Business Wire

Progression-Free Survival Data from ECHO-202 Trial of Incyte’s Epacadostat in Combination with KEYTRUDA® (pembrolizumab) Underscore Durability of Response in Patients with Advanced Melanoma

Jaa

Incyte Corporation (Nasdaq:INCY) today announced updated data from the ongoing Phase 1/2 ECHO-202 trial (KEYNOTE-037) evaluating epacadostat, Incyte’s selective IDO1 enzyme inhibitor, in combination with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy marketed by Merck & Co., Inc., Kenilworth, NJ USA (known as MSD outside the United States and Canada), in patients with advanced melanoma. Among all patients with advanced melanoma, including treatment-naïve and treatment-experienced, data showed an overall response rate (ORR) of 56 percent (n=35/63) in patients treated with the combination of epacadostat and KEYTRUDA; median progression-free survival (PFS) was 12.4 months, with PFS rates of 65 percent at six months, 52 percent at 12 months, and 49 percent at 18 months. Results were generally consistent across dosing schedules of epacadostat combined with KEYTRUDA, including epacadostat 100 mg BID, the epacadostat dose being studied in the Phase 3 ECHO-301 trial.

These results will be presented at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid, Spain, in an oral presentation on Saturday, September 9 from 3-3:15 pm CEST (Location: Madrid Auditorium) (Abstract #1214O).

“The updated results of the ECHO-202 trial support earlier published findings, and continue to suggest that the novel immunotherapy combination of epacadostat plus KEYTRUDA has the potential to offer a favorable efficacy and safety profile for the treatment of patients with advanced melanoma,” said Omid Hamid, M.D., Chief of Translational Research and Immuno-Oncology and Director of Melanoma Therapeutics, The Angeles Clinic and Research Institute, Los Angeles, California. “Data have shown that combination immunotherapy can offer higher response rates and improved progression-free survival. These results show that this combination has demonstrated increased and durable response rates and improved progression-free survival, compared to what we would expect from KEYTRUDA alone, without sacrificing safety.”

Key Findings from the ECHO-202 (KEYNOTE-037) Melanoma Cohort

Data at ESMO (as of June 9, 2017) show an ORR of 56 percent among all patients with advanced melanoma treated with the combination of epacadostat and KEYTRUDA, with a complete response (CR) in nine patients (14%); partial response (PR) in 26 patients (41%); and stable disease (SD) in 10 patients (16%). Data also show a disease control rate (DCR) of 71 percent (n=45/63). Of the 35 responses to treatment, 30 were ongoing at the time of analysis; the median duration of response was 45 weeks (range: 1+ to 121+).

ECHO-202 Overall Response Rates (ORR), Disease Control Rates (DCR), Durability of Response (DoR), and Progression-Free Survival (PFS) in Advanced Melanoma Cohort
  All

Patients

(N=65)

Treatment-Naïve

(all epacadostat doses)

(N=54)

Treatment-Naïve (epacadostat 100 mg BID)

(N=39)

Per-protocol evaluable n (%) 1 n=63 n=53 n=38
ORR 35 (56) 29 (55) 22 (58)
9 CR (14)

26 PR (41)

10 SD (16)

7 CR (13)

22 PR (42)

9 SD (17)

3 CR (8)

19 PR (50)

6 SD (16)

DCR 45 (71) 38 (72) 28 (74)
18 PD or death (29)

2 not evaluable2

15 PD or death (28)

1 not evaluable2

10 PD or death (26)

1 not evaluable2

DoR

30/35 responses ongoing

 

Duration of response:
<1+ to 121+ weeks

 

4/5 patients completing
study treatment maintained
ongoing response at last
follow-up

25/29 responses

ongoing

 

Duration of response:
<1+ to 121+ weeks

 

3/4 patients completing study
treatment maintained ongoing
response at last follow-up

20/22 responses

ongoing

 

Duration of response:

<1+ to 81+ weeks

 

1/1 patient completing study
treatment maintained ongoing response
at last follow-up

Median PFS, months (90% CI) 12.4

(6.2, 23.8)

22.8

(6.2, 23.8)

Not yet reached

(4.2, NR)

PFS rate, % (90% CI) 6-month:

65 (54, 74)

 

12-month:

52 (40, 63)

 

18-month:

49 (37, 60)

6-month:

65 (53, 75)

 

12-month:

52 (38, 64)

 

18-month:

52 (38, 64)

6-month:

64 (49, 76)

 

12-month:

55 (39, 69)

 

18-month:

55 (39, 69)

1.   ≥1 post-baseline scan, or discontinuation or death before first post-baseline scan
 
2. Scan data not documented in the clinical trial database at time of data cutoff
 

The most common (≥10 percent) all grade treatment-related adverse events (TRAEs) were rash (46 percent), fatigue (43 percent), pruritus (29 percent), and arthralgia (17 percent). Grade ≥3 TRAEs were observed in 20 percent of patients; the most common were increased lipase (6 percent) and rash (5 percent). Four patients (6 percent) discontinued for TRAEs. No treatment-related deaths occurred. 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 KEYTRUDA (pembrolizumab) monotherapy.

About ECHO-202 (KEYNOTE-037)

The ECHO-202 study (NCT02178722) is evaluating the safety and efficacy of epacadostat, Incyte’s selective IDO1 enzyme inhibitor, in combination with 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 + KEYTRUDA 2 mg/kg IV Q3W and epacadostat 300 mg BID + KEYTRUDA 200 mg IV Q3W) and Phase 1 dose expansion (epacadostat 50, 100, and 300 mg BID + KEYTRUDA 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 are evaluating epacadostat in combination with PD-1 and PD-L1 inhibitors 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 KEYTRUDA in combination with epacadostat or placebo for the treatment of patients with unresectable or metastatic melanoma, is also ongoing and fully recruited. For more information about the ECHO clinical trial program, visit www.ECHOClinicalTrials.com.

About Epacadostat (INCB024360)

The immunosuppressive effects of indoleamine 2,3-dioxygenase 1 (IDO1) enzyme activity on the tumor microenvironment help cancer cells evade immunosurveillance. Epacadostat is an investigational, highly potent and selective oral inhibitor of the IDO1 enzyme. In single-arm studies, the combination of epacadostat and immune checkpoint inhibitors has shown proof-of-concept in patients with unresectable or metastatic melanoma, non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck and bladder cancer. In these studies, epacadostat combined with the CTLA-4 inhibitor ipilimumab or the PD-1 inhibitors KEYTRUDA or nivolumab improved response rates compared with studies of the immune checkpoint inhibitors alone.

Incyte Conference Call Information

Incyte will host an investor conference call and webcast at 17:00 CET (11:00 a.m. ET) on 9 September 2017—the call and webcast can be accessed via the Events and Presentations tab of the Investor section of www.incyte.com.

To access the conference call on Saturday 9 September 2017, please dial 877-407-3042 for domestic callers or +1-201-389-0864 for international callers. When prompted, provide the conference identification number, 13667084.

If you are unable to participate, a replay of the conference call will be available for 30 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is +1-201-612-7415. To access the replay you will need the conference identification number, 13667084.

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 whether the combination of epacadostat plus KEYTRUDA will offer a safe and effective treatment for patients with advanced melanoma and the phase 3 trial of epacadostat in combination with KEYTRUDA for the treatment of melanoma, 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 June 30, 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

düber Technologies Inc. Secures Funding for 15 Distribution Centers with $50 Million Agreement with Vacone Real Estate26.9.2017 23:59Tiedote

düber Technologies Inc., a software-as-a-service (SaaS) provider serving the cannabis industry, today announced it has signed a $50 million funding agreement with Vacone Real Estate for the acquisition, fit out and master lease for 15 cannabis distribution centers in Washington, Oregon, California, Nevada and Arizona. The deal will allow düber to expand operations to include 400,000 square feet of distribution space that will form the basis of the düber unified distribution technology platform. “At düber, we see an unmet market opportunity for cannabis producers, processors and retailers in key parts of the country,” said Glenn Ballman, founder of düber. “This expansion will allow us to serve our distribution and courier partners while continuing to expand our integrated, omnichannel, real-time platform to partners and consumers in key markets in the cannabis industry

Piraeus Bank Comments on Bank of Greece Audit26.9.2017 19:20Tiedote

In response to a query by the Hellenic Capital Markets Committee, Piraeus Bank notifies the investment community that, on 19 September 2017 and following our prior announcement regarding the same matter, we received a draft report for an audit conducted by the Bank of Greece in the course of an Annual Audit Plan. The audit commenced in February 2017, was concluded in July 2017, and focused on a review of the Bank’s procedures for the implementation of the regulatory framework, as well as risk management procedures and special credit issues. Piraeus Bank cooperated fully and constructively with the Bank of Greece during the audit process. Piraeus Bank will respond to the Bank of Greece within a specific timeline and the final report from the Bank of Greece is expected to follow. Piraeus Bank considers that the historic issues covered by the Bank o

Oxera Releases New Analysis on Europe’s Aviation Market, Revealing Increased Competition between Airports26.9.2017 19:13Tiedote

Oxera Consulting LLP has revisited the subject of airport competition in Europe, conducting research and analysis on the implications of recent market trends on the dynamics between airports and airlines in Europe. Oxera found that the European aviation market grew by 25% between 2010 and 2016, with key trends including the continuing rapid expansion of LCCs (low-cost carriers) and non-traditional hubs in the Middle East and Istanbul. These developments have contributed to an intensification of the rivalry between airports, across all channels through which they compete. With many of these trends now being long established, the competitive pressures on airports, of all sizes, across Europe are highly likely to endure and continue to develop, implying that regulators and government stakeholders will need to address this ‘new normal’. Andrew Meaney, Partner and H

RHÖN-KLINIKUM AG Diligently Presses Ahead with Digitalization26.9.2017 18:29Tiedote

RHÖN-KLINIKUM AG is forging ahead with the implementation of its digitalization strategy and is launching a new collaboration with Austrian enterprise search and big data provider Mindbreeze, a subsidiary of the publicly listed Fabasoft AG. The clinic group will use Mindbreeze’s AI-based (artificial intelligence) search engine technology. With this application ─ in the form of a medical cockpit ─ that has been further developed in close cooperation with RHÖN-KLINIKUM AG, the entire medical staff can orient themselves more quickly and their workload is immediately alleviated. “This new approach to medical information will help us to structure the increasing amount of data and then make the information analyzable and evaluable. This is another aspect in which digitalization presents a tangible, concrete benefit,” says Stephan Holzinger, CEO of the group. The medical cockpit is initially being

Before the winter season, Mytyres.co.uk presents: Europe’s most popular summer tyres in 201726.9.2017 18:14Tiedote

In 2017, Europe’s most popular summer tyres were the Continental PremiumContact 6, the Uniroyal Rainsport 3, and the Dunlop SportMaxx RT2. This is the result of a survey conducted by Mytyres.co.uk, the end-user online shop for tyres, car spare parts and accessories from Europe's largest Internet tyre wholesaler Delticom. The survey was conducted throughout July and August in twelve European countries. Nearly 2,600 visitors to the online store cast their votes before the end of the summer tyre season. They were able to choose from five models by leading brands. “Interestingly, the results show that throughout Europe, high-quality premium brand models are the most popular”, comments Thierry Delesalle from Mytyres.co.uk. “These brands rightly enjoy a good reputation, but these days attractive alternatives are also available in the low-cost quality tyre segment. This also applies to

Quadient Launches Alliances and ISV/Technology Partner Tracks of Partner Advantage Program26.9.2017 17:30Tiedote

www.quadient.com : Quadient, formerly GMC Software, the award-winning leader in Customer Communications Management (CCM), announced today the launch of the Alliances Partner and ISV/Technology Partner tracks of its Partner Advantage Program intended to engage, empower and enable all types of Quadient partners. The two tracks complete the four-track program, which began with the announcement in April 2017 of the Delivery Partner track, designed to provide seamless implementation services for Quadient’s customer base. It was followed by the launch of the Business Partner track in May 2017, which offers technology service providers access to new revenue opportunities. Companies approved to become certified Alliances Partners are system integrators/consultants that deliver services, implement and support the Quadient solutions they recommend to their customers. ISV/Technolo

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