Pfizer, Astellas’ Prostate Cancer Drug Xtandi Achieves Goals In Phase 3

Pfizer and Astellas have announced their prostate cancer therapy, Xtandi (enzalutamide), has achieved its main objectives in a Phase 3 trial. 

The latest trial win comes days after Astellas announced a success in the Arches study of Xtandi plus androgen deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC). 

Xtandi has been approved for the treatment of mHSPC, metastatic castration-resistant prostate cancer (mCRPC) and its non-metastatic form (nmCRPC) in the US. One or more of the mentioned indications have been approved in more than 100 countries, including the European Union and Japan. 

Related Article: Astellas Clears Primary Endpoints In Prostate Cancer And Menopause Trials

Xtandi Improves Metastasis-Free Survival Compared to Placebo

In the Phase 3 Embark trial assessing Xtandi (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer (mmHSPC) with high-risk biochemical recurrence (BCR), Xtandi plus leuprolide, a GnRH receptor agonist showed a statistically significant and clinically meaningful improvement in metastasis-free survival (MFS) compared to placebo plus leuprolide. The improvement was also seen in Xtandi monotherapy alone versus placebo, satisfying a secondary endpoint. 

The results noted a positive trend in overall survival (OS), another key secondary endpoint, but the data was not yet mature and will be followed for a final OS analysis, the companies said. Other secondary endpoints showing statistical significance included time to prostate-specific antigen (PSA) progression and time to first use of new antineoplastic therapy. 

No new safety signals were observed in Embark so far, which is consistent with the known safety profile of Xtandi. 

“The topline findings from EMBARK are highly encouraging and we look forward to engaging with health authorities to potentially bring XTANDI to men with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development. 

As Pfizer and Astellas readies their latest data to support a potential FDA regulatory submission for the mmHSPC indication, detailed results from Embark are expected to be presented at a future medical meeting. 

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Joy Lin

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