Medivir announce improved durable clinical benefit with fostrox
Medivir, whose ongoing rights issue ends today December 21, has announced that the lasting clinical benefit from the ongoing phase Ib/IIa study in advanced hepatocellular carcinoma continues to improve. According to the company, these data provide further support for accelerating the development program with fostrox and initiating a pivotal phase IIb study in second-line HCC in 2024.
Hepatocellular carcinoma (HCC) is the most common form of primary liver cancer and approximately twenty per cent of patients do not respond to current first-line treatment (Tecentriq/Avastin). Medivir is developing fostrox to address the high unmet medical need that arises when current first- or second-line treatment is ineffective or not tolerable.
The goal is to initiate a pivotal phase IIb study in 2024 and to obtain accelerated approval in the US in 2027, without the need to conduct a phase III study. If the company obtains such approval, the development time could be shortened.
New positive data
Fostrox is currently being evaluated in a fully recruited phase Ib/IIa study in combination with the cancer drug Lenvima to evaluate safety and efficacy. Interim data published earlier this fall indicate clinical benefits when fostrox is combined with Lenvima in second-line HCC.
The study is ongoing and about half of the patients are still being treated and have been followed-up for at least 12 weeks. The combination therapy remains tolerable with no unexpected new safety events and a lower need for dose reduction than expected. Furthermore, the company states in a press release, maintained disease control at 12 weeks has improved to 80 per cent. In addition, there is consistent anti-tumour activity and more than 75 per cent of patients show tumour shrinkage. The patient with the longest benefit remains on treatment after 16 months with a sustained partial response.
In a press release, Dr. Pia Baumann, Chief Medical Officer at Medivir, said:
“Patients with advanced HCC, who have progressed on at least one prior line of treatment, is a difficult-to-treat population. Achieving durable clinical benefit for the majority of the patients with a good safety and tolerability profile, enables patients to benefit from the combination treatment longer. It provides us with added confidence in accelerating the fostrox development program and we look forward to engaging further with FDA to discuss final study design of the planned, registrational phase 2b study with accelerated approval intent.”
More data will be presented in January
More data from the study will be presented at the ASCO Gastrointestinal Cancer Symposium, January 19, 2024 in San Francisco. The abstract will be presented by Dr. Maria Reig, Director of the Barcelona Clinic Liver Cancer (BCLC) and Liver Oncology Unit at the Hospital Clinic of Barcelona.
Rights issue to accelerate the development
The timing of the announcement of the new positive data from the Ib/IIa study is undoubtedly good as Medivir is in the final phase of a rights issue of up to approximately 148 million SEK. The company intends to use the proceeds to accelerate necessary activities ahead of the pivotal phase IIb study in 2024, with the aim of obtaining an accelerated approval from the FDA in 2027. The share issue commenced on December 7 and ends today, December 21. Watch a video interview with CEO Jens Lindberg below (in Swedish).
