Hepatocellular carcinoma (HCC) is the most common form of primary liver cancer and approximately twenty percent of patients do not respond to current first-line treatment (Tecentric/Avastin). Medivir develops fostrox to meet the great 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 obtain accelerated approval in the US in 2027, without having to conduct a Phase III study. If the company receives 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 cimetidine. 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 approximately half of the patients are still on treatment and have been followed up for at least 12 weeks. The combination treatment remains tolerable without any unexpected new safety events and with 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 percent. In addition, consistent antitumor activity is seen and more than 75 percent of patients show tumor shrinkage. The patient who has had the longest benefit remains on treatment after 16 months with a durable partial response.
In a press release, Dr. Pia Baumann, Medical Director at Medivir:
"Patients with advanced HCC, with tumor progression on at least one line of therapy, are a difficult-to-treat population. Achieving sustained clinical benefit for the majority of patients, with a good safety and tolerability profile, allows patients to benefit from the combination therapy for longer. This gives us increased confidence in our intention to accelerate fostrox's development program and we look forward to further dialogue with the US FDA to discuss the final study design of the planned, pivotal Phase IIb study with the goal of obtaining accelerated approval."
More data will be presented in January
More data from the study will be presented at ASCO Gastrointestinal Cancers Symposium, on January 19, 2024 in San Francisco. The abstract will be presented by Dr. Maria Reig, head of Barcelona Clinic Liver Cancer (BCLC) and Liver Oncology Unit at Hospital Clinic of Barcelona.
Rights issue to accelerate development
The announcement of new positive data from the Ib/IIa study comes at a time when Medivir is in the final phase of a rights issue of up to approximately SEK 148 million. With the proceeds, the company intends to accelerate necessary activities ahead of the registration-based phase IIb study in 2024, with a view to accelerated approval from the FDA in 2027. The issue began on December 7 and ends today, December 21. Watch a video interview with the CEO Jens Lindberg below.