On November 13, 2023 Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported that clinical data from the ongoing phase 1b/2a study of in fostroxacitabine bralpamide (fostrox) in combination with Lenvima (lenvatinib) in hepatocellular carcinoma (HCC), will be presented at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, January 18-20, 2024 in San Francisco, USA (Press release, Medivir, NOV 13, 2023, View Source;lenvima-in-hcc-and-shares-positive-response-from-type-d-meeting-with-fda-301985850.html [SID1234637582]).
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The abstract, titled "First safety and efficacy data from phase Ib/IIa study of fostroxacitabine bralpamide (fostrox, MIV-818) in combination with lenvatinib in patients with hepatocellular carcinoma (HCC)" will be presented by Dr. Maria Reig, Director of the Barcelona Clinic Liver Cancer (BCLC) and the Liver Oncology Unit at the Hospital Clinic of Barcelona in Spain. The presentation will include updated safety and independently reviewed efficacy data regarding the clinical benefit of fostrox in combination with Lenvima, a tyrosine kinase inhibitor.
Medivir furthermore announces that interactions with the FDA regarding fostrox’s clinical development plan have intensified with a first Type D meeting with a positive response regarding critical elements of the design for the planned phase 2b study. The finalization of the study design will take place in connection with an upcoming Type C meeting to enable study start in 2024. The goal of the upcoming study, as previously communicated, is to apply for accelerated approval.
– "In this phase 1b/2a study, the fostrox + Lenvima combination has shown a good safety profile and promising tumor control in second-line HCC, and we confidently look forward to presenting these data at ASCO (Free ASCO Whitepaper)-GI. Despite some success with first-line immunotherapy, patients with HCC have a poor prognosis and effective second-line treatment options are lacking. The data from this study, combined with the great medical need, opens the possibility of an accelerated approval path, which is why we are now planning for a pivotal, randomized phase 2b study. The FDA’s response at our Type D meeting was a positive step towards our ambition to give this vulnerable patient group access to fostrox as a new treatment option.", says Pia Baumann, CMO at Medivir.