Nubeqa significantly improved overall survival with a favorable safety profile in men with non-metastatic prostate cancer.- Bayer HealthCare

Darolutamide (Nubeqa) from Bayer Healthcare is shown to significantly improve overall survival (OS) and significantly delay the onset of cancer-associated symptoms, while minimizing the toxicity associated with treating men with non-metastatic castration-resistant prostate cancer (nmCRPC). These data from the pre-specified final OS analysis of the Phase III ARAMIS trial will be presented at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program, which takes place from May 29-31, 2020.

Previously published results from the ARAMIS trial demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median of 40.4 months for darolutamide plus androgen deprivation therapy (ADT) compared to 18.4 months for placebo plus ADT (p<0.001); however, OS data were not yet mature at the time of the MFS analysis.

“Men with nmCRPC typically do not have cancer symptoms. In selecting a treatment for these patients, my goal as a clinician is to improve their overall survival while limiting side effects and drug interactions,” said Karim Fizazi, M.D., Ph.D., Professor of Medicine at the Institut Gustave Roussy, Villejuif, France. “These data add to the growing evidence for darolutamide as an effective treatment option with a favorable safety profile that extends patients’ lives and delays cancer symptoms and morbidities, without disrupting their daily activities.”

Final OS Analysis Presented at ASCO Virtual Scientific Program. Men receiving darolutamide plus ADT demonstrated a significant improvement in OS compared to placebo plus ADT, with a 31 percent reduction in risk of death (HR=0.69, 95% CI 0.53-0.88; p=0.003). Darolutamide has a distinct chemical structure and inhibits the growth of prostate cancer cells while limiting the burden of side effects on patients’ everyday lives. With extended follow-up, darolutamide’s safety profile remains favorable, allowing men with nmCRPC to continue their daily lives without disruption. Consistent with the previously reported primary analysis results, darolutamide plus ADT showed a favorable tolerability confirmed by a longer-term safety analysis compared to ADT alone, without clinically relevant increases in rates of hypertension, falls or central nervous system (CNS) effects. In the follow-up analysis of secondary endpoints, all secondary endpoints were statistically significant. Darolutamide plus ADT significantly delayed time to pain progression, time to first initiation of cytotoxic chemotherapy and time to first symptomatic skeletal event (SSE) versus placebo plus ADT.

The ARAMIS trial is a randomized, Phase III, multi-center, double-blind, placebo-controlled trial evaluating the safety and efficacy of oral darolutamide in patients with nmCRPC who are currently being treated with ADT and are at high risk for developing metastatic disease. In the clinical study, 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of darolutamide orally twice daily or placebo along with ADT. Patients with a history of seizure were allowed in the study.