England's NICE rebuffs Pfizer and Astellas' Xtandi in nonmetastatic prostate cancer

Pfizer and Astellas’ Xtandi is looking for a leg up on prostate cancer rival Erleada from J&J. But it won't be getting it in England.

In a final appraisal released Monday, the National Institute for Health and Care Excellence (NICE) chose not to recommend Xtandi for treatment of hormone-relapsed, non-metastatic prostate cancer, citing unconvincing data from a recent trial coined PROSPER.

"The committee concluded that the latest evidence available did not show a survival benefit with enzalutamide (Xtandi) relative to placebo for hormone-relapsed non-metastatic prostate cancer," the appraisal said.

The final decision followed NICE’s draft guidance released in early January not recommending Xtandi for inclusion on NHS England.

Xtandi, which received a nod from the FDA for the nonmetastatic, castration-resistant indication in July 2018, is in a heated battle with J&J’s Erleada—the drugmaker’s follow up to Xtandi nemesis Zytiga—as a supplement for androgen deprivation therapy (ADT).

The FDA approved Erleada in February 2018.

On the back of the PROSPER data and the subsequent FDA approval, Xtandi has put up a strong sales showing in the nonmetastatic indication, with Pfizer pulling in $189 million in fourth-quarter U.S. sales—a 12% increase from the previous year. Overall, Xtandi reported U.S. market share quadruple that of Erleada for the nonmetastatic indication in its first six months.

Despite PROSPER results that showed a combination of Xtandi and ADT could stave off cancer progression for a median 21.3 months longer than hormone therapy on its own, NICE determined the drug did not significantly extend patients’ lives and that it could be relatively ineffective when used early on in treatment.

In addition, NICE found Xtandi was not cost effective in comparison to solely using ADT, despite a confidential discount from the drugmakers.

Pfizer and Astellas’ setback comes as the partners look to extend Xtandi into the hormone-sensitive prostate cancer (HSPC) market.

In February, the companies released data from a phase 3 trial of men with metastatic HSPC showing a combination of Xtandi and ADT cut the risk of cancer worsening or death by 61% compared with ADT alone.

A separate phase 3 trial, titled EMBARK, treating men with HSPC with a combination of Xtandi and the hormone therapy leuprolide, is expected to finish in mid-2020.

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