Medivir announces first patient enrolled in FLEX-HCC study

Stockholm — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments in areas of high unmet medical need, announced today that the first patient has been enrolled in the FLEX-HCC study. FLEX-HCC is a randomized, comparative phase 2 study evaluating fostrox in combination with lenvatinib vs lenvatinib monotherapy in second-line advanced liver cancer (HCC).

The study is an investigator-initiated study led by Dr. Hong Jae Chon from CHA Bundang Hospital within the Korean Cancer Study Group. The study will be performed at 12 major hospitals in Korea. The primary objective of the study is to confirm superior efficacy with fostrox + lenvatinib over lenvatinib monotherapy, with objective response rate (ORR) as the primary endpoint and secondary endpoints that includes progression free survival (PFS), time to progression (TTP) and overall survival (OS). Evaluation of response/disease progression will be carried out with MRI and/or CT every 6 weeks.

• “The inclusion of the first patient in the FLEX-HCC study is an important step for the continuous development of fostrox in advanced liver cancer, where there is still a significant unmet medical need for therapies that will provide long-term tumor control while preserving liver function. The early clinical experience of the fostrox + lenvatinib combination showed far more encouraging results compared to traditional second-line lenvatinib monotherapy. In order to objectively validate and confirm these promising data, a randomized comparative study with fostrox + lenvatinib versus lenvatinib monotherapy in a larger patient population is needed. I am pleased that we now have the opportunity to run this important phase 2 study within the Korean Cancer Study Group.” says Dr. Hong Jae Chon, principal investigator of FLEX-HCC, CHA Bundang Hospital in Korea.

• "It is truly gratifying to see the FLEX-HCC study up and running in Korea and we are delighted to collaborate with the passionate and hard-working Dr. Chon, his team at CHA Bundang University Hospital and the Korean Cancer Study Group. We just had the opportunity to experience first-hand the dedication to FLEX-HCC and the high quality of the different teams and hospitals participating in the study, on our recent visits to 8 of the 12 hospitals participating in the study. We look forward with great anticipation to the progress and results of the study, which, if successful, will add an important treatment option for patients suffering from advanced liver cancer." says Dr. Pia Baumann, CMO at Medivir.