Last September, Johnson & Johnson said prostate cancer med Erleada had “barely missed” showing it could extend the lives of patients with nonmetastatic castration-resistant disease. But it’s now crossed that threshold.
A combination of Erleada (apalutamide) and androgen deprivation therapy (ADT) slashed patients’ risk of death by 22% compared with a combination of ADT plus placebo, J&J said ahead of the American Society of Clinical Oncology virtual annual meeting.
Those on the Erleada regimen lived a median 73.9 months—more than six years—versus the 59.9 months seen among those in the placebo group, marking a 14-month improvement.
What’s more, researchers measured that Erleada benefit despite nearly one-fifth of patients—19%—crossing over to the Erleada arm.
When adjusting for crossover, J&J found a 21-month difference in survival, with patients who stayed on ADT alone living just over four years compared with the more than six years Erleada patients saw, said Mark Wildgust, Ph.D., vice president of global medical affairs for oncology at J&J’s Janssen unit.
"It really does point to the fact that you've got to start early in these patients … You can't wait. If you give them ADT and wait to give them something afterward, these patients never catch up," he said.
The results should "create a confidence" among prescribers, Wildgust said. Erleada had already shown it could keep cancer metastases at bay for 40.5 months, compared with just 16.2 months for placebo, and on that data it snagged the FDA’s first green light in nonmetastatic castration-resistant prostate cancer (nmCRPC) back in February 2018. But in oncology, overall survival results are generally considered the gold standard.
"I think it's simple: You can use apalutamide and know that you're going to improve survival, and I think the data also speaks to this kind of urgency to how we treat patients in this setting," Wildgust said, adding that "ADT is not enough."
There’s just one hitch: Erleada won’t be alone in bearing that gold standard. The drug’s archrival, Pfizer and Astellas’ Xtandi, also unveiled overall survival data Wednesday showing it, too, could extend lives in the nmCRPC population, reducing patients’ risk of death by 27%.
Erleada has been duking it out in the field against Xtandi since the heavyweight drug, previously the nemesis of Erleada’s predecessor Zytiga, won a July 2018 nmCRPC approval. But last month, Chris DelOrefice, J&J’s VP of investor relations, said the New Jersey pharma giant was “pleased” with Erleada’s launch progress, which amounted to $143 million in first-quarter sales across the drug’s two indications.