Business Wire

Combination of Epacadostat plus Keytruda® (pembrolizumab) Demonstrates Activity in Clinical Trial of Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)

Jaa

Incyte Corporation (NASDAQ:INCY) today announced updated data from the advanced non-small cell lung cancer (NSCLC) patient cohort of 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). Data showed an overall response rate (ORR) of 35 percent (n=14/40) among all patients with advanced squamous and non-squamous NSCLC treated with the combination of epacadostat and pembrolizumab, irrespective of PD-L1 status. Findings will be highlighted in a poster discussion at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on Saturday, June 3, from 3:00 pm to 4:15 p.m. CDT (Location: Hall D2) (Abstracts #9014).

“These updated data suggest that the combination of epacadostat and pembrolizumab has promise for patients with advanced NSCLC, irrespective of PD-L1 status,” said ECHO-202 study investigator Tara Gangadhar, M.D., Assistant Professor of Medicine, Perelman School of Medicine at the Hospital of the University of Pennsylvania. “The results show a clinical benefit for patients with advanced lung cancer and establish a strong basis for progressing this novel, investigational immunotherapy combination into pivotal studies for the first-line treatment of these patients.”

Key Findings from the ECHO-202 NSCLC Cohort

Data at ASCO (as of February 27, 2017) show an ORR of 35 percent (n=14/40) among all patients with advanced NSCLC treated with the combination of epacadostat and pembrolizumab, with a complete response (CR) in two patients (5%) and partial response (PR) in 12 patients (30%). The data show a disease control rate (DCR) of 63 percent (n=25/40), with 71 percent (n=10/14) of responses ongoing at the time of the data cut-off (duration of response, range: 8.9 to 76.6+ weeks). Responses were observed in patients with high levels of PD-L1 expression [tumor proportion score (TPS) ≥50%], as well as in those patients with lower levels of PD-L1 expression (TPS of less than 50%). All responses were observed in the subgroup of patients with zero to two prior lines of therapy for advanced disease.

ECHO-202 Overall Response Rates (ORR), Disease Control Rates (DCR) and Durability of Response (DoR) in Advanced NSCLC
n/N
(%)
 

All pts

 

0-2 prior lines of therapy for advanced disease

  Total   Total   TPS ≥50%*   TPS <50%*
ORR n=14/40
(35)
 

n=14/36

(39)

  n=3/7
(43)
  n=6/18
(33)
  2 CR (5)

12 PR (30)

  2 CR (6)

12 PR (33)

  all PR   1 CR (6)

5 PR (28)

DCR   n=25/40
(63)
  n=23/36

(64)

  n=4/7
(57)
  n=10/18
(56)
DoR   10/14 responses ongoing

Median (range) duration of response: 26.9+ (8.9 to 76.6+) weeks

*Note: PD-L1 status was not available for 11 of the 36 patients.

Among patients treated with pembrolizumab in combination with epacadostat ≥100 mg twice daily, the ORR was 40 percent (n=14/35).

The most common treatment-related adverse events (TRAEs) for epacadostat plus pembrolizumab included fatigue (28%), arthralgia (17%), nausea (14%), decreased appetite (10%), pruritus (10%), and rash (10%). Grade ≥3 TRAEs that occurred in >1 patient were limited to lipase increased (n=3), fatigue (n=2), and rash (n=2). TRAEs led to discontinuation of treatment in 5 percent of study patients. The safety profile was consistent with previously reported Phase 1 findings, as well as the Phase 1/2 safety results in other tumor cohorts and pooled safety data from this study. In general, the safety profile of the combination was also consistent with pembrolizumab monotherapy.

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 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 of updated ECHO-202 data at ASCO, whether epacadostat and pembrolizumab may be an effective and safe treatment for NSCLC patients, 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 Corporation
Media
Catalina Loveman, +1 302-498-6171
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

More Firms Select Duco for Mandatory MiFID II Reconciliation19.10.2017 10:01Tiedote

Duco, the global provider of self-service data normalization and reconciliation services, today announced that a further three firms will be using Duco Cube, the company’s flagship reconciliation solution, for MiFID II reporting reconciliation. The firms include Redburn, Europe’s largest independent equities broker, and two global banks. Ranith de Silva, Operations Manager at Redburn, said: “MiFID II transaction data needs to undergo a number of enrichment processes between front office capture and the final report, which need to be replicated in the reconciliation process, covering large complex data sets. The quick deployment, flexibility and usability of Duco's self-service application enables us to efficiently build towards this reconciliation process with very little technical support.” Regular reconciliation is a mandatory requirement under MiFID II. The firms w

SIAE MICROELETTRONICA Successfully Tests The SDN Application iVeritas in Telefónica Deutschland’s SDN Live Wireless Network19.10.2017 10:00Tiedote

SIAE MICROELETTRONICA announces the successful deployment of iVeritas in Telefónica Deutschland's mobile backhaul as part of the TST project. Telefónica Deutschland Transport SDN Trial (TST), is a project whose long-term aim is offering value added services on future 5G network infrastructure in an SDN environment. As part of this project SIAE MICROELETTRONICA, a Telefónica long term supplier of wireless technology, deployed its new SDN application named iVeritas offering multivendor performance analytics and preventive maintenance analysis. iVeritas sits on top of the OpenDaylight transport SDN controller that through an SDN mediator interfaces to existing SNMP microwave links, the selected portion of the network was composed by links from three different vendors. iVeritas collected performance information from the links, correlating the data and presenting them acco

Rimini Street Expands Investment and Operations in Europe19.10.2017 01:00Tiedote

Rimini Street, Inc., (Nasdaq: RMNI), a global provider of enterprise software products and services, and the leading third-party support provider for Oracle and SAP software products, today announced the appointment of industry leader Marc Chesover as general manager of Europe, the Middle East and Africa (EMEA). The Company also announced the launch of its French subsidiary, hiring of new staff and opening of its new office in Paris, France. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171018006654/en/ Rimini Street Expands Investment and Operations in Europe (Photo: Business Wire) Enterprise Software Veteran Leads EMEA Operations Rimini Street’s new general manager, Marc Chesover, will lead the Company’s sales and service delivery operations across EMEA, and the next p

Kite’s Yescarta™ (Axicabtagene Ciloleucel) Becomes First CAR T Therapy Approved by the FDA for the Treatment of Adult Patients With Relapsed or Refractory Large B-Cell Lymphoma After Two or More Lines of Systemic Therapy19.10.2017 00:43Tiedote

Kite, a Gilead Company, (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted regular approval to Yescarta™ (axicabtagene ciloleucel), the first chimeric antigen receptor T cell (CAR T) therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (transformed follicular lymphoma, or TFL). Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171018006639/en/ CAR T therapy is a breakthrough in hematologic cancer treatment in which

IFF Launches Re-Imagine…™ Programs to Tap Unmet Consumer Opportunities, Speed Innovation18.10.2017 23:15Tiedote

Regulatory News: International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris:IFF), a leading innovator of sensory experiences that move the world, launched their Re-Imagine programs to accelerate innovation and increase agility to capture unmet opportunities in the changing food and beverage market. Based on a combination of future trends analysis, consumer insights, and a modernized cross-category development process, the programs guide the Company’s research and development efforts to ensure an innovation pipeline that addresses evolving consumer needs and desires. “The Re-Imagine programs area tangible expression of our commitment to advance taste for our customers – and consumers,” said IFF Chairman and CEO Andreas Fibig. “It is another way in which we show how we are dedicated to being our customers’ partner of choice as we progress on our business strategy, imbu

Sparkol Launches VideoScribe 318.10.2017 16:24Tiedote

Introducing VideoScribe Version 3 by Sparkol. Already used by over two million people across the world to create engaging explainer videos, Version 3 of the highly intuitive software comes packed full of new features, including: An improved user experience and slick UI - animate easier than ever before Enhanced search - find exactly the image you need in record time Intelligent image recommendations - focus your creativity on your video instead Smoother performance - maximum productivity when using the software VideoScribe customers include the world’s largest brands (HP, BBC, Sky and the University of British Columbia), businesses across every sector, leading education providers, award-winning teachers, charities, campaigners, and coun

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