FDA Approval of Tisotumab Vedotin in Cervical Cancer Provides New Treatment 'Where We've Had Very Few Other Options'

The antibody drug conjugate could provide patients with symptomatic relief, along with manageable side effects.

A treatment regimen of tisotumab vedotin in patients with recurrent or metastatic cervical cancer may give patients with the disease an additional option to shrink tumors, according to an expert.

The drug, which was recently approved by the Food and Drug Administration, demonstrated an objective response rate of 24% in patients with recurrent and/or metastatic cervical cancer who were previously treated with doublet chemotherapy and Avastin (bevacizumab).

“The most important impact to the patient (from this approval) is that this provides another strategy that has proven to shrink tumors. This is a new entity to enter into the clinical domain where we've had very few other options,” explained Dr. Robert Coleman, chief scientific officer of U.S. Oncology Research and gynecological oncologist affiliated with Memorial Hermann, in an interview with CURE®.

Tisotumab vedotin is an antibody-drug conjugate that releases a chemotherapeutic agent into the body “that can then induce cell death through a number of mechanisms, this one being microtubules disrupting an agent called MMAE (monomethyl auristatin E) or a statin analog,” he said.

According to Coleman, the drug can also provide symptomatic relief to patients who often experience pelvic burden like metastases near a pelvic nerve by shrinking the tumor and relieving pain. “This ability to halt the natural progression of the disease is also very, very important to patients,” he said.

A benefit of antibody drug conjugates is that they tend to have a lower rate of hematologic side effects like myelosuppression (when bone marrow activity is decreased), neuropathy (nerve damage) and alopecia (an autoimmune disorder that causes hair loss), says Coleman. With this said, researchers did see some cases of myelosuppression, conjunctivitis and dry eye. “The good news is that it's predictable, and with these types of mitigating strategies, it’s certainly not permanent and can resolve in a relatively short period of time,” he said, emphasizing the importance of an eye care program using pre- and post-treatment eyedrops as well as cool packs.

Of note, the standard of care for cervical cancer continues to be chemotherapy and radiation, with some targeted therapies as well. Coleman said that the hope is that antibody drug conjugates like tisotumab vedotin will be able to replace some of the traditional chemotherapies like paclitaxcel.

“Our hope is that we can actually replace some of the traditional chemotherapies with this. There's a large program ongoing now with (tisotumab vedotin) looking at various different combinations that would make sense particularly with chemotherapy like platinum and with bevacizumab, which of course also is approved in combination with platinum and paclitaxel in cervix cancer,” Coleman concluded. “So our hope is that we can potentially replace some of these other chemotherapy agents like paclitaxel, which has a high rate of neuropathy and alopecia and things that we can potentially mitigate with this with this new therapy. So the investigative environment of this is only started.”

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