While they were both approved several years back to treat the same two types of prostate cancer, Astellas and Pfizer’s Xtandi has held a larger slice of the market than Johnson & Johnson’s rival medicine Erleada.
But a real-world, head-to-head study of the pair of androgen receptor pathway inhibitors (ARPI) indicates that Erleada provides an edge in overall survival in patients with metastatic castration-sensitive prostate cancer (mCSPC).
The study looked at treatment outcomes for more than 3,700 patients and found that Erleada reduced the risk of death by 23% over Xtandi after 24 months, J&J said in a Tuesday release. The difference was statistically significant and clinically meaningful, the company said.
After 24 months, 88% of patients on Erleada were still alive, which J&J said was “consistent” with results from the phase 3 TITAN trial. That trial showed an 82% survival rate at the same 24-month time point. In the real-world study, the survival rate for Xtandi patients was 85%.
“Since Erleada’s approval, multiple ARPIs have been introduced, but no one has directly compared their effectiveness on a large scale, until now,” Luca Dezzani, M.D., J&J’s U.S. VP, medical affairs, solid tumors, said in an email interview. “This real-world study is exciting as the comprehensive data and rigorous methodology used in this study offers real-world insights on overall survival which can provide prescribers with important information to consider when choosing an ARPI.”
Using information gathered from electronic databases for five years starting in December of 2018, the real-world study identified 1,800 mCSPC patients who were introduced to ARPI therapy with Erleada and 1,909 whose first APRI therapy was Xtandi.
"While controlled and randomized, head-to-head Phase 3 studies continue to be the gold standard in determining the safety and effectiveness of oncology medicines, real-world data help us to continue to evaluate the effectiveness of medicines in real-world clinical settings to complement and validate findings from controlled clinical trials.," Dezzani said.
The results were presented on Tuesday at the European Congress of Oncology Pharmacy in Lisbon, Portugal.
Roughly 300,000 people are diagnosed with prostate cancer each year in the U.S. with approximately 35,000 deaths. Last year 56,000 new cases of mCSPC were identified.
Last year, Erleada generated $2.4 billion in sales, which was lss than half of what Xtandi rolled up.
In 2019 both drugs were approved to treat mCSPC. A year earlier, both gained nods to treat non-metastatic castration-resistant prostate cancer (nmCRPC).
Part of Xtandi’s commercial edge is that it hit the market first in 2012 for late-stage, castration resistant prostate cancer. The FDA also tacked on an approval 11 months ago for Xtandi to be combined with Pfizer’s Talzenna to treat HRR gene-mutated metastatic, castration-resistant prostate cancer.