On July 31, 2017 Transgene (Euronext Paris: TNG), a company that designs and develops viral-based immunotherapies, reported that the first patient has been treated in a Phase 1/2 clinical trial evaluating the combination of Pexa-Vec with Opdivo (nivolumab) as a first-line treatment of advanced hepatocellular carcinoma (HCC), which accounts for approximately 75% of liver cancers (Press release, Transgene, JUL 31, 2017, View Source [SID1234519950]). Schedule your 30 min Free 1stOncology Demo! This open-label trial will assess the safety and tolerability as well as the anti-tumor activity and efficacy of this immunotherapy combination regimen in up to 36 patients (NCT03071094). The principal investigator of this multi-center trial is Prof Olivier Rosmorduc, MD, Head of Hepatogastroenterology department at La Pitié-Salpêtrière Hospital in Paris (France). More information on the trial is available on clinicaltrials.gov. Pexa-Vec: an oncolytic immunotherapy that has shown efficacy Pexa-Vec is an oncolytic immunotherapy product based on an oncolytic vaccinia virus expressing GMCSF. In a Phase 2 trial of Pexa-Vec in first-line HCC, overall survival was improved in a dose dependent manner. The median overall survival was 14.1 months for the high-dose group compared to 6.7 months for the low-dose group. Pexa-Vec is designed to: – selectively destroy cancer cells through the direct lysis (breakdown) of cancer cells via viral replication, – reduce the blood supply to tumors through tumor vascular disruption, and – stimulate the body’s immune response against cancer cells. Pexa-Vec + Opdivo (nivolumab): a promising immunotherapy combination regimen Pexa-Vec’s mechanism of action and its safety profile make it an appropriate candidate for use in combination with immune checkpoint inhibitors (ICIs) such as nivolumab. Nivolumab (Opdivo, Bristol-Myers Squibb) is a monoclonal antibody targeted against the PD-1 receptor. It is approved in several cancer indications and is currently being investigated in HCC within a global Phase 3 trial. By targeting two distinct steps in the immune response against cancer cells, the combination of Pexa-Vec and nivolumab has the potential to be significantly more effective than either product alone. There is a strong scientific rationale that suggests that Pexa-Vec’s anti-cancer effects could be enhanced by combining it with nivolumab, which suppresses the cancer cells’ ability to escape the body’s immune response. Commenting on this innovative clinical trial, Prof Olivier Rosmorduc, MD, head of Hepatogastroenterology department at La Pitié-Salpêtrière Hospital in Paris and principal investigator of the trial, added: "Improving the treatment of HCC needs a therapeutic approach capable of significantly boosting the immune system. I am confident that combining immunotherapies with local and systemic effects such as anti-PD1 nivolumab and the oncolytic virus Pexa-Vec is a powerful strategy to better treat patients with advanced hepatocellular carcinoma."
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Page 2 / 2 Maud Brandely, Chief Medical Officer of Transgene, said: "HCC has a dismal prognosis which has been marginally improved by current therapeutic options. Preclinical and clinical data generated respectively with Pexa-Vec and nivolumab suggest that, in combination, these novel immunotherapies, with their complimentary modes of action, have the potential to be more active than each single agent alone. This may translate into better response rate and increased overall survival in HCC patients."