Swedish biotechnology company Medivir has reported promising interim findings from its ongoing Phase Ib/IIa trial of fostrox in combination with Lenvima for advanced hepatocellular carcinoma (HCC).
The data reaffirmed the previously disclosed positive safety and tolerability profile.
The combined therapy is intended for advanced HCC patients who have either not responded to current first or second-line treatments or cannot tolerate them.
Fostrox is a pro-drug designed for the selective treatment of liver cancers and the reduction of side effects.
Medivir has carried out a central review of the six patients in the Phase Ib dose escalation part.
Of the six patients evaluated with mRECIST by an independent radiologist, one showed a complete response and two had a partial response, while two maintained stable disease.
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The Phase IIa dose expansion portion of the study is currently in progress and has successfully recruited all its participants.
Medivir chief marketing officer Dr Pia Baumann said: “We are excited about the interim data from the Phase Ib dose escalation part.
“HCC patients, for whom current first or second-line treatment has proven ineffective, is a difficult-to-treat patient group and expectation regarding clinical benefit and tumour shrinkage is low.
“This is why it is so encouraging to see that overall response is shown in three out of six patients and even more so that a complete response was recorded in one patient.
“Considering that the medical need for a new, effective treatment for HCC is large, these are very encouraging data for the future development of fostrox.”
Earlier this year, Medivir completed the initial dose escalation segment of the Phase Ib/IIa trial of fostrox and Lenvima for HCC.
The trial’s preliminary data from the dose cohorts were positive and demonstrated a good safety and tolerability profile for the combination therapy.