When hormone therapy significantly increases overall survival…
The arrival of next-generation hormone therapy to treat non-metastatic castration-resistant prostate cancer provides a significant opportunity for men and their families. Non-metastatic castration resistant prostate cancer treatment NUBEQA® (darolutamide) significantly improves overall survival with a favourable safety profile in men with non-metastatic prostate cancer.
MISSISSAUGA, ON, June 16, 2020 – Data from the pre-specified final overall survival (OS) analysis of the Phase III ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) trial has shown NUBEQA® (darolutamide) plus androgen-deprivation therapy (ADT) significantly improves OS and significantly delays the onset of cancer-associated symptoms, with a comparable safety profile to standard treatment with ADT alone, in patients with non-metastatic castration-resistant prostate cancer (nmCRPC). NUBEQA® is an oral non-steroidal androgen receptor (AR) inhibitor therapy, for the treatment of patients with nmCRPC.
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 this analysis.
Highlights of the new and final OS analysis from the ARAMIS trial demonstrated that darolutamide:
- Significantly reduced risk of death by 31 percent (HR=0.69, 95% CI 0.53-0.88; p=0.003) in patients with nmCRPC
- Significantly delayed the time to pain progression, time to first initiation of cytotoxic chemotherapy, and time to first symptomatic skeletal event (SSE)
- Continues to demonstrate a favourable safety profile, with no new safety signals observed, even with a longer treatment duration, allowing men with nmCRPC to maintain their lifestyle quality
NUBEQA® recommended for reimbursement in Canada
In April, both the pan-Canadian Oncology Drug Review (pCODR) and the Institut national d’excellence en santé et en services sociaux (INESSS) issued positive recommendations for the reimbursement of NUBEQA® for the treatment of nmCRPC in patients who are at high risk of developing metastases.[i],[ii]
The recommendations represent an important step in providing access to treatment for patients suffering from nmCRPC.
"The Canadian Cancer Survivor Network is very pleased that NUBEQA® has been recommended for prostate cancer patients,” said Jackie Manthorne, President & CEO of the Canadian Cancer Survivor Network (CCSN). “It is important that patients have access to new treatment options to help fill their unmet needs."
"It is very gratifying to have recognized therapeutic treatments for patients at high risk of developing metastases and who need an alternative treatment, as this particular cancer cannot be cured. A message of hope that offers all prostate cancer victims an improvement in their quality of life”, said Laurent Proulx, president and CEO of PROCURE: The Force Against Prostate Cancer.
“Despite the current context, it is imperative to continue to support these patients and families by offering them treatments that are not only effective but, above all, within reach thanks to public reimbursement. It is essential that we commit to the negotiation process in each province, because the health and well-being of thousands of patients are at stake. On average, 64 Canadians will be diagnosed with prostate cancer every day, and we must do everything we can to give them access to the best care."
NUBEQA® was approved by Health Canada on February 20, 2020.
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Sources and references
Non-metastatic castration resistant prostate cancer treatment NUBEQA® (darolutamide) significantly improves overall survival with a favourable safety profile in men with non-metastatic prostate cancer.
Written by PROCURE. © All rights reserved - 2020