MIV-818, a novel prodrug, had an acceptable safety and tolerability profile in patients with liver cancer, including cholangiocarcinoma, according to study results being presented at the European Society for Medical Oncology (ESMO).

The most common adverse event associated with the use of the treatment was hematological suppression. Other adverse events included elevated liver enzymes and pruritus.

The aim of the multicenter open-label study was to assess the safety and tolerability of MIV-818 in patients with different solid tumors that originate in the liver or have spread to the liver. The primary outcome measure was the number of participants with treatment-related adverse events. The secondary outcome measure was the preliminary efficacy of the treatment as assessed by monitoring tumor response and progression.


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MIV-818 is an oral nucleotide DNA polymerase inhibitor being developed for individuals with liver cancer. It is designed to treat liver cancers selectively and reduce side effects. It is stable in the gastrointestinal tract and when it is absorbed, it accumulates in the liver before entering the bloodstream, therefore minimizing the risk of side effects.

The study abstract, titled “Phase 1 study of the novel prodrug MIV-818 in patients with hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (iCCA) or liver metastases (LM),” is published on the ESMO website. The ESMO Congress 2021 is taking place September 16-21, 2021.

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On September 16, Debashis Sarker, PhD, a senior lecturer and consultant in medical oncology at King´s College, London will present the results as an electronic poster and Medivir, the company developing the prodrug, will host a conference call to give an update on the progress and plans for the MIV-818 program. according to a press release from the company.

Reference

Abstract for MIV-818 phase 1b monotherapy for ESMO Congress published. News release. Medivir; September 13, 2021.

Sarker D. Phase I study of the novel prodrug MIV-818 in patients with hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (iCCA) or liver metastases (LM). Abstract presented at: ESMO Congress 2021; September 16-21, 2021; Virtual.