Incyte to Present Diversified Development Portfolio and Opportunities for Accelerated Growth at 2018 Investor and Analyst Event
- Five late-stage oncology product candidates being developed in 15 different indications have the potential to significantly accelerate near-term revenue growth
- Pivotal REACH1 study of Jakafi® (ruxolitinib) in steroid-refractory acute GVHD met primary endpoint; sNDA submission expected in the third quarter of 2018
- Development programs for PD-1 antagonist and JAK1, FGFR and PI3Kδ inhibitors progressing as planned, with the first NDA submission for INCB54828 (FGFR) in cholangiocarcinoma expected in 2019
- Inflammation/autoimmunity portfolio highlighted by success of randomized study of topical ruxolitinib in mild-to-moderate atopic dermatitis
“The presentations today are intended to highlight our diversified
development portfolio and its potential to accelerate our top-line
growth in the near term,” said Hervé Hoppenot, Chief Executive Officer,
A live webcast of the 2018 investor and analyst event will begin at
COMFORT – Extending leadership in myeloproliferative neoplasms (MPNs)
Jakafi® (ruxolitinib) has transformed the lives of thousands
of patients with MPNs since it was launched in the U.S. in 2011.
However, there remain certain patients with MPNs that may have an
inadequate response to, or are unable to tolerate, Jakafi monotherapy at
its currently approved doses. These patients represent an R&D priority
for Incyte—clinical trials are ongoing to evaluate combination
strategies with Jakafi and
REACH – Jakafi (ruxolitinib, JAK1/JAK2) in steroid-refractory GVHD
earlier today, the REACH1 pivotal trial of ruxolitinib in
combination with corticosteroids for the treatment of patients with
steroid-refractory acute GVHD met its primary endpoint. Based on these
GRAVITAS –Itacitinib (JAK1) in steroid-naïve GVHD
Itacitinib is being developed for the treatment of patients with treatment-naïve GVHD. The GRAVITAS-301 study in newly-diagnosed acute GVHD is underway, with data expected in 2019. Additionally, a pivotal trial in newly-diagnosed chronic GVHD is being initiated, and a proof-of-concept trial in the prophylactic setting is already recruiting patients.
FIGHT – INCB54828 (FGFR) in cholangiocarcinoma and bladder cancer
Initial data from the FIGHT-202 trial evaluating INCB54828 in patients
with advanced cholangiocarcinoma are encouraging; showing promising
efficacy in patients with FGFR2 translocations.
Additionally, initial data from the FIGHT-201 trial of INCB54828 in patients with advanced bladder cancer with FGFR3 mutations or fusions are also encouraging, and a continuous dosing cohort has been added to this ongoing study.
CITADEL – INCB50465 (PI3Kδ) in non-Hodgkin lymphoma (
INCB50465 is being developed as a treatment for different forms of
POD1UM – INCMGA0012 (PD-1) in solid tumors
The POD1UM clinical development program for INCMGA0012 will include combination studies with internal candidates and monotherapy, single-arm, registration-directed studies in Merkel cell carcinoma, anal cancer and microsatellite instability (MSI)-high endometrial cancer, as well as other indications where PD-1 axis blockade is standard of care. Recruitment for these studies is expected to begin later this year, and initial data are expected in 2020.
TRuE-Derm – Topical ruxolitinib (JAK1/JAK2) in dermatology
The recently completed randomized trial of topical ruxolitinib in
patients with mild-to-moderate atopic dermatitis showed a significant
benefit over vehicle control; these data have been accepted for oral
presentation at the 27th
About Jakafi® (ruxolitinib)
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the
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
Important Safety Information
Jakafi can cause serious side effects, including:
Low blood counts: Jakafi® (ruxolitinib) may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you develop or have worsening symptoms such as unusual bleeding, bruising, tiredness, shortness of breath, or a fever.
Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.
Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions.
Increases in Cholesterol: You may have changes in your blood cholesterol levels. Your healthcare provider will do blood tests to check your cholesterol levels during your treatment with Jakafi.
The most common side effects of Jakafi include: low platelet count, low red blood cell counts, bruising, dizziness, headache.
These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.
Before taking Jakafi, tell your healthcare provider about: all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had tuberculosis (TB), or have been in close contact with someone who has TB, have or had hepatitis B, have or had liver or kidney problems, are on dialysis, had skin cancer or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change or stop taking Jakafi without first talking to your healthcare provider. Do not drink grapefruit juice while on Jakafi.
Women should not take Jakafi while pregnant or planning to become pregnant, or if breast-feeding.
Except for the historical information set forth herein, the matters set
forth in this presentation contain predictions, estimates and other
forward-looking statements, including without limitation statements
regarding: our ability to capitalize on potential opportunities for
additional growth, grow our top-line revenue quickly or at all and
develop any of the compounds in our development portfolio successfully;
the expectation that top-line growth could be accelerated by future
launches and the anticipated and possible timing of future NDAs and
sNDAs; our plans to extend our leadership in MPNs; our expectations for
revenue acceleration from multiple products and in new indications and
near-term product launches; our plans for development and clinical
trials of ruxolitinib in additional indications and for our other
product candidates, including the timing of clinical development and
availability and submission of data, and our expectations regarding the
pivotal nature of ongoing trials; and our expectations that we can
exploit our existing expertise and develop new products and product
candidates to address new and additional indications. These
forward-looking statements are based on our current expectations and are
subject to risks and uncertainties that may cause actual results to
differ materially, including unanticipated developments in and risks
related to: the effects of competition; unanticipated delays; further
research and development and the results of clinical trials possibly
being unsuccessful or insufficient to meet applicable regulatory
standards or warrant continued development; the ability to enroll
sufficient numbers of subjects in clinical trials; determinations made