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Incyte Corporation

Partner : Novartis ex. U.S.

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Scroll down to the Results sections (below) to see the outcome of this event.

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Paul A. Friedman, M.D., President and CEO, updated guidance for the INCB-18424 in myelofibrosis programs, COMFORT-I and COMFORT-II. He stated, "Beyond these accomplishments, we are especially looking to the completion of the two phase-III trials with 18424 in myelofibrosis. The controlled portion of the U.S. trial COMFORT-I has completed, and we expect to release the top-line results in the second half of December. Provided the results are positive, we intend to submit a new drug application in the first half of 2011. The European registration trial COMFORT-II, being conducted by Novartis, is also expected to be completed this year, and the MAA submission is planned in the first half of 2011."
Source: Q3 2010 earnings conference call, 11/09/10.

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Paul A. Friedman, M.D., President and CEO, updated guidance for the COMFORT-I and COMFORT-II phase III trial results. He stated, "Both phase III trials in Myelofibrosis patients have been fully enrolled for some time and the trials are progressing as planned. Release of the top-line results for the US trial COMFORT-I is still expected in December with full results for both COMFORT-1 and the European trial COMFORT-II for which Novartis now has responsibility, results from both those trials are likely to be formally presented at ASCO."
Source: Q2 2010 earnings conference call, 8/05/10.

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* Top-line results from COMFORT-I, the U.S. Phase III MF trial, are expected in December. Full results from COMFORT-I and COMFORT-II, the European Phase III trial being conducted by Novartis, are expected in mid-2011.
Source: press release, 8/05/10. http://investor.incyte.com/phoenix.zhtml?c=69764&p=irol-newsArticle&ID=1...

WILMINGTON, Del., Sep 13, 2010 (BUSINESS WIRE) -- Incyte Corporation (Nasdaq:INCY) announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase III trial for its JAK1 and JAK2 inhibitor, INCB18424 in patients with polycythemia vera (PV), a blood cancer that belongs to a group of diseases known as myeloproliferative neoplasms (MPNs). Two Phase III trials of INCB18424 in myelofibrosis, also an MPN, COMFORT-I and COMFORT-II, are already fully enrolled and are expected to be completed later this year.
Source: press release, 9/13/10. http://investor.incyte.com/phoenix.zhtml?c=69764&p=irol-newsArticle&ID=1...

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Paul A. Friedman, M.D., Chief Executive Officer, gave guidance for results from COMFORT-2 with INCB-18424. He stated, "The European phase III trial COMFORT-2 which called for 150 patients has also benefited from strong patient and physician interest and enrolled 219 patients. Novartis is now responsible for conducting this study and for presenting the results, most likely at EHA in June of next year."
Source: Q1 2010 earnings conference call, 5/06/10.

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Paul A. Friedman, M.D., President and CEO, commented on the phase III 18424 programs. He stated, "With respect to recent clinical developments and our 2010 objectives, I’m going to begin with the lead clinical program, Incyte 18424 for Myelofibrosis. The European Phase III trial, COMFORT-II, which began about two months before the U.S. trial is fully enrolled and includes over 200 patients. It’s a 48-week trial expected to complete late this year. Novartis is in the process of taking over COMFORT-II and will also have responsibility for the MAA filing, which they anticipate will occur in the second half of 2011. COMFORT-I, which is the U.S. Phase III trial, is expected to be fully enrolled before the end of the quarter. Our goal is to present the data at ASH in December and submit the NDA in early 2011."
Source: Q4 2009 earnings conference call, 2/18/10.

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Initiation of a second Phase III trial, COMFORT-II, in Europe began enrolling patients in July and is expected to enroll 150 patients in approximately 70 clinical sites.
Source: press release, 7/30/09. http://investor.incyte.com/phoenix.zhtml?c=69764&p=irol-newsArticle&ID=1...

COMFORT-II - Randomized Study of INCB018424 Tablets Compared to Best Available Therapy in Subjects With Primary Myelofibrosis, Post-Polycythemia Vera-Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis
Estimated Enrollment: 150
Study Start Date: July 2009
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT00934544?term=INCB18424&phase=2&ra...

Compound/DeviceSpecialtyIndicationCompound ClassTarget
Jakafi (Ruxolitinib) (INCB-18424) (oral) MyelofibrosisOncology HematologicMyelofibrosisJanus-associated Kinase InhibitorsJanus-associated Kinase

Mechanism of action: Jakafi (Ruxolitinib) (INCB-18424), a SM-inhibitor, reduces cell proliferation by disrupting the signaling of the Janus-associated kinases (JAK) pathway. Aberrant activation of the JAK-STAT pathway has been documented in a variety of cancers.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2010-12-01 - 2011-01-31

Results:

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Two Phase 3 Studies Reinforce Sustained Benefits of Treatment with Jakafi® (ruxolitinib) in Patients with Myeloproliferative Neoplasms (MPNs)
COMFORT-II data demonstrate that patients with myelofibrosis treated with Jakafi achieved a 33 percent reduction in the risk of death after five years
WILMINGTON, Del.--(BUSINESS WIRE)--Dec. 5, 2015-- Incyte Corporation (Nasdaq:INCY) announces data from two Phase 3 studies evaluating the long-term safety and efficacy of Jakafi® (ruxolitinib) in patients with Myeloproliferative Neoplasms (MPNs). In myelofibrosis (MF), results of a five-year follow-up from the COMFORT-II study demonstrate a continued survival benefit in patients originally randomized to ruxolitinib compared with patients randomized to best available therapy (BAT), with a 33 percent reduction in the risk of death (HR, 0.67; 95%CI, 0.44-1.02; P=.06). Because patients in the BAT arm had crossed over to receive ruxolitinib therapy (median 17 months after randomization), these data may suggest that earlier treatment with ruxolitinib may be associated with improved long-term survival in patients with intermediate-2 or high-risk MF. Additionally, 53 percent of patients treated with ruxolitinib (n=78/146) achieved at least a 35 percent reduction in spleen volume from baseline that was sustained over time (median duration 3.2 years).
“These data from the COMFORT-II study reinforce the positive and long-term clinical benefits seen in patients with myelofibrosis who are treated with Jakafi,” said Rich Levy, MD, Chief Drug Development Officer, Incyte. “The reduction in the risk of death and the sustained improvements in spleen volume are meaningful and important results for the community of patients with this rare blood cancer.”
An analysis of the RESPONSE study is also planned for presentation at ASH. Previously published results in the New England Journal of Medicine showed that treatment with ruxolitinib, compared to standard therapy improved hematocrit control and reduced spleen volume in patients with polycythemia vera (PV) who had an inadequate response to or had unacceptable side effects from hydroxyurea (HU). The data at ASH demonstrate that in patients with elevated white blood cell (WBC) counts at baseline, a greater proportion of patients in the ruxolitinib treatment arm (45%) achieved normalization of their WBC counts (achieving a WBC ≤10×109/L or a ≥50% reduction from baseline) compared to BAT (22%) or HU (9%) at week 32.
These data are scheduled for presentation at the 57th American Society of Hematology Annual Meeting taking place December 5-8, 2015 in Orlando, FL.
Results from the COMFORT-II Study
Data from a five-year follow-up of the COMFORT-II trial, a randomized, open-label Phase 3 study evaluating long-term safety and efficacy of ruxolitinib in patients with intermediate-2 or high-risk primary myelofibrosis, post-PV myelofibrosis, or post-ET myelofibrosis, allowing crossover from the BAT arm to ruxolitinib after 48 weeks upon protocol-defined progression, revealed that 53 percent of patients treated with ruxolitinib (n=78/146) achieved at least a 35 percent reduction in spleen volume from baseline while on treatment during the study. Additionally, approximately one-third of evaluable JAK2 V617F-positive patients had more than a 20 percent reduction in allele burden at 3.2 years (38%) and 3.7 years (31%). Patients treated with ruxolitinib also experienced improvements in bone marrow fibrosis (15.8%) with 32.2 percent reporting stable fibrosis scores.
Overall, 59 (40%) and 35 (48%) deaths were reported in the ruxolitinib and BAT arms, respectively. Median overall survival (OS) was not reached in the ruxolitinib arm and was 4.1 years in the group of patients originally receiving BAT. There was a 33 percent reduction in risk of death with ruxolitinib (HR, 0.67; 95 percent CI, 0.44-1.02; P=.06). The estimated probability of survival at 5 years was 56 percent with ruxolitinib and 44 percent with patients originally receiving BAT. At week 48, BAT patients were allowed to cross over to receive ruxolitinib upon protocol-defined progression and after week 48 all BAT patients, irrespective of their progression status, were allowed to crossover to receive ruxolitinib; therefore, a confounding effect on OS was observed. An analysis correcting for crossover will be presented.
Adverse events (AEs) were consistent with those reported in previous studies of ruxolitinib and there was no increase in the incidence of AEs with longer exposure to treatment.
COMFORT-II is scheduled for presentation as an oral session by Dr. Claire Harrison, Guy’s and St. Thomas’ NHS Foundation Trust, Guy’s Hospital, Saturday, December 5, 2015, 9:30-11:30 AM EST, Room W224.
Results from the RESPONSE Study
The RESPONSE trial is a Phase 3 open-label study evaluating long-term safety and efficacy of ruxolitinib in patients with PV compared to BAT who had an inadequate response to or had unacceptable side effects from HU. The analysis from RESPONSE to be presented at ASH shows that patients who received ruxolitinib had greater mean reductions in WBC counts compared with BAT or the HU subgroup of the BAT arm, and these reductions were maintained over time. In patients with baseline WBC counts ≥11×109/L, worsening WBC counts were observed in 10.8 percent of patients in the ruxolitinib arm versus 35.4 percent in the BAT arm (P=0.0002) and 47.8 percent in the HU subgroup (P<0.0001). In this same subgroup of patients with elevated WBC counts at baseline, a greater proportion of patients in the ruxolitinib arm (45%) normalized their WBC counts (achieving a WBC ≤10×109/L or a ≥50% reduction from baseline) compared with BAT (22%) or HU (9%) at week 32. The median time to achieve this response with ruxolitinib therapy was 8 weeks.
These data are scheduled for presentation as a poster session by Dr. Carole Miller, Saint Agnes Cancer Institute, Monday, December 7, 2015, 6:00-8:00 PM EST, Hall A.
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Source: press release, 12/05/15. http://incyte.com/press-releases/

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Incyte Drug Jakafi® (ruxolitinib) Improved Overall Survival in Phase III Trial of Patients with Myelofibrosis

New three-year COMFORT-II study data presented at the European Hematology Association (EHA) meeting show that patients treated with Jakafi experienced sustained reductions in spleen size and a 52 percent reduction in the risk of death relative to patients treated with best available therapy
COMFORT-II data also show that Jakafi continues to be well-tolerated after three years of treatment
Results from a Phase I/II study also presented at EHA offer evidence that long-term treatment with Jakafi may stabilize or reverse bone marrow fibrosis, a key marker of worsening disease in patients with myelofibrosis

STOCKHOLM--(BUSINESS WIRE)--Jun. 16, 2013-- Incyte Corporation (Nasdaq: INCY) today announced results from two ongoing clinical trials of Jakafi® (ruxolitinib), an oral JAK1 and JAK2 inhibitor that is FDA-approved for the treatment of patients with intermediate or high-risk myelofibrosis (MF), that were presented at the 18th Congress of the European Hematology Association (EHA) in Stockholm, Sweden. In a three-year follow-up analysis of the Phase III COMFORT-II study, treatment with Jakafi, which is marketed as Jakavi® by Novartis outside the United States, was associated with improved overall survival and sustained reductions in spleen size compared to best available therapy. In a separate exploratory analysis of bone marrow fibrosis data from an ongoing Phase I/II single-arm, open-label clinical trial, by 48 months of treatment, Jakafi stabilized or reversed fibrosis of the bone marrow in 56 percent and 22 percent, respectively, of patients with MF, a magnitude of an effect not seen historically with best available therapy.

“Results of these studies represent the continuing evolution in our understanding of the clinical benefits of Jakafi for patients with intermediate or high-risk myelofibrosis and further support my confidence that long-term treatment with Jakafi may modify this progressive and life-threatening blood cancer,” stated Srdan Verstovsek, M.D., Ph.D., Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center in Houston.

“Data from the Phase I/II study provide the first evidence that long-term treatment with Jakafi may stabilize or improve bone marrow fibrosis, a key marker of worsening disease in patients with myelofibrosis. These findings, in addition to what was presented at ASCO, provide a result not seen before with best available therapy, including hydroxyurea. Future studies should improve our understanding of the significance of these findings,” stated presenting author Hans Michael Kvasnicka, M.D., of the University of Frankfurt in Germany.
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Source: press release, 6/16/13. http://investor.incyte.com/phoenix.zhtml?c=69764&p=irol-newsArticle&ID=1...

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New Data for Jakafi® (ruxolitinib) Presented at the 2012 American Society of Hematology Annual Meeting

In long-term results from two randomized Phase III clinical trials (COMFORT-I and COMFORT-II), patients with myelofibrosis treated with Jakafi had improved survival over placebo and best available therapy, suggesting an overall survival benefit
Data from an ongoing Phase II trial suggest that long-term treatment with Jakafi may be a durably efficacious therapy for patients with polycythemia vera

Incyte to host a webcast for investors featuring key results on Monday, Dec. 10, at 8:45 p.m. EST

ATLANTA--(BUSINESS WIRE)--Dec. 10, 2012-- Incyte Corporation (Nasdaq: INCY) announced today that several analyses from clinical studies of Jakafi® (ruxolitinib) were presented at the 2012 American Society of Hematology (ASH) Annual Meeting from Dec. 8 to 11 at the Georgia World Congress Center in Atlanta. Jakafi, an oral Janus kinase (JAK) inhibitor, is FDA-approved for the treatment of patients with intermediate or high-risk myelofibrosis (MF).
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Source: press release, 12/10/12. http://investor.incyte.com/phoenix.zhtml?c=69764&p=irol-newsArticle&ID=1...

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First FDA-Approved Treatment for Myelofibrosis, Jakafi™ (ruxolitinib), Discussed in Multiple Presentations at 2011 ASH Annual Meeting

Incyte to host a webcast for investors featuring these results on Monday, December 12 at 7:00 p.m. PT

SAN DIEGO--(BUSINESS WIRE)--Dec. 12, 2011-- Incyte Corporation (Nasdaq:INCY) today announced that further analyses from the global, pivotal Phase III clinical program of Jakafi (ruxolitinib or INC424) are being presented at the 2011 American Society of Hematology (ASH) Annual Meeting.
Source: press release, 12/12/11. http://investor.incyte.com/phoenix.zhtml?c=69764&p=irol-newsArticle&ID=1...

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WILMINGTON, Del., Mar 15, 2011 (BUSINESS WIRE) --

COMFORT-II, the second pivotal Phase III trial of Incyte Corporation's (Nasdaq: INCY) investigational Janus kinase (JAK) inhibitor, ruxolitinib (INCB18424 or INC424), has met its primary endpoint of significantly reducing spleen size in patients with myelofibrosis (MF), when compared to best available therapy. This trial was conducted by Novartis as part of the Incyte-Novartis worldwide collaboration and license agreement for ruxolitinib, an oral JAK1 and JAK2 inhibitor.
Source: press release, 3/15/11. http://investor.incyte.com/phoenix.zhtml?c=69764&p=irol-newsArticle&ID=1...