The Lynx Group
Cholangiocarcinoma News

August 2020, Vol 1, No 1

It is my great pleasure to launch the inaugural issue of CCA News, an important new publication highlighting the latest research and development in cholangiocarcinoma (CCA). I am proud that we now have a focused publication on biliary tract cancers and am humbled to serve as the first editor-in-chief.
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The COVID-19 pandemic has changed the way we do business, the way we interact with one another, and other tangible aspects of our work and personal lives. The pandemic has also provided many of us with much-needed time for personal reflection. Often, when we have the opportunity to take a step back, or in this case when we are forced to step back, the result of our thoughtful reflection can be an opportunity to slingshot forward.
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The National Comprehensive Cancer Network (NCCN) added the targeted agent ivosidenib (Tibsovo) to its recent 2020 hepatobiliary cancers guidelines update, which was published on June 1, 2020.1 Recommendations within the NCCN’s hepatobiliary cancers guidelines are derived from critical evaluation of evidence, integrated with the clinical expertise and consensus of a multidisciplinary panel of cancer specialists, clinical experts, and researchers.
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Several hot topics were presented at the recent ASCO 2020 annual meeting about cholangiocarcinoma (CCA), which I would briefly discuss here. First, it was very exciting to see 3 important studies regarding immunotherapy for CCA, which may represent a step forward in the development of CCA therapies.
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Immunotherapies have shown early promising efficacy in some patients with biliary tract cancer. Investigators evaluated the benefit of durvalumab (Imfinzi), a PD-L1 inhibitor, with or without tremelimumab, a CTLA-4 inhibitor, plus chemotherapy with gemcitabine and cisplatin as a first-line treatment for Korean patients with biliary tract cancer. The researchers also performed an extensive biomarker analysis.
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The combination of a CTLA-4 inhibitor and a PD-1 inhibitor with ipilimumab (Yervoy) and nivolumab (Opdivo) has demonstrated superior efficacy compared with single-agent anti–PD-1 therapy in a previous study of patients with advanced melanoma and renal-cell carcinoma.
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Arandomized, phase 2 multi-institutional study compared the role of combination immunotherapy with nivolumab (Opdivo) plus ipilimumab (Yervoy) versus nivolumab plus chemotherapy with gemcitabine and cisplatin in the first-line treatment of patients with advanced biliary tract cancer.
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Cholangiocarcinoma (CCA) is the most common biliary tract malignancy, with an estimated incidence of 8000 to 10,000 patients annually in the United States. Chemotherapy is the most common second-line treatment with response rates of <10% and median progression-free survival (PFS) of approximately 3 to 4 months, including FOLFOX in the ABC-06 trial. Fibroblast growth factor receptor (FGFR) 2 fusions occur in 13% to 17% of patients with CCA, and multiple targeted agents are in development for patients with FGFR2 fusions. To date, the outcome of patients with CCA and FGFR2 fusions who receive standard second-line chemotherapy is unknown.
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Genetic alterations in the fibroblast growth factor receptor (FGFR) pathway are emerging as promising therapeutic targets in patients with cholangiocarcinoma (CCA). A retrospective chart review, led by Lipika Goyal, MD, MPhil, Medical Oncologist, Tucker Gosnell Center for Gastrointestinal Cancers, Massachusetts General Hospital, Boston, was performed in patients with CCA who had an FGFR alteration found by tumor molecular profiling as part of routine care.1 Dr Goyal presented this study at the 2020 ASCO annual meeting.
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Futibatinib is a highly selective irreversible fibroblast growth factor receptor (FGFR)1-4 inhibitor, administered as a continuous once-daily oral regimen. The FOENIX-CCA2 phase 2 clinical trial was initiated after the results from a phase 1 dose-escalation/expansion study showed the tolerability and preliminary efficacy of futibatinib in patients with intrahepatic cholangiocarcinoma (CCA) and FGFR2 fusions.
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