Breaking News
June 24, 2018 - Enlist a Pharmacist to Help Manage High Blood Pressure
June 24, 2018 - Genes found related to the reduction of proteins that contribute to Alzheimer’s onset
June 24, 2018 - 1 in 5 immigrant children detained during ‘zero tolerance’ border policy are under 13
June 24, 2018 - Personal automated cell lab assistant from Leica saves time with quality results
June 24, 2018 - Drug use can have social benefits, and acknowledging this could improve rehabilitation
June 24, 2018 - AMSBIO introduces MyEZGel 3D-iPSC Matrix for more accurate in vivo predictions
June 24, 2018 - RaySearch releases new RayStation 8A to expand support for TomoTherapy platform
June 24, 2018 - Dying cancer cells make remaining glioblastoma cells more aggressive and therapy-resistant
June 24, 2018 - Researchers discover new type of cell that hinders formation of fat cells
June 24, 2018 - Scientists develop unique program to predict a form of Parkinson’s disease
June 24, 2018 - Adult Obesity Prevalence Varies With Level of Urbanization
June 24, 2018 - Picking an exercise boot camp
June 24, 2018 - Researchers outline a connection between subplate neurons and brain disorders
June 24, 2018 - Four cups of coffee a day shown to protect heart muscle
June 24, 2018 - ‘Antifreeze’ molecules may hold key to better treatments for brain injuries
June 24, 2018 - Opening onsite health clinics for workers can cut health care costs
June 24, 2018 - Glooko to demonstrate new version of diabetes management mobile application at ADA meeting
June 24, 2018 - Florida Teen First Human Case of Another Mosquito-Borne Virus
June 24, 2018 - Blood type O patients may have higher risk of death from severe trauma
June 24, 2018 - New studies on molecular and cellular proteomics
June 24, 2018 - Algorithm predicts dangerous low blood pressure during surgery
June 24, 2018 - Herpes may play role in pathogenesis of Alzheimer’s
June 24, 2018 - Inaccurate measurement of sodium intake may account for paradoxical results, study suggests
June 24, 2018 - Aquinnah Pharmaceuticals wins NINDS grant to advance novel therapies for ALS
June 24, 2018 - Study upends conventional view of opioid mechanism of action
June 24, 2018 - Floppy eyelids may be sign of sleep apnea, study finds
June 23, 2018 - Researchers highlight new nurse training model to address shortage of primary care
June 23, 2018 - New Olympus cellSens 2.1 speeds up image analysis
June 23, 2018 - Attitudes Among Obese Are Not Aligned With Healthy Living
June 23, 2018 - Early birds less prone to depression
June 23, 2018 - Scientists use novel approach to uncover how brain networks interact to make word-choice decisions
June 23, 2018 - Researchers discover shared genetic basis for psychiatric disorders
June 23, 2018 - Study shows fat cells increase in size and number upon exposure to fracking chemicals
June 23, 2018 - Water-limited landscapes can facilitate disease transmission
June 23, 2018 - Exercise May Ease Inflammation Tied to Obesity
June 23, 2018 - Is it their own fault?! How people judge the exclusion of others
June 23, 2018 - Researchers use advanced technology to identify proteomes of Th17 and iTreg cells
June 23, 2018 - Researchers develop low-cost plastic sensors to monitor wide range of health conditions
June 23, 2018 - Lipid-scrambling DNA enzyme outperforms naturally occurring counterpart, say researchers
June 23, 2018 - Apps for children should emphasize parent and child choice, researchers say
June 23, 2018 - Teenage girls report higher degree of daytime sleepiness than boys
June 23, 2018 - Protein Data Bank at Rutgers impacts research, education and drug discovery
June 23, 2018 - Study unravels new piece of information in the Huntington’s disease puzzle
June 23, 2018 - Scientists develop new device to test cancer drug combinations quickly and cheaply
June 23, 2018 - Neural Analytics wins CE Mark for NeuralBot System
June 23, 2018 - Infant omega-3 supplementation tied to decreased waist size
June 23, 2018 - Massive analysis of genomes reveals insights into genetic overlap among psychiatric diseases
June 23, 2018 - New therapeutic approach may delay neurodegeneration in rare genetic disease
June 23, 2018 - Broken shuttle protein may hinder learning in patients with brain disorders
June 23, 2018 - Study finds increase in daily cannabis use among American adults
June 23, 2018 - Researchers create electronic skin that brings back real sense of touch to prosthetic limbs
June 23, 2018 - FIRS: Guidance Offered for Protecting Youth From E-Cigarettes
June 23, 2018 - Scientists unravel molecular mechanisms of Parkinson’s disease
June 23, 2018 - When the Heart Stops, Drugs Often to Blame
June 23, 2018 - Scientists show that a key Parkinson’s biomarker can be identified in the retina
June 23, 2018 - Study finds factors underlying current rise in radicalization among European youth
June 23, 2018 - New study finds higher heart disease risk in bisexual men
June 23, 2018 - Coconut oil diet increases vitality, lifespan of fruit flies with peroxisomal disorder
June 23, 2018 - Jumping genes or transposons and their role in the genetic code
June 23, 2018 - The Current issue of “The view from here” is concerned with Therapeutics
June 23, 2018 - Abnormal lipid metabolism in fat cells predicts future weight gain and diabetes in women
June 23, 2018 - Alcohol problems linked to sex without condom use among black gay men
June 23, 2018 - DNA patterns in circulating blood cells can help identify spastic cerebral palsy
June 23, 2018 - Unsubstantiated health claims widespread within weight loss industry
June 23, 2018 - FDA grants marketing authorization for use of two catheter-based devices in hemodialysis patients
June 23, 2018 - An ingrown toenail not the same as a bypass
June 23, 2018 - Study suggests proteinuria lowering as important target in managing pediatric CKD
June 23, 2018 - Dynamic model helps make predictions about gut microbiome
June 23, 2018 - Research consortium wins £2.9 million to help tackle antibacterial resistance in Thailand
June 23, 2018 - Schizophrenia patients account for over 1 in 10 suicide deaths, study shows
June 23, 2018 - Overdose risk increases five-fold with concurrent opioid and benzodiazepine use
June 23, 2018 - FDA Alert: Kratom (mitragyna speciosa) powder products by Gaia Ethnobotanical: Recall
June 23, 2018 - Study highlights inadequate effort of health care insurers to combat opioid epidemic
June 23, 2018 - CDC chief asks for, and gets, cut to his record $375K pay
June 22, 2018 - Novel cellular pathway may clarify how arterial inflammation develops into atherosclerosis
June 22, 2018 - Pioneering exercise program improves physical, mental health of elderly people living in care homes
June 22, 2018 - Rutgers Cancer Institute educates childhood cancer survivors about late effects of treatment
June 22, 2018 - Study tests accuracy of device designed to detect heart dysfunction in childhood cancer survivors
June 22, 2018 - Study links annual haze with increased hospitalizations for respiratory problems
June 22, 2018 - Robotic surgery appears to be as effective as open surgery in treating bladder cancer
Erdafitinib Phase 2 Study Results Show Promise in the Treatment of Metastatic Urothelial Cancer

Erdafitinib Phase 2 Study Results Show Promise in the Treatment of Metastatic Urothelial Cancer

image_pdfDownload PDFimage_print

Chicago Ill., June 3, 2018 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced findings today from a Phase 2 study that showed treatment with erdafitinib, a once-daily oral pan-fibroblast growth factor receptor (FGFR) inhibitor, resulted in durable responses in patients with metastatic or surgically unresectable urothelial cancer (mUC) and FGFR alterations (FGFRalt), a population with high unmet need based on poor outcomes when treated with available therapies. FGFRs are cell proteins that, if altered, can contribute to the development of cancer. Alterations occur in approximately 20 percent of mUC patients. The results were presented at the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting in Chicago (Abstract #4503) and have been selected for the Best of ASCO Meetings.

“Despite the improvements in outcomes reported with immune checkpoint inhibitors, the majority of patients do not respond to treatment. Additionally, there is no targeted therapy approved for treating specific subsets of patients with urothelial cancer who have genetic alterations,” said Arlene O. Siefker-Radtke, M.D., Professor of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, and lead study investigator. “These encouraging Phase 2 data showed treatment with erdafitinib resulted in promising response rates and progression-free survival in an important patient population.”

BLC2001 (NCT02365597) is a multicenter, open-label Phase 2 study evaluating the efficacy and safety of erdafitinib in the treatment of adult patients with locally advanced or metastatic urothelial cancer, whose tumors have certain FGFR alterations. Ninety-nine patients were treated with an optimized dosing schedule using pharmacodynamically guided dose up-titration: a starting dose of erdafitinib at 8 mg daily, with the possibility to increase the dose to 9 mg daily based on serum phosphate levels. Twelve percent of patients were chemo-naïve, 89 percent of patients had received one or more lines of therapy, 43 percent of patients had received two or more prior lines of therapy, and 78 percent of patients had visceral metastases. There was a 40 percent confirmed overall response rate (RECIST 1.1;* 3% Complete Response, 37% Partial Response), a median progression-free survival of 5.5 months and median overall survival of 13.8 months. In patients who experienced grade 3 adverse events (AEs), the most common were stomatitis (9%), hand-foot syndrome (5%) and diarrhea (4%). Seven patients discontinued due to treatment-related AEs.

“We are pleased to present these data here at ASCO with the Phase 2 results of the efficacy and safety of erdafitinib in the treatment of metastatic or surgically unresectable urothelial cancer with FGFR alterations,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. “Following the U.S. Food and Drug Administration Breakthrough Therapy Designation in March 2018, our aim is to move toward regulatory submission with the Phase 2 data and continue to pursue erdafitinib in Phase 3 clinical development, as well as in combination with anti-PD-1 therapy.”

*RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumors which is a standard way to measure how well a cancer patient responds to treatment and is based on whether tumors shrink, stay the same, or get bigger.[1]

About Urothelial Cancer

Urothelial cancer starts in the urothelial cells that line the inside of the bladder.[2] This cancer is the most prevalent among bladder cancers, which constitute the sixth most common type of cancer in the U.S.2 In 2018, an estimated 81,190 new cases of bladder cancer are expected, resulting in 17,240 deaths.2 For patients with metastatic disease, outcomes can be dire due to the often rapid progression of the tumor and the lack of efficacious treatments, especially in relapsed or refractory disease.2 The relative five-year survival rate for patients with metastatic disease is five percent.2

About Erdafitinib

Erdafitinib is a once-daily oral pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor being evaluated by Janssen Research & Development in Phase 2 and 3 clinical trials in patients with advanced urothelial cancer.[3] FGFRs are a family of receptor tyrosine kinases, which may be upregulated in various tumor cell types and may be involved in tumor cell proliferation, tumor angiogenesis and tumor cell survival.[4] In 2008, Janssen entered into an exclusive worldwide license and collaboration agreement with Astex Therapeutics Ltd. to develop and commercialize erdafitinib.

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.com. Follow us at www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC is one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

# # #

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 erdafitinib. 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 materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies of Johnson & Johnson 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; 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 behavior and spending patterns 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 December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s subsequent Quarterly Reports on Form 10-Q and other 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. None of 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] National Cancer Institute. NCI Dictionary of Cancer Terms. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/recist. Accessed May 2018.
[2] National Cancer Institute. Cancer Stat Facts: Bladder Cancer. Available at: https://seer.cancer.gov/statfacts/html/urinb.html. Accessed April 2018.
[3] Tabernero J, Bahleda R, Dienstmann R, Infante JR, Mita A, Italiano A, Calvo E, Moreno V, Adamo B,
Gazzah A, et al. Phase I dose-escalation study of JNJ-42756493, an oral pan-fibroblast growth factor
receptor inhibitor, in patients with advanced solid tumors. J Clin Oncol. 2015;33:3401–3408. doi:
10.1200/JCO.2014.60.7341.
[4] Dienstmann R, Rodon J, Prat A, et al. Genomic aberrations in the FGFR pathway: Opportunities for
targeted therapies in solid tumors. Ann Oncol. 2014;25:552–563.

Source: Johnson & Johnson

Posted: June 2018

Tagged with:

About author

Related Articles