The Food and Drug Administration (FDA) recently approved two new treatments for recurrent or metastatic (cancer spread to other parts of the body) cervix cancers.

1st Line Treatment for recurrent or metastatic cervix cancer:
• Current Standard Treatment: Treatment comprises of chemotherapy with or without bevacizumab (targeted therapy).
• New Treatment: On October 2021, FDA Approves pembrolizumab, an immunotherapy, in combination with chemotherapy (with or without bevacizumab) 1.

The approval was based on the Keynote 826 study, a large clinical study which demonstrated that the addition of pembrolizumab to the current standard treatment of chemotherapy with or without bevacizumab led to greater tumour shrinkage, longer duration of tumour control and importantly, a 36% reduction in the risk of death, compared to women treated with the current standard of care treatment. Pembrolizumab is a type of immunotherapy called an immune checkpoint inhibitor. It boosts the immune system to better recognize and kill cancer (Please LINK to section on Immunotherapy/ immune checkpoint inhibitor). Pembrolizumab is administered as a short infusional treatment in the outpatient clinic.

Cervix cancers that progressed during or following 1st line treatment :
• Current standard treatment:
o Chemotherapy.
o Pembrolizumab (immunotherapy) : cancers with PD-L1 protein or are microsatellite instable (MSI-High)

• New treatment:
On September 2021, FDA approves Tisotumab Vedotin for treatment of recurrent or metastatic cervical cancer that got worse on or after chemotherapy

FDA based its approval on the inovaTV 204 clinical study. In this study, women with recurrent or metastatic cervix cancer with cancer progression on or after chemotherapy treated with Tisotumab Vedotin, achieved high cancer control rate of up to 72% which is also durable. These treatment outcomes are promising and compare very favourably with our existing standard treatment with immunotherapy or chemotherapy. Tisotumab vedotin is a novel drug, called an antibody-drug conjugate, where an antibody is coupled with a potent chemotherapy drug, Monomethylauristatin E (MMAE). The antibody part acts like a homing signal, which specifically targets and binds to Tissue Factor, a protein that is highly prevalent in cervical cancer. This helps to deliver the chemotherapy drug, MMAE, directly into the cervical cancer cell to kill the cancer cells.

Tisotumab is a 30-minute infusional treatment administered every 3 weekly in the outpatient clinic. There are many more exciting studies on cervix cancer that are ongoing. Do stay tuned for these study updates!

Written by:
Dr Lim Sheow Lei
MBBS (Australia, Honours), MRCP (United Kingdom), MD (United Kingdom)

References:
1. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-combination-first-line-treatment-cervical-cancer

2. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tisotumab-vedotin-tftv-recurrent-or-metastatic-cervical-cancer