FGFR1 antagonists(Fibroblast growth factor receptor 1 antagonists), FGFR2 antagonists(Fibroblast growth factor receptor 2 antagonists), FGFR3 antagonists(Fibroblast growth factor receptor 3 antagonists)

Therapeutic Areas

NeoplasmsCongenital DisordersDigestive System Disorders+ [6]

Active Indication

Advanced Bile Duct CarcinomaChromosome 8p11 myeloproliferative syndromeBile Duct Neoplasms+ [21]

Inactive Indication

Advanced cancerBreast CancerChromosomal translocation+ [9]

Originator Organization

Incyte Corp.

Active Organization

Incyte Biosciences Distribution BV

Incyte Corp.Incyte Biosciences International SARL

+ [4]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (17 Apr 2020),

FGFR2 positive Intrahepatic Cholangiocarcinoma

RegulationPriority Review (US), Breakthrough Therapy (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN), Orphan Drug (KR), Orphan Drug (AU), Conditional marketing approval (CN)

Structure/Sequence

Molecular FormulaC24H27F2N5O4

InChIKeyHCDMJFOHIXMBOV-UHFFFAOYSA-N

CAS Registry1513857-77-6

Clinical Trials associated with Pemigatinib

NCT06300528

/ Not yet recruitingPhase 2IIT

Pemi in R/R B-cell NHL: A Phase II Study of Pemigatinib in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphomas

The purpose of this clinical trial is to learn if the study drug pemigatinib is effective in treating patients with relapsed or refractory B-cell non-Hodgkin lymphomas.

Start Date01 Feb 2025

Sponsor / Collaborator

University of Utah

[+1]

NCT06728410

/ Not yet recruitingPhase 2IIT

A Phase II Study of Pemigatinib Plus Durvalumab (MEDI4736) in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement

This is a single arm phase II study of pemigatinib and durvalumab combination in patients with FGFR-2 fusion or rearrangement positive intrahepatic cholangiocarcinoma. Each cycle will be 3 weeks. Pemigatinib is administered at 13.5 mg orally daily 2 weeks on and 1 week off. Durvalumab is administered at 1500 mg intravenously once every 3 weeks. Subjects will require a visit with appropriate laboratory work prior to the start of each cycle. Disease assessment will occur every 9 weeks. Subjects will continue treatment until progression per RECIST 1.1, toxicity or subject/physician decision. A maximum of 24 months (about 35 cycles) of pemigatinib and durvalumab treatment from Cycle 1 Day 1 is allowed.

Start Date01 Jan 2025

Sponsor / Collaborator

Hoosier Cancer Research Network

[+3]

NCT06653777

/ Not yet recruitingPhase 2IIT

Phase II Trial Evaluating the Efficacy of Pemigatinib in Patients With Recurrent and/or Metastatic Solid Tumor Harboring a FGFR Alteration

Alterations in the fibroblast growth factor receptor (FGFR) gene are involved in the development of cancer. These anomalies are found at very variable frequencies (from less than 1% to around 10%) in cancers of the bile ducts, bladder, uterus, brain, ovary, lung, airways, digestive tract, breast, etc.
Pemigatinib is an anti-cancer drug that acts on cells with alterations in the FGFR gene. It is used in Europe to treat people with biliary tract cancer who carry a specific FGFR alteration.
However, in various clinical trials, pemigatinib has shown interesting activity in a number of patients with different cancers presenting with an alteration in the FGFR gene. This treatment could therefore be effective in several types of cancer where an alteration in the FGFR gene is detected.
The aim of this clinical trial is to learn if pemigatinib works to treat patients with recurrent and/or metastatic cancer (whatever the type of cancer excluding blood cancers and those already treated with pemigatinib) presenting an alteration in the FGFR gene.
Patients will:
* Take oral pemigatinig in 3-week cycles (every day for 2 weeks followed by one week without pemigatinib) as long as they benefit from it.
* Visit the clinic once every 3 weeks for checkups and tests during the treatment period
* Visit the clinic once every 3 months for checkups after stopping treatment for at least 12 months.

Start Date15 Dec 2024

Sponsor / Collaborator

UNICANCER

[+2]

100 Clinical Results associated with Pemigatinib

100 Translational Medicine associated with Pemigatinib

100 Patents (Medical) associated with Pemigatinib

188

Literatures (Medical) associated with Pemigatinib

01 Jan 2025·Med

If it is a solid tumor target, then it may be a hematologic cancer target: Bridging the great divide

Review

Author: Adashek, Jacob J ; Munoz, Javier L ; Kurzrock, Razelle

Tumor-agnostic US Food and Drug Administration approvals are transforming oncology. They include larotrectinib/entrectinib/repotrectinib (NTRK fusions), selpercatinib (RET fusions), dabrafenib/trametinib (BRAF^V600E mutations), pembrolizumab/dostarlimab (microsatellite instability), pembrolizumab (high tumor mutational burden), and trastuzumab deruxtecan (HER2 3+ expression) (all solid cancers). Pemigatinib is approved for FGFR1-rearranged myeloid/lymphoid neoplasms. The genomically driven tissue-agnostic approach has a strong biological rationale (cancer is a disease of the genome), yields remarkably high response rates, and provides drug access to patients with an unmet need (rare/ultra-rare malignancies). Despite the solid tumor focus, both solid and hematologic cancers can harbor identical driver molecular abnormalities and respond to cognate therapies. For example, BRAF^V600E and IDH1/2 mutations; ALK, FGFR, and NTRK fusions; PD-L1 amplification; and CD70 antigens are druggable in both solid and blood malignancies by gene-/immune-targeted therapies/chimeric antigen receptor T cells. Future biomarker-based tissue-agnostic basket studies/approvals should bridge the great divide and include both solid and hematologic cancers.

16 Dec 2024·Journal of biomolecular structure & dynamics

Computational identification and exploration of novel FGFR tyrosine kinase inhibitors for the treatment of cholangiocarcinoma

Article

Author: Mandal, Debasish ; Kaur, Amanpreet

Tyrosine kinase inhibitors are a specific drug class revolutionizing cancer treatment. FGFR (Fibroblast Growth Factor Receptor) is a member of the receptor tyrosine kinase family that has been involved in various alterations which have been increasingly recognized as critical molecular drivers in cholangiocarcinoma, a malignant tumor originating from bile duct epithelial cells. The paper focuses on stepwise computational investigations for the discovery of novel inhibitors of FGFR using pharmacophore modeling, virtual screening, docking, ADMET analysis, molecular dynamics, and knowledge-based structure-activity relationship. To begin with, we have considered a library of 120314868 compounds from the ZINC 15 database through pharmacophore modeling, which was narrowed down to 110 having binding affinity >-8.0 kcal mol^-1. The 110 compounds were analyzed using virtual screening and compared with the FDA-approved drug pemigatinib, which provided the 34 hits with binding affinities >-6.5 kcal mol^-1. Finally, the top 4 hits were considered for docking, and ADMET property analysis for drug-likeness. MD and MM-GBSA analysis were performed to predict the binding free energy of these chemicals and determine their stability. To gain insight into the structure and binding interactions of these compounds, knowledge-based SAR analyses were performed using their electrostatic potential maps computed with DFT. Several techniques were employed to build improved inhibitors based on these SAR, and they were then analyzed utilizing ADMET, MD studies, and MM-GBSA analyses. Finally, the results suggested that the identified four compounds and developed inhibitors from this current work can be employed effectively as prospective FGFR inhibitors for treating Cholangiocarcinoma.Communicated by Ramaswamy H. Sarma.

01 Dec 2024·International Journal of Clinical Oncology

Clinical utility of a comprehensive genomic profiling test for patient with advanced biliary tract cancer

Article

Author: Nosaka, Kisato ; Tanaka, Yasuhito ; Baba, Hideo ; Oda, Hisanobu ; Hayashi, Hiromitsu ; Miyamoto, Hideaki ; Shinriki, Satoru ; Narahara, Satoshi ; Yoshii, Daiki ; Nagaoka, Katsuya ; Fukubayashi, Kotaro ; Yoshinari, Motohiro ; Inada, Hiroki

BACKGROUND:

Biliary tract cancer (BTC) comprises a heterogeneous group of malignancies with poor prognosis because of the limited treatment options. With the recent advances of next generation sequencing technologies, comprehensive genomic profiling (CGP) tests have been widely introduced into daily clinical practice.

PATIENTS AND METHODS:

We performed a retrospective, multicenter, observation cohort study. The genomic and clinical data of 85 BTC patients, who underwent CGP testing from August 2021 to September 2023, were analyzed.

RESULTS:

There were 62 (73%) cases in which treatment recommendations were raised during expert meetings, including 34 intrahepatic cholangiocarcinoma (ICC), 20 extrahepatic cholangiocarcinoma (ECC) and 8 gall bladder carcinoma (GBC). The drug accessibility rate of the BTC patients was 15.3% (13 cases): ten ICCs, two ECCs, and one GBC. Five ICC patients (three male and two female) with the FGFR2 fusion gene were treated with pemigatinib. Those patients who received a genomically matched therapy had significantly longer median overall survival than those patients who not received. (n = 13; not reached [95% CI not reached-not reached] vs n = 72; 8.6 months [95% CI 6.6-10.0]; hazard ratio 0.24 [95% CI 0.12-0.49], p = 0.013). The median observation period of pemigatinib treatment was 15.4 months (range 10.1-27.4). The responses were classified as PR in three patients, SD in one patient and PD in one patient. The median progression free survival is 9.0 months. No patient had grade 3/4 AEs requiring discontinuation of the treatment.

CONCLUSION:

The drug accessibility rate of ICC is high and pemigatinib is effective and well-tolerated in ICC patients harboring FGFR2 gene fusions.

157

News (Medical) associated with Pemigatinib

03 Jan 2025

·www.prnewswire.com

Innovent Announces Second New Drug Application of DOVBLERON ® (Taletrectinib Adipate Capsule, ROS1 Inhibitor) was Approved by China's National Medical Products Administration

SAN FRANCISCO and SUZHOU, China, Jan. 2, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, today announced that China's National Medical Products Administration (NMPA) has approved the second New Drug Application (NDA) of DOVBLERON® (taletrectinib adipate capsule), a next-generation ROS1 tyrosine kinase inhibitor (TKI), for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. The approval is based on positive results from the pivotal Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated the safety, tolerability and efficiency of taletrectinib in Chinese patients with advanced ROS1-positive NSCLC. The findings, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology (JCO), demonstrated that taletrectinib continued to show high and durable overall responses and robust activity against intracranial lesions. In ROS1 TKI-naïve (n=106) patients, confirmed objective response rate (cORR, as assessed by an independent review committee, IRC) and intracranial cORR reached as high as 91% and 88%, respectively. After median follow-up of 23.5 months in TKI-naïve patients, median duration of response (IRC-assessed) and median progression-free survival (IRC-assessed) were not reached. [Link] In December 2024, DOVBLERON® was approved by the NMPA for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs. DOVBLERON® is the 13th addition to Innovent's commercial portfolio, representing an innovative precision therapy expected to benefit more lung cancer patients alongside our strong TKI franchise. Caicun Zhou, M.D., Ph.D., Director of the Department of Oncology at Shanghai East Hospital, Tongji University, commented: "We are glad to see that DOVBLERON® has been approved for ROS1-positive NSCLC across treatment lines at a fast pace. DOVBLERON® demonstrated superior efficacy compared to the first-generation TKIs. These TRUST-I results reinforce taletrectinib's high overall response and prolonged PFS. The efficacy and safety profile of DOVBLERON® offers a more effective first-line treatment option and I look forward to its benefit in the ROS1-positive NSCLC patients in China." Dr. Hui Zhou, Senior Vice President of Innovent, stated: "The two NDAs approval of DOVBLERON® is a reflection of its potential best-in-class efficacy to fulfill the urgent need of patients with ROS1-positive NSCLC. We recently just launched the first batch of DOVBLERON® to market, rapidly bringing this precision therapy to NSCLC patients who need novel treatment options. Innovent's robust TKI product pipeline—including RETSEMOV®, PEMAZYRE®, DUPERT® and DOVBLERON®—showcases our leadership and synergistic strengths in precision oncology. We endeavor to advance more innovative medicines to enhance patients' quality of life." About ROS1-positive Non-small Cell Lung Cancer Lung cancer continues to have one of the highest global incidences and mortality rates, with NSCLC accounting for about 85% of all cases. In China, it is estimated that approximately 2.6% of patients living with NSCLC are ROS1-positive[i]. Despite recent progress for patients with ROS1-positive NSCLC, there remains a need for more effective and tolerable treatment options. In patients with metastatic ROS1-positive NSCLC that progressed following initial treatment, many have tumors spread to their brain (up to 55%) or acquired resistance mutations, including G2032R. Next-generation ROS1 TKIs demonstrated robust intracranial and G2032R activity. In the clinical management of ROS1-positive NSCLC patients, the first-line application of the new generation ROS1 TKIs can bring a prolonged progression-free survival and provide patients with greater survival benefits. About DOVBLERON ® (Taletrectinib Adipate Capsule) DOVBLERON® is an oral, potent, central nervous system-active, selective, next-generation ROS1inhibitor. Taletrectinib, the active ingredient in DOVBLERON® is being evaluated for the treatment of patients with advanced ROS1-positive NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study. DOVBLERON® was approved by China's National Medical Products Administration (NMPA): 1) for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who have previously been treated with ROS1 TKIs; 2) for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. Taletrectinib has been granted Orphan Drug Designation by the U.S. FDA for the treatment of patients with ROS1-positive NSCLC and other NSCLC indications, and Breakthrough Therapy Designations by both the U.S. FDA and China's NMPA for the treatment of patients with locally advanced or metastatic ROS1-positive NSCLC. Based on pooled results of the TRUST-I and TRUST-II clinical studies, Nuvation Bio Inc. (NYSE: NUVB) submitted an NDA for taletrectinib to the U.S. FDA for the treatment of patients with advanced ROS1-positive NSCLC (line agnostic, full approval). This NDA was accepted by the U.S. FDA for priority review in December 2024. In June 2021, Innovent and AnHeart Therapeutics (Hangzhou) Co. Ltd., a Nuvation Bio Inc. company, entered into an exclusive license agreement for the co-development and commercialization of taletrectinib in Greater China, including mainland China, Hong Kong, Macau and Taiwan. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 13 products in the market. It has 4 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. References [i] Zhang et al. Prevalence of ROS1 fusion in Chinese patients with non-small cell lung cancer. Thorac Cancer. 2019 Jan;10(1):47-53. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Orphan DrugDrug ApprovalLicense out/inPhase 2Breakthrough Therapy

20 Dec 2024

·www.prnewswire.com

Innovent Receives Approval of DOVBLERON® (Taletrectinib Adipate Capsule, ROS1 Inhibitor) by China's National Medical Products Administration

SAN FRANCISCO and SUZHOU, China, Dec. 20, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, today announced that China's National Medical Products Administration (NMPA) has approved a New Drug Application (NDA) of DOVBLERON ® (taletrectinib adipate capsule), a next-generation ROS1 tyrosine kinase inhibitor (TKI), for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs. DOVBLERON® marks the 13th addition to Innovent's commercial portfolio, representing an innovative precision therapy expected to benefit more lung cancer patients alongside our strong TKI franchise. Lung cancer continues to have one of the highest global incidences and mortality rates, with NSCLC accounting for about 85% of all cases. In China, it is estimated that approximately 2.6% of patients living with NSCLC are ROS1-positive[i]. Furthermore, brain metastases are a common challenge, affecting up to 35% of patients newly diagnosed with metastatic ROS1-positive NSCLC, and increasing to as much as 55% of patients whose cancer has progressed following initial treatment. In addition, patients treated with approved ROS1 TKIs often develop resistance mutations to these therapies, representing a major limitation for patients in terms of duration of response. The approval of DOVBLERON® provides a new and effective treatment option for patients who are no longer responding to previously approved therapies. The approval is based on positive results from the pivotal Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated taletrectinib in Chinese patients with advanced ROS1-positive NSCLC. The findings, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology (JCO), demonstrated the potential of DOVBLERON® to address unmet needs, particularly in patients with limited therapeutic options after treatment with prior ROS1-targeted therapies. [Link] In addition, a second NDA for DOVBLERON® was accepted and granted Priority Review Designation by China's NMPA in March 2024 for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who have not previously been treated with ROS1 TKIs. Caicun Zhou, M.D., Ph.D., Director of the Department of Oncology at Shanghai East Hospital, Tongji University, commented: "The treatment landscape for advanced ROS1-positive NSCLC remains challenging, especially for patients with brain metastases, who account for more than half of patients who have progressed following initial treatment with a ROS1 TKI, as well as those patients who develop resistance mutations. DOVBLERON® demonstrated significant therapeutic effects on brain lesions, as well as efficacy in crizotinib-resistant patients. Moreover, DOVBLERON® has a favorable safety profile and tolerability with low rates of dose reduction and treatment discontinuation due to adverse events. The efficacy and safety profile of DOVBLERON® offers a new hope for patients and I look forward to its benefit in the ROS1-positive NSCLC patients in China ." Dr. Hui Zhou, Senior Vice President of Innovent, stated: "The approval of DOVBLERON® is a reflection of its potential best-in-class efficacy and safety profile, as demonstrated in the TRUST-I trial. We are delighted about the approval of DOVBLERON® and will bring this precision therapy to NSCLC patients who need novel treatment options. Innovent's robust TKI product pipeline—including RETSEMOV®, PEMAZYRE®, DUPERT® and DOVBLERON®—showcases our leadership and synergistic strengths in precision oncology. We endeavor to advance more innovative medicines to enhance patients' quality of life." About ROS1-positive Non-small Cell Lung Cancer Lung cancer continues to have one of the highest global incidences and mortality rates, with NSCLC accounting for about 85% of all cases. In China, it is estimated that approximately 2.6% of patients living with NSCLC are ROS1-positive Up to 35% of patients newly diagnosed with metastatic ROS1-positive NSCLC have tumors that spread to their brain, increasing to as much as 55% for those whose cancer has progressed following initial treatment. Despite recent progress for patients with ROS1-positive NSCLC, there remains a need for more effective and tolerable treatment options. About DOVBLERON® (Taletrectinib Adipate Capsule) DOVBLERON® is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1-positive NSCLC. Taletrectinib, the active ingredient in DOVBLERON® is being evaluated for the treatment of patients with advanced ROS1-positive NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II(NCT04919811), a global study. In December 2024, DOVBLERON® was approved by China's National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who have previously been treated with ROS1 TKIs. In addition, a second NDA for taletrectinib was accepted and granted Priority Review Designation by China's NMPA for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who have not previously been treated with ROS1 TKIs. Taletrectinib has been granted Orphan Drug Designation by the U.S. FDA for the treatment of patients with ROS1-positive NSCLC and other NSCLC indications, and Breakthrough Therapy Designations by both the U.S. FDA and China's NMPA for the treatment of patients with locally advanced or metastatic ROS1-positive NSCLC. Based on pooled results of the TRUST-I and TRUST-II clinical studies, Nuvation Bio Inc. (NYSE: NUVB) submitted an NDA for taletrectinib to the U.S. FDA for the treatment of patients with advanced ROS1-positive NSCLC (line agnostic, full approval). In June 2021, Innovent and AnHeart Therapeutics (Hangzhou) Co. Ltd., a Nuvation Bio Inc. company, entered into an exclusive license agreement for the co-development and commercialization of taletrectinib in Greater China, including mainland China, Hong Kong, Macau and Taiwan. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 13 products in the market. It has 4 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. References SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/inPhase 2Breakthrough TherapyOrphan DrugDrug Approval

25 Nov 2024

·www.businesswire.com

Incyte to Spotlight New Data, Including a Late Breaking Oral Presentation for Tafasitamab in Follicular Lymphoma, at the 2024 ASH Annual Meeting

WILMINGTON, Del.--( BUSINESS WIRE )--Incyte (Nasdaq: INCY) today announced that the Company will present new data from across its oncology portfolio at the 2024 American Society of Hematology (ASH) Annual Meeting in San Diego. “These data illustrate our innovative approach that aims to identify new and best-in-class treatments for patients with a range of cancers,” said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. “At ASH, we’re presenting comprehensive data from our Phase 3 inMIND trial in relapsed or refractory follicular lymphoma. This late-breaking presentation provides valuable insights into the potential role of tafasitamab in improving outcomes for FL patients who currently face limited effective treatment options.” Details on key abstracts accepted for presentation include: ASH Abstracts Late-Breaking Oral Presentation Tafasitamab Tafasitamab Plus Lenalidomide and Rituximab for Relapsed or Refractory Follicular Lymphoma: Results from a Phase 3 Study (inMIND) Session: Late-Breaking Abstracts Session. Publication Number: LBA-1. December 10, 10:30 a.m. ET (7:30 a.m. PT). Oral Presentations Axatilimab Dynamics of Overall and Organ-Specific Responses to Axatilimab in Chronic Graft-Versus-Host Disease: Analysis from the AGAVE-201 Study Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Predicting and Treating Acute and Chronic GVHD. Publication Number: 98. December 7, 12:45 p.m. ET (9:45 a.m. PT). INCB057643 Safety and Efficacy of Bromodomain and Extra-Terminal Inhibitor INCB057643 in Patients with Relapsed or Refractory Myelofibrosis and Other Advanced Myeloid Neoplasms: A Phase 1 Study Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Advancing Treatment Paradigms in Myeloproliferative Neoplasms and Mastocytosis. Publication Number: 658. December 8, 8:15 p.m. ET (5:15 p.m. PT). Poster Presentations Ruxolitinib (Myeloproliferative Neoplasms [MPN]) Clinical and Molecular Characterization of Disease Progression in Patients (Pts) with Low-Risk Myelofibrosis (MF) Enrolled in the MOST Study Poster Session: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster II. Publication Number: 3136. December 8, 9:00 p.m. – 11:00 p.m. ET. (6:00 p.m. – 8:00 p.m. PT). Molecular Predictors of Disease Progression to Myelofibrosis (MF) in Patients (Pts) with Polycythemia Vera (PV) Enrolled in REVEAL Poster Session: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster II. Publication Number: 3145. December 8, 9:00 p.m. – 11:00 p.m. ET. (6:00 p.m. – 8:00 p.m. PT). Real-World Treatment Patterns and Blood Count Control in Patients with Polycythemia Vera Who Switched From Hydroxyurea to Ruxolitinib Poster Session: 908. Outcomes Research: Myeloid Malignancies: Poster II. Publication Number: 3813. December 8, 9:00 p.m. – 11:00 p.m. ET. (6:00 p.m. – 8:00 p.m. PT). Clinical Outcomes in Patients with Myelofibrosis Treated with Ruxolitinib and Anemia-Supporting Medications Poster Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III. Publication Number: 4546. December 9, 9:00 p.m. – 11:00 p.m. ET. (6:00 p.m. – 8:00 p.m. PT). Ruxolitinib (Graft-versus-host Disease [GVHD]) Real-World Ruxolitinib and Corticosteroid Treatment Patterns in Patients with Chronic Graft-Versus-Host Disease in the United States Poster Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster III. Publication Number: 4900. December 9, 9:00 p.m. – 11:00 p.m. ET. (6:00 p.m. – 8:00 p.m. PT). Tafasitamab Real-World Effectiveness of Tafasitamab (Tafa) for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) in the United States Poster Session: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster I. Publication Number: 2375. December 7, 8:30 p.m. – 10:30 p.m. ET (5:30 p.m. – 7:30 p.m. PT). Maintenance of CD19 Expression After Tafasitamab Treatment in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) From Clinical Trial and Real-World Settings Poster Session: 622. Lymphomas: Translational – Non-Genetic: Poster II. Publication Number: 2991. December 8, 9:00 p.m. – 11:00 p.m. ET. (6:00 p.m. – 8:00 p.m. PT). Axatilimab Axatilimab Abrogates Inflammatory Cytokines and Chemokines and Interrupts the Differentiation of Monocytes to Macrophages, a Pathogenic Driver of Inflammation and Fibrosis in cGVHD Poster Session: 201. Granulocytes, Monocytes, and Macrophages: Poster I. Publication Number: 1147. December 7, 8:30 p.m. – 10:30 p.m. ET (5:30 p.m. – 7:30 p.m. PT). Exposure-Response Relationships for Axatilimab, a Humanized Monoclonal Antibody Targeting CSF-1R, in Patients with Chronic Graft-Versus-Host Disease Poster Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster I. Publication Number: 2140. December 7, 8:30 p.m. – 10:30 p.m. ET (5:30 p.m. – 7:30 p.m. PT). Real-World Patient Characteristics and Treatment Patterns in Patients with Chronic Graft-Versus-Host Disease Receiving Belumosudil in the United States Poster Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster II. Publication Number: 3522. December 8, 9:00 p.m. – 11:00 p.m. ET. (6:00 p.m. – 8:00 p.m. PT). Ponatinib The Impact of Ponatinib on Pregnancy Outcomes Poster Session: 908. Outcomes Research: Myeloid Malignancies: Poster I. Publication Number: 2435. December 7, 8:30 p.m. – 10:30 p.m. ET (5:30 p.m. – 7:30 p.m. PT). Long-Term Safety and Effectiveness of Ponatinib Treatment in Patients with TKI Intolerance: Subgroup Analysis of the Observational Study of Ponatinib Treatment in Patients with CML in Italy (OITI) Poster Session: 908. Outcomes Research: Myeloid Malignancies: Poster I. Publication Number: 2427. December 7, 8:30 p.m. – 10:30 p.m. ET (5:30 p.m. – 7:30 p.m. PT). Ponatinib Safety Profile: An Analysis of 10-Years of Real-World Experience Poster Session: 908. Outcomes Research: Myeloid Malignancies: Poster II. Publication Number: 3816. December 8, 9:00 p.m. – 11:00 p.m. ET. (6:00 p.m. – 8:00 p.m. PT). INCB057643 Machine Learning in Predicting Longitudinal Platelet Counts: Applications in Dose Optimization Poster Session: 803. Emerging Tools, Techniques, and Artificial Intelligence in Hematology: Poster III. Publication Number: 4985. December 9, 9:00 p.m. – 11:00 p.m. ET. (6:00 p.m. – 8:00 p.m. PT). More information regarding the 2024 ASH Annual Meeting can be found on their website: https://www.hematology.org/meetings/annual-meeting/schedule-and-program . All sessions will be broadcast virtually, and access to the meeting’s virtual platform is included with registration. Conference Call and Webcast Incyte will hold a conference call and webcast on Thursday, December 12, 2024, from 4:00-5:00 p.m. ET, to discuss key data presentations at ASH, including data from the Phase 3 inMIND study presented during the late breaking session and its BET inhibitor program. To access the conference call, please dial 877-407-3042 for domestic callers or 201-389-0864 for international callers. When prompted, provide the conference identification number, 13750244. If you are unable to participate, a replay of the conference call will be available for thirty days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay, you will need the conference identification number, 13750244. The live webcast with slides can be accessed at Investor.Incyte.com and will be available for replay for ninety days. 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 a registered trademark of Incyte. About Monjuvi ® (tafasitamab-cxix) Monjuvi ® (tafasitamab-cxix) 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 Zynyz ® (retifanlimab-dlwr) Zynyz ® (retifanlimab-dlwr), is an intravenous PD-1 inhibitor indicated in the U.S. for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). 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 confirmatory trials. Zynyz is marketed by Incyte in the U.S. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab. Zynyz is a registered trademark 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 and the Pemazyre logo are registered trademarks of Incyte. * Pemazyre ® (pemigatinib) [Package Insert]. Wilmington, DE: Incyte; 2020. About Niktimvo™ (axatilimab-csfr) Niktimvo™ (axatilimab-csfr) is a first-in-class anti-CSF-1R antibody approved for use in the U.S. for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs). In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize Niktimvo from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for Niktimvo in cGVHD and any future indications. Axatilimab is being studied in frontline combination trials in chronic GVHD – a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids are expected to initiate by year end. Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256). Niktimvo is a trademark of Incyte. All other trademarks are the property of their respective owners. Niktimvo (axatilimab-csfr) is licensed from Syndax. About Iclusig ® (ponatinib) tablets Iclusig ® (ponatinib) targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs. In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. Click here to view the Iclusig EU Summary of Medicinal Product Characteristics. Incyte has an exclusive license from Takeda Pharmaceuticals International AG to commercialize ponatinib in the European Union and 29 other countries, including Switzerland, UK, Norway, Turkey, Israel and Russia. Iclusig is marketed in the U.S. by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. 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 potential 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 September 30, 2024. We disclaim any intent or obligation to update these forward-looking statements.

Phase 3Drug ApprovalLicense out/inASHClinical Result

100 Deals associated with Pemigatinib

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KEGG	Wiki	ATC	Drug Bank
D11417	Pemigatinib	L01XE	DB15102

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Advanced Bile Duct Carcinoma	KR	Handok, Inc.	25 Apr 2023
Chromosome 8p11 myeloproliferative syndrome	US	Incyte Corp.	26 Aug 2022
Bile Duct Neoplasms	CA	Incyte Corp.	17 Sep 2021
Locally Advanced Cholangiocarcinoma	EU	Incyte Biosciences Distribution BV	26 Mar 2021
Locally Advanced Cholangiocarcinoma	IS	Incyte Biosciences Distribution BV	26 Mar 2021
Locally Advanced Cholangiocarcinoma	LI	Incyte Biosciences Distribution BV	26 Mar 2021
Locally Advanced Cholangiocarcinoma	NO	Incyte Biosciences Distribution BV	26 Mar 2021
Metastatic Cholangiocarcinoma	EU	Incyte Biosciences Distribution BV	26 Mar 2021
Metastatic Cholangiocarcinoma	IS	Incyte Biosciences Distribution BV	26 Mar 2021
Metastatic Cholangiocarcinoma	LI	Incyte Biosciences Distribution BV	26 Mar 2021
Metastatic Cholangiocarcinoma	NO	Incyte Biosciences Distribution BV	26 Mar 2021
FGFR2 fusion or rearranged Cholangiocarcinoma	JP	Incyte Corp.	23 Mar 2021
FGFR2 positive Intrahepatic Cholangiocarcinoma	US	Incyte Corp.	17 Apr 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Unresectable Intrahepatic Cholangiocarcinoma	Phase 3	US	Incyte Corp.	03 Jun 2019
Unresectable Intrahepatic Cholangiocarcinoma	Phase 3	CN	Incyte Corp.	03 Jun 2019
Unresectable Intrahepatic Cholangiocarcinoma	Phase 3	JP	Incyte Corp.	03 Jun 2019
Unresectable Intrahepatic Cholangiocarcinoma	Phase 3	AT	Incyte Corp.	03 Jun 2019
Unresectable Intrahepatic Cholangiocarcinoma	Phase 3	BE	Incyte Corp.	03 Jun 2019
Unresectable Intrahepatic Cholangiocarcinoma	Phase 3	CA	Incyte Corp.	03 Jun 2019
Unresectable Intrahepatic Cholangiocarcinoma	Phase 3	DK	Incyte Corp.	03 Jun 2019
Unresectable Intrahepatic Cholangiocarcinoma	Phase 3	FI	Incyte Corp.	03 Jun 2019
Unresectable Intrahepatic Cholangiocarcinoma	Phase 3	FR	Incyte Corp.	03 Jun 2019
Unresectable Intrahepatic Cholangiocarcinoma	Phase 3	DE	Incyte Corp.	03 Jun 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04949191 (CTgov)	Phase 2	Neoplasms	10	Pemigatinib (Pemigatinib 6 mg Monotherapy)	bxuamsxdye(sqcfmxyjqh) = ghpjydiger fsdmnsxydo (nqdhhwynwt, pbbemfgwhy - jlcqeiojsk) View more	-	19 Sep 2024
				Pemigatinib (Pemigatinib 9 mg Monotherapy)	bxuamsxdye(sqcfmxyjqh) = mzpxkvuglu fsdmnsxydo (nqdhhwynwt, txekwiqmfn - kdbskqunxm) View more
NCT05253807 (FIGHT-210, CTgov)	Phase 2	Recurrent Lung Small Cell Carcinoma \| Advanced Lung Non-Small Cell Carcinoma	8	Pemigatinib	nrbserwrrd(nqywottpot) = urtzhkvzpg xcqiioiehw (oebahsnokv, ybefidznkt - oqougtzuns) View more	-	06 Aug 2024
NCT03011372 (FIGHT-203, EHA2024) Manual	Phase 2	Chromosome 8p11 myeloproliferative syndrome FGFR1 gene rearrangement	47	Pemigatinib 13.5 mg once daily (intermittent dose [ID; 2 weeks on/1 week off]	ibqriikjcr(hocfkmwmuo) = ufmwwnxszn ekxdthsvzp (rczolmbztg ) View more	Positive	14 May 2024
NCT03822117 (FIGHT-207, Pubmed) Manual	Phase 2	Solid tumor Second line FGFR1-FGFR3 alterations	107	Pemigatinib	lfagapbmww(qgryptjpzs) = gsrypldwyr oqbjjbnsus (meyzdylgmo ) View more	Positive	06 May 2024
				pemigatinib	lfagapbmww(qgryptjpzs) = sawgzmuoiq oqbjjbnsus (meyzdylgmo ) View more
NCT04088188 (CTgov)	Phase 1	Unresectable Intrahepatic Cholangiocarcinoma \| Advanced biliary tract cancer \| Metastatic Cholangiocarcinoma	8	Ivosidenib+Gemcitabine+cisplatin (Arm A (Ivosidenib, Cisplatin, Gemcitabine))	sggaucpcpp(tbvjlkasym) = etxpgxjssj uxxhkgoqhy (gzyrcgzwsx, uajikzpzrx - dmfmxavffj) View more	-	02 May 2024
				Gemcitabine+cisplatin+Pemigatinib (Arm B (Pemigatinib, Cisplatin, Gemcitabine))	kasldpzeyu(ciyklskfhd) = kkrjkkfofr wyuvpklmmi (amrxmvtcan, keemogggfr - bybggrebdm) View more
NCT04096417 (ACCRU-GI-1701, CTgov)	Phase 2	Chromosomal translocation \| Unresectable Colorectal Carcinoma \| Colorectal Cancer, Hereditary Nonpolyposis, Type 1 ... View more	14	Quality-of-Life Assessment+Pemigatinib	trkpyhidhs(rawbuvoxsu) = yieyttxqkp amzigczlxt (czsqzbhupa, nbwynhgdbz - wavnidcgnw) View more	-	21 Feb 2024
NCT02872714 (FIGHT-201, Pubmed) Manual	Phase 2	Transitional Cell Carcinoma FGFR3 Mutation	260	Pemigatinib 13.5 mg once daily continuously	lkmtxazyba(sxuimaugjq) = rauszbwtyx uuaprgafrg (ajbrsnzcvw, 10.9 - 26.7) View more	Positive	01 Feb 2024
				Pemigatinib 13.5 mg once daily intermittently	lkmtxazyba(sxuimaugjq) = jywfgyyfmu uuaprgafrg (ajbrsnzcvw, 15.5 - 32.7) View more
NCT02924376 (FIGHT-202, ASCO_GI2024) Manual	Phase 2	Bile Duct Neoplasms FGFR2 Mutation	120	Pemigatinib	ddlweyzzrw(xtxrdrfrbk) = xvubyqkrsb wfzxrvfrlr (sydzpeyupr, 6.4 - 8.6) View more	Positive	18 Jan 2024
NCT03822117 (FIGHT-207, AACR2023) Manual	Phase 2	Solid tumor	107	pemigatinib 13.5 mg (cohorts A)	hpukomymcm(mclrpyvmhu) = ybsfhhkmfl atcprgeyqq (wbdmcwqcrj )	Positive	14 Apr 2023
				pemigatinib 13.5 mg (cohorts B)	hpukomymcm(mclrpyvmhu) = oihhlpllct atcprgeyqq (wbdmcwqcrj )
NCT04256980 (AACR2023) Manual	Phase 2	FGFR2 fusion or rearranged Cholangiocarcinoma Second line FGFR2	30	Pemigatinib 13.5 mg	eemnwsyouj(yqalevzwjc) = jrkcnogmdh dgjkpbgbzm (uchlgxjzgw, 15.2 - NC) View more	Positive	14 Apr 2023

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