patients had previously received bevacizumab as part of a systemic treatment regimen. Tisotumab vedotin-tftv 2 mg/kg was given to patients every 3 weeks until disease progression or unacceptable toxicity.

The primary efficacy outcome measures were the confirmed objective response rate (ORR), as determined by an independent review committee (IRC) using RECIST v1.1, and response duration (DOR). With a median response time of 8.3 months, the ORR was 24 percent (95 percent CI: 15.9%, 33.3 percent) (95 percent CI: 4.2, not reached).

Hemoglobin decreased, fatigue, lymphocytes decreased, nausea, peripheral neuropathy, alopecia, epistaxis, conjunctival adverse reactions, haemorrhage, leukocytes decreased, creatinine increased, dry eye, prothrombin international normalised ratio increased, activated partial thromboplastin time prolonged, diarrhoea, and rash were the most common adverse reactions (25 percent), including laboratory abnormalities. A boxed warning for ocular toxicity is included on the product label.

The recommended dose is 2 mg/kg (up to 200 mg for patients under 100 kg) administered as a 30-minute intravenous infusion every three weeks until disease progression or intolerable toxicity.

Take second opinion on cervical cancer treatment

Send Details

Susan Hau

Website |  + postsBio ⮌

Susan Hau is a distinguished researcher in the field of cancer cell therapy, with a particular focus on T cell-based approaches and cancer vaccines. Her work spans several innovative treatment modalities, including CAR T-cell therapy, TIL (Tumor-Infiltrating Lymphocyte) therapy, and NK (Natural Killer) cell therapy.

Hau's expertise lies in cancer cell biology, where she has made significant contributions to understanding the complex interactions between immune cells and tumors.

Her research aims to enhance the efficacy of immunotherapies by manipulating the tumor microenvironment and exploring novel ways to activate and direct immune responses against cancer cells.

Throughout her career, Hau has collaborated with leading professors and researchers in the field of cancer treatment, both in the United States and China.

These international experiences have broadened her perspective and contributed to her innovative approach to cancer therapy development.

Hau's work is particularly focused on addressing the challenges of treating advanced and metastatic cancers. She has been involved in clinical trials evaluating the safety and efficacy of various immunotherapy approaches, including the promising Gamma Delta T cell therapy.

• Susan Hau

  https://cancerfax.com/author/susan/

  4th Generation CAR T Cell Therapy with IL-15: A new era in cancer treatment
• Susan Hau

  https://cancerfax.com/author/susan/

  Gene Therapy for Gaucher’s Disease in China
• Susan Hau

  https://cancerfax.com/author/susan/

  Gene Therapy for Wilson’s Disease in China
• Susan Hau

  https://cancerfax.com/author/susan/

  Gene Therapy for Phenylketonuria in China