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
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 epacadostat doses)
Treatment-Naïve (epacadostat 100 mg BID)
|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
30/35 responses ongoing
Duration of response:
4/5 patients completing
Duration of response:
3/4 patients completing study
Duration of response:
<1+ to 81+ weeks
1/1 patient completing study
|Median PFS, months (90% CI)||
Not yet reached
|PFS rate, % (90% CI)||
65 (54, 74)
52 (40, 63)
49 (37, 60)
65 (53, 75)
52 (38, 64)
52 (38, 64)
64 (49, 76)
55 (39, 69)
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.
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.
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.
Catalina Loveman, +1 302-498-6171
Michael Booth, DPhil, +1 302-498-5914
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, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Pierre Fabre & Array BioPharma Announce a 62% Observed OS at One Year from the Phase 3 BEACON CRC Safety Lead-In of the Combination of Encorafenib, Binimetinib and Cetuximab in BRAF-Mutant CRC at the ESMO GI Congress23.6.2018 14:00 | Tiedote
Not intended for UK- and US-based media Pierre Fabre and its partner Array BioPharma Inc. today announced updated safety and efficacy results, including OS, from the safety lead-in of the Phase 3 BEACON CRC trial evaluating the triplet combination of encorafenib, a BRAF inhibitor, binimetinib, a MEK inhibitor and cetuximab, an anti-EGFR antibody, in patients with BRAF V600E -mutant metastatic colorectal cancer (CRC). The results showed that, at the time of analysis, the OS data were fully mature through 12.6 months and that the median OS had not yet been reached. The one-year overall survival rate for this cohort was 62%. These data were presented in an oral presentation on Saturday, June 23, at the ESMO 20th World Congress on Gastrointestinal Cancer in Barcelona, Spain. The median progression-free survival (mPFS) for patients treated with the triplet was 8 months [95% CI 5.6-9.3] and is similar between patients receiving one prior line of therapy and patients receiving two prior lines
Compelling Data for LONSURF® (trifluridine/tipiracil) in Metastatic Colorectal Cancer Presented at ESMO’s World Congress on Gastrointestinal Cancer by Servier and Taiho23.6.2018 11:10 | Tiedote
Servier and Taiho Pharmaceutical Co., Ltd. today announced that the TASCO-1 trial demonstrated promising results for LONSURF® (trifluridine/tipiracil) in combination with bevacizumab in patients with previously untreated metastatic colorectal cancer (mCRC) who are not suitable for intensive treatment, with a median progression-free survival (PFS) of 9.2 months (ranging from 7.6 to 11.5 months). A second non-comparative arm in the trial, evaluated the outcome of patients treated with the current standard of care of capecitabine in combination with bevacizumab. The median PFS of this arm was 7.8 months (ranging from 5.5 to 10.1 months). “Colorectal cancer is the third most common cancer in the world. While there has been some progress in treatment, there are still few options for patients with metastatic disease who are not suitable for intensive treatment,” said Professor Eric Van Cutsem, Head of Digestive Oncology at the University of Leuven, Belgium. “These compelling results suggest
Softomotive and Accelerate RPA Partner to Help Enterprises Achieve Faster Time to Value from RPA22.6.2018 18:13 | Tiedote
Softomotive, a world–class Robotic Process Automation (RPA) technology provider offering best time to value and affordability for all sizes and types of enterprises, is pleased to announce a strategic partnership with AccelerateRPA, a high calibre professional services provider of trained and certified RPA Consultants within Robotic Process Automation. This partnership means that customers and end users of Softomotive’s software, will have additional knowledgeable and professional guidance available to help achieve significant value quickly from their investment in RPA. Companies who are looking to implement Softomotive’s RPA product suite (WinAutomation and ProcessRobot software) will now have direct access to AccelerateRPA’s highly skilled consultants and Developers. Further, AccelerateRPA has also become a licensed reseller of Softomotive’s products, offering customers a single point of contact for delivering both RPA software and services. Ashley Hudson, Director of AccelerateRPA,
Ascend Performance Materials Announces Price Increase for Intermediate Materials22.6.2018 17:00 | Tiedote
Ascend Performance Materials announced today a price increase for its intermediate materials. The price increase will take effect globally on July 1, 2018, and includes the following terms: Material Price Increase Terms Hexamethylene diamine (HMD) $0.17/lb. • As contracts allow. • Non-contract business – price determined on an order-by-order basis. Acrylonitrile (AN) $0.20/lb. • As contracts allow. • Non-contract business – price determined on an order-by-order basis. Customers should contact their local sales representative for additional information. About Ascend Performance Materials Ascend Performance Materials is a global premium provider of high-quality plastics, fibers and chemicals and is the world’s largest integrated producer of PA66 resin. Headquartered in Houston, Texas, Ascend has eight global locations, including five fully-integrated manufacturing facilities located in the southeastern United States, all dedicated to the innovation and safe production of nylon 6,6. With
Different Countries, Different Customs: Get Ready for the Motorbike Holidays with Moto-tyres.co.uk22.6.2018 16:41 | Tiedote
Pack your bags, close the boot and get away on holiday? When you start your holidays on a motorcycle, you usually have to consider a few things more when getting ready for your trip. The right preparation is therefore a must. So that nothing stands in the way of a smooth journey, Moto-tyres.co.uk has put together some tips for your next trip. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180622005345/en/ Different countries, different customs: get ready for the motorbike holidays with Moto-tyres.co.uk (Photo: Business Wire) Whether a weekend trip or extended adventure, it all depends on the right equipment. Functional clothing, protectors and rain protection are a must on long trips. Wearing a suitable motorcycle helmet is a legal requirement almost everywhere. However, there are also very different rules and regulations for motorbike equipment and accessories depending on the destination, and you should familiarise yoursel
Boehringer Ingelheim bolsters biologics research and development with 230 million euro investment in new development center22.6.2018 15:00 | Tiedote
Today Boehringer Ingelheim announced a 230 million euro investment into a new Biologicals Development Center (BDC) at the company’s Research and Development site in Biberach, Germany during the foundation stone laying for the new center. “The BDC is another key building block supporting the company’s long-term strategy for increasing the pipeline’s share of biologicals. This is particularly driven by two of our core areas, immune oncology and immunology,” says Dr. Fridtjof Traulsen, Corporate Senior Vice President Development at Boehringer Ingelheim. “The share of new biological entities in Boehringer Ingelheim’s research pipeline has been consistently increasing over the past few years and has now reached forty percent.” The BDC will help to maximize synergies by integrating biologicals analytical and process development as well as manufacturing for clinical studies into one seamless unit, while at the same time increasing development capacity. Following a staggered launch beginning i
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