Business Wire

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

Del

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

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

FINEOS Announces Three New Customers in the Cloud14.12.2017 15:57Pressemelding

FINEOS Corporation, the market leading provider of core systems for Life, Accident and Health (LA&H) insurance, today announced three new customers who have acquired FINEOS as a cloud service. The three new FINEOS customers, based in the US, Sweden and Canada respectively, have licenced FINEOS for their group insurance core processing needs. FINEOS is partnering with Amazon Web Services (AWS), the world’s largest IaaS cloud provider, to deliver the FINEOS Software as a Service (SaaS) offering. FINEOS Insurance Cloud is designed for the specific compliance and security needs of the LA&H industry. With simple subscription pricing, a FastTrack implementation approach, 24 x 7 support and continuous upgrades, the FINEOS Insurance Cloud is the way forward for LA&H insurance core systems. Speaking about the cloud, Gartner has said “By 2020, a Corporate ‘

UniPrint Infinity Now Available in Epic App Orchard14.12.2017 15:52Pressemelding

UniPrint.net announced today that UniPrint Infinity software is now available in the Epic App Orchard Marketplace. Users can now take advantage of UniPrint Infinity’s secure release print suite which works with any printer, any device, and in any computing environment. UniPrint Infinity’s PDF-based Healthcare Printing Suite provides industry standard 256-bit data encryption and compression, high availability, archiving, and “follow-the-user” printing, resulting in increased security and compliance in addition to reduced print costs. Implementation of UniPrint Infinity is proven to reduce wait times and help desk calls. By improving workflows for doctors, nurses, and other healthcare providers, UniPrint Infinity allows healthcare staff to focus their attention on their most important task: providing better patient care. “Building upon our recent Imprivata SSO integrati

Abdullah bin Zayed Honors Winners of the Al Hassan Bin Ali Award 2017 as Part of the Fourth Annual Forum for Promoting Peace in Muslim Societies14.12.2017 15:19Pressemelding

His Highness Sheikh Abdullah bin Zayed Al Nahyan, Minister of Foreign Affairs and International Cooperation, hosted a ceremony to honor the ‘Egyptian Family House’, winner of the Imam Al Hassan bin Ali Award 2017, represented by Dr. Mahmoud Hamdi Zaqzouq, Secretary General, and His Eminence Anba Ermia, Assistant Secretary General. Also present were H.E Sheikh Nahyan bin Mubarak Al Nahyan, Minister of Tolerance and H.E Shaykh Abdallah Bin Bayyah, President of the Forum for Promoting Peace in Muslim Societies. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171214005883/en/ Left to right: H.E Sheikh Nahyan bin Mubarak Al Nahyan, Minister of Tolerance, H.H Sheikh Abdullah bin Zayed Al Nahyan, Minister of Foreign Affairs and International Cooperation, H.E Shaykh Abdallah Bin Bayyah, President of the Forum for Promoting Peace in Muslim

Kymeta Announces Commercial Availability of KĀLO™ Mobile Internet Access Services14.12.2017 15:00Pressemelding

Kymeta—the communications company making good on the promise of global, mobile connectivity—and Intelsat S.A. (NYSE:I)—operator of the world’s first globalized network—have announced that Kymeta KĀLO internet access is now available with broad initial geographic coverage. Kymeta is redefining how satellite services are purchased with KĀLO internet services, and making mobile communications as easy to buy as a mobile phone plan. KĀLO internet services, powered by the IntelsatOne® Flex network, deliver broad connectivity when paired with the world’s only commercially available flat panel, electronically-steered satellite terminals from Kymeta as well as other satellite terminal solutions. Kymeta™ KyWay™ terminals and mTennau7 antenna subsystem modules open new markets for the satellite industry and allow organizations that require high-bandwidth mobile internet access to do busine

BioVectra and Keryx Biopharmaceuticals Enter Agreement for Ferric Citrate Production Expansion14.12.2017 13:47Pressemelding

BioVectra Inc., an innovative global contract development and manufacturing organization (CDMO), today announced a long-term supply agreement with Keryx Biopharmaceuticals, Inc., to manufacture Ferric Citrate, the active pharmaceutical ingredient (API) in Auryxia® tablets, a medicine approved for the treatment of two common complications of chronic kidney disease. BioVectra Inc. brings over 45 years of contract development and manufacturing experience to the partnership, including working with Keryx to manufacture Ferric Citrate API since 2003. BioVectra will prepare for the anticipated growth in the long-term Ferric Citrate API supply needs by expanding production capacity at their headquarters facility in Charlottetown, PEI, Canada. “This partnership is a pivotal step in our journey as BioVectra. It is a shining example of the innovation, talent and determination we have

DoubleTree by Hilton Closes Out Milestone Year with 30+ New Hotels, 510 Hotels Worldwide14.12.2017 13:01Pressemelding

2017 was a monumental year for DoubleTree by Hilton, one of Hilton’s (NYSE: HLT) 14 market-leading brands, surpassing 500 hotels worldwide and introducing 30+ new hotels to guests around the world. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171214005385/en/ DoubleTree by Hilton Dubai - Business Bay (Photo: DoubleTree by Hilton) To close out the year, the brand recently welcomed an additional three hotels to its portfolio. With convenient locations, inspired design and thoughtful upscale amenities, these hotels are now delivering unparalleled hospitality to guests and visitors, all starting with the brand’s signature, warm DoubleTree Cookie welcome. DoubleTree by Hilton Neenah : This contemporary hotel, which recently completed a multimillion

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom