On October 5, 2023 Medivir AB (Nasdaq:MVIR) (Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported that all patients in the ongoing phase 2a study in advanced hepatocellular carcinoma (HCC) has now dosed at least two treatment cycles and the treatment continues to show very promising clinical benefit (Press release, Medivir, OCT 5, 2023, View Source;lenvima-continues-to-show-promising-tumor-control-in-hcc-all-patients-have-now-dosed-at-least-two-treatment-cycles-301948293.html [SID1234635700]). The study evaluates safety and efficacy with the candidate drug fostrox in combination with Lenvima in patients for whom current first- or second-line treatment has proven ineffective or is not tolerable.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The study, which is an open-label, multi-center, dose-escalation and dose-expansion study, continues to show early and durable clinical benefit across the cohort, as measured by local review. Of the 13 patients with sustained tumor control at 3 months, 3 patients achieved Partial Response and 10 patients Stable Disease, providing 17% Overall Response Rate (ORR) and 72% Disease Control Rate (DCR). The patient who has benefited the longest remains on treatment after 13.5 months, with sustained partial response.
The combination remains tolerable with no unexpected new safety events and adverse events are transient and manageable. Continued lower need for dose reductions or interruptions than expected. The observed tolerability is of outmost importance as patients with HCC often have an increased sensitivity to drugs in general due to impaired liver function.
"Overall, the consistent early and durable signals of clinical benefit and the favorable safety profile are very encouraging. Patients with advanced HCC, who have progressed on at least one line of treatment, are a very difficult-to-treat population with few effective treatment options. The overall response rate of 17% already at 2nd scan is very encouraging and indicates a higher share of responders than historically seen in second line treatment of HCC. We can also see that for many patients, their target lesions continue to shrink with longer follow-up," says Dr. Pia Baumann, CMO at Medivir.
Medivir plans to provide an update in connection with the company’s upcoming quarterly results presentation on Friday October 27. This will include a more comprehensive update of local review data as most of the patients will have had the opportunity to have at least three scans, with each scan scheduled to take place every 6 weeks. In addition to the data update, the company will also provide further context what these more mature data could mean for future clinical practice in second line HCC, a patient population for whom there are no approved medical treatments today.