CrystalGenomics Publishes 'Phase 2 Clinical Trial Results for Pancreatic Cancer' in International Journal

[Asia Economy Reporter Hyungsoo Park] CrystalGenomics announced on the 7th that the results of a Phase 2 clinical trial demonstrating the therapeutic effect of Ivaltinostat, a histone deacetylase (HDAC) inhibitor targeting epigenetic diseases, on pancreatic cancer have been published in an international cancer journal.

The research team led by Professors Siyoung Song and Junghyun Cho from the Department of Gastroenterology at Yonsei University Severance Hospital in Sinchon evaluated the safety and efficacy of administering three drugs?Ivaltinostat, gemcitabine, and erlotinib?to 24 patients with unresectable advanced or metastatic pancreatic cancer who had not received prior treatment.

Among the 24 enrolled patients, 16 were able to have their drug efficacy measured at least once after receiving the combination therapy of Ivaltinostat, gemcitabine, and erlotinib.

The efficacy results showed a disease control rate (DCR) of 93.8%, an objective response rate (ORR) of 25%, a median overall survival (mOS) of 10.8 months, and a median progression-free survival (mPFS) of 5.8 months. Compared to the results from the dual therapy of gemcitabine and erlotinib, these key indicators improved nearly twofold.

The combination therapy of gemcitabine and erlotinib alone showed a disease control rate (DCR) of 57.5%, an objective response rate (ORR) of 8.6%, a median overall survival (mOS) of 6.24 months, and a median progression-free survival (mPFS) of 3.75 months.

Correlation studies with gene expression induced by the treatment drugs confirmed that mutation burdens detected by cfDNA (cell-free DNA) and blood genes such as TIMP1 (tissue inhibitor of metalloproteinases), pro-MMP10 (pro-matrix metalloproteinase 10), PECAM1 (platelet endothelial cell adhesion molecule), proMMP-2 (pro-matrix metalloproteinase 2), and IGFBP1 (insulin-like growth factor binding protein 1) were related to the drug efficacy results.

The expressed genes can be utilized for biomarker development to predict drug efficacy through analysis of more patient samples in the future. This suggests the potential to monitor the effectiveness of anticancer treatment.

The triple combination therapy of Ivaltinostat, gemcitabine, and erlotinib is considered a potential treatment option for pancreatic cancer patients. The Phase 2 clinical trial results confirmed that this therapy can treat pancreatic cancer by inhibiting cancer cell growth and enhancing the chemo-sensitivity of the combination drugs. Publication in an international academic journal objectively demonstrated that pancreatic cancer can be treated with Ivaltinostat.

A CrystalGenomics official stated, "The publication of the Phase 2 clinical trial results for Ivaltinostat in pancreatic cancer provides objective and scientific evidence for the ongoing pancreatic cancer clinical trials in the United States, raising expectations for the success of these clinical trials."

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