Janssen's new treatment for prostate cancer receives European licence
- Prostate cancer is the most common cancer in men in the UK,[i] resulting in over 47,000 diagnoses each year, or 129 each day[ii]
- Every 45 minutes, one man dies from prostate cancer, totalling more than 11,000 deaths each year2
- Erleada™ (apalutamide) offers a new treatment option for men with non-metastatic castration-resistant prostate cancer who are at high risk of metastatic disease[iii]
High Wycombe, 17th January 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson has today announced that the European Commission (EC) has licensed Erleada (apalutamide), for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.
Today’s licence is based on the results of the phase III SPARTAN trial, which found that apalutamide in combination with Androgen Deprivation Therapy (ADT) significantly decreased risk of death or distant metastasis by 72 percent, compared to ADT alone.3 It was also found to improve median metastasis-free survival (MFS) by over three years (40.5 months) compared to just over one year (16.2 months) in the placebo group.3
The most common Grade 3/4 treatment-emergent adverse events in the SPARTAN study were hypertension (14.3 percent vs. 11.8 percent), rash (5.2 percent vs. 0.3 percent), fall (1.7 percent vs. 0.8 percent) and fracture (2.7 percent vs. 0.8 percent).3 Treatment discontinuation due to adverse events was 10.6 percent in the apalutamide arm compared to 7 percent in the placebo arm.3 Rates of serious adverse events were similar in the apalutamide in combination with ADT arm versus placebo in combination with ADT arm (24.8 percent vs. 23.1 percent respectively).3
Prostate cancer is the most common cancer diagnosed in males in England,[iv] and approximately 84 percent (34,010 people) of those diagnosed suffer from the non-metastatic form of the disease, meaning that the cancer has not spread to other parts of the body (for example, the bones).[v] If the disease is castration-resistant, it no longer responds to medical or surgical treatments that lower testosterone.[vi] 90 percent of patients with nmCRPC will eventually develop bone metastases,7 which is a turning point in prostate cancer, as it is a key cause of complications and death.3 Extending the period without metastases is therefore an important treatment goal.3,[vii],[viii]
Commenting on the EC licence, Dr Simon Chowdhury, Consultant Medical Oncologist, Guy's and St Thomas' Hospitals, said: “Apalutamide is one of the first treatments shown to be effective in this group of patients, as phase 3 clinical data demonstrated that it significantly prolonged the time that patients with non-metastatic castration-resistant prostate cancer survived without their cancer becoming metastatic (spreading to other sites in their bodies).”
“We are pleased that the EC has authorised apalutamide for the treatment of patients with high-risk non-metastatic castration-resistant prostate cancer.” said Mohamed Lockhat, Therapeutic Area Medical Affairs Director for Oncology at Janssen UK. “At Janssen, we remain committed to our goal of developing and delivering innovative medicines that transform patients’ lives, and today’s approval brings us one step closer to achieving this.”
About Non-Metastatic Castration-Resistant Prostate Cancer
Non-metastatic castration-resistant prostate cancer (nmCRPC) refers to a disease stage when the cancer no longer responds to medical or surgical treatments that lower testosterone, but has not yet been discovered in other parts of the body using a bone scan or CT scan.[ix] Features include: lack of detectable metastatic disease; rapidly rising prostate-specific antigen while on androgen deprivation therapy (ADT) and serum testosterone level below 50 ng/dLa.9 90 percent of patients with non-metastatic CRPC will eventually develop bone metastases, which can lead to pain, fractures and spinal cord compression.[x] The relative 5-year survival rate for patients with distant stage prostate cancer (prostate cancer that has spread to distant lymph nodes, bones or other organs) is 28 percent.[xi]
Apalutamide is a next-generation oral androgen receptor (AR) inhibitor that blocks the androgen signaling pathway in prostate cancer cells. Apalutamide inhibits the growth of cancer cells in three ways: by preventing the binding of androgen to the AR; by stopping the AR from entering the cancer cells; and by preventing the AR from binding to the DNA of the cancer cell.[xii]
Janssen submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) in February 2018 seeking approval for apalutamide for the treatment of patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). In November 2018, the EMA’s human medicines committee (CHMP) issued a positive opinion, recommending apalutamide’s authorisation.[xiii]
Apalutamide received authorisation from the United States Food and Drug Administration for the treatment of patients with nmCRPC in February 2018.[xiv]
About the SPARTAN Phase 3 clinical study
The SPARTAN clinical study showed that apalutamide, when added to ADT, significantly reduced the risk of developing distant metastasis or death (metastasis free survival [MFS]) by 72 percent, compared to placebo in combination with ADT (hazard ratio [HR] = 0.28; 95% CI, 0.23-0.35; P < 0.001). The median MFS was improved by over two years (40.5 months vs 16.2 months) in patients with nmCRPC with a PSA doubling time of less or equal to 10 months.3
The most common Grade 3/4 treatment-emergent adverse events in the SPARTAN study comparing APA+ADT vs the placebo (PBO)+ADT were hypertension (14.3 percent vs. 11.8 percent), rash (5.2 percent vs. 0.3 percent), fall (1.7 percent vs. 0.8 percent) and fracture (2.7 percent vs. 0.8 percent).3 This study was published in The New England Journal of Medicine.3
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.co.uk. Follow us at www.twitter.com/JanssenUK.
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[i] Cancer Research UK. Prostate cancer incidence. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/prostate-cancer#heading-Zero. Last accessed January 2019.
[ii] PCUK. About Prostate Cancer. Available at: https://prostatecanceruk.org/prostate-information/about-prostate-cancer. Last accessed January 2019.
[iii] Smith, R. M. et al. Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl J Med 2018; 378:1408-1418. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa1715546?query=featured_home. Last accessed January 2019.
[iv] Office for National Statistics (2018) Cancer registration statistics, England, 2016. Available at: https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/conditionsanddiseases/bulletins/cancerregistrationstatisticsengland/final2016#breast-prostate-lung-and-colorectal-cancers-continue-to-be-the-most-common Last accessed January 2019.
[v] National Prostate Cancer Audit. Annual Report 2017. Available at: https://www.npca.org.uk/content/uploads/2018/02/NPCA-2017-Annual-Report_final_211117.pdf. Last accessed January 2019.
[vi] Saad. F. Guidelines for the management of castrate-resistant prostate cancer. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2997826/ Last accessed January 2019.
[vii] Hotte SJ, Saad F. Current management of castrate-resistant prostate cancer. Curr Oncol. 2010; 17(Suppl 2): S72–S79. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2935714/. Last accessed January 2019.
[viii] Coleman RE. Clinical Features of Metastatic Bone Disease and Risk of Skeletal Morbidity. Clin Cancer Res. Available at: http://clincancerres.aacrjournals.org/content/12/20/6243s.long. Last accessed December 2018.
[ix] Luo J., et al. Treatment of Non-metastatic Castration-Resistant Prostate Cancer. Oncology. 2016;30(4):336–344.
[x] Hong JH, Kim IY. Non-metastatic Castration-Resistant Prostate Cancer. Korean J Urol. 2014 Mar;55(3):153-60. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3956942/. Last accessed January 2019.
[xi] American Cancer Society. Survival Rates for Prostate Cancer. January 2019.
[xii] Clegg NJ, et al. ARN-509: a novel antiandrogen for prostate cancer treatment. Cancer Res. 2012;72:1494-1503.
[xiii] European Medicines Agency. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2018. Available at: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-12-15-november-2018. Last accessed January 2019.
[xiv] FDA. FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint. Available at https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm596768.htm. Last accessed January 2019.