Progression-Free Survival Data from ECHO-202 Trial of Incyte’s Epacadostat in Combination with Merck’s KEYTRUDA® (pembrolizumab) Underscore Durability of Response in Patients with Advanced Melanoma

Updated Data to be Presented at ESMO 2017 Congress

WILMINGTON, DE & KENILWORTH, NJ, USA I September 9, 2017 I Incyte Corporation (Nasdaq:INCY) and Merck (NYSE:MRK), known as MSD outside the United States and Canada, 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), Merck’s anti-PD-1 therapy, 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.

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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 KEYTRUDA® (pembrolizumab) Injection 100mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Studies of KEYTRUDA (pembrolizumab) – from the largest immuno-oncology program in the industry with more than 550 trials – include a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand factors that predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including the exploration of several different biomarkers across a broad range of tumors.

KEYTRUDA (pembrolizumab) Indications and Dosing

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma at a fixed dose of 200 mg every three weeks until disease progression or unacceptable toxicity.

Lung Cancer

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression [tumor proportion score (TPS) ≥50%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, as a single agent, is also indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

KEYTRUDA, in combination with pemetrexed and carboplatin, is indicated for the first-line treatment of patients with metastatic nonsquamous NSCLC. This indication is approved under accelerated approval based on tumor response rate and progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

In metastatic NSCLC, KEYTRUDA is administered at a fixed dose of 200 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

When administering KEYTRUDA in combination with chemotherapy, KEYTRUDA should be administered prior to chemotherapy when given on the same day. See also the Prescribing Information for pemetrexed and carboplatin.

Head and Neck Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. In HNSCC, KEYTRUDA is administered at a fixed dose of 200 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after three or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. In adults with cHL, KEYTRUDA (pembrolizumab) is administered at a fixed dose of 200 mg every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression. In pediatric patients with cHL, KEYTRUDA is administered at a dose of 2 mg/kg (up to a maximum of 200 mg) every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

KEYTRUDA is also indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

In locally advanced or metastatic urothelial carcinoma, KEYTRUDA is administered at a fixed dose of 200 mg every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

Microsatellite Instability-High (MSI-H) Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

  • solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
  • colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

In adult patients with MSI-H cancer, KEYTRUDA is administered at a fixed dose of 200 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression. In pediatric patients with MSI-H cancer, KEYTRUDA is administered at a dose of 2 mg/kg (up to a maximum of 200 mg) every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

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.

About Merck

For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world - including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.comand connect with us on TwitterFacebookInstagram, YouTube and LinkedIn.

SOURCE: Merck

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