Data from Incyte’s Oncology Portfolio to be Featured at the 2019 ESMO Congress
3.9.2019 15:14:00 EEST | Business Wire | Press release
Incyte (Nasdaq:INCY) announces that abstracts highlighting data from its oncology portfolio will be presented at the upcoming European Society for Medical Oncology (ESMO) 2019 Congress taking place in Barcelona, Spain from September 27-October 1, 2019.
Results from FIGHT-202, a Phase 2 study of pemigatinib as a second-line treatment for patients with advanced/metastatic or surgically unresectable cholangiocarcinoma, including updated safety and efficacy data in patients with FGFR2 fusions or rearrangements, as well as genomic profiling and correlations with clinical outcomes will be presented. Results from the Phase 1 study of INCB001158, an arginase inhibitor being developed with Calithera Biosciences, alone and in combination with pembrolizumab as a treatment for advanced or metastatic solid tumors, will also be presented.
“Incyte is committed to advancing treatments that have the potential to address areas of high unmet need and we look forward to sharing data on our investigational therapies with the oncology community at ESMO 2019,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “Data from the Phase 2 FIGHT-202 study assessing pemigatinib as a potential treatment for cholangiocarcinoma are encouraging and may represent an important step forward for patients in urgent need of effective treatment options.”
Abstracts will be available on the ESMO Congress website at https://www.esmo.org/Conferences/ESMO-Congress-2019.
Oral Presentations:
FIGHT-202: a Phase 2 study of pemigatinib in patients (pts) with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) (Abstract #2550, proffered paper session)
- Friday, September 27, 2019 from 3:00 p.m. CEST to 3:15 p.m. CEST (9 a.m. ET to 9:15 a.m. ET) in Madrid Auditorium (Hall 2)
Phase 1 study of the arginase inhibitor INCB001158 (1158) alone and in combination with pembrolizumab (PEM) in patients (Pts) with advanced/metastatic (Adv/Met) solid tumors (Abstract #1621, oral abstract session)
- Sunday, September 29, 2019 from 4:54 p.m. CEST to 5:06 p.m. CEST (10:54 a.m. ET to 11:06 a.m. ET) in Malaga Auditorium (Hall 5)
Poster Details:
Comprehensive genomic profiling and clinical outcomes in patients (pts) with fibroblast growth factor receptor rearrangement-positive (FGFR2+) cholangiocarcinoma (CCA) treated with pemigatinib in the FIGHT-202 trial (Abstract #2078, poster session)
- Sunday, September 29, 2019 from 12:00 p.m. CEST to 1:00 p.m. CEST (6:00 a.m. ET to 7:00 a.m. ET) in Poster Area (Hall 4)
Full session details and data presentation listings for ESMO 2019 can be found at: https://cslide.ctimeetingtech.com/esmo2019/attendee.
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 presentation of data from the Company’s ongoing clinical development programs for pemigatinib and an arginase inhibitor as monotherapy and in combination with pembrolizumab and the potential of such programs, including the potential for pemigatinib to treat cholangiocarcinoma, 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, 2019. The Company disclaims any intent or obligation to update these forward-looking statements.
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Contact information
Incyte Contacts
Media
Catalina Loveman
+1 302 498 6171
cloveman@incyte.com
Investors
Michael Booth, DPhil
+1 302 498 5914
mbooth@incyte.com
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