J&J decides against Erleada+Zytiga combination prostate cancer filing

Johnson & Johnson won’t be filing a prostate cancer therapy combining its Erleada and Zytiga drugs with regulators, after a phase 3 trial showed it didn’t improve survival compared with Zytiga alone.

Zytiga is the older of the two drugs and was used in the active control arm of the ACIS study, which tested the combination of Erleada (apalutamide) and Zytiga (abiraterone) in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC).

Erleada is an androgen receptor inhibitor and is intended to counter the threat of Zytiga generics and competition from Astellas and Pfizer’s arch-rival Xtandi (enzalutamide), which has been on the market since 2012.

J&J made the announcement ahead of first quarter results showing a strong performance from Erleada in Q1, with sales growing 44% to $171m compared with corresponding quarter last year.

But Zytiga has been almost wiped out by generic competition, with the former blockbuster producing revenues of $50m, down 64% compared with the last Q1 and a fraction of the $755 million reported in the final quarter of 2018,.

Results announced at the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium in February showed ACIS met its main goal of radiographic progression-free survival (rPFS).

While this showed the combination was better at halting the progression of disease it did not show a significant benefit over Zytiga alone in secondary goals including overall survival.

J&J’s Janssen pharma unit had hoped that the combination would have expanded the use of Erleada, which is FDA-approved in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and for metastatic castration-sensitive prostate cancer (mCSPC).

While the outcome is a disappointment, Janssen said data from patient subgroups with luminal type in a PAM50 test, and tumours with average or high androgen receptor activity, warrant further investigation.

J&J reported Q1 sales of $22.3 billion, up 7.9%, with net earnings increasing 6.9% to just under $6.2 billion. Its pharma business saw sales increase by a reported 9.6% to nearly $12.2 billion