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NEW YORK/TOKYO - Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (TSE:4503) announced Tuesday that their combination therapy of PADCEV (enfortumab vedotin) plus KEYTRUDA (pembrolizumab) demonstrated significant survival improvements in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy. Astellas, with a market capitalization of $19.9 billion and impressive revenue growth of 14.3% over the last twelve months, has maintained a strong position in the pharmaceutical sector with an industry-leading gross profit margin of 81.9%.
The Phase 3 EV-303 clinical trial evaluated the therapy as a neoadjuvant and adjuvant treatment (before and after surgery) compared to surgery alone, the current standard of care. The study met its primary endpoint of event-free survival as well as key secondary endpoints including overall survival and pathologic complete response rate. According to InvestingPro analysis, Astellas maintains a "GREAT" overall financial health score, suggesting strong operational stability to support its clinical development programs.
According to the companies, this marks the first time a systemic treatment approach used before and after surgery has significantly extended survival over standard-of-care surgery in this patient population.
"These EV-303 study results mark the first time a systemic treatment approach, used before and after surgery, significantly extended survival over standard-of-care surgery in this population," said Christof Vulsteke, M.D., Ph.D., Head of Integrated Cancer Center Ghent and principal investigator of the trial.
Up to half of patients with MIBC are not eligible to receive cisplatin and face limited treatment options, typically undergoing surgery alone. Bladder cancer is the ninth most common cancer worldwide, with MIBC representing approximately 30% of all cases.
The safety profiles for PADCEV plus KEYTRUDA were consistent with the known profiles of each treatment regimen. The companies plan to present detailed results at an upcoming medical congress and discuss them with global health authorities for potential regulatory filings.
PADCEV plus KEYTRUDA is already approved for the treatment of locally advanced or metastatic urothelial cancer in several countries.
The announcement was based on a company press release. InvestingPro analysis indicates that Astellas is currently trading below its Fair Value, presenting a potential opportunity for investors interested in the pharmaceutical sector. For deeper insights into Astellas’s financial metrics and more exclusive ProTips, check out the full analysis on InvestingPro.
In other recent news, Pfizer Inc. and Astellas Pharma Inc. have reported significant findings related to their drug XTANDI (enzalutamide). According to the companies, XTANDI, when combined with leuprolide, showed a statistically significant improvement in overall survival for men with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence. These results come from the Phase 3 EMBARK study, marking XTANDI as the first androgen receptor inhibitor-based treatment to demonstrate an overall survival benefit in this patient group. Additionally, results from the five-year follow-up of the Phase 3 ARCHES trial revealed that XTANDI, when used alongside androgen deprivation therapy (ADT), reduced the risk of death by 30% in men with metastatic hormone-sensitive prostate cancer. The study noted a 66% probability of survival at five years with XTANDI plus ADT, compared to a 53% probability with placebo plus ADT. The ARCHES trial involved 1,150 patients globally and confirmed XTANDI’s long-term efficacy in various patient subgroups. Importantly, the safety profile of XTANDI over the five-year period remained consistent with earlier analyses, and no new safety concerns were identified.
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