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J&J's Erleada Meets Both Primary Endpoints in Late-Stage Study

Zacks Equity Research

Johnson & Johnson’s JNJ subsidiary announced the unblinding of a  phase III study evaluating its newly launched prostate cancer drug, Erleada (apalutamide) plus androgen deprivation therapy (ADT) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). 

Erleada is presently marketed in the United States for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. It was approved in EU for the same indication in January 2019.

The phase III TITAN study was unblinded as it met both the primary endpoints, significantly improving radiographic progression-free survival (rPFS) and overall survival (OS). The decision was based on the recommendation of Independent Data Monitoring Committee, which coincided with a pre-planned analysis. Based on the positive data with Erleada, the committee recommended that patients on the placebo plus ADT arm be permitted to cross over to the apalutamide group.

Patients will continue to be followed for OS and long-term safety as part of TITAN. Based on these data, the company plans to file regulatory applications to get approval for Erleada in this expanded patients population in 2019.

J&J stock has declined 2.2% in the past year, against growth of 2.1% recorded by the industry.


Erleada was added to J&J’s portfolio through the August 2012 Aragon acquisition. Also, Erleada’s approval has strengthened J&J’s prostate cancer franchise, especially as generic versions of J&J’s blockbuster prostate cancer drug, Zytiga have been launched by Apotex, Mylan MYL Teva TEVA and Patriot Pharmaceuticals.,

Zacks Rank & Stock to Consider

J&J currently carries a Zacks Rank #3 (Hold).

Another stock worth considering is Eli Lilly and Company LLY carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Lilly’s earnings per share estimates have increased from $5.47 to $5.58 for 2018 and from $5.78 to $5.87 for 2019 in the past 90 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 10.03%.


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