US stock futures rise after Trump announces Japan trade deal
NEW YORK/TOKYO - Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (TSE:4503), a $16.8 billion market cap company with impressive 81.7% gross margins, announced Thursday that their drug XTANDI (enzalutamide) demonstrated a statistically significant improvement in overall survival when combined with leuprolide in men with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence. According to InvestingPro analysis, Astellas maintains a GOOD financial health score, suggesting strong operational stability.
The positive topline results from the Phase 3 EMBARK study mark XTANDI as the first androgen receptor inhibitor-based treatment to show an overall survival benefit in this specific patient population.
The study evaluated XTANDI both in combination with leuprolide and as a monotherapy. While the combination therapy met its key secondary endpoint with a statistically significant improvement in overall survival compared to placebo plus leuprolide, the monotherapy showed a favorable trend that did not reach statistical significance. Astellas has demonstrated strong performance with 19.25% revenue growth in the last twelve months, reflecting its successful drug development strategy. InvestingPro analysis indicates the stock is currently undervalued, presenting a potential opportunity for investors.
"These data demonstrate that treatment with XTANDI can extend life for men with nmHSPC and high-risk BCR who have relapsed after initial curative-intent therapy," said Neal Shore, M.D., F.A.C.S, START Carolinas/Carolina Urologic Research Center.
The EMBARK trial previously met its primary endpoint of metastasis-free survival, with results published in The New England Journal of Medicine in 2023. No new safety concerns emerged in the latest analysis.
Among men who undergo definitive prostate cancer treatment, an estimated 20-40% experience biochemical recurrence within 10 years, with approximately 90% of high-risk patients eventually developing metastatic disease.
XTANDI is currently approved in more than 80 countries for various prostate cancer indications. According to the companies, over 1.5 million men with advanced prostate cancer have been treated with the drug since its initial approval in 2012.
Detailed overall survival results from the EMBARK study will be presented at a future medical meeting, according to the companies’ press release statement. With Astellas’ next earnings report due in 20 days and analyst targets suggesting upside potential, investors can access deeper insights and exclusive ProTips through InvestingPro’s comprehensive financial analysis platform.
In other recent news, Astellas Pharma Inc. and Pfizer Inc. announced significant findings from the five-year follow-up of their Phase 3 ARCHES trial. The study demonstrated that XTANDI, in combination with androgen deprivation therapy (ADT), reduces the risk of death by 30% in men with metastatic hormone-sensitive prostate cancer. The trial included 1,150 patients worldwide and showed a 66% probability of survival at five years for those treated with XTANDI plus ADT, compared to a 53% probability with placebo plus ADT. These results highlight XTANDI’s long-term efficacy, particularly in patients with high-volume disease and no prior docetaxel use. The safety profile of XTANDI remained consistent over the five-year period, with no new safety concerns reported. The findings are considered a substantial improvement over standard hormonal therapy, with XTANDI now being a standard of care for this condition. Additionally, eight-year data from the independent ENZAMET study will be presented at the upcoming American Society of Clinical Oncology Annual Meeting, further supporting XTANDI’s efficacy. The ARCHES study results will be submitted for publication in a peer-reviewed journal, reinforcing the drug’s role in changing treatment outcomes for patients.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.