Combination of Epacadostat plus Keytruda® (pembrolizumab) Demonstrates Activity in Clinical Trial of Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)
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|
0-2 prior lines of therapy for advanced disease
|Total||Total||TPS ≥50%*||TPS <50%*|
2 CR (5)
12 PR (30)
2 CR (6)
12 PR (33)
1 CR (6)
5 PR (28)
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.
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.
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
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 tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Steeper Energy Announces EUR 50.6 M (DKK 377 M) Advanced Biofuel Project with Norwegian-Swedish joint venture Silva Green Fuel in Licensing Deal18.12.2017 10:00 | Tiedote
Steeper Energy, a Danish-Canadian clean-fuel company, is partnering with Silva Green Fuel, a Norwegian-Swedish joint venture, to construct a EUR 50.6 M (DKK 377M) industrial scale demonstration plant at a former pulp mill located in Tofte, Norway leading to a future commercial scale project. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171217005029/en/ Steeper will license its proprietary Hydrofaction™ technology to Silva, who will build the facility over the next 18 months. The demonstration plant will use woody residues as feedstock that are converted to renewable crude oil and, in turn, will be upgraded to renewable diesel, jet or marine fuel. Steeper’s Hydrofaction™ technology was selected by Silva after an exhaustive due diligence review of some 40 other technologies. Hydrofaction™ harnesses water
Yokogawa Develops N-IO Standard Field Enclosure and Control System Virtualization Platform18.12.2017 05:00 | Tiedote
Yokogawa Electric Corporation (TOKYO:6841) announces that it has developed an N-IO standard field enclosure and a control system virtualization platform. The enclosure is a weatherproof remote IO cabinet that stores IO devices used by the CENTUM(R) VP integrated production control system and the ProSafe(R)-RS safety instrumented system, and the virtualization platform enables the control of multiple virtual devices on a single server. By reducing the amount of time and effort to engineer a new system, these solutions help to both speed up project execution and reduce total cost of ownership (TCO). The N-IO standard field enclosure is scheduled to be released in February 2018, and the virtualization platform will be released in May 2018. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171217005010/en/ N-I
Celltrion Receives Positive CHMP Opinion for Herzuma® for Trastuzumab Biosimilar16.12.2017 01:13 | Tiedote
Celltrion, Inc. (KOSDAQ: 068270) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending that Herzuma® (trastuzumab biosimilar) be granted marketing authorization in the European Union (EU) for the treatment of patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification. The CHMP’s opinion will now be sent to the European Commission (EC) for final review. Herzuma® is a biosimilar to Herceptin®i, a breast cancer and gastric cancer treatment antibody biologic drug developed by Genentech and marketed by Roche. Herceptin® is a blockbuster drug which had worldwide sales of CHF 6.8 billionii (US$6.8 billion) in 2016, of which CHF 2.1 billioniii (US$2.1 billion) was in
Takeda and TiGenix announce that Cx601 (darvadstrocel) has received a positive CHMP opinion to treat complex perianal fistulas in Crohn’s disease15.12.2017 15:34 | Tiedote
Takeda Pharmaceutical Company Limited (TSE: 4502) (“Takeda”) and TiGenix NV (Euronext Brussels and NASDAQ: TIG) (“TiGenix”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), in conjunction with the Committee for Advanced Therapies (CAT), has adopted a positive opinion recommending a marketing authorization (MA) for investigational compound Cx601 (darvadstrocel). Cx601 is expected to be indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy.2 This recommendation marks the first allogeneic stem cell therapy to receive a positive CHMP opinion in Europe. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/201712
Bitcoin Romania and Twispay Announce Integration Partnership Providing Users with the Ability to Purchase Bitcoin with Bank Cards15.12.2017 15:21 | Tiedote
Bitcoin Romania, leading Eastern European Bitcoin exchange & brokerage firm, and Twispay, Swiss-owned European payment processor and FinTech pioneer, today announced the availability of a payment integration that allows a global clientele to acquire Bitcoin and Ethereum cryptocurrencies using Visa and Mastercard bank cards. Unprecedented in Romania, this is one of the first East-Central European integration partnerships that allow consumers to use their cards to purchase cryptocurrency. Until recently, investors could only acquire cryptocurrencies through bank transfers and cash deposits, but the volatility of cryptocurrency markets dictates the need for additional operational flexibility. Investors require faster, safer, more reliable, and more comfortable ways to complete purchases. “One minute can make the difference between a million lost and a million earned. That is pr
Upon Conclusion of the Fourth Annual Forum for Promoting Peace in Muslim Societies, Scholars and Intellectuals Visit the Louvre Abu Dhabi Museum15.12.2017 14:38 | Tiedote
A high-level delegation of dignitaries, scholars and intellectuals participating in the fourth annual Forum for Promoting Peace in Muslim Societies, visited the Louvre Abu Dhabi museum. The delegation was headed by H.E Mustafa Ceric, former Grand Mufti of Bosnia; alongside Sheikh Mohammad Mukhtar Ould Imbala, Head of Mauritania’s Fatwa & Grievances Supreme Council; H.E Amar Mirghani Hussein, Sudanese Minister of (religious) Guidance and Endowments; and H.E Salho Jay, Imam of the Juma Masjid in South Africa. The Forum was held in Abu Dhabi from 11-13 December 2017, with the participation of more than 700 scholars, intellectuals and religious dignitaries from around the world. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171215005255/en/ Group Photo of the Scholars and Intellectuals during their visit to the L
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