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

Erleada
Johnson & Johnson plans to file for an Erleada approval in mCSPC this year. (Johnson & Johnson)

Johnson & Johnson is counting on Erleada to carry the prostate cancer baton as Zytiga battles generics. And it just got one step closer to a new indication.

Wednesday, the New Jersey drugmaker said investigators had cut short a phase 3 study of Erleada in combination with androgen deprivation therapy in patients with metastatic, castration-sensitive prostate cancer (mCSPC) after the combo showed it could significantly stave off disease progression and extend patients’ lives. Based on the results, an independent data monitoring committee recommended placebo-plus-ADT patients switch over into the Erleada group.

Now, the pharma giant will submit those results for presentation at an upcoming medical meeting, and in the meantime, it’s planning to file for approval in mCSPC this year, it said.

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RELATED: Pfizer's Xtandi blows by Johnson & Johnson's Erleada with hot start in new prostate cancer field

A green light for Erleada would add to its first indication, a nod in nonmetastatic castration-resistant prostate cancer that brought it to the market last February. There, it’s battling Pfizer and Astellas’ Xtandi—also known as Zytiga’s longtime nemesis—which picked up its own go-ahead in July. Despite Erleada’s head start, Xtandi has a sizeable lead in the market, Pfizer said this week, pegging Xtandi’s share at quadruple Erleada’s.

A new approval would also bring in patients from the castration-sensitive group who aren’t currently eligible for Zytiga. The elder drug is OK’d only in high-risk patients, while Erleada’s newest data applies to a broader patient pool.

All in all, analysts expect Erleada to eventually cross the blockbuster barrier but not to show up its predecessor. Barclays analyst Geoff Meacham has projected $1.3 billion in peak sales, which is less than half of the $2.71 billion Zytiga pulled in over the first nine months of 2018.

RELATED: FDA gives Johnson & Johnson's Erleada a quick push over the finish line with first-ever nonmetastatic prostate cancer nod

Meanwhile, looking to dodge the impact of Zytiga generics on Xtandi’s original market—metastatic castration-resistant prostate cancer—Pfizer and Astellas are going after new indications, too. Executives are looking ahead to two key trials in hormone-sensitive prostate cancer, a market Angela Hwang, president of Pfizer’s biopharmaceuticals group, called the one “we’re really excited about.”

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