Pfizer, Astellas tout positive PhIII data to potentially expand Xtandi label
Pfizer and Astellas are gunning to add a fourth indication to their cancer drug Xtandi with Phase III trial results released today.
The study, looking at Xtandi plus leuprolide and Xtandi as a monotherapy in men with non-metastatic hormone-sensitive prostate cancer, met its primary endpoint with a “statistically significant and clinically meaningful improvement” in metastasis-free survival in the patients treated with Xtandi plus leuprolide, according to the companies, though no detailed data was given.
Xtandi is already approved in the US in men as a daily therapy with metastatic hormone-sensitive prostate cancer, metastatic castration-resistant prostate cancer and non-metastatic castration-resistant prostate cancer.
Leuprolide is an already-approved drug commonly used to treat symptoms of advanced prostate cancer, often under the brand names Eligard and Lupron. It works by lowering the amount of testosterone, which can help slow the growth of cancer cells. Lupron was first approved for use in prostate cancer in 1985.
“While current treatment options for localized prostate cancer are intended to be curative, some men remain at higher risk for biochemical recurrence following primary treatment, which may result in metastases,” Ahsan Arozullah, senior VP and head of development in therapeutics at Astellas, said in a statement.
“The EMBARK trial is the first study to demonstrate a statistically significant improvement in MFS using the combination of XTANDI plus leuprolide in men with this stage of disease.”
The secondary endpoint, overall survival, showed a “positive trend” but the data aren’t mature, according to the companies. There will be a final analysis of the data after following up with the patients.
Another secondary endpoint looking at Xtandi as a monotherapy also showed “statistically significant” improvement in metastasis-free survival.
According to the press release, the companies will discuss the data with the FDA about a potential new submission for Xtandi in this cancer.
Xtandi was first approved back in 2012 for late-stage castration-resistant prostate cancer, and since then, more than 720,000 patients have been treated with XTANDI globally, according to data from Astellas.
But the price has been a growing concern — in January, democratic lawmakers added their voices to the mix and pressed for the federal government to use its march-in rights to lower the price of Xtandi.
The lawmakers requested a public hearing on a petition to lower Xtandi’s price filed by patients by allowing generic drugmakers to produce cheaper versions of the drug, overriding the patent monopoly. The average wholesale price is more than $189,000 per year, the petitioners wrote to HHS Secretary Xavier Becerra.