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|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|
Updated Data to be Presented at ESMO 2017
These results will be presented at the
“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
Key Findings from the ECHO-202 (KEYNOTE-037) Melanoma Cohort
Data at ESMO (as of
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.
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Forward-Looking Statement of
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
KEYTRUDA® is a registered trademark of