BARCELONA—Johnson & Johnson may not have technically shown yet that Erleada can extend the lives of patients with nonmetastatic castration-resistant prostate cancer. But the company still thinks its latest batch of data will give doctors a confidence boost when it comes to prescribing the med.
Friday at the European Society for Medical Oncology annual meeting, the company rolled out survival results showing that using Erleada (apalutamide) alongside androgen deprivation therapy (ADT) cut patients’ risk of death by 25% compared with a combination of ADT plus placebo. The thing is, that benefit wasn’t a statistically significant one.
As Mark Wildgust, Ph.D., VP of global medical affairs for oncology at J&J’s Janssen unit, was quick to point out, Erleada “barely missed” the threshold for statistical significance—the difference-makers were “just a couple of events on either side, really,” he said.
And because patients were allowed to cross over from placebo to Erleada treatment once the trial was unblinded, the placebo arm got a boost. “The placebo arm is no longer just placebo. It’s actually placebo plus apalutamide,” Wildgust said.
With those facts in mind, he doesn’t expect that miss to discourage prescribers; on the contrary, “I think this will greatly reassure” physicians that “treating early with apalutamide provides patients with meaningful benefit,” he said.
In February 2018, Erleada became the first drug ever to snag an FDA approval in nonmetastatic castration-resistant prostate cancer. It did so on the back of data showing it could ward off cancer metastases for 40.5 months, compared with just 16.2 months for placebo.
But for cancer drugmakers, the ultimate goal is to show their treatments can lengthen patients’ lives, which was the goal with this interim look-in—the second from that trial, which is called Spartan. The analysis came at the 41-month mark after treatment, doubling the follow-up from the last analysis, done at 20 months.
“In a new area, you want to look at long-term follow-up and you want to look at data like this,” Wildgust said.
So while J&J is pleased with current results, it’ll be looking to pass the statistical significance bar at the third and final check—something it thinks Erleada can do, if its experience with predecessor drug Zytiga is any indication.
With the elder prostate cancer therapy, “it was really the final analysis that … reached that very high bar of statistical significance,” he said. And with Erleada, “at the final analysis, we will hopefully see that.”
In the meantime, Erleada is now battling back another competitor in the indication in Pfizer and Astellas' Xtandi. As the chief rival to Zytiga, it's a familiar foe for the New Jersey drugmaker—and one Pfizer execs say is dominating the field.