ASCO: J&J pads case for new Erleada use with prostate cancer survival data

The FDA recently accepted Johnson & Johnson's Erleada filing under its Real-Time Oncology Review program. (J&J)

CHICAGO—Johnson & Johnson’s Erleada may be the follow-up to blockbuster Zytiga, but it’s also ready to go where its predecessor hasn’t gone before.

Friday at the American Society of Clinical Oncology annual meeting, the New Jersey drugmaker rolled out results showing that adding Erleada to androgen deprivation therapy (ADT) cut the risk of death by 33% compared with a placebo-ADT combo in men with metastatic castration-sensitive prostate cancer (mCSPC).

RELATED: Johnson & Johnson's Erleada trial stops early on good news, setting up case for new prostate cancer nod

Another thing that’s impressive about the data shows up when they are plotted onto a chart. According to Mark Wildgust, vice president of global medical affairs for oncology at J&J’s Janssen, “You see the survival curves split very early … at about eight months, which shows you that these men are getting benefit immediately” from adding Erleada.

Importantly, the study—dubbed Titan—enrolled a broad patient pool, unlike other trials that have shown overall survival benefits only in subgroups of men with mCSPC. It’s the first trial to demonstrate that a drug can prolong patients' lives “in this kind of all-comer, broad patient population,” Wildgust noted.

And the way he sees it, that could ultimately lead to an advantage for Erleada, known generically as apalutamide, when it comes to doctors' decision-making.  

“This is simple. Every man who has metastatic prostate cancer, whether they had surgery, radiation, some ADT, maybe some docetaxel—when you give them apalutamide, they live longer. It makes it unique, and it makes it easy for clinicians,” he said.

In that sense, Erleada could eclipse Zytiga, which is restricted to high-risk patients. J&J, for its part, certainly wouldn’t mind, what with Zytiga now facing generic rivals; that drug brought in $3.5 billion last year, but its first-quarter 2019 sales stalled in the U.S. as copycats hit the scene.

Erleada, meanwhile, is coming up against stiff competition in its only approved indication—nonmetastatic castration-resistant prostate cancer—from Pfizer and Astellas’ Xtandi.

RELATED: J&J eyes prostate cancer boost as FDA accepts Erleada for real-time review

And of course, Erleada will first need the FDA’s favor in mCSPC before it can start kicking in additional sales. But that could come sooner rather than later, thanks to Erleada’s recent acceptance under the agency’s new Real-Time Oncology Review program that allows regulators to begin going through data before a company officially submits its complete application.