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FDA approves Seagen/Genmab’s antibody-drug conjugate Tivdak for women with advanced cervical cancer

The drug has been granted accelerated approval, and the companies have also released positive data on first-line treatment


While screening and prevention programmes have slashed the number of women developing cervical cancer, it remains a leading cause of cancer-related death among women globally. Advanced cervical cancer has also proved extremely difficult to treat.

However, there is good news on the horizon for the 15,000 women diagnosed with the disease each year in the US.

The Food and Drug Administration (FDA) has approved the antibody-drug conjugate Tivdak (tisotumab vedotin-tftv) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Also, two clinical trials involving combination therapies – involving both Tivdak and Merck’s Keytruda – have shown encouraging results.

Tivdak – which was granted priority review by the FDA in April – is an antibody-drug conjugate composed of Genmab’s human monoclonal antibody and Seagen’s ADC technology involving monomethyl auristatin E (MMAE). The ADC is directed to tissue factor, a cell-surface protein expressed on multiple solid tumours associated with tumour growth, angiogenesis and metastasis.

The FDA approval is based on results from a phase 2 trial, innovaTV 204, which evaluated Tivdak as second or third-line treatment in 101 women with recurrent or metastatic cervical cancer, two-thirds of which had previously received Avastin (bevacizumab).

“This is an important development for patients with recurrent or metastatic cervical cancer,” said Robert Coleman, Seagen chief scientific officer, US oncology research and lead investigator of the innovaTV 204 clinical trial.

He added that not all women with advanced cervical cancer will benefit from Tivdak – the response rate in the trial was low, at 24%.

A global, randomised phase 3 clinical trial (innovaTV 301) is underway and is also intended to support global registrations.

New data is also available on first-line treatment for cervical cancer involving Merck’s megablockbuster immunotherapy, Keytruda (pembrolizumab).

Merck announced that its pivotal phase 3 KEYNOTE-826 trial showed that Keytruda (pembrolizumab) plus chemotherapy with or without bevacizumab reduced the risk of death by one-third versus chemotherapy with or without bevacizumab in persistent, recurrent or metastatic cervical cancer.

Seagen has released interim data from its phase 1b/2 innovaTV 205 trial that showed encouraging and durable anti-tumour activity among two cohorts – a 55% response rate for Tivdak plus carboplatin in patients with advanced cervical cancer who had not received prior systemic therapy and a 38% response rate for Tivdak plus Keytruda in patients with advanced cervical cancer who experienced disease progression after one to two lines of prior systemic therapy.

Article by
Hugh Gosling

22nd September 2021

From: Research, Regulatory



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