#Japan #Tokyo #Prostate Cancer #XTANDI #enzalutamide

XTANDI™ Shows Long-Term Survival in Metastatic Hormone-Sensitive Prostate Cancer

Astellas Pharma and Pfizer have revealed encouraging five-year follow-up results from the Phase 3 ARCHES trial, which underscores the efficacy of XTANDI™ (enzalutamide) in treating men with metastatic hormone-sensitive prostate cancer (mHSPC). In a meticulous study period of median 61.4 months, findings reveal that the combination of XTANDI and androgen deprivation therapy (ADT) significantly elevated overall survival rates.

The data indicates a striking 66% survival probability at the five-year mark for those treated with XTANDI plus ADT, compared to just 53% for patients receiving placebo combined with ADT. Most notably, XTANDI stands out as the pioneering androgen receptor inhibitor demonstrating this substantial survival benefit after five years of treatment.

Dr. Andrew J. Armstrong, the primary investigator of the ARCHES trial and Director of Research at the Center for Prostate Urologic Cancers at Duke Cancer Institute, expressed his optimism regarding these results. He noted that advancements in treatment strategies, particularly the introduction of XTANDI, have fundamentally shifted the prognosis for men diagnosed with metastatic hormone-sensitive prostate cancer. This trial corroborates earlier findings, with data showing a relative 30% reduction in mortality risk compared to standard hormonal therapies.

The number of patients demonstrating improved survival varies across several subgroups, including those with high-volume disease and those who haven’t undergone prior docetaxel therapy, marking a significant milestone in cancer treatment methodologies. As Dr. Armstrong stated, “two-thirds of men in this five-year follow-up are now surviving, a testament to the effectiveness of combining XTANDI with ADT.”

Evaluating different patients’ classifications showed beneficial outcomes across various demographics, with subgroup analysis revealing enhanced survival rates across patients with both high-volume and low-volume diseases. This comprehensive data flexibly underscores the versatility of XTANDI as a treatment option.

Additionally, adverse events recorded during the five-year follow-up were consistent with previous reports, and no new safety features have been observed. This positions XTANDI not just as a medication with a positive track record but as a standard treatment for men grappling with this severe form of cancer.

Further underlining these findings, Dr. Shontelle Dodson, EVP and Head of Medical Affairs at Astellas, emphasized the growing body of data supporting XTANDI's long-term efficacy. This continuous validation not only highlights its performance in advanced cases but also showcases its potential to revolutionize the treatment landscape for those afflicted by prostate cancer.

In conjunction with these findings, other studies like the ENZAMET trial, which compares enzalutamide versus non-steroidal anti-androgens in the same patient population, also offer additional layers of understanding regarding the long-term effects and optimal treatment strategies for mHSPC.

As a further testament to the potential breakthrough in treating prostate cancer, it is projected that the results from the five-year follow-up will soon be published in a peer-reviewed journal, emphasizing XTANDI’s status as a critical therapeutic option. With regulatory approvals in over 90 countries and treating more than a million patients globally since its launch in 2012, the impact of XTANDI on mHSPC cannot be overstated.

The implications of this data are extensive, painting a hopeful picture for those diagnosed with advanced prostate cancer and serving as a solid foundation for ongoing research into more effective treatment methodologies. As we continue navigating through the variables that influence cancer treatment and patient survivability, studies like ARCHES validate the progress we have made and reinforce the importance of innovative treatments in dramatically altering patient outcomes.