Seattle Genetics gain breakthrough therapy designation

Seattle Genetics and Astellas have confirmed that the drug candidate they are co-developing, enfortumab, has been given FDA breakthrough therapy designation.

The designation means that the FDA will work closely with the partners to speed through an approval, if the treatments trials come back with positive data.

The drug is an antibody-drug conjugate that is being tested for the treatment of locally advanced or metastatic urothelial cancer.

If the treatment is able to match earlier, promising Phase 1 data in later trials, it could offer hope to patients running out of options. The patient pool will be those individuals who have already been treated with checkpoint inhibitors, leaving them without many options for treatment.

In Phase 1 trials, it was revealed that, of the 71 patients enrolled, 29 patients had an objective response rate, including three complete responses.

Enfortumab is the first drug to target Nectin-4, which is expressed on many solid tumours and is found commonly in bladder cancers.

"The FDA Breakthrough Therapy Designation underscores the potential of enfortumab vedotin as a meaningful treatment for patients with locally advanced or metastatic urothelial cancer. Further, it supports our rapid development plans for this ADC, including the ongoing pivotal study in this patient population," said Robert Lechleider, Senior Vice President, Clinical Development at Seattle Genetics. "Enfortumab vedotin is at the forefront of our late-stage clinical pipeline, and we are working closely with our partner and the FDA to bring this potential new treatment to patients as quickly as possible."

Both partners are also looking at testing the treatment in other solid tumour areas, including ovarian and non-small cell lung carcinoma.

Recruitment is currently on-going for taking the treatment into Phase 2 trials, as well as there being an ongoing combination trial with CPI therapy, EV-103.

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