Incyte to Highlight Data From its Oncology Portfolio at the 2024 ASCO Annual Meeting and EHA2024 Congress

Incyte (Nasdaq: INCY) today announced that several abstracts featuring data from its oncology portfolio will be presented at the upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting held May 31 – June 4 in Chicago, and at the European Hematology Association 2024 (EHA2024) Congress held on June 13-16 in Madrid, Spain, and virtually.

"The data being presented at ASCO and EHA demonstrates Incyte’s dedication to our comprehensive research approach to identifying new first and best in class treatments for cancer patients," stated Steven Stein, M.D., Chief Medical Officer at Incyte. "The research we're presenting emphasizes promise within our oncology pipeline in areas where there is a continued need for therapeutic development across a breadth of cancers."

Key abstracts accepted for presentation at ASCO and EHA include:

ASCO Abstracts

Abstracts will be available to registered attendees on the ASCO Congress platform beginning on May 23, 2024. Posters and slides will be available to registered attendees at the scheduled session start time.

Poster Presentations

INCB099280

A Phase 1 study of the Small-Molecule PD-L1 inhibitor INCB099280 in Select Advanced Solid Tumors: Updated Safety, Efficacy, and Pharmacokinetics (PK) Results (Abstract #2608. Session: Developmental Therapeutics—Immunotherapy. Saturday, June 1, 9:00 a.m. -12:00 p.m. ET)

INCB057643

Bromodomain and Extra-Terminal (BET) Inhibitor INCB057643 in Patients with Relapsed or Refractory Myelofibrosis (MF) and Other Advanced Myeloid Neoplasms: A Phase 1 Study (Abstract #6576. Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant. Monday, June 3, 9:00 a.m.-12:00 p.m. ET)

EHA Abstracts

Abstracts are available on the EHA2024 Congress platform and accessible for on-demand viewing until August 15, 2024.

Oral Presentations

Ruxolitinib

Analysis of Molecular Mechanisms and Predictive Biomarkers of Disease Transformation in Polycythemia Vera (Abstract #S217. Topic: Myeloproliferative Neoplasms – Biology & Translational Research. Friday, June 14, 8:45 a.m. – 10:00 a.m. ET)

Poster Presentations

Ruxolitinib

A Real-World Evaluation of Risk Factors for Disease Progression in Patients With Polycythemia Vera (PV) Enrolled in REVEAL (Abstract #P1047. Topic: Myeloproliferative Neoplasms - Clinical. Friday, June 14)

Ruxolitinib Treatment in Patients With Polycythemia Vera Reduces JAK2 Allele Burden and Improves Hematocrit Control and Symptom Burden (Abstract #P1049. Topic: Myeloproliferative Neoplasms - Clinical. Friday, June 14)

The Impact of New or Worsening Anemia on Clinical Outcomes in 2233 Patients With Myelofibrosis Treated With Ruxolitinib: Results From the Expanded-Access JUMP Study (Abstract #P1044. Topic: Myeloproliferative Neoplasms - Clinical. Friday, June 14)

High Rate of Disease Progression in Patients With Low-Risk Myelofibrosis (MF) Enrolled in the Prospective MOST Study (Abstract #P1053. Topic: Myeloproliferative Neoplasms - Clinical. Friday, June 14)

Progression to Myelofibrosis in Patients With Essential Thrombocythemia: An Analysis From the Prospective MOST Study (Abstract #P1030. Topic: Myeloproliferative Neoplasms - Clinical. Friday, June 14)

Zilurgisertib

ALK2 and JAK2 Inhibition for Improved Treatment of Anemia in Myelofibrosis Patients: Preclinical Profile of an ALK2 Inhibitor Zilurgisertib in Combination With Ruxolitinib (Abstract #P1019. Topic: Myeloproliferative Neoplasms - Biology & Transitional Research. Friday, June 14)

The Activin Receptor-Like Kinase-2 Inhibitor Zilurgisertib (INCB000928) as Monotherapy or With Ruxolitinib in Patients with Anemia Due to Myelofibrosis: Phase 1/2 Study Results (Abstract #P1060. Topic: Myeloproliferative Neoplasms – Clinical. Friday, June 14)

INCB057643

Bromodomain and Extra-terminal (BET) Inhibitor INCB057643 in Patients With Relapsed or Refractory Myelofibrosis (MF) and Other Advanced Myeloid Neoplasms: A Phase 1 Study (Abstract #P1065. Topic: Myeloproliferative Neoplasms – Clinical. Friday, June 14)

INCA033989

Efficacy of INCA033989 in Chronic and Advanced Forms of CALRdel52 and CALRins5 MPN models (Abstract #P1002. Topic: Myeloproliferative Neoplasms - Biology & Translational Research. Friday, June 14)

INCB160058

Preclinical Evaluation of INCB160058 – A Novel and Potentially Disease-Modifying Therapy for JAK2V617F Mutant Myeloproliferative Neoplasms (Abstract #P1028. Topic: Myeloproliferative Neoplasms - Biology & Translational Research. Friday, June 14)

Axatilimab

Axatilimab for Chronic Graft-Versus-Host Disease: Responses in Fibrosis-Dominant Organs in AGAVE-201 (Abstract #P1321. Topic: Stem Cell Transplantation – Clinical. Friday, June 14)

Pemigatinib

A Phase 2 Study of Pemigatinib (FIGHT-203; INCB054828) in Patients With Myeloid/Lymphoid Neoplasms With Fibroblast Growth Factor Receptor 1 Gene Rearrangement (Abstract #P1042. Topic: Myeloproliferative Neoplasms - Clinical. June 14)

Tafasitamab

CD19 Expression Persists in Diffuse Large B-Cell Lymphoma Patient Biopsies After Treatment With Tafasitamab (Abstract #P1234. Topic: Lymphoma Biology & Translational Research. Friday, June 14

EARLYMIND, a Retrospective, Multicentric Study in Real World Settings to Characterize the Efficacy of Tafasitamab-Lenalidomide in Transplant Ineligible Patients With Relapsed/Refractory Large B-cell Lymphoma (Abstract #P1214. Topic: Aggressive Non-Hodgkin Lymphoma – Clinical. Friday, June 14)

For full session details and data presentation listings, please see the ASCO (https://conferences.asco.org) and EHA2024 (https://ehaweb.org/congress) online programs.

About Jakafi^® (ruxolitinib)

Jakafi^® (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi^® (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States.

About Monjuvi^® (tafasitamab-cxix) [or Minjuvi^® (tafasitamab)]

Monjuvi^® (tafasitamab-cxix) [or Minjuvi^® (tafasitamab)] is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb^® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). MorphoSys and Incyte entered into: (a) in January 2020, a collaboration and licensing agreement to develop and commercialize tafasitamab globally; and (b) in February 2024, an agreement whereby Incyte obtained exclusive rights to develop and commercialize tafasitamab globally.

In the United States, Monjuvi^® (tafasitamab-cxix) received accelerated approval by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). In Europe, Minjuvi^® (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

XmAb^® is a registered trademark of Xencor, Inc.

Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the “triangle” design are registered trademarks of Incyte.

About Pemazyre^® (pemigatinib)

Pemazyre^® (pemigatinib) is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test*. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Pemazyre is also the first targeted treatment approved for use in the United States for treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.

In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy.

In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.

Pemazyre is marketed by Incyte in the United States, Europe and Japan.

Pemazyre is a trademark of Incyte Corporation.

About Incyte

A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia. For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube.

Incyte Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from Incyte’s clinical development pipeline, the promise presented by that pipeline, whether or when any development compounds or combinations will be approved or commercially available for use in humans anywhere in the world outside of the already approved indications in specific regions and Incyte’s goal of improving the lives of patients, contain predictions, estimates, and other forward-looking statements.

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: 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 and the ability to enroll subjects in accordance with planned schedules; determinations made by the FDA and regulatory agencies outside of the United States; the efficacy or safety of our products; the acceptance of our products in the marketplace; market competition; unexpected variations in the demand for our products and the products of our collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for our products; sales, marketing, manufacturing, and distribution requirements, including our ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional new products that become approved; and other risks detailed from time to time in our reports filed with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K and our quarterly report on Form 10-Q for the quarter ended March 31, 2024. We disclaim any intent or obligation to update these forward-looking statements.

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