Business Wire

Updated Data from ECHO-202 Trial of Epacadostat in Combination with KEYTRUDA® (pembrolizumab) Demonstrate Clinical Activity Across Multiple Tumor Types

Jaa

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:

     

SCCHN
(Abstract #6010)

UC
(Abstract #4503)

RCC
(Abstract #4515)

Total
Subgroup
N (%)

 

Prior Lines of
Treatment
N (%)

Total
Subgroup
N (%)

 

Prior Lines of
Treatment
N (%)

Total
Subgroup
N (%)

 

Prior Lines of
Treatment
N (%)

Total 1-2   >3 Total 0-1   ≥2 Total 0-1   ≥2
13/38 12/31 1/7 14/40 12/32 2/8 10/30 9/19 1/11
(34) (39) (14) (35) (38) (25) (33) (47) (9)
ORR
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  
DCR 23/38 20/31 3/7 21/40 19/32 2/8 15/30 11/19 4/11
  (61) (65) (43) (53) (59) (25) (50) (58) (36)
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)
  90.3+) weeks weeks weeks
 

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.

About ECHO

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.

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 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.

Contact information

Incyte
Media
Catalina Loveman
+1 302-498-6171
or
Investors
Michael Booth, DPhil
+1 302-498-5914

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 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

TIP Trailer Services Announces the Successful Refinancing of its ABS program21.9.2017 18:16Tiedote

On 21 September 2017, TIP Trailer Services announced that it had successfully refinanced its Asset Backed Securitisation (ABS) program. The Pan-European program was originally established in 2014 and is a securitisation structure common under Dutch law for operating leases. The new program will run until March 2019. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170921005815/en/ At the official signing of the TIP ABS refinancing were: From left to right: Jorrit Achterberg (Legal Counsel, TIP Trailer Services), Patrick Vergouwen (International Investor Relations Manager, TIP Trailer Services), Bart de Boo (Director, Asset Based Finance, Rabobank), Gert Huizing (Quality Assurance Manager Capital Market Services, Intertrust), Leo van der Sman (Legal Counsel, Intertrust) (Photo: Business Wire) “The extra funding and improved co

Tohatsu, Major Outboard Manufacturer, to Launch Global Brand Campaign Targeting Millennial Generation Boat Users21.9.2017 17:30Tiedote

On September 21, 2017, Tohatsu Corporation (headquartered in Tokyo, Japan; hereinafter "TOHATSU") announced the outline of its global brand campaign at the 57th Genoa International Boat Show held in Genova, Italy. TOHATSU’s global brand campaign based on a new branding strategy will be deployed at boat shows around the world, starting from the Genoa International Boat Show in September 2017. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170921005018/en/ Feel the Wind (Photo: Business Wire) The campaign sets “SMARTS” millennials as its core target, revealing TOHATSU’s new brand logo, “Blue Wings” and its unique “Simpliq™ Technology” The feature of the new branding strategy is its target demographic called “SMARTS”, millennial boat owners (born between 1977 and 199

Sigma Systems Chief Technology Officer to Address CSPs at Futurecom 201721.9.2017 17:00Tiedote

Sigma Systems, the global leader in catalog-driven software, has today announced that its Chief Technology Officer, Catherine Michel, will be speaking at Futurecom 2017 – the largest ICT event in Latin America. Catherine will address communications service providers (CSPs) and industry professionals at the Sao Paulo event on what’s driving the digitalization mandate for operators. Ahead of her presentation, Catherine commented: “The digitalization of the CSP is about transforming business operations, based on a thorough understanding of customer needs, behaviours and experiences. This requires a shift in corporate culture, and many CSPs are not making the changes necessary to embrace digital innovation and become market leading digital service providers. To deliver on a digital transformation, operators must embrace digital innovation and enable the rapid launch a

Encanto Potash Corp Secures CAD $100 Million Capital Commitment from GEM Global21.9.2017 16:00Tiedote

Encanto Potash Corp. ("Encanto" or the "Company") the TSX-V listed Potash development; Mining and Operating company (TSX-V: EPO) is pleased to announce that it has secured a commitment for a CAD $100 million funding facility. Under the funding agreement signed 15th September, 2017 (the "Agreement"), GEM Investments America, LLC and GEM Global Yield LLC SCS undertake to invest up to CAD $100,000,000 over the next three years. The proceeds will be used to commence the engineering and design phase of the mine in anticipation of a shovel-ready construction date of September 2019. Under a joint venture agreement with Muskowekwan Resources Ltd and Chief Reginald Bellerose of the First Nation’s Muskowekwan tribe, Encanto has secured the mineral rights for the mine and completed preliminary studies. In the interim, proceeds will also be used for the procurement an

CyberOptics Launches Coordinate Measurement Software Suite for New High Speed SQ3000™ CMM System21.9.2017 15:45Tiedote

CyberOptics Corporation (Nasdaq: CYBE), a leading global developer and manufacturer of high-precision 3D sensing technology solutions, launches new SQ3000™ 3D CMM (Coordinate Measurement) system, powered by Multi-Reflection Suppression (MRS) technology and CyberCMM™, a new comprehensive software suite for coordinate measurement. In a lab or production environment, the SQ3000 CMM system is fast and highly accurate, with repeatable and reproducible measurements for metrology applications in manufacturing of a wide variety of products such as PCBs, semiconductors and consumer electronics. CyberOptics’ break-through MRS technology can be utilized for 3D automated optical inspection (AOI), and both 3D automated optical measurement (AOM) and 3D coordinate measurement (CMM) – far beyond a pass or fail inspection result. “We’re pairing our proprietary MRS sensor te

Scientist.com Partners with Top Pharma to Launch COMPLI™, a Global Compliance Standard for Human Biosample Acquisition21.9.2017 15:06Tiedote

Scientist.com, the world's leading marketplace for outsourced scientific services, today announced the launch of a global process for the ethical sourcing of human biosamples using its COMPLI™ functionality. Created in partnership with leading pharmaceutical companies, suppliers and biobank organizations such as the ESBB and UKCRC TCC, COMPLI™ introduces a common, comprehensive process and supply agreement supporting access to human biosamples. The goal is to enable biobanks and other well-known human sample suppliers to more easily connect with researchers in the pharmaceutical and biotech industries and academia. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170921005353/en/ “By simplifying and standardizing processes that previously took months, this initiative should shorten the research cycle and increase the pa

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