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news.Janssen Pharmaceutical's androgen receptor inhibitor Erleada (apalutamide) succeeded in a phase 3 trial by significantly cutting down the risk of prostate specific antigen (PSA) progression in patients having non-metastatic castration-resistant prostate cancer (nmCRPC).
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The late-stage trial named SPARTAN was held by the Johnson & Johnson (J&J) subsidiary in nmCRPC patients who had a rapidly increasing PSA while receiving continuous androgen deprivation therapy (ADT).
The randomized, double-blind, placebo-controlled, multicenter SPARTAN trial study assessed Erleada in combination with ADT, in comparison to placebo plus ADT.
According to the trial results, the Erleada combination with ADT reduced the risk of PSA progression by 94%, compared with the placebo arm. The primary endpoint of the trial was metastasis-free survival (MFS) which was improved by two years by the Erleada ADT combination.
In addition to that, in the Erleada plus ADT patient arm, the median time to PSA response was 29 days. Janssen Pharmaceutical said that the median PSA decreased by 90% in the Erleada arm at 12 weeks after randomization while the same increased by 40% in the placebo arm.
Janssen research & development vice president and oncology therapeutic area prostate cancer disease area stronghold leader Marco Gottardis said: “The data presented today demonstrated that a shorter PSA doubling time can result in poor outcomes for patients, supporting the benefit of ERLEADA in reducing the risk of PSA progression in patients with non-metastatic castration-resistant prostate cancer.
“Janssen is fully committed to the discovery and development of next-generation treatments and bringing forward data that may help physicians consider treatment options for patients with rapidly rising PSA levels who are at high-risk for metastasis.”
In February, Erleada (apalutamide) was approved by the US Food and Drug Administration (FDA) for the treatment of nmCRPC.
The approval was based on the SPARTAN trial in patients with NM-CRPC in which Erleada was shown to have cut down the risk of distant metastasis or death by 72%.
Image: Johnson & Johnson’s headquarters in New Brunswick, New Jersey. Photo: courtesy of user:ekem/English Wikipedia.
