Updated Data to be Presented at ESMO 2017
Congress
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 completingstudy treatment
maintainedongoing response at lastfollow-up
25/29 responses
ongoing
Duration of response:<1+ to 121+
weeks
3/4 patients completing studytreatment
maintained ongoingresponse at last follow-up
20/22 responses
ongoing
Duration of response:
<1+ to 81+ weeks
1/1 patient completing studytreatment
maintained ongoing responseat 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.
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IncyteMediaCatalina Loveman, +1
302-498-6171orInvestorsMichael Booth, DPhil, +1
302-498-5914
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