According to AdisInsight, the global drug pipeline for oncology currently contains 10,950 unique drug programs that are either marketed, in regulatory approval, in clinical development, in preclinical development, or have been discontinued for the treatment of cancer.

A gap analysis of the global drug pipeline reveals a potential unmet medical need for the treatment of Cholangiocarcinoma. Cholangiocarcinoma is considered to be an incurable and rapidly lethal cancer unless both the primary tumor and any metastases can be fully removed by surgery.  There are currently 28 drug programs in clinical development to fill this need.

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 Ivosidenib, is one of the three drugs showing promise in Phase III studies.  It has been granted USA FDA fast track designation and USA FDA orphan drug designation for the treatment of Cholangiocarcinoma.  Below is an example of the AdisInsight drug profile for Ivosidenib.  

AdisInsight shows 33,038 clinical studies investigating pharmaceutical treatment for cancer being conducted in 159 countries.  Some of these studies will be active in either the planning, recruitment, or administration stage while other will be inactive either completed or discontinued.  The clinical trial map shown below aggregates information across all trials researching cancer to show where active clinical studies are taking place at a regional level.

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One of those clinical studies which is taking place in France and USA is a phase 1, multicenter, open-label, dose-escalation, safety, pharmacokinetic, pharmacodynamic, and clinical activity study of orally administered Ivosidenib  (AG-120) in subjects with advanced solid tumors, including glioma, with an IDH1 mutation.  This trial sponsored by Agios Pharmaceuticals is currently active and no longer recruiting subjects.  Results from this study were presented at 2017 ASCO Annual Meeting showed morphologic changes suggestive of cellular differentiation.  In the 73 patients studied, Ivosidenib was safe and well-tolerated with a favorable safety profile observed.  Partial response was found in four patients (5%).  Stable disease was demonstrated in 41 patients (56%). The progression free survival observed at 6 and 12 months were 38.5% and 20.7% respectively. The median progression free survival was reported to be 3.8 months.  

Biomarker selection is becoming an essential part of clinical development. Successful use of biomarkers can accelerate the pace of development by predicting drug efficacy more quickly, identifying optima patient populations, and early detection of safety signals.

AdisInsight catalogs 1,001 biomarkers associated with the drugs being studied to treat cancer.  800 of these biomarkers are being used as outcome measures, 445 are being used to detect safety issues, 596 are being used for patient inclusion, and 463 are being used for patient exclusion.  The top 15 biomarkers being used in oncology drug research are shown below.