Updated Data from ECHO-202 Trial of Epacadostat in Combination with KEYTRUDA® (pembrolizumab) Demonstrate Clinical Activity Across Multiple Tumor Types
Incyte Corporation (Nasdaq:INCY) today announced that updated data from the ongoing Phase 1/2 ECHO-202 trial evaluating epacadostat, Incyte’s selective IDO1 enzyme inhibitor, in combination with pembrolizumab (KEYTRUDA®), an anti-PD-1 therapy marketed by Merck & Co., Inc., Kenilworth, NJ USA (known as MSD outside the United States and Canada), will be highlighted in multiple presentations at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Updated efficacy data at ASCO are from multiple tumor cohorts – metastatic or recurrent squamous cell carcinoma of the head and neck (SCCHN), advanced urothelial bladder cancer (UC), and advanced renal cell carcinoma (RCC) – as well as a pooled safety analysis (Phase 2) of the total study population (across all tumor cohorts). Data will be highlighted in two oral presentations (SCCHN and UC) and two poster discussions (RCC and pooled safety).
“We are pleased to report additional data from multiple tumor-specific cohorts of our Phase 1/2 ECHO-202 trial, which continue to provide encouraging efficacy and safety data for this investigational treatment combination,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “These and other data presented here in Chicago underscore the potential of this novel investigational immunotherapy combination in multiple advanced cancers, supporting the advancement of our clinical development program for epacadostat and pembrolizumab into multiple Phase 3 clinical trials.”
Efficacy Data from ECHO-202 (Abstract #6010, #4503, #4515)
Results of these tumor cohorts (as of February 27, 2017) include:
Prior Lines of
Prior Lines of
Prior Lines of
|3 CR||3 CR||1 PR||3 CR||3 CR||2 PR||1 CR||1 CR||1 PR|
|10 PR||9 PR||11 PR||9 PR||9 PR||8 PR|
|10/13 responses ongoing||10/14 responses ongoing||7/10 responses ongoing|
|DoR||Median range: 18.4+ (7.1 to||Median range: 30.6+ (9.7 to 93.1+)||Median range: 26.8+ (18.1+ to 53.1)|
Objective Response Rate (ORR), Disease Control Rate (DCR), Duration of Response (DoR), Complete Response (CR), Partial Response (PR)
Safety Data from ECHO-202 (Abstract #3012)
In addition to the efficacy data above, an updated pooled analysis evaluated 294 patients with advanced cancers in the ECHO-202 Phase 2 safety population. Treatment-related adverse events (TRAEs) occurred in 67 percent (n=197/294) of patients. The most common TRAEs included fatigue (29%), rash (17%), nausea (11%), and pruritus (10%). Grade ≥3 TRAEs occurred in 18 percent (n=52/294) of patients, the most common of which were increased lipase (asymptomatic) (4%) and rash (3%). TRAEs led to discontinuation of treatment in four percent of study patients. The safety profile of epacadostat plus pembrolizumab was generally consistent with previously reported ECHO-202 Phase 1 data and with the safety profile of KEYTRUDA monotherapy.
“The combination of pembrolizumab and epacadostat as a treatment for multiple advanced solid tumors has shown promise in our preliminary Phase 1/2 clinical trials,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “We welcome the opportunity to collaborate with Incyte and we look forward to progressing this combination in pivotal trials.”
About ECHO-202 (KEYNOTE-037)
The ECHO-202 study (NCT02178722) is evaluating the safety and efficacy of epacadostat, Incyte’s selective IDO1 inhibitor, in combination with pembrolizumab (KEYTRUDA). Patients previously treated with anti-PD-1 or anti-CTLA-4 therapies were excluded from this trial. Enrollment is complete for the Phase 1 dose escalation (epacadostat 25, 50, 100 mg BID + pembrolizumab 2 mg/kg IV Q3W and epacadostat 300 mg BID + pembrolizumab 200 mg IV Q3W) and Phase 1 dose expansion (epacadostat 50, 100, and 300 mg BID + pembrolizumab 200 mg IV Q3W) portions of the trial. For more information about ECHO-202, visit https://clinicaltrials.gov/ct2/show/NCT02178722.
The ECHO clinical trial program was established to investigate the efficacy and safety of epacadostat as a core component of combination therapy in oncology. Ongoing Phase 1 and Phase 2 studies evaluating epacadostat in combination with PD-1 and PD-L1 inhibitors collectively plan to enroll over 900 patients in a broad range of solid tumor types as well as hematological malignancies. ECHO-301 (NCT02752074), a Phase 3 randomized, double-blind, placebo-controlled study investigating pembrolizumab (KEYTRUDA) in combination with epacadostat or placebo for the treatment of patients with unresectable or metastatic melanoma, is also underway. For more information about the ECHO clinical trial program, visit www.ECHOClinicalTrials.com.
About Epacadostat (INCB024360)
Indoleamine 2,3-dioxygenase 1 (IDO1) is a key immunosuppressive enzyme that modulates the anti-tumor immune response by promoting regulatory T cell generation and blocking effector T cell activation, thereby facilitating tumor growth by allowing cancer cells to avoid immune surveillance. Epacadostat is an investigational, highly potent and selective oral inhibitor of the IDO1 enzyme that regulates the tumor immune microenvironment, thereby restoring effective anti-tumor immune responses. In single-arm studies, the combination of epacadostat and immune checkpoint inhibitors has shown proof-of-concept in patients with unresectable or metastatic melanoma. In these studies, epacadostat combined with the CTLA-4 inhibitor ipilimumab or the PD-1 inhibitor pembrolizumab (KEYTRUDA) improved response rates compared with studies of the immune checkpoint inhibitors alone.
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 Statement of Incyte Corporation
Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation and discussion of data regarding the Company’s ECHO-202 study and the planned pivotal trials of epacadostat in combination with pembrolizumab, 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 and the risks related to the efficacy or safety of the Company’s development pipeline, the results of further research and development, the high degree of risk and uncertainty associated with drug development, clinical trials and regulatory approval processes, other market or economic factors and competitive and technological advances; 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 March 31, 2017. Incyte disclaims any intent or obligation to update these forward-looking statements.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ USA.
Michael Booth, DPhil
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 jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Biogen Appoints Jeff Capello as Executive Vice President and Chief Financial Officer21.11.2017 15:30 | Tiedote
Biogen (Nasdaq: BIIB) announced today the appointment of Jeffrey D. Capello as Executive Vice President and Chief Financial Officer effective as of December 11, 2017. Mr. Capello will lead Biogen’s Business Planning, Tax, Treasury, Internal Audit, Accounting, and Investor Relations functions. He will report to Michel Vounatsos, CEO of Biogen, will be a member of the Executive Committee, and will be based in Cambridge, Mass. Mr. Capello brings 26 years of experience in finance. Most recently he was Executive Vice President and Chief Financial Officer of Beacon Health Options Inc. His previous experience includes founding and running his own company, Monomy Advisors, and serving as Chief Financial Officer of Ortho Clinical Diagnostics, Boston Scientific Corporation, and Perkin Elmer. Earlier in his career he was also a partner in the Boston and Amsterdam offices of PwC.
The Brightline Initiative Announces the Addition of Saudi Telecom Company - STC21.11.2017 15:20 | Tiedote
The Brightline Initiative announced today that Saudi Telecom Company (STC) is joining the Brightline Initiative coalition to help advance the discipline of strategic initiative management and bridge gaps between enterprise strategy design and delivery. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171121005474/en/ Signature of Coalition agreement by STC Group CEO, Dr. Khaled Biyari and Brightline Executive Director Ricardo Vargas (Photo: Business Wire) The initiative’s agreement has been signed by STC Group CEO, Dr. Khaled Biyari and by Brightline Executive Director Ricardo Vargas. Launched early in 2017 by the Project Management Institute (PMI), the Boston Consulting Group (BCG) and the Agile Alliance, the Brightline Initiative is a non-commercial coalition dedicated to helping executives
SES and ESA Set Up New Government Satcom Platform21.11.2017 13:20 | Tiedote
SES leads a European consortium of industry partners to sign an agreement with the European Space Agency (ESA) to set up Pacis-1, a new satellite communication platform for governments that is aimed at making secure satellite communications accessible and available to governments and institutions. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171121005423/en/ Carlo Elia, Head of the Telecommunications Technologies, Products and Systems Department, ESA, and Gerhard Bethscheider, Managing Director of SES TechCom Services, SES Networks (Photo: Business Wire) Pacis-1 is part of the ESA’s Govsatcom Precursor programme and is the first step in demonstrating how the European space industry can support the EU’s Govsatcom initiative and leverage governmental and commercial satellite services to provide secure access
CORRECTING and REPLACING "Complete Your Game!"The 13th Global Game Exhibition G-STAR 2017 Opens to Success21.11.2017 13:10 | Tiedote
Please replace the release with the following corrected version due to multiple revisions. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171120006218/en/ Opening Ceremony of G-STAR 2017 (Photo: Business Wire) The corrected release reads: "COMPLETE YOUR GAME!" THE 13TH GLOBAL GAME EXHIBITION G-STAR 2017 OPENS TO SUCCESS The exhibition reached record success featuring 2,857 booths by 676 companies from 35 countries It showcases an array of newly released games of various genres and scales The start of the G-STAR Game Show and Trade All Round 2017, an international game exhibition that examines the global gaming industry and its future possibilities, was announced at BEXCO, Busan, on Nove
Telstra and Sigma Systems to Present Catalog-Driven Dynamic Offer Creation at TM Forum Live! Asia21.11.2017 13:00 | Tiedote
Sigma Systems, the global leader in catalog-driven software, announced today that it will be presenting at TM Forum Live! Asia in partnership with Telstra, Australia’s leading telecommunications and technology company. Sigma’s Chief Technology Officer (CTO), Catherine Michel, will be on stage with Telstra's Chief Technology Officer (Customer), Dr. Fawad Nazir, to discuss why traditional service providers must adopt a “digital native” mindset and the corresponding operational agility to thrive in a digital economy. The ability to create and launch new offers in minutes, rather than months, and rapidly enable new business models is critical to an operator’s success. “Sigma Catalog creates the ability to sell through and then orchestrate the fulfillment of an order from different channels into the full B/OSS stack and across various delivery networks. The product’s Offer Canvas
Seoul Semiconductor First in the World to Receive Low Risk Eye Safety Certification for its Natural Light LED SunLike21.11.2017 12:00 | Tiedote
The world-leading LED company Seoul Semiconductor (Head office: Ansan-si, Korea, CEO: Chung Hoon Lee, hereinafter Seoul Semiconductor) announced that SunLike, which implements light which comes closest to sunlight, received an RG-1 Eye Safety certification based on the safety of its light source and was recognized for the highest level of safety amongst 25W COB type LED. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171121005036/en/ 25W SunLike light source which acquired RG-1 grade in Eye Safety certification (Photo: Business Wire) Eye Safety certification is a rating based on safety from analyzing the LED wavelengths. In Europe, where top priority is placed on the safety of lighting, Eye Safety certification is essential and the light source must be higher than RG-3 level, otherwise eye sight may b
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