Janssen Submits Marketing Authorisation Application for Apalutamide to Treat Patients with High-Risk Non-Metastatic Castration-Resistant Prostate Cancer
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that it has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) for apalutamide, an investigational, next generation oral androgen receptor (AR) inhibitor for the treatment of patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC).
The submission is based on data from the pivotal SPARTAN Phase 3 clinical trial which assessed the safety and efficacy of apalutamide versus placebo in men with nmCRPC who have a rapidly rising prostate specific antigen (PSA) level, despite receiving continuous androgen deprivation therapy (ADT). The SPARTAN clinical trial showed a significantly decreased risk of distant metastasis or death (definition of the primary endpoint, metastasis free survival) by 72 percent, compared to placebo in combination with ADT (HR = 0.28; 95% CI, 0.23-0.35; P < 0.0001) and improved median metastasis-free survival (MFS) by over two years (difference of 24.3 months) in patients with nmCRPC whose PSA is rapidly rising. The results were presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in San Francisco (Abstract 161). Study findings were simultaneously published in The New England Journal of Medicine.
“The results of the SPARTAN trial are the first to show that metastases can be delayed in patients with castration-resistant prostate cancer, suggesting that apalutamide could become a new standard of care for patients with high-risk non-metastatic CRPC,” said Dr Simon Chowdhury, Consultant Medical Oncologist, Guy's and St Thomas' Hospitals, and a SPARTAN study investigator.
SPARTAN, a Phase 3, randomised, double-blind, placebo-controlled, multicenter study, enrolled 1,207 patients with non-metastatic castration-resistant prostate cancer and was conducted at 332 sites in 26 countries in North America, Europe, Asia-Pacific and Australia. Patients were randomised 2:1 to receive apalutamide in combination with androgen deprivation therapy (ADT) (n = 806), or placebo in combination with ADT (n = 401).
Apalutamide in combination with ADT decreased the risk of distant metastasis or death by 72 percent, compared to placebo in combination with ADT (HR = 0.28; 95% CI, 0.23-0.35; P < 0.0001).1 The median MFS was 40.5 months for apalutamide in combination with ADT compared to 16.2 months for placebo in combination with ADT, prolonging MFS by over two years. MFS benefit was consistently seen across all subgroups of patients.1
“At Janssen we are committed to transforming prostate cancer management. By treating earlier and delaying the cancer from spreading we aim to improve outcomes for patients with this devastating disease,” said Dr Ivo Winiger-Candolfi, Oncology Solid Tumor Therapy Area Lead, Janssen-Cilag International NV. “We look forward to working with the European Medicines Agency to bring this potential new treatment option to patients in the European Union as soon as possible.”
“Delaying prostate cancer from metastasising is critical. Once the cancer starts to spread, a patient’s overall health, well-being and prognosis change drastically,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head of Oncology at Janssen Research & Development, LLC. “It’s exciting to see apalutamide data at ASCO GU and these strong results truly underscore Janssen’s commitment to addressing unmet needs for treatment across all stages of disease progression.”
In addition to significantly improving metastasis free survival, apalutamide in combination with ADT, compared to placebo in combination with ADT, demonstrated clinical improvement across all secondary endpoints, with statistically significant improvements in time to metastasis (TTM; median of 40.5 months in the apalutamide arm compared to median of 16.6 months in the placebo arm) and progression-free survival (PFS; median of 40.5 months compared to median of 14.7 months in the placebo arm). Treatment with apalutamide significantly decreased the risk of symptomatic progression by 55 percent compared with placebo (HR = 0.447; 95% CI: 0.315, 0.634; P <0.0001). Apalutamide was associated with a 30 percent risk reduction of death compared to placebo at this early interim analysis for overall survival (OS) (HR = 0.70; P = 0.07).1 In exploratory endpoints, apalutamide in combination with ADT, compared to placebo in combination with ADT, also achieved a 94 percent risk reduction in time to PSA progression (HR = 0.06; 95% CI, 0.05-0.08; P <0.0001), and a 51 percent risk reduction in second progression-free survival (PFS2) (HR = 0.49; P < 0.001). The combination of apalutamide and ADT was tolerable, with maintenance of overall health-related quality of life.
The most common Grade 3/4 treatment-emergent adverse events (TEAEs) for apalutamide in combination with ADT versus placebo in combination with ADT were 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). Treatment discontinuation due to adverse events was 11 percent in the apalutamide arm compared to 7 percent in the placebo arm. Rates of serious adverse events (SAEs) were similar in the apalutamide in combination with ADT arm versus placebo in combination with ADT arm (25 percent vs. 23 percent respectively).
About Non-Metastatic Castration-Resistant Prostate Cancer
Non-metastatic castration-resistant prostate cancer (CRPC) 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.2 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/dL.2 Ninety percent of patients with non-metastatic CRPC will eventually develop bone metastases, which can lead to pain, fractures and spinal cord compression.3 The relative 5-year survival rate for patients with distant stage castration sensitive or castration resistant prostate cancer is 30 percent.4,5 While it is critical to delay the onset of metastasis in patients with non-metastatic CRPC, there are currently no FDA or EMA approved treatments.6
Apalutamide is an investigational, 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.7
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. Janssen-Cilag International NV is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Learn more at www.janssen.com/emea. Follow us at http://www.twitter.com/janssenEMEA.
# # #
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of apalutamide. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns or financial distress of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including under “Item 1A. Risk Factors,” its most recently filed Quarterly Report on Form 10-Q, including under the caption “Cautionary Note Regarding Forward-Looking Statements,” and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson. Neither the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
# # #
1 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.
2 Hong JH, Kim IY. Nonmetastatic Castration-Resistant Prostate Cancer. Korean J Urol. 2014 Mar;55(3):153-60. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3956942/. Accessed February 2018.
3 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/. Accessed February 2018.
4 Saad F, et al. The 2015 CUA-CUOG Guidelines for the management of castration-resistant prostate cancer (CRPC). Can Urol Assoc J. 2015;9(3-4):90-96.
5 American Cancer Society. Survival Rates for Prostate Cancer. Available at: www.cancer.org/cancer/prostate-cancer/detection-diagnosis-staging/survival-rates.html. Accessed February 2018.
6 Tombal B. Non-metastatic CRPC and asymptomatic metastatic CRPC: which treatment for which patient? Ann Oncol. 2012;23 Suppl 10:x251-8.
7 Clegg NJ, et al. ARN-509: a novel antiandrogen for prostate cancer treatment. Cancer Res. 2012;72:1494-1503.
Natalie Buhl, +353 85 7446696
Lesley Fishman, 1-732-524-3922
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Incyte Announces Positive Interim Data from Phase 2 Trial of Pemigatinib, Its Selective FGFR Inhibitor, in Patients with Cholangiocarcinoma21.10.2018 13:45 | Tiedote
Incyte Corporation (Nasdaq:INCY) announces updated data from its ongoing Phase 2 FIGHT-202 trial evaluating pemigatinib (INCB54828), its selective fibroblast growth factor receptor (FGFR) inhibitor, in patients with advanced/metastatic or surgically unresectable cholangiocarcinoma (bile duct cancer) who failed at least one previous treatment. In patients with FGFR2 translocations who were followed for at least eight months, interim study results demonstrated an overall response rate (ORR) of 40 percent, the primary endpoint, and a median progression free survival (PFS) of 9.2 months, a key secondary endpoint. These results are being presented at the European Society for Medical Oncology (ESMO) 2018 Congress in Munich, Germany in a poster presentation on Sunday, October 21 from 12:45 p.m. CEST to 1:45 p.m. CEST (6:45 a.m. ET to 7:45 a.m. ET). (Location: Hall A3 – Poster Area Networking Hub; Abstract #756P) “We are pleased to share updated interim results from our ongoing FIGHT-202 trial
Servier and Taiho Oncology Announce Phase III LONSURF® Study Has Met Primary and Secondary Endpoints Demonstrating Prolonged Overall Survival and Progression-Free Survival in Patients with Refractory Metastatic Gastric Cancer21.10.2018 12:10 | Tiedote
Servier and Taiho Oncology, Inc. (U.S.), a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), jointly announced today clinical data from the pivotal Phase III TAS-102 Gastric Study (TAGS) evaluating LONSURF® (trifluridine/tipiracil, TAS-102) versus placebo and best supportive care in patients with heavily pre-treated metastatic gastric cancer who have progressed or are intolerant to previous lines of therapy. The study met its primary endpoint of prolonged overall survival (OS) and secondary endpoint measures of progression-free survival (PFS) consistently supported the OS results, as well as continuing to demonstrate the predictable safety and tolerability profile of trifluridine/tipiracil. Data from TAGS was presented by Dr. Hendrik-Tobias Arkenau, Executive Medical Director of the Sarah Cannon Research Institute UK and an investigator for TAGS, at the ESMO 2018 Congress in Munich, Germany during an oral session (Abstract #LBA25). The study results were simultaneously published in
Phase 3 Data on Filgotinib in Biologic-Experienced Rheumatoid Arthritis to Be Presented at 2018 ACR/ARHP Annual Meeting21.10.2018 01:30 | Tiedote
Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced detailed results from the Phase 3 FINCH 2 clinical trial of filgotinib, an investigational, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis and prior inadequate response or intolerance to biologic agents. The data, which are being presented as a late-breaking poster at the 2018 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in Chicago, suggest filgotinib has a potential role in addressing important unmet needs in the treatment of rheumatoid arthritis. Positive efficacy data from FINCH 2 were previously announced in September 2018. The data show statistically significant improvements in the proportion of patients achieving a range of clinical efficacy endpoints, including the proportion of patients achieving American College of Rheumatology 20 percent (ACR20, primary endpoint), 50 percent
Manchester United and True Religion Launch Denim Range19.10.2018 20:37 | Tiedote
Manchester United (NYSE:MANU) and luxury denim brand True Religion have collaborated to launch a range of premium club branded denim wear. A first for the club, the new global partnership with the iconic American denim brand will see a range of men’s & women’s co-branded styles go on sale beginning 26th October in the club’s Megastore as well as online via United Direct and truereligion.com & eu.truereligion.com. The exclusive collection features jeans, shirts and jackets, including a highly desirable limited edition denim jacket embroidered with the club’s crest. Fans will have the opportunity to win a selection of clothing from the new range by visiting www.manutd.com/truereligion. Manchester United’s Group Managing Director, Richard Arnold, comments: “True Religion is a well-known, established name in fashion, creating unique designs without compromising on quality. The range we have collaborated on includes the same attention to detail and craftsmanship that has made True Religion
Arch Insurance Announces Strategic Leadership Changes19.10.2018 16:10 | Tiedote
Arch Insurance today announced that Matt Shulman will assume the newly created role of CEO, Arch Insurance North America, effective January 1, 2019. In this role, he will lead Arch Insurance’s operations in the United States and Canada. He will report to Nicolas Papadopoulo, Chairman and CEO of Arch Worldwide Insurance Group. Mr. Shulman, who has more than 20 years of experience in the insurance industry, has been with Arch Insurance since 2009 and has served as the President and CEO of Arch Insurance Europe since 2016. “Matt brings significant U.S. and international experience to this role. Under his leadership, together with our senior team, Arch Insurance will continue to enhance our value proposition to our customers through a robust, diversified product portfolio, creative solutions and excellent service,” Mr. Papadopoulo said. Arch Insurance has also created a new organizational structure with three Chief Underwriting Officers (CUO) dedicated to specific lines of business. These
Takeda to Present Results from Phase 3 ALTA-1L Trial Highlighting Intracranial Efficacy of ALUNBRIG® (brigatinib) Versus Crizotinib in First-Line Advanced ALK+ Non-Small Cell Lung Cancer19.10.2018 15:00 | Tiedote
Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that intracranial efficacy data from the Phase 3 ALTA-1L (ALK in Lung Cancer Trial of BrigAtinib in 1 st Line) trial showed improved intracranial progression-free survival (PFS) and intracranial objective response rate (ORR) with ALUNBRIG (brigatinib) compared to crizotinib among anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) patients. Data for these secondary endpoints will be presented in a poster discussion at the European Society for Medical Oncology (ESMO) 2018 Congress on Friday, October 19 at 2:00 p.m. CET in Munich, Germany. These results further support ALUNBRIG as a potential treatment for adults with ALK+ locally advanced or metastatic NSCLC who had not received a prior ALK inhibitor. ALUNBRIG is currently not approved as first-line therapy for advanced ALK+ NSCLC. “ALK+ NSCLC often spreads to the brain, so having options that can clearly demonstrate efficacy both in the brain an
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme