Business Wire

Updated Results of the SPARTAN Study Show 25 Percent Reduction in the Risk of Death in Patients With Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC) Treated with ERLEADA® (apalutamide)

Share

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced updated, longer-term results from the pivotal Phase 3 SPARTAN study following a second interim analysis. Treatment with ERLEADA® (apalutamide) plus androgen deprivation therapy (ADT) in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were at high-risk of developing metastases, resulted in a 25 percent reduction in the risk of death compared with placebo plus ADT [HR=0.75; 95 percent CI, 0.59–0.96; p=0.0197 (to reach statistical significance, a p-value of p<0.0121 needed to be observed)].1,2

The updated findings showed overall survival (OS) results supported the first interim analysis, despite a crossover of placebo patients to the apalutamide treatment group.1,2 Results were presented in an oral session at the 2019 European Society for Medical Oncology (ESMO) Annual Congress (abstract #843O), and simultaneously published in Annals of Oncology.

At the second interim analysis, a longer median follow-up of 41 months, four-year OS rates were 72.1 percent for patients treated with apalutamide and 64.7 percent for patients treated with placebo.1,2 The OS benefit of apalutamide was consistent across baseline subgroups, such as race, prior treatments, baseline PSA and performance status.1,2

This interim analysis took place when 67 percent of the required OS events had been observed, compared with the original report when only 24 percent of required OS events had occurred (HR=0.70; 95 percent CI, 0.47–1.04; p=0.07).1,2 After unblinding the study, and prior to the second interim analysis, 76 non-progressing patients in the placebo group (19 percent of all placebo patients) crossed over to open-label apalutamide for an average of 15 months; the OS rates in the placebo group included those patients who were crossed over to apalutamide treatment, thereby underestimating the true treatment effect.1,2 The rates of treatment-emergent adverse events for apalutamide at the second interim analysis were consistent with rates previously reported.1,2 In the SPARTAN study, the most common adverse events (≥10 percent) were fatigue, hypertension, rash, diarrhea, nausea, weight decreased, arthralgia, falls, hot flush, decreased appetite, fracture and peripheral edema.3

“The data presented at ESMO 2019 add to the growing body of evidence demonstrating a trend for survival benefit achieved by apalutamide in patients with high-risk nmCRPC. This interim analysis for survival is in line with the initial data presented for all androgen signaling inhibitors in this disease setting. Hence all data presented to date reinforce the benefit of treating men with non-metastatic (by conventional imaging) castration-resistant prostate cancer,” said Dr Eleni Efstathiou, MD, PhD, Associate Professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, U.S. “For nmCRPC patients who remain at risk of their cancer spreading, and the clinicians that treat them, these data are very encouraging as they show the potential of this treatment in improving survival rates and slowing progression to a fatal stage of the disease – the ultimate goal when treating this population.”

Initial results from the SPARTAN trial were presented at the 2018 American Society of Clinical Oncology Genitourinary Annual Meeting Cancers Symposium (ASCO GU), and simultaneously published in The New England Journal of Medicine.4,5

“Despite many advances in the treatment of prostate cancer in recent years, there remains a high unmet need, particularly in the treatment of those patients who are at risk of their disease progressing to the most advanced form; the metastatic disease stage,” said Dr Joaquín Casariego, Janssen Therapeutic Area Lead Oncology for Europe, Middle East & Africa, Janssen-Cilag S.A.. “We are very excited to share these new data from the SPARTAN trial, which reinforces the importance of apalutamide as a treatment option for patients with high-risk nmCRPC, for whom delaying the onset of metastases becomes a crucial objective in their disease journey. We will persist in our efforts to improve outcomes for patients through our robust research programme and remain committed to achieving our goal of making prostate cancer a manageable or even a curable disease.”

-ENDS-

About the SPARTAN study

SPARTAN (NCT01946204) was a Phase 3, randomised, double-blind, placebo-controlled, multicentre study that evaluated ERLEADA® (apalutamide) in combination with ADT in patients with high-risk nmCRPC with a rapidly rising PSA (PSA Doubling Time ≤10 months).4 The SPARTAN study enrolled 1,207 patients who were randomised 2:1 to receive either apalutamide orally at a dose of 240 mg once daily in combination with ADT (n=806) or placebo once daily in combination with ADT (n=401).4 Study results were initially reported at the 2018 ASCO Genitourinary Cancers Symposium and published in The New England Journal of Medicine.4,5

In the SPARTAN study, the most common adverse reactions (≥10 percent) were fatigue, hypertension, rash, diarrhea, nausea, decreased weight, arthralgia, falls, hot flushes, decreased appetite, bone fractures and peripheral edema.1

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 treatments that lower testosterone but has not yet been discovered in other parts of the body using a total body bone scan and CT/MRI scan.6 Features include: lack of detectable metastatic disease; rapidly rising prostate-specific antigen while on ADT with serum testosterone level below 50 ng/dL.7,8 Ninety percent of patients with nmCRPC will eventually develop metastases, which can lead to pain, fractures and other symptoms.9 The relative five-year survival rate for patients diagnosed at a distant-stage prostate cancer is 30 percent.10 It is critical to delay the development of metastasis in patients with nmCRPC.

About ERLEADA ® (apalutamide)

ERLEADA® (apalutamide) is an androgen receptor (AR) inhibitor indicated for use in Europe for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.3 In the U.S. apalutamide is indicated for the treatment of nmCRPC and metastatic castration-sensitive prostate cancer.11 Apalutamide is currently under review by the European Medicines Agency (EMA) for the treatment of metastatic hormone-sensitive prostate cancer.12

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at www.janssen.com/emea. Follow us at www.twitter.com/janssenEMEA for our latest news. Janssen-Cilag S.A., Janssen R&D, LLC and Janssen Biotech are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

References

1 Smith, M, et al. Apalutamide and Overall Survival in Patients with Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC): Updated Results from the Phase 3 SPARTAN Study. Annals of Oncology (2019) 30 (suppl_5): v325-v355. 10.1093/annonc/mdz248. Accessed September 2019.

2 Smith, M, et al. Apalutamide and Overall Survival in Patients with Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC): Updated Results from the Phase 3 SPARTAN Study. 2019 European Society for Medical Oncology. Abstract #843O.

3 European Medicines Agency. Erleada. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/erleada#authorisation-details-section. Accessed September 2019.

4 Smith, M, et al. Apalutamide Treatment and Metastasis-Free Survival in Prostate Cancer. N Engl J Med. 2018; 378:1408–1418. Accessed September 2019.

5 Small E., et al. SPARTAN, a phase 3 double-blind, randomized study of apalutamide (APA) vs placebo (PBO) in patients (pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC). 2018 Genitourinary Cancers Symposium. Abstract #161.

6 Scher HI, et al. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol. 2008;26:1148–1159. Accessed September 2019.

7 Scher HI, et al. Trial Design and Objectives for Castration-Resistant Prostate Cancer: Updated Recommendations From the Prostate Cancer Clinical Trials Working Group 3. J Clin Oncol. 2016;34:1402–1418. Accessed September 2019.

8 Virgo K, et al. Second-Line Hormonal Therapy for Men with Chemotherapy-Naïve, Castration-Resistant Prostate Cancer: American Society of Clinical Oncology Provisional Clinical Opinion. J Clin Oncol. 2017; 0732-183X/17/3599-1. Accessed September 2019.

9 Saad F, et al. The 2015 CUA0CUOG guidelines for the management of castration-resistant prostate cancer (CRPC). Can Urol Assoc J. 2015;9(3–4):90–96. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4455631/. Accessed September 2019.

10 American Cancer Society. Cancer Facts & Figures. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2018/cancer-facts-and-figures-2018.pdf. Accessed September 2019.

11 ERLEADA product information Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210951s000lbl.pdf. Accessed September 2019.

12 Janssen. Janssen Seeks to Expand Use of ERLEADA® (apalutamide) in the Treatment of Patients with Metastatic Hormone-Sensitive Prostate Cancer. Available at: https://www.janssen.com/emea/sites/www_janssen_com_emea/files/final_approved_erleada_ema_filing_press_release_20190604.pdf Accessed September 2019.

EM-18996

Contact information

Media Enquiries:
Laura Coughlan
Phone: +353 87 147 9356
Investor Relations:
Christopher DelOrefice
Phone: +1 732 524 2955
Lesley Fishman
Phone: +1 732 524 3922

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

bitFlyer Europe and Quazard Partner to Bring First Ever Trading Competition to Botwars Ultimate Trading1.6.2020 06:00:00 CESTPress release

Leading cryptocurrency exchange bitFlyer, is partnering with crypto-trading game developer Quazard, to bring the first ever gamified trading competition to the Botwars Ultimate Trading universe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200531005005/en/ bitFlyer and Quazard bring the first gamified trading competition to the Botwars Ultimate Trading universe (Graphic: Business Wire) The competition, which launches today, allows Botwars players to compete in a free to enter crypto-trading simulator to win real Bitcoin. This is the first trading competition to launch on Botwars, and the only live trading competition of its type. In Botwars Ultimate Trading, players need to build an army of trading robots (each representing a trade) and lead them into battle to conquer the cryptocurrency markets. Botwars is a real-time, gamified currency trading experience where you will learn new trading skills, unlock powerful new tradin

Celltrion Announces Positive Pre-clinical Results for COVID- 19 Antiviral Antibody Treatment, Showing Improvement in Recovery Time1.6.2020 03:00:00 CESTPress release

Celltrion Group today announced positive pre-clinical results for its COVID-19 antiviral antibody treatment, with data demonstrating a 100-fold reduction in the viral load of SARS-CoV-2, the virus causing COVID-19. The treatment was also able to show improvement in lung lesions to a normal activity level in animal models. The pre-clinical study was conducted in an animal model in collaboration with one of the Korean National Universities, Chungbuk National University College of Medicine. The trial set out to assess the efficacy of two dosage amounts (low and high) for the antiviral antibody treatment. In comparison to the placebo-controlled group, the research team observed improved recovery in terms of clinical symptom scores such as runny nose, cough and body aches, after the first day of treatment. From the fifth day, significant clinical remission was observed. Reverse transcriptase polymerase chain reaction (RT-PCR) measurement and cell culture-based viral diagnosis were used to a

Idriverplus Joins the “Automate with Velodyne” Ecosystem29.5.2020 20:31:00 CESTPress release

Velodyne Lidar, Inc. and Idriverplus today announced an expanded partnership and Idriverplus inclusion into the Automated with Velodyne integrator ecosystem, which helps companies grow their businesses while using Velodyne lidar technology. Through the program, Velodyne will further collaborate with Idriverplus to support its continued innovation and promote Idriverplus autonomous vehicles, including street cleaners, passenger cars and logistics vehicles. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200529005589/en/ Velodyne Lidar, Inc. and Idriverplus announced an expanded partnership and Idriverplus inclusion into the Automated with Velodyne integrator ecosystem, which helps companies grow their businesses while using Velodyne lidar technology. (Photo: Velodyne Lidar) Recently, Velodyne signed a multi-year sales agreement with Idriverplus to provide Puck™ sensors for the mass production of autonomous vehicles. Idriverplu

Takeda Announces Compelling Data from the Phase 2 Trial of Pevonedistat Plus Azacitidine in Patients with Higher-Risk MDS29.5.2020 14:00:00 CESTPress release

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced the results of the Phase 2 Pevonedistat-2001 trial will be presented during oral sessions at the virtual 56thAmerican Society of Clinical Oncology (ASCO) Annual Meeting and the virtual 25thEuropean Hematology Association (EHA) Annual Meeting. The study evaluated pevonedistat plus azacitidine versus azacitidine alone in patients with rare leukemias, including higher-risk myelodysplastic syndromes (HR-MDS). These results show that the combination of pevonedistat and azacitidine is a highly active, promising therapeutic approach and suggest benefit in the HR-MDS subgroup across multiple clinically meaningful endpoints, including overall survival (OS), event-free survival (EFS), complete remission (CR) and transfusion independence, with a safety profile similar to azacitidine alone. The Pevonedistat-2001 trial was designed as a proof-of-concept study in patients with HR-MDS, higher-risk chronic myelomonocytic leukemi

Interim Data from the Open Label Phase 2 OPTIC Study of Iclusig ® (ponatinib) for Chronic Phase-CML Presented at the ASCO and EHA Virtual Meetings29.5.2020 14:00:00 CESTPress release

Incyte (Nasdaq:INCY) today announced that data from the interim analysis of the Phase 2 OPTIC (Optimizing Ponatinib Treatment In CML) trial, which was sponsored by Takeda and co-funded by Incyte, will be presented during an oral session at the upcoming 2020 American Society of Clinical Oncology Virtual Meeting (ASCO20; May 29 – May 31) (Abstract #7502)1; and at the virtual 25th Congress of the European Hematology Association (EHA25; June 11 – 14) (Abstract #S172)2. The OPTIC trial is an ongoing randomized, open-label study prospectively evaluating response-based dosing regimens of Iclusig® (ponatinib) over a range of three starting doses (45 mg, 30 mg, 15 mg) with the aim of optimizing its efficacy and safety in patients with chronic-phase chronic myeloid leukemia (CP-CML), who are resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy. With a median follow up of approximately 21 months, data from the interim analysis of the OPTIC trial show that the optimal benefit-r

Takeda Receives Positive CHMP Opinion for Pre-Filled Syringe Presentation of TAKHZYRO ® (lanadelumab) for Use as a Preventive Treatment for Hereditary Angioedema Attacks29.5.2020 14:00:00 CESTPress release

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on a Type II Variation regulatory application and recommended the approval of a pre-filled syringe presentation of TAKHZYRO® (lanadelumab). TAKHZYRO is a subcutaneous injectable prescription medication approved in Europe for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older. HAE is a rare genetic disorder that results in recurrent attacks of oedema – swelling – in various parts of the body, including the abdomen, face, feet, genitals, hands and throat.1,2,3 “Our goal is to continuously innovate in all areas of HAE management,” said Isabel Kalofonos, Global Product Strategy Lead, HAE, Takeda. “This positive opinion marks another important step forward as we aim to enhance the experience of treatment administration for peo