Medivir has determined the recommended phase 2 dose for fostrox in combination with Lenvima in HCC
Tuesday, February 21, 2023
Medivir AB, a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that the initial dose escalation part (phase 1b) of the company's 1b/2a study with the candidate drug fostroxacitabine bralpamide (fostrox) in hepatocellular carcinoma (HCC), in combination with Lenvima®, was successfully completed.
The preliminary results from the dose cohorts are positive with a good safety and tolerability profile and no dose-limiting toxicity has been observed. The recommended dose (RP2D) for the first combination arm of the phase 2a part of the study has been determined to 30 mg for fostrox.
- " It is very satisfactory that we have now completed the first part of the study with good preliminary results and have been able to determine the starting dose for the first combination arm in the phase 2a part of the study. With the great interest we have seen in the study, it is also gratifying for the patients that we can now start the first combination arm in the phase 2a part," says Jens Lindberg, CEO at Medivir AB. "Although Lenvima is now widely used as a second-line treatment for advanced HCC, there is still a need to improve the number of patients who respond to the treatment. By using fostrox in addition to Lenvima®, our hope is that more of these patients will obtain a clinical response to their treatment."
In the open-label multi-center study, fostrox is given in combination with two other medicines, either with Lenvima®, a tyrosine kinase inhibitor, or with Keytruda®, an anti-PD-1 checkpoint inhibitor. The study includes patients with HCC for whom current first-line treatment has shown to be ineffective or intolerable. The purpose of the study is to evaluate safety and tolerability, as well as to get an indication of the efficacy of fostrox in combination with two already existing drugs. The phase 1b dose escalation part with Keytruda is still ongoing. Currently six patients are on active treatment in the study.
In the phase 2a part of the study, a total of up to 30 further patients with HCC will be recruited for an initial evaluation of safety and efficacy. The study is being conducted at 14 clinics in the UK, Spain and South Korea.
