Placeholder agenda
Improving life for advanced liver cancer (HCC) patients
Displacing chemotherapy with the first oral, liver-activated inhibitor of DNA replication
Medivir Q3 REPORT 2025
Fostrox - The first oral, liver-targeted treatment for advanced HCC
Q3 Highlights
Right's issue enables rapid generation of randomized, comparative data to confirm benefit of fostrox combination with Lenvima
Design of planned phase 2 study strengthened by latest data in advanced HCC
Remetinostat out-license generates significant potential value upside
Placeholder agenda3
Slide
Today's presenters
CEO
Jens Lindberg
CMO
Pia Baumann
CFO
Magnus Christensen
CSO
Fredrik Öberg
Slide 4
Phase 2 study enables rapid generation of randomized, comparative data to confirm benefit of fostrox combination with Lenvima
Slide 5
Latest data in HCC presented at ESMO highlights continued significant unmet medical need in second-line
Absence of second line data in liver cancer
High unmet medical need without any real new options
Potential promising options (CAR-T, ADC etc) in other tumour types is so far not applicable in HCC
Continued high interest in fostrox post immunotherapy among investigators
Latest data reinforces immunotherapy in 1st line HCC
ESMO 2025: Tecentriq/Avastin entrenched as 1st line SOC in HCC
Global, randomized Phase 3 in 1st line advanced HCC (IMbrave152/SKYSCRAPER-14) with TIGIT + Tecentriq + Avastin vs Tecentriq + Avastin
669 pats randomized 1:1
PFS curves superimposed - no difference in PFS
Recently announced data in earlier stage HCC strengthens the positioning of fostrox + Lenvima in 2nd line advanced HCC
ESMO 2024: Positive PFS with Keytruda + Lenvima + TACE vs TACE in intermediate stage HCC (LEAP-012)1
Oct 2025: No OS benefit with addition of Keytruda + Lenvima to TACE (LEAP-012)2
1Llovet et al, ESMO 2024, Presidential session
2Merck & Eisai press release on October 29, 2025
Slide 8
KEYTRUDA plus LENVIMA in addition to TACE did not provide significant OS benefit, one of the study's primary endpoints
As a result, the study will be closed
The results from LEAP-012 further reinforces immunotherapy combinations to be used in 1st line advanced stages of HCC
The outcome also strengthens the strategic positioning of fostrox + Lenvima in 2nd line HCC
Randomized, comparative phase 2 study to strengthen evidence for fostrox + Lenvima combination in 2nd line HCC
Inclusion criteria
2L advanced HCC
One prior IO regimen
Child-Pugh A
ECOG PS 0-1
Fostrox 30 mg + Lenvima SD* N=40
1:1
Lenvima SD* N=40
*standard weight based dose in HCC
Response assessments every 6 week with CT or MRI
Study design:
Primary endpoint:
ORR (BICR)
Secondary endpoints:
DoR
PFS
OS
Safety
2026
2027
80 pts randomized: Fostrox + Lenvima vs Lenvima
8 sites in Korean Cancer Study Group
Enrolment: 12 months
Primary endpoint FU: 3-6 months
Efficacy evaluated by Blinded Independent Central Review (BICR)
Key benefits:
Generates robust comparative efficacy and safety data in collaboration with established research consortium
Enables rapid data read out
Strengthens design of registrational study
Slide 9
Korean Cancer Study Group prospective study data with Lenvima post Tecentriq + Avastin, aligns with other 2nd line outcome data
1Kim et al., Journal of Hepatology, Sept 04 2025
Slide
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Medivir AB published this content on November 06, 2025, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on November 06, 2025 at 14:01 UTC.

















