J&J’s Erleada has big shoes to fill, and a tough competitor

• Erleada, a prostate cancer drug from Johnson & Johnson, met the dual primary endpoints of a late-stage study testing it in patients with metastatic, castration-sensitive forms of the disease.
• A pre-planned interim analysis of the study, called TITAN, showed patients taking a combination of Erleada and androgen deprivation therapy (ADT) were living significantly longer without their cancer progressing and without dying than those who were getting ADT plus placebo.
• Investigators unblinded TITAN at the recommendation of an independent data monitoring committee to give participants in the placebo group the opportunity to join the experimental group. J&J said it will continue to evaluate overall survival and long-term safety, and plans to use the study data in an additional regulatory filing for Erleada.

J&J has for years held a dominant position in the prostate cancer therapy market with Zytiga (abiraterone acetate). In 2018 alone the drug raked in $3.5 billion for the big pharma, up nearly 40% from the year prior.

But that growth story won’t last much longer. Generic competition to Zytiga entered the U.S., which accounts for around half of drug’s worldwide sales, during the fourth quarter and has been snagging market share. Between the end of October and Jan. 25, Zytiga’s share of total stateside prescriptions slid from 56% to 31%, according to Iqvia data cited by investment bank Credit Suisse.

On an earnings call earlier this month, J&J noted that Zytiga sales declined 13% in the U.S. over the last quarter because of copycats, leading to a more modest year-over-year growth of 4%.

The situation isn’t entirely dire, however, as both analysts and J&J foresee Erleada (apalutamide) making up for some of Zytiga’s losses.

Though Erleada sales haven’t been astronomical since it came to market almost a year ago, the expectation is that it will be a key growth driver moving forward. The drug carries an approval for prostate cancer that hasn’t spread yet and continues to grow in spite of hormone therapy. With supportive data from TITAN, that label may soon expand.

Erleada’s path forward does face at least one challenge. Astellas and Pfizer’s Xtandi (enzalutamide) has since 2012 been approved for metastatic castration-resistant prostate cancer.

Last July, Xtandi received a label expansion of its own, making it the only oral medication available for both metastatic and non-metastatic prostate cancer. And in December it hit the primary endpoint of a Phase 3 study assessing the drug plus ADT in men with metastatic, hormone-sensitive prostate cancer — a market Pfizer claims sees 38,000 new patients annually.

Pfizer noted on its own January earnings call that six months after gaining an approval in the non-metastatic, castrate-resistant setting, Xtandi’s market share was quadruple that of Erleada’s. Newly minted CEO Albert Bourla said his company remains “focused on demonstrating the value of moving Xtandi into earlier treatment settings” and expects the drug to be “one of the pillars of our oncology portfolio for years to come.”

Xtandi has already demonstrated its value to Pfizer’s top line, as the big pharma recorded $699 million of revenue from the drug during 2018, up from $590 million in 2017.

J&J, meanwhile, contends it can grow market share for Erleada.

Joseph Wolk, the big pharma’s chief financial officer, said on the Jan. 22 earnings call that J&J will continue to mold its payer strategies to best convey the benefits of its products.

“We’ll continue to change our contracting with the landscape,” Wolk said. “We do have some outcomes-based pilots out there that are across a number of therapeutic areas. We think that’s a way that could potentially be a long-term solution.”

https://www.biopharmadive.com/news/johnson-erleada-titan-prostate-cancer-xtandi-zytiga/547313/