Business Wire

Incyte Announces Positive Interim Data from Phase 2 Trial of Pemigatinib, Its Selective FGFR Inhibitor, in Patients with Cholangiocarcinoma

Jaa

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 at ESMO, which underscore the potential of pemigatinib as an effective new treatment option for patients with advanced cholangiocarcinoma who have FGFR2 translocations,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “If the full data set warrant it, we look forward to submitting our new drug application to the FDA in 2019, seeking approval of pemigatinib as a first-in-class selective FGFR inhibitor to treat patients with advanced cholangiocarcinoma, a devastating disease.”

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 – and are found in up to 20 percent of iCCA patients. The incidence of cholangiocarcinoma with FGFR2 translocation is increasing and is currently estimated at 2,500-3,000 patients in the U.S., Europe and Japan.

Key Findings from FIGHT-202

Updated, longer-term follow-up data from the interim analysis presented today at ESMO (data cut as of July 24, 2018) show that in patients with advanced/metastatic or surgically unresectable iCCA with FGFR2 translocations treated with pemigatinib who had at least eight months of follow up (Cohort A, n=47), the combined overall response rate (ORR) was 40 percent, including 19 (40 percent) patients with confirmed partial responses and 21 (45 percent) patients with stable disease (SD). The combined disease control rate (DCR) was 85 percent (40/47). Additionally, median progression free survival (PFS) was 9.2 months and median overall survival (OS) was 15.8 months.

 

FIGHT-202 Overall Response Rates (ORR), Disease Control Rates (DCR), Durability of
Response (DOR), Progression-Free Survival (PFS) and Overall Survival (OS) by Patient Cohort

       

Cohort A

FGFR2 Translocations

 

(N=47)

   

Cohort B

Other FGF/FGFR
Genetic Alterations

(N=22)

   

Cohort C

No FGF/FGFR Genetic
Alterations

(N=18)

ORR, % (95% CI)       40 (26.4-55.7)     0 (0.0-15.4)     0 (0.0-18.5)
Best OR, n (%)       0 CR (0.0)

19 PR (40)

21 SD (45)

    0 CR (0.0)

0 PR (0.0)

10 SD (46)

   

0 CR (0.0)

0 PR (0.0)

4 SD (22)

Median DOR,
Months (95% CI)

     

NE (6.93-NE)

 

Median (range) duration
of response has not been
reached

   

NE (NE-NE)

 

Median (range) duration
of response has not been
reached

   

NE (NE-NE)

 

Median (range) duration
of response has not been
reached

DCR, % (95% CI)       85 (71.7-93.8)     46 (24.4-67.8)     22 (6.4-47.6)

Median PFS,
Months (95% CI)

      9.2 (6.44-NE)     2.1 (1.18-6.80)     1.68 (1.38-1.84)

Median OS,
Months (95% CI)

      15.8     6.8     4.0

NE = not evaluable, upper limit was not reached

 

Pemigatinib was well-tolerated. The most common treatment-emergent adverse events (TEAEs) were hyperphosphatemia (61 percent), alopecia (42 percent), diarrhea (39 percent), decreased appetite (37 percent) and fatigue (36 percent). Grade ≥3 TEAEs (observed >5 percent of patients) were hypophosphatemia (14 percent), hyponatremia (8 percent), abdominal pain (7 percent) and arthralgia (7 percent). Five patients had TEAEs with a fatal outcome, none of which were related to study treatment.

“I am extremely encouraged by the interim results of the FIGHT-202 study, which demonstrated meaningful clinical activity and promising preliminary progression-free survival estimates, and, as a practicing clinician, I am excited about the potential of pemigatinib to provide a new treatment option for my patients suffering from the life-threatening nature of advanced cholangiocarcinoma,” said Antoine Hollebecque, M.D., Institut de Cancérologie Gustave Roussy, Villejuif, France.

About FIGHT-202

The FIGHT-202 open-label, multicenter study (NCT02924376) is evaluating the safety and efficacy of pemigatinib (INCB54828), Incyte’s investigational, selective, potent, oral fibroblast growth factor receptor (FGFR) inhibitor in adult (age ≥ 18 years) patients with advanced/metastatic or surgically unresectable cholangiocarcinoma with known fibroblast growth factor (FGF)/FGFR alterations and who have failed at least one previous treatment.

Patients were enrolled into one of three cohorts – Cohort A (FGFR2 translocations), Cohort B (other FGF/FGFR genetic alterations [GA]) or Cohort C (no FGF/FGFR GAs). All patients received 13.5 mg pemigatinib orally once daily (QD) on a 21-day cycle (two weeks on/one week off) until radiological disease progression or unacceptable toxicity.

The primary endpoint of FIGHT-202 is overall response rate (ORR) in Cohort A, assessed by independent review per RECIST v1.1. Secondary endpoints include ORR in Cohorts B, C and A plus B, progression free survival (PFS), overall survival (OS), duration of response (DOR), disease control rate (DCR) and safety.

The FIGHT-202 study is fully recruited outside of Japan, and updated data are expected to be presented in the second half of 2019. For more information about FIGHT-202, visit https://clinicaltrials.gov/ct2/show/NCT02924376.

About FIGHT

Phase 2 studies investigating the safety and efficacy of pemigatinib monotherapy across several FGFR-driven malignancies are ongoing—the FIGHT (FIbroblast Growth factor receptor in oncology and Hematology Trials) clinical trial program currently comprises 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; and FIGHT-203 in patients with myeloproliferative neoplasms with activating FGFR1 translocations. FIGHT-302, a randomized Phase 3 trial in newly-diagnosed patients with cholangiocarcinoma and activating FGFR2 translocations, is expected to be initiated before the end of 2018 (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.

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, the Company’s plans to file an NDA for pemigatinib and the expected timing of such filing, whether further data will support the interim results, and plans for commencing FIGHT-302 before the end of 2018, 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 ended June 30, 2018. The Company disclaims any intent or obligation to update these forward-looking statements.

Contact information

Incyte
Media
Catalina Loveman
+1 302 498 6171
cloveman@incyte.com
or
Investors
Michael Booth, DPhil
+1 302 498 5914
mbooth@incyte.com

Tietoja julkaisijasta

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

Quanterix Announces Agreement to Acquire UmanDiagnostics, World’s Leading Neurofilament Light (Nf-L) Antibody Supplier26.6.2019 23:00:00 EESTTiedote

Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, today announced that it has entered into a definitive agreement to acquire privately held UmanDiagnostics AB for $22.5 million, comprised of $16 million in cash plus $6.5 million in Quanterix common stock. Uman is widely recognized to possess the leading antibodies available today to measure neurofilament light (Nf-L) and has become the provider of choice for biopharmaceutical and diagnostic applications. Uman, based in Umeå, Sweden, supplies Nf-L antibodies and ELISA kits, which are widely recognized by researchers and biopharmaceutical and diagnostics companies world-wide as the premier solution for the detection of Nf-L to advance the development of therapeutics and diagnostics for neurodegenerative conditions. Nf-L has seen a dramatic growth in the last three years since Quanterix developed the first assay using Uman’s antibodies that could relia

Elliott Statement on Bayer26.6.2019 19:44:00 EESTTiedote

Elliott Advisors (UK) Limited (“Elliott”), which advises funds that collectively hold shares of Bayer A.G. (“Bayer” or “the Company”) and economic equivalents with an aggregate value of €1.1 billion, acknowledges Bayer’s announcement to create a special litigation committee of the Supervisory Board (the “Special Committee”), and the retention of Mr. John Beisner of Skadden, Arps, Slate, Meagher & Flom LLP, as legal advisor to the Supervisory Board and Special Committee. Elliott welcomes these steps, and is confident that today’s statement marks a step change in Bayer’s approach to addressing the legal challenges currently facing the Company. Elliott believes that the creation of the Special Committee will provide a new level of oversight and a fresh perspective to a litigation strategy in need of a radical overhaul, and help guide the Company towards a rational, fair and swift settlement. The appointment of Mr. John Beisner not only provides Bayer with relevant litigation expertise, bu

Louisiana Launches Hepatitis C Innovative Payment Model With Asegua Therapeutics, Aiming to Eliminate the Disease26.6.2019 18:30:00 EESTTiedote

Today, Governor John Bel Edwards joined Secretary Rebekah Gee of the Louisiana Department of Health, Secretary James LeBlanc of the Louisiana Department of Corrections, and Asegua Therapeutics LLC, a wholly-owned subsidiary of Gilead Sciences, Inc. (Nasdaq: GILD), to announce a deal that will allow the implementation of an innovative payment model for hepatitis C treatment, part of Louisiana’s plan to eliminate the disease. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190626005539/en/ “This new model has the potential to save many lives and improve the health of our citizens. It is an important day for our state, for our partner Asegua Therapeutics, for providers, but most importantly for the patients and their families who will benefit from treatment,” said Governor Edwards. “Asegua was willing to come to the table to work with us to help Louisiana residents and we are pleased to initiate this five year partnership. Ultim

Nextflow Software Introduces Nextflow Studio, Its Newest Fluid Simulation Software26.6.2019 17:00:00 EESTTiedote

Nextflow Software is an Independent Software Vendor (ISV) based in Nantes, France. Nextflow Software is one of the leaders in innovative Computational Fluid Dynamics (CFD) methods. The startup exhibits at the NAFEMS World Congress in Quebec City, Canada, on June 17-20, featuring live demos if its latest product Nextflow Studio. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190626005482/en/ Nextflow Studio conception simulation (Photo: Nextflow Software) A full environment covering all stages of CFD simulation Nextflow Studio is a software platform that covers the entire CFD flow, from pre-processing, to computation and post-processing. This environment lets engineers manage easily their simulation projects and provides a Graphical User Interface (GUI) based on the latest software technologies. Nextflow Studio offers an experience that allows users to accelerate the resolution of their field-specific design objectives. Main

BrandSafway Selects Rimini Street Application Management Services for Salesforce26.6.2019 16:00:00 EESTTiedote

Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, the leading third-party support provider for Oracle and SAP software products and a Salesforce partner, today announced that BrandSafway, a global leader in access, industrial services and forming and shoring solutions for the industrial, commercial and infrastructure markets, has selected Rimini Street Application Management Services (AMS) for Salesforce for its Salesforce Sales Cloud system. BrandSafway has been leveraging Rimini Street support for its Oracle Database, E-Business Suite and JD Edwards software products since 2014, and now, BrandSafway is expanding its support service scope with Rimini Street to maximize the value and business impact of Salesforce and the Salesforce Sales Cloud system. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190626005022/en/ BrandSafway Selects Rimini Street Application Management Servi

Modern Governance 4.0: Global Compliance Is Now Integrated with the World’s Leading Board Platform26.6.2019 16:00:00 EESTTiedote

With its second major product announcement this week, Diligent today introduced the integration of its trusted entity management technology into the Governance Cloud with new powerful reporting and dashboard functionality. Diligent Entities, formerly Blueprint OneWorld, greatly improves transparency and decreases the burden and risks for subsidiary and entity management in a fast-paced, digital environment. This launch positions Diligent as the first of its kind to provide a holistic technology platform that can power modern governance, offering leadership and the board the most effective tools – from a board portal to secure file sharing to entity compliance – accessible in one place. Business today is global and decentralized, adding layers of regulatory and ethical compliance complexity. Such distributed business interests – with various entities and subsidiaries – are often spread across multiple jurisdictions and subject to increasing regulatory obligations that make reporting and

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