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PHASE III TRIAL RESULTS OF EISAI’S ANTICANCER AGENT HALAVEN(R) IN SOFT TISSUE SARCOMA PUBLISHED IN THE LANCET

On February 12, 2016 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that the results of a Phase III clinical study (Study 309) of its in-house discovered and developed anticancer agent Halaven (eribulin mesylate) in patients with locally advanced, recurrent or metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma)1 have been published in the online version of The Lancet, a leading medical journal that is highly regarded worldwide (Press release, Eisai, FEB 12, 2016, View Source [SID:1234509044]).

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Halaven is the first and only single agent systemic therapy to demonstrate an improvement in overall survival (OS) in people previously treated for soft tissue sarcomas in a randomized controlled trial. In Study 309, which examined the efficacy and safety of Halaven versus dacarbazine in patients with locally advanced, recurrent or metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma) who had disease progression following standard therapies (including an anthracycline and at least one other additional regimen), Halaven demonstrated a statistically significant extension in the study’s primary endpoint of OS over the comparator treatment dacarbazine (Halaven median OS: 13.5 months vs dacarbazine median OS: 11.5 months; Hazard Ratio (HR) 0.77 [95% CI=0.62-0.95], p=0.0169).
In this study, the most common treatment-emergent adverse events (incidence greater than or equal to 25%) in patients treated with Halaven were fatigue, neutropenia, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia, which was consistent with the known side-effect profile of Halaven.

Halaven is a halichondrin class microtubule dynamics inhibitor with a novel mechanism of action. Recent non-clinical studies showed that Halaven is associated with increased vascular perfusion and permeability in tumor cores.2 Halaven promotes the epithelial state and decreases the capacity of breast cancer cells to migrate.3 It was first approved for the treatment of metastatic breast cancer in the United States in November 2010, and is currently approved for use in the treatment of breast cancer in approximately 60 countries including Japan and countries in Europe, the Americas and Asia.

In January 2016, Halaven was approved in the United States for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen, and applications seeking approval for use in the treatment of soft tissue sarcoma are currently under review in Japan and Europe. Halaven has been designated as an orphan drug for the treatment of soft tissue sarcoma in the United States and Japan.

Eisai remains committed to providing further clinical evidence for Halaven aimed at maximizing value of the drug as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

1. About Halaven (eribulin mesylate)
Halaven is a halichondrin class microtubule dynamics inhibitor with a novel mechanism of action. Structurally Halaven is a simplified and synthetically produced version of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai. Halaven is believed to work by inhibiting the growth phase of microtubule dynamics which prevents cell division. In addition, recent non-clinical studies showed that Halaven is associated with increased vascular perfusion and permeability in tumor cores.2 Halaven promotes the epithelial state and decreases the capacity of breast cancer cells to migrate.3
Halaven was first approved as a treatment in the United States in November 2010 for patients with metastatic breast cancer who have received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. Halaven is currently approved for use in the treatment of breast cancer in approximately 60 countries worldwide, including Japan and countries in Europe, Americas and Asia. In Japan, Halaven has been approved to treat inoperable or recurrent breast cancer and was launched in the country in July 2011. Halaven has also been approved in countries in Europe and Asia indicated as a treatment for patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.
Regarding soft tissue sarcoma, Halaven has been approved in the United States for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen, and applications seeking approval for use in the treatment of soft tissue sarcoma have been submitted in Japan and Europe. Halaven has been designated as an orphan drug for the treatment of soft-tissue sarcoma in the United States and Japan.

2. About Soft Tissue Sarcoma
Soft tissue sarcoma is a collective term for a diverse group of malignant tumors that occur throughout the soft tissue (fat, muscle, nerves, fibrous tissues and blood vessels) in the body. As the structures where the tumors originate are diverse, there are various types of soft tissue sarcoma, and the most common types include leiomyosarcoma, liposarcoma and malignant fibrous histiocytoma. Approximately 12,000 patients in the United States and 29,000 patients in Europe are diagnosed with soft tissue sarcoma each year. According to a patient survey conducted by Japan’s Ministry of Health, Labour and Welfare, there are approximately 4,000 patients with soft tissue sarcoma in Japan. While treatment of soft tissue sarcoma is focused on curative surgery, if the degree of malignancy is high, treatment then becomes a combination of chemotherapy and radiation therapy. As outcomes are poor for patients with advanced disease, it remains a disease with significant unmet medical need.

3. About Study 3091
Conducted primarily in Europe and the United States, Study 309 was a multicenter, open-label, randomized Phase III study comparing the efficacy and safety of Halaven versus dacarbazine in 452 patients (aged 18 or over) with locally advanced, recurrent or metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma) who had disease progression following standard therapies which must have included an anthracycline and at least one other additional regimen. Patients received either Halaven (1.4 mg/m2 administered intravenously on Day 1 and Day 8) or dacarbazine (850–1200 mg/m2 administered intravenously on Day 1) every 21 days until disease progression.
From the results for the study, Halaven demonstrated a statistically significant extension in the study’s primary endpoint of overall survival (OS) over the comparator treatment dacarbazine (Halaven median OS: 13.5 months vs dacarbazine median OS: 11.5 months; Hazard Ratio (HR) 0.77 [95% CI=0.62-0.95], p=0.0169). Furthermore, in the study’s secondary endpoint of progression-free rate at 12 weeks (PFR12wks), while there was a numerical difference in PFR12wks between the Halaven and dacarbazine arms (33% vs 29%), this was not statistically significant. Median progression-free survival was 2.6 months in both arms.
The most common adverse reactions (incidence greater than or equal to 25%) in patients treated with Halaven were fatigue, neutropenia, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia, which was consistent with the known side-effect profile of Halaven.

20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

(Filing, 20-F, Teva, FEB 11, 2016, View Source [SID:1234509047])

BIOCAD announces the first trastuzumab biosimilar approved by the Ministry of Health of the Russian Federation

On February 11 2016 Biocad reported that the trastuzumab biosimilar, to be marketed under the trade name HERtiCAD, is the first trastuzumab biosimilar to receive authorization from the Russian regulatory body (Press release, Biocad, FEB 11, 2016, View Source [SID1234527807]).

The market authorization of the trastuzumab biosimilar (fully developed and produced by BIOCAD) followed the results of a randomized multicenter clinical study comparing the pharmacokinetics, immunogenicity, safety, and efficacy of BCD-022 (trastuzumab biosimilar by BIOCAD) to the innovator Herceptin (F. Hoffmann-La Roche Ltd).

BIOCAD started development of trastuzumab biosimilar in 2010 in the context of a federal innovative project that was approved by the Presidential Commission on Modernization and Technological Advancement simultaneously with other two biosimilars of rituximab and bevacizumab, which were also registered in Russia in 2014 and 2015, respectively. The scope of the project included in-house development of mAb manufacturing technology, comprehensive characterization of developed biosimilars, and comparative non-clinical and clinical studies.

Dmitry Morozov, founder and CEO of BIOCAD, said, "In 2014, world sales of the original drug trastuzumab were over $6.8 billion. Russia’s government spent over 5 billion rubles (130 mln USD) for original medicine and there are still uncovered medical need of Russian patients in trastuzumab. The approval of trastuzumab biosimilar is definitely good news for patients who previously had limited access to advanced therapeutics, and in particular for those hindered by the extra high cost of antibody biopharmaceuticals.

Mr. Morozov expressed hope that domestic capacity for production of high-quality, high-value biosimilars for treating diseases with the most profound social effects will not only make the drugs more affordable, but also help make the Russian healthcare sector less dependent on foreign imports.

BIOCAD’s trastuzumab biosimilar is produced in a new, ultra-modern Neudorf facility set in a special economic development district outside St. Petersburg. The company has already registered two other biosimilars of rituximab and bevacizumab. Rituximab was the first mAb biosimilar approved in Russia under the trade name Acellbia and by now used in more than 6 000 patients with non-Hodgkin’s lymphoma and chronic lymphoid leukemia under federal reimbursement.

Neurocrine Biosciences Reports Year-End 2015 Results and Provides Investor Update for 2016

On February 11, 2016 Neurocrine Biosciences, Inc. (NASDAQ:NBIX) reported its financial results for the quarter and year ended December 31, 2015 (Press release, Neurocrine Biosciences, FEB 11, 2016, View Source;p=RssLanding&cat=news&id=2137766 [SID:1234509048]).

For the fourth quarter of 2015, the Company reported a net loss of $29.3 million, or $0.34 loss per share, compared to a net loss of $19.4 million, or $0.26 loss per share for the same period in 2014. For the year ended December 31, 2015, the Company reported a net loss of $88.9 million, or $1.05 loss per share, as compared to a net loss of $60.5 million, or $0.81 loss per share for 2014. The increase in net loss for the fourth quarter and full year results primarily from increased research and development expenses in connection with the Company’s advancing clinical stage pipeline, valbenazine pre-commercialization activities for tardive dyskinesia and higher share-based compensation expense as detailed below.

The Company’s balance sheet at December 31, 2015 reflected total assets of $474.8 million, including cash, investments and receivables of $464.3 million compared with balances at December 31, 2014 of $243.0 million and $232.6 million, respectively.

"We begin 2016 with positive top-line data from our partner AbbVie in the second Phase III study of elagolix in endometriosis coupled with the start of two Phase III studies of elagolix in uterine fibroids," said Kevin Gorman, Ph.D., President and Chief Executive Officer of Neurocrine Biosciences. "Recently we reported a highly positive Phase III study of valbenazine in tardive dyskinesia and now look forward to filing our valbenazine NDA for tardive dyskinesia with the FDA this year. We have also initiated two Phase II studies of valbenazine in Tourette syndrome with data on these expected around the end of the year. Additionally, we have NBI-640756, our drug candidate for essential tremor, in the clinic and we look to add yet another new compound to our clinical pipeline later this year."

Research and development expenses were $21.8 million during the fourth quarter of 2015, compared to $15.5 million for the same period in 2014. For the year ended December 31, 2015, research and development expenses were $81.5 million, compared to $46.4 million for all of 2014. The increase in research and development expense was due to higher external clinical development expenses and associated internal costs related to NBI-98854, which initiated Phase III development in the second half of 2014, as well as preparations for a potential New Drug Application filing in 2016. Additionally, year-to-date share-based compensation expense increased by $7.9 million from 2014 levels primarily due to performance-based restricted stock units.

General and administrative expenses increased from $5.0 million for the fourth quarter of 2014 to $8.9 million for the fourth quarter of 2015. For the year ended December 31, 2015 general and administrative expenses were $32.5 million, compared to $18.0 million for the prior year. The increase in general and administrative expense is primarily due to higher personnel related costs, including a $10.1 million increase in year-to-date share-based compensation expense primarily due to performance-based restricted stock units. Additionally, professional costs related to market research and pre-commercialization activities contributed to the overall increase in general and administrative expenses.

2016 Financial Guidance

The Company expects to have a cash burn of approximately $135 million to $145 million in 2016. The increase in cash burn from 2015 is primarily due to preparing for commercialization of valbenazine in tardive dyskinesia coupled with expansion and progression of the clinical pipeline. Revenues for 2016 are expected to be approximately $15 million. Expenses for 2016 should approximate $185 million to $195 million. The anticipated expenses include an estimated $30 million for share-based compensation expense.

Pipeline Highlights

Valbenazine Update

During the fourth quarter of 2015, the Company announced positive top-line results from the Kinect 3 study, a Phase III trial that included moderate to severe tardive dyskinesia in patients with underlying schizophrenia, schizoaffective disorder, bipolar or major depressive disorder. The Kinect 3 study randomized 234 subjects to either placebo, once-daily 40mg of NBI-98854 (valbenazine), or once-daily 80mg of valbenazine for six weeks of placebo-controlled dosing followed by an extension of active dosing through Week 48. The primary efficacy endpoint was the change-from-baseline in the Abnormal Involuntary Movement Scale (AIMS) at Week 6 in the 80mg once-daily dosing group compared to placebo as assessed by central blinded video raters. The AIMS ratings at Week 6 for the 80mg once-daily valbenazine intention-to-treat (ITT) population was reduced 3.1 points (Least-Squares Mean) more than placebo (p<0.0001). During the six-week placebo-controlled treatment period valbenazine was generally well tolerated. The frequency of adverse events was similar among all treatment groups and treatment emergent adverse effects were consistent with those of prior studies.

In addition to the ongoing safety assessment of Kinect 3, the Company is also conducting a separate one-year open-label safety study of valbenazine, Kinect 4, to support the anticipated 2016 filing of a New Drug Application of valbenazine in tardive dyskinesia. As announced previously, Neurocrine has received Breakthrough Therapy Designation from the FDA for valbenazine in the treatment of tardive dyskinesia.

The Company is also exploring valbenazine in Tourette syndrome. The initial Tourette’s clinical trial, the T-Force study, was an open-label, multi-dose, two-week evaluation of 28 subjects with Tourette syndrome. Children and adolescents enrolled in the trial are receiving a once-daily dose of valbenazine during a two-week treatment period to assess both the safety and tolerability of valbenazine. Valbenazine was generally safe and well tolerated. The Yale Global Tic Severity Scale was also assessed and after two weeks of treatment showed a mean reduction of 31% from baseline scores, with over half of the subjects considered clinical responders.

The Company recently announced the initiation of two Phase II Tourette syndrome studies evaluating valbenazine in adults and pediatrics, the T-Forward study and T-Force GREEN study, respectively.

The T-Forward study is a randomized, double-blind, placebo-controlled, multi-dose, parallel group, study of up to 90 adults. Subjects will receive once-daily dosing of valbenazine during an eight-week treatment period to assess the safety, tolerability and efficacy of valbenazine in adult Tourette patients. The primary endpoint of this study is a change from baseline of placebo vs. active scores utilizing the Yale Global Tic Severity Scale at the end of Week 8.

The T-Force GREEN study is a randomized, double-blind, placebo-controlled, multi-dose, parallel group, study of up to 90 children and adolescents. Subjects will receive once-daily dosing of valbenazine during a six-week treatment period to assess the safety, tolerability and efficacy of valbenazine in pediatric Tourette patients. The primary endpoint of this study is the change from baseline of the Yale Global Tic Severity Scale between placebo and active treatment groups at the end of week six.

Data from both of these Tourette studies is expected around year-end 2016.

Elagolix Update

AbbVie recently announced positive top-line results from the second of two Phase III clinical trials, the Solstice Study, a multinational study designed to evaluate the efficacy and safety of elagolix in 815 premenopausal women with endometriosis. The top-line results from this trial were consistent with those of the initial Phase III clinical trial, the Violet Petal Study, where after six months of treatment, both doses of elagolix (150 mg once-daily and 200 mg twice-daily) met the study’s co-primary endpoints of reducing scores of non-menstrual pelvic pain and menstrual pain (or dysmenorrhea) associated with endometriosis at month three, as well as month six, as measured by the Daily Assessment of Endometriosis Pain scale. The observed safety profile of elagolix in the Solstice study was consistent with observations from prior studies. Among the most common adverse events (AEs) were hot flush, headache, and nausea. While most AEs were similar across treatment groups some, such as hot flush and bone mineral density loss, were dose-dependent. AbbVie is targeting a 2017 New Drug Application filing with the FDA for elagolix in endometriosis.

In early 2016, AbbVie announced the initiation of the Phase III uterine fibroids program consisting of two replicate randomized, parallel, double-blind, placebo-controlled clinical trials evaluating elagolix alone or in combination with add-back therapy in women with heavy uterine bleeding associated with uterine fibroids. The studies are expected to enroll approximately 400 subjects each for an initial six-month placebo-controlled dosing period. At the end of the six-months of placebo-controlled evaluation, subjects are eligible to enter an additional six-month safety extension study. The primary efficacy endpoint of the study is an assessment of the change in menstrual blood loss utilizing the alkaline hematin method comparing baseline to month six. Additional secondary efficacy endpoints will be evaluated including assessing the change in fibroid volume and hemoglobin. Bone mineral density will be assessed via DXA scan at baseline, the conclusion of dosing, and six months post-dosing.

In September 2015, AbbVie announced positive top-line results from a Phase IIb clinical trial in women with heavy menstrual bleeding associated with uterine fibroids. The trial evaluated the safety and efficacy of elagolix alone or in combination with add-back therapy compared to placebo. Preliminary results showed that all of the elagolix treatment arms, with and without add-back therapy, reduced heavy menstrual bleeding as compared to placebo (p<0.001). Among the most common adverse AEs were hot flush, headache, nausea, and vomiting. Some AEs such as hot flush were more frequent in the elagolix only treatment arms as compared to the placebo and elagolix with add-back therapy treatment arms. Bone mineral density loss associated with elagolix alone was attenuated when elagolix was co-administered with add-back therapy.

Essential Tremor Program (NBI-640756) Update

NBI-640756 for patients with essential tremor was discovered in the Neurocrine laboratories. The Company has initiated a single site, randomized, double-blind, placebo-controlled, sequential dose-escalation, pharmacokinetic study assessing the safety and tolerability of a single dose of NBI-640756 in up to 32 healthy volunteers. The study is being conducted in multiple sequential cohorts of eight subjects per cohort. Top-line data from this Phase I study is expected in the first-half of 2016.

Incyte Reports 2015 Fourth-Quarter and Year-End Financial Results, Provides 2016 Financial Guidance and Updates Shareholders on Key Clinical Programs

On February 11, 2016 Incyte Corporation (Nasdaq: INCY) reported 2015 fourth-quarter and year-end financial results, highlighting strong revenue growth driven by increased Jakafi (ruxolitinib) sales in the U.S. as well as growing ex-U.S. Jakavi (ruxolitinib) royalties from Novartis. Additionally, Incyte provided financial guidance for 2016 (Press release, Incyte, FEB 11, 2016, View Source;p=RssLanding&cat=news&id=2137496 [SID:1234509039]).

Incyte’s strong position in the field of JAK inhibition is demonstrated by the ongoing commercial success of Jakafi and by the recent submissions, by Eli Lilly and Company, seeking regulatory approval of baricitinib for the treatment of rheumatoid arthritis. Baricitinib was licensed to Lilly by Incyte, and met the primary endpoint in all four of its global Phase 3 studies. If approved, Lilly expects to launch baricitinib in early 2017. In addition, epacadostat, Incyte’s first-in-class IDO1 inhibitor, is expected to enter Phase 3 during the first half of 2016 in first-line advanced or metastatic melanoma in combination with Merck & Co’s pembrolizumab. Multiple Phase 2, tumor-specific, expansion cohorts of epacadostat in combination with anti-PD-1 and anti-PD-L1 checkpoint modulators are also underway.

"The momentum of Jakafi, now into its fifth year of commercialization, continues to be strong, and, pending regulatory approval, we look forward to a second important source of revenue from baricitinib," stated Hervé Hoppenot, Incyte’s President and Chief Executive Officer. "Despite the outcome of the JANUS program, our development portfolio remains robust, comprised of 13 candidates against 10 molecular targets, demonstrating Incyte’s commitment to innovation and the productivity of our drug discovery and development engine."

2015 Fourth-Quarter and Full-Year Financial Results

Revenues For the quarter ended December 31, 2015, net product revenues of Jakafi were $182 million as compared to $106 million for the same period in 2014, representing 72 percent growth. For the full year ended December 31, 2015, net product revenues of Jakafi were $601 million as compared to $358 million for the same period in 2014, representing 68 percent growth. For the quarter and full year ended December 31, 2015, product royalties from sales of Jakavi outside of the United States received from Novartis were $24 million and $75 million, respectively, as compared to $15 million and $49 million, respectively, for the same periods in 2014. For the quarter ended December 31, 2015, contract revenues were $38 million as compared to $3 million for the same period in 2014. The $35 million increase in contract revenues for the quarter ended December 31, 2015 compared to the same period in 2014 relates to an increase in milestone payments earned from Novartis. For the full year ended December 31, 2015, contract revenues were $78 million as compared to $105 million for the same period in 2014. The $27 million decrease in contract revenues for the full year ended December 31, 2015 compared to the same period in 2014 relates to a decrease in milestone payments earned from Novartis. For the quarter ended December 31, 2015, total revenues were $244 million as compared to $124 million for the same period in 2014. For the full year ended December 31, 2015, total revenues were $754 million as compared to $511 million for the same period in 2014.

Year Over Year Revenue Growth

Research and development expenses Research and development expenses for the quarter and full year ended December 31, 2015 were $117 million and $480 million, respectively, as compared to $99 million and $348 million, respectively, for the same periods in 2014. Included in research and development expenses for the quarter and full year ended December 31, 2015 were non-cash expenses related to equity awards to our employees of $10 million and $40 million, respectively. The increase in research and development expenses was primarily due to the expansion of the Company’s clinical portfolio, including costs related to external alliances. Also included in research and development expenses for the full year ended December 31, 2015 was the one-time upfront payment to Agenus related to our license, development and commercialization agreement and the one-time upfront payment to Jiangsu Hengrui Medicine Co., Ltd. (Hengrui) related to our global license and collaboration agreement.

Selling, general and administrative expenses Selling, general and administrative expenses for the quarter and full year ended December 31, 2015 were $52 million and $197 million, respectively, as compared to $48 million and $166 million, respectively, for the same periods in 2014. Included in selling, general and administrative expenses for the quarter and full year ended December 31, 2015 were non-cash expenses related to equity awards to our employees of $8 million and $30 million, respectively. Increased selling, general and administrative expenses are driven primarily by additional costs related to the commercialization of Jakafi.
Unrealized loss on long term investment Unrealized loss on long term investment of $0 million and $5 million, respectively, for the quarter and full year ended December 31, 2015 represents the fair market value adjustments of the Company’s investment in Agenus.

Net income / (loss) Net income for the quarter ended December 31, 2015 was $55 million, or $0.30 per basic and $0.29 per diluted share, as compared to net loss of $37 million, or $0.22 per basic and diluted share, respectively, for the same period in 2014. Net income for the full year ended December 31, 2015 was $7 million, or $0.04 per basic and $0.03 per diluted share as compared to a net loss of $48 million, or $0.29 per basic and diluted share, for the same period in 2014.

Cash, cash equivalents and marketable securities position As of December 31, 2015, cash, cash equivalents and marketable securities totaled $708 million, as compared to $600 million as of December 31, 2014.

2016 Financial Guidance

Portfolio Update

JAK Inhibitors
A New Drug Application (NDA) and a Marketing Authorization Application (MAA) have been submitted by Lilly to the U.S. Food and Drug Administration and the European Medicines Agency, respectively, for baricitinib, a JAK1 / JAK2 inhibitor licensed by Incyte to Lilly. These submissions triggered $35 million (NDA, as previously disclosed) and $20 million (MAA) in milestone payment obligations from Lilly to Incyte. Incyte expects to recognize both in full in the first quarter of 2016. Incyte expects to earn global regulatory milestones and will also be eligible for royalties on global net sales of baricitinib.
As previously announced, the clinical development program investigating the hypothesis that JAK inhibition may benefit patients with solid tumors and high levels of systemic inflammation has been discontinued. All commercial activities with Jakafi, and all investigational activities of JAK inhibition outside this hypothesis, are unaffected.
Ongoing studies of ruxolitinib and selective JAK1 inhibitors in hematology indications will continue. Ongoing studies of selective JAK1 inhibition in solid tumor indications that are based on different hypotheses will also continue. These include a series of combination studies evaluating INCB39110, a selective JAK1 inhibitor, with either pembrolizumab (anti-PD-1 antibody), epacadostat (Incyte’s IDO1 inhibitor), or INCB50465 (Incyte’s PI3Kδ inhibitor) that will assess the therapeutic utility of JAK1 inhibition based on its effects on the tumor microenvironment. Additionally, the potential for JAK1 inhibition to improve the benefit of targeted therapies will be investigated via a Phase 1/2 study of INCB39110 plus osimertinib, AstraZeneca’s next generation EGFR inhibitor.
INCB39110 is also in a proof-of-concept trial for the treatment of patients with graft versus host disease.
Incyte’s second selective JAK1 inhibitor, INCB52793, is in a dose escalation study in patients with advanced malignancies. INCB52793 has shown synergistic efficacy in combination with standard of care in preclinical models of multiple myeloma.

IDO1 Inhibitor
The ECHO (Epacadostat Clinical development in Hematology and Oncology) program has been designed to investigate combinations of Incyte’s IDO1 inhibitor, epacadostat, across the full cycle of anti-tumor immunity, including with checkpoint blockade, vaccines and other modulators of the tumor immune response.
The Phase 3 ECHO-301 study evaluating the combination of epacadostat with the anti-PD-1 antibody pembrolizumab for the first-line treatment of patients with advanced or metastatic melanoma is expected to begin in the first half of 2016.
During 2016, Incyte expects to have recruited over 600 patients into Phase 2 expansion cohorts investigating the safety and efficacy of epacadostat in combination with anti-PD-1 and anti-PD-L1 agents.

Additional Programs
With two of our new programs expected to enter the clinic in the coming months, Incyte will have a total of 13 development molecules in pivotal and proof-of-concept trials across a variety of oncology and non-oncology indications. Below is a portfolio summary, in addition to Incyte’s JAK inhibitor franchise and its IDO1 inhibitor epacadostat.

About Jakafi (ruxolitinib)
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. Food and Drug Administration for treatment of people with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.

Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi (ruxolitinib) outside the United States.