On January 17, 2024 Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported further improved clinical benefit with fostrox + Lenvima as data from the ongoing phase 1b/2a study in advanced hepatocellular carcinoma (HCC) will be presented at the ASCO (Free ASCO Whitepaper) (American Society of Clinical Oncology) GI (Gastrointestinal Cancers) Symposium in San Francisco on January 19 (Press release, Medivir, JAN 17, 2024, View Source;lenvima-shows-further-improved-response-rates-and-time-to-progression-in-advanced-liver-cancer-hcc-at-asco-gi-symposium-302036736.html [SID1234639298]). The updated data further supports accelerating the fostrox development program to initiate a registrational phase 2b study in second-line HCC in 2024.
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– "We are excited by these results in a poor prognosis patient population where low disease control and response rates are usually seen. The updated data presented at ASCO (Free ASCO Whitepaper) GI has further strengthened our belief in the combination of fostrox + Lenvima as a potential treatment for patients with advanced HCC. In addition to the promising clinical benefit, the combination continues to be tolerable with a good safety profile enabling patients to stay on treatment long-term. It reinforces our confidence in advancing fostrox development and engaging with regulatory authorities to discuss final study design of the planned, registrational phase 2b study with accelerated approval intent," says Dr. Pia Baumann, CMO at Medivir.
The data is from a phase 1b/2a open-label, multi-center, dose-escalation and dose-expansion study evaluating the safety and efficacy with fostroxacitabine bralpamide (fostrox) in combination with Lenvima in patients for whom current first- or second-line treatment has proven ineffective or is not tolerable. The combination remains tolerable with no new, unexpected safety events. Only 5% have discontinued fostrox due to adverse events and lower need for dose reductions than expected. With a high and durable disease control rate of 61% at 18 weeks, the majority of patients in this study have continuous clinical benefit.
– "Hepatocellular cancer is a particularly complex disease," says Dr Maria Reig, Director of the Barcelona Clinic Liver Cancer (BCLC) and the Liver Oncology Unit at the Hospital Clinic of Barcelona in Spain, and investigator in the fostrox + Lenvima study. "A clear unmet need remains for safe and effective combination treatments. These data show that fostrox + Lenvima have encouraging results related to clinical outcome in patients with second-line advanced HCC without jeopardizing safety. I look forward to further explore the efficacy of fostrox added to Lenvima in a randomized, controlled trial."
The results from the phase 1b/2a study will be presented by Dr Maria Reig, poster number 476P, at ASCO (Free ASCO Whitepaper) GI on Friday January 19. Medivir will host a conference call to provide additional details from the study, comments on the data and the plans moving forward with fostrox, at 14.00 CET on January 23.
Conference call for investors, analysts and the media
Presenters from Medivir: Jens Lindberg, CEO, Pia Baumann, CMO and Fredrik Öberg, CSO.
Time: Tuesday January 23, 2024, at 14.00 CET
To access the webcast and information about the teleconference, please click HERE