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

Del

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

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

Cancer Patients, Survivors, Supporters and Caregivers Undertake UAE's First Relay for Life19.11.2017 16:31Pressemelding

Sharjah, the third largest of the United Arab Emirate’s seven emirates, was the host for the MENA region’s first ever ‘Global Relay for Life,’ (RFL) a 24-hour walkathon that is the biggest fundraising event for cancer in the world. Conducted in conjunction with the American Cancer Society, the event was organised by Friends of Cancer Patients (FoCP), a non-profit organisation that supports cancer patients and their families. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171119005048/en/ During MENA's first Global Relay For Life walkathon - Source: Friends of Cancer Patients Taking place November 17-18 at the American University Sharjah, the inaugural UAE RFL saw more than 2,000 relayers participating in the overnight event, with a large number of individuals and institutions involved including 52 sch

New Data Show Benefit of Tagrisso in Patients with EGFR-mutated Non-small Cell Lung Cancer and Central Nervous System Metastases18.11.2017 23:00Pressemelding

AstraZeneca today presented new data from a subgroup analysis of the Phase III FLAURA trial, which explored osimertinib as 1st-line therapy in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). Results presented at the ESMO Asia 2017 Congress in Singapore showed that patients with central nervous system (CNS) metastases at baseline had a higher objective response rate with their brain metastasis and suggest a lower risk of CNS progression when treated with osimertinib, a third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI), versus current standard-of-care EGFR-TKIs (erlotinib or gefitinib) [Abstract LBA5].1 The analysis included patients with ≥1 measurable and/or non-measurable CNS lesion present on baseline scan (as assessed by blinded independent central review), accounting for 23

New England Journal of Medicine Publishes Results of Phase III FLAURA Trial in the 1st-Line Treatment of EGFR-mutated Non-small Cell Lung Cancer18.11.2017 18:20Pressemelding

AstraZeneca today announced that the New England Journal of Medicine has published the positive results from the Phase III FLAURA trial which provide data for Tagrisso’s (osimertinib) use in the 1st-line treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).1 The trial showed a statistically significant, clinically meaningful progression-free survival (PFS) advantage for osimertinib, a third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI), compared with current 1st-line EGFR-TKIs, erlotinib or gefitinib.1 This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171118005044/en/ Dr. Suresh S. Ramalingam, Principal Investigator of the FLAURA trial, from the Winship Cancer Institute

Much-Anticipated CHTF 2017 Top 10 Products Are Unveiled18.11.2017 09:11Pressemelding

The 19th China Hi-Tech Fair (CHTF 2017), with the theme of “Innovation-Driven Development and Supply Quality Upgrade”, is taking place from November 16 to 21 at Shenzhen Convention and Exhibition Center. On the afternoon of November 10, the CHTF 2017 Top 10 Products were unveiled at the awards ceremony by Mr. Gao Zimin, Vice Mayor of Shenzhen City. A total of 322 entries competed for the honor Top 10 Products, and the voting lasted nearly 3 months. 60 candidate products in the fields of new energy, 3D print, flexible display, life sciences, unmanned vehicles and AI were shortlisted by the organizer, experts and media representatives and went for open voting online. The final Top 10 Products all represent the most advanced technologies in their respective sectors: the water-making device that can make water out of air, the smart sportswear that can monitor heartbeat and other

Madison Realty Capital Provides $64.0 Million Construction Financing for 200 Kent Avenue Development in Williamsburg, Brooklyn17.11.2017 16:20Pressemelding

Madison Realty Capital (MRC) announced the closing of a $64.0 million construction loan for 200 Kent Avenue, a 117,326 square foot mixed-use development located in Williamsburg, Brooklyn. The retail portion of the property, which will include over 600 feet of frontage, will be anchored by a popular national grocery chain. Overall, the project will offer 50,101 square feet of retail space, 22,055 square feet of office and restaurant space, and 45,170 square feet of parking. “We continue to establish MRC as the one-stop shop for financing transitional real estate, including ground-up development deals like 200 Kent Avenue,” said Josh Zegen, Co-Founder and Managing Principal of MRC. “In this case, we’re working with a repeat MRC borrower who understands our ability to execute efficiently, given our firm’s up-to-the minute knowledge of local market conditions and non-bureaucratic approach to

Ncardia Announces Completion of €10.5M Investment Round17.11.2017 12:31Pressemelding

Ncardia, an emerging drug discovery and development stem cell technology company whose mission is to deliver cardiac and neural solutions based on its best-in-class human induced pluripotent stem cell (iPSC)-derived technology, today announced the completion of a €10.5 million series B financing round. The round was led by Épimède, a Belgium venture capital firm. Ncardia is a privately-held company with operations in Europe and the US, that produces and commercializes high-quality, fully-functional human iPSC-derived cardiovascular and neuronal cell types. Using its cell products, Ncardia develops and commercializes assay services for drug safety and efficacy testing. Additionally the company has built up a strong portfolio of patents covering the use of stem cell models for these applications. Stefan Braam, CEO of Ncardia, commented: “At Ncardia, important progress h

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

Besøk vårt presserom