INCB62079 / Incyte - LARVOL DELTA

First-in-Human Study of INCB062079, a Fibroblast Growth Factor Receptor 4 Inhibitor, in Patients with Advanced Solid Tumors. (PubMed, Target Oncol) - P1 | "With C4 cut-off and prophylactic bile acid sequestrant implementation, INCB062079 demonstrated a manageable safety profile and evidence of target inhibition. In view of the rarity of FGF19/FGFR4 alterations and slow patient accrual, the study was terminated before establishing an MTD."

Journal • Metastases • P1 data • Gastrointestinal Cancer • Hepatology • Liver Cancer • Oncology • Ovarian Cancer • Solid Tumor • FGF19 • FGFR4

An Open-Label Safety and Tolerability Study of INCB062079 in Subjects With Advanced Hepatocellular Carcinoma and Other Malignancies (clinicaltrials.gov) - P1; N=25; Terminated; Sponsor: Incyte Corporation; N=100 ➔ 25; Trial completion date: Apr 2021 ➔ Jun 2020; Recruiting ➔ Terminated; Trial primary completion date: Feb 2021 ➔ Jun 2020; Strategic Business Decision

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Biliary Cancer • Cholangiocarcinoma • Esophageal Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Head and Neck Cancer • Hepatocellular Cancer • Nasopharyngeal Carcinoma • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor

An Open-Label Safety and Tolerability Study of INCB062079 in Subjects With Advanced Hepatocellular Carcinoma and Other Malignancies (clinicaltrials.gov) - P1; N=100; Recruiting; Sponsor: Incyte Corporation; Not yet recruiting ➔ Recruiting

Enrollment open • Biliary Cancer • Biosimilar • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Head and Neck Cancer • Hepatocellular Cancer • Oncology • Ovarian Cancer • Solid Tumor

INCB62079: Initiation of P1/2 dose-escalation trial in HCC in 2017 (Incyte) - Q1 FY2017 Results

New P1/2 trial • Hepatocellular Cancer • Oncology

Incyte reports 2020 first quarter financial results and provides updates on key clinical programs (Businesswire) - "Delays in data collection and validation, caused by COVID-19 related disruption, mean that data from the FIGHT-201 clinical trial of pemigatinib in patients with bladder cancer are now expected to be presented at a medical conference in early 2021....In February, the FDA granted Priority Review for tafasitamab in combination with lenalidomide for the treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL), and set a PDUFA goal date of August 30, 2020....Incyte no longer plans to pursue the Phase 3 POD1UM-301 trial of retifanlimab in combination with chemoradiation therapy (CRT) in participants with unresectable, Stage III NSCLC....Based on emerging data from the FGFR4 inhibitor program, development of INCB62079 has been discontinued because of insufficient efficacy in the target patient population."

Discontinued • PDUFA date • Bladder Cancer • Cholangiocarcinoma • Diffuse Large B Cell Lymphoma • Esophageal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hematological Malignancies • Hepatocellular Cancer • Liver Cancer • Lung Cancer • Lymphoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Solid Tumor • Thoracic Cancer • Urothelial Cancer

Product discontinued (Businesswire) - Oncology

Cholangiocarcinoma • Esophageal Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Head and Neck Cancer • Hepatocellular Cancer • Liver Cancer • Nasopharyngeal Carcinoma • Oncology • Ovarian Cancer • Solid Tumor