Business Wire

Incyte Announces First Patient Treated in Phase 3 Clinical Trial of Pemigatinib as a First-Line Therapy for Cholangiocarcinoma

Share

Incyte (Nasdaq:INCY) today announced that the first patient has been treated in FIGHT-302, an open-label Phase 3 study evaluating pemigatinib (INCB54828), its selective fibroblast growth factor receptor (FGFR) inhibitor, compared to gemcitabine with cisplatin chemotherapy, the current standard of care, as a first-line therapy for patients with metastatic or surgically unresectable cholangiocarcinoma (bile duct cancer) and activating FGFR2 rearrangements.

“We are pleased to initiate FIGHT-302 – the first Phase 3 study of pemigatinib – which we hope will add to the growing body of evidence demonstrating its potential as a safe and effective treatment for patients with cholangiocarcinoma with known FGFR2 rearrangements, a rare and potentially life-threatening form of cancer,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “Most patients that present with cholangiocarcinoma, like those patients to be enrolled in the FIGHT-302 study, have an advanced form of the disease that cannot be surgically removed, and the majority do not respond to the current standard of care, demonstrating the significant need for new treatment options.”

Cholangiocarcinoma is a cancer that arises from the cells within the bile ducts. It is often diagnosed late (stages III and IV) and the prognosis is poor. It is most common in those over 70 years old and is more common in men than women. FGFR2 fusion genes are drivers of the disease – occurring almost exclusively in patients with intrahepatic cholangiocarcinoma (iCCA), a subset of the disease. The incidence of cholangiocarcinoma with FGFR2 rearrangements is increasing and is currently estimated at 2,000-3,000 patients in the U.S., Europe and Japan.

About FIGHT and FIGHT-302

The FIGHT (FIbroblast Growth factor receptor in oncology and Hematology Trials) clinical trial program includes several ongoing studies investigating the safety and efficacy of pemigatinib monotherapy across several FGFR-driven malignancies. Currently, the program is comprised of the recently initiated FIGHT-302 study, and three Phase 2 studies: FIGHT-201 in patients with metastatic or surgically unresectable bladder cancer, including with activating FGFR3 alterations; FIGHT-202 in patients with metastatic or surgically unresectable cholangiocarcinoma who have failed previous therapy, including with activating FGFR2 translocations; FIGHT-203 in patients with myeloproliferative neoplasms with activating FGFR1 translocations; and FIGHT-207 in patients with previously-treated, locally-advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or translocations, irrespective of tumor type.

FIGHT-302 (NCT03656536) is an open-label, randomized, active-controlled Phase 3 trial evaluating the safety and efficacy of pemigatinib (INCB54828), Incyte’s selective oral fibroblast growth factor receptor (FGFR) inhibitor compared to the current standard of care – gemcitabine plus cisplatin chemotherapy – as a first-line treatment for adult (age ≥ 18 years) patients with metastatic or surgically unresectable cholangiocarcinoma with a known FGFR receptor 2 (FGFR2) rearrangements.

The study will enroll approximately 432 participants 1:1 into one of two treatment groups – Group A will receive pemigatinib (13.5 mg once daily [QD]) administered as continuous therapy schedule (a cycle is three weeks), and Group B will receive gemcitabine (1000 mg/m2) plus cisplatin (25 mg/m2) administered on Days 1 and 8 of every three-week cycle for up to eight cycles.

The primary endpoint of FIGHT-302 is progression free survival (PFS) across both groups, assessed by independent review per RECIST v1.1. Secondary endpoints include overall response rate (ORR), overall survival (OS), duration of response (DOR), disease control rate (DCR), safety and quality of life impact.

FIGHT-302 is currently recruiting participants; for more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT03656536.

About FGFR and Pemigatinib (INCB54828)

Fibroblast growth factor receptors (FGFRs) play an important role in tumor cell proliferation and survival, migration and angiogenesis (the formation of new blood vessels). Activating mutations, translocations and gene amplifications in FGFRs are closely correlated with the development of various cancers.

Pemigatinib is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations. The U.S. Food and Drug Administration (FDA) has granted pemigatinib Breakthrough Therapy designation for the second-line treatment of cholangiocarcinoma. The FDA’s Breakthrough Therapy designation is designed to expedite the development and review of drugs for serious conditions that have shown encouraging early clinical results and may demonstrate substantial improvements over available medicines.

About Incyte

Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit the Company’s website at www.incyte.com.

Follow @Incyte on Twitter at https://twitter.com/Incyte.

Forward Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the Company’s ongoing clinical development program for pemigatinib and its potential in treating cholangiocarcinoma, and the enrollment, design, timing and results of the FIGHT-302 study, contain predictions, estimates and other forward-looking statements.

These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA; the Company’s dependence on its relationships with its collaboration partners; the efficacy or safety of the Company’s products and the products of the Company’s collaboration partners; the acceptance of the Company’s products and the products of the Company’s collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ending March 31, 2019. The Company disclaims any intent or obligation to update these forward-looking statements.

Contact information

Media
Catalina Loveman
+1 302 498 6171
cloveman@incyte.com

Investors
Michael Booth, DPhil
+1 302 498 5914
mbooth@incyte.com

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

VR Fitness Developer FitXR Secures $7.5 Million In Series A Venture Round Led by Hiro Capital10.7.2020 08:00:00 CESTPress release

FitXR, the leading VR fitness company, today announces that it has secured $6.3m in investment funding, led by Hiro Capital, with continued support from U.S.-based BoostVC, Maveron and TenOneTen Ventures, together with an additional $1.2m in the form of an innovation loan, from Innovate UK. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200709005856/en/ Cherry Freeman, Co-Founding Partner, Hiro Capital (Photo: Business Wire) FitXR, who had previously secured $1.25 million in seed funding from investors, will use the new investment to expand its operations in Europe and North America, and to accelerate launch of several exciting new products and services for people to keep fit in Virtual Reality. The investment marks a significant show of belief in FitXR, who over the last year has grown to become one of the leaders of the VR fitness sector, with its mission to put the fun back into fitness. Its first product, the boxing rhyt

Laboratory Studies Confirm BETADINE® Antiseptic Products’ Effectiveness Against COVID-19 Virus10.7.2020 00:37:00 CESTPress release

Mundipharma today announced that laboratory testing at the Duke-NUS Medical School in Singapore, has confirmed the effectiveness of its BETADINE® antiseptic products against the novel coronavirus (SARS-CoV-2) which causes COVID-19 disease. Testing has demonstrated BETADINE’s® strong in-vitro virucidal activity, killing 99.99% of the SARS-CoV-2 virus in 30 seconds. The products subjected to testing were: BETADINE® antiseptic products, namely Solution (10% PVP-I), Skin Cleanser (7.5% PVP-I), Gargle and Mouthwash (1.0% PVP-I) and Throat Spray (0.45% PVP-I). The research has been published in the respected Infectious Disease and Therapy Journal on 08 July 2020. “These results confirm our view that BETADINE® antiseptic products, used appropriately and in conjunction with other preventative treatment options including PPE, can play a role in limiting the spread of infections, including COVID-19,” said Raman Singh, CEO Mundipharma. “It also provides the medical community as well as consumers

New Evidence Shows Morinaga Milk’s Probiotic Bifidobacterium breve A1 Improves Memory of Older Adults With Cognitive Dysfunction9.7.2020 20:00:00 CESTPress release

Morinaga Milk Industry Co., Ltd. (TOKYO:2264), a leading Japanese dairy product company and a key global probiotics manufacturer, confirmed that its proprietary probiotic strain Bifidobacterium breve A1 (a.k.a. B. breve MCC1274) is safe and effective for improving memory functions of older adults with suspected mild cognitive impairment (MCI) in a randomized, double-blind, placebo-controlled trial (RCT). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200709005032/en/ Figure 1. Changes of RBANS scores at 16 weeks from baseline. Values are indicated as mean with error bars as the standard error. **p<0.001, ***p<0.0001, inter-group difference, Student’s t-test. (Graphic: Business Wire) The new study, published recently in the Journal of Alzheimer’s Disease, has produced breakthrough results uncovering a novel promising probiotic intervention for early dementia prevention. The clinical study conducted by a clinical research orga

rf IDEAS and Ricoh Simplify Secure Access to Multifunction Printers9.7.2020 18:05:00 CESTPress release

rf IDEAS, a leading manufacturer of credential readers for authentication and logical access, today announced with Ricoh the integration of its WAVE ID® Plus dual-frequency card reader technology with Ricoh’s Smart Operation Panel (SOP), Gen 2.5. The new WAVE ID Ricoh Universal SOP Reader is the most innovative reader for secure pull-print applications with Ricoh multifunction printers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200709005764/en/ WAVE ID® Ricoh Universal SOP Reader (Photo: Business Wire) rf IDEAS and Ricoh have a proven record of working together to deliver secure workplace solutions that feature the most advanced identification and authentication capabilities. “As we continue our worldwide partnership with a leader in the print industry, we are delighted that Ricoh chose rf IDEAS to develop an innovative credential reader design that connects to its A3 multifunction devices,” said Tod Besse, senior vice

Immersive Labs Adds Tenable Co-Founder and Security Industry Veteran Jack Huffard to its Board of Directors as Demand for Improving and Measuring Cyber Talent Grows9.7.2020 17:46:00 CESTPress release

Immersive Labs, the company empowering organizations to equip, exercise, and evidence human cyber capabilities, announced Jack Huffard, a co-founder and board member of Tenable (Nasdaq: TENB) will join its board of directors to help drive growth. This comes on the heels of Immersive Labs’ recent expansion into the U.S. market, backed by Goldman Sachs and Summit Partners with $50M in financing, after four successful years of fast-growth and an impressive customer roster in the UK and the U.S. With the addition of Huffard to the board, a cybersecurity industry business leader who helped Tenable through its fast growth and successful IPO, the Immersive Labs team is well-suited for its next phase of innovation and market leadership. Huffard also currently serves as a board director for Norfolk Southern Corporation (NYSE: NSC) and is a member of the National Security Telecommunications Advisory Committee (NSTAC), helping the US government navigate pressing national security issues and stren

Jonckers Announces New CEO9.7.2020 17:08:00 CESTPress release

Jonckers, a global leader in language platform technology and multilingual solutions, today announced that its Board of Directors has appointed Silke Zschweigert as Chief Executive Officer, effective immediately. Zschweigert previously held the position of Chief Revenue Officer. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200709005715/en/ Silke Zschweigert Newly appointed CEO of Jonckers - a global leader in language platform technology and multilingual solutions (Photo: Business Wire) “I’m very privileged to be asked by the Board to be the next CEO of this dynamic and forward-thinking company,” said Zschweigert. “The company transitioned from being a pure language service provider to an AI-driven Language Platform with a multilingual community. I look forward to scaling this capability and further developing advanced solutions creating significant value for Enterprises going global.” Zschweigert succeeds Geo Janssens who