Medivir Breaks New Ground: First Complete Response in Phase 1b HCC Study with Fostrox and Lenvima
STOCKHOLM, Sept. 4, 2023 /PRNewswire/ — Medivir AB (Nasdaq Stockholm: MVIR), a pioneering pharmaceutical company dedicated to creating innovative solutions for cancer in areas of critical medical need, unveils promising interim results from its groundbreaking phase 1b/2a study. This study explores the potential of the first-of-its-kind candidate drug, fostrox, when combined with Lenvima® to treat advanced hepatocellular carcinoma (HCC) patients who have exhausted current treatment options.
The interim data delivers an encouraging revelation: In the phase 1b dose escalation part of the study, a remarkable complete response was observed in one patient, accompanied by partial responses in two patients, and stable disease in two more—validated by an independent radiologist using mRECIST criteria.
These findings underscore the exceptional safety and efficacy profile previously reported. The combination therapy not only continues to demonstrate tolerability but also holds the promise of transforming the outlook for HCC patients in dire need of effective treatments.
The ongoing phase 2a dose expansion part of the study has successfully recruited participants, and the results from phase 1b/2a will be unveiled at an upcoming scientific congress.
Dr. Pia Baumann, Medivir’s CMO, expressed her excitement, stating, “HCC patients, who have exhausted current treatment options, face formidable challenges. The fact that we’ve witnessed overall responses in 3 out of 6 patients, including a complete response, is highly encouraging. Given the substantial medical need for a novel and effective HCC treatment, these findings hold immense promise for the future development of fostrox.”
As a reminder, Medivir will be hosting an Expert Perspectives Webcast on the Evolving Treatment Landscape and the Unique Treatment Challenges in HCC later this week on Friday, September 8th at 13:00 CET/07:00 EST. Dr. Pia Baumann, CMO at Medivir, will also participate in the webcast to provide additional insights into the fostrox development and its transformative potential.
Enter Fostrox, a trailblazing pro-drug meticulously crafted to deliver a targeted strike against liver cancers while safeguarding patients from the burden of side effects. This remarkable innovation holds the promise of being the very first orally administered, liver-targeted therapeutic option for patients grappling with hepatocellular carcinoma (HCC).
Fostrox’s journey of innovation is well underway. Having successfully completed a phase 1b monotherapy study, it now forges ahead, embarking on an exciting combination study tailored specifically for HCC. The future of liver cancer treatment is here, and Fostrox is at the forefront, reshaping the landscape of hope for patients.
About primary liver cancer
In a world fraught with medical challenges, primary liver cancer emerges as the third leading cause of cancer-related fatalities globally. At the heart of this formidable adversary lies hepatocellular carcinoma (HCC), the most prevalent liver cancer, silently wreaking havoc within.
While existing treatments offer a glimmer of hope, their efficacy falls short, and mortality rates continue to soar. Each year, a staggering 660,000 individuals join the ranks of primary liver cancer patients, with a disheartening five-year survival rate struggling to breach the 20 percent mark.
HCC’s complexity further complicates the battle. Unlike many other cancers, it lacks clear-cut defining mutations, making molecularly targeted therapies elusive. The result? An unmet medical need of monumental proportions, leaving patients with intermediate and advanced HCC facing a daunting prognosis.
The quest for effective treatments rages on, as we confront the dire realities of liver cancer head-on, determined to rewrite the story of hope for those who need it most.
In the relentless battle against cancer, Medivir takes center stage, guided by an unwavering mission: to pioneer groundbreaking drugs that target areas of critical unmet medical need. Our journey is fueled by a dedication to those who face limited or nonexistent treatment options, with a burning desire to usher in remarkable improvements in their lives.
Our spotlight shines brightly on fostroxacitabine bralpamide, affectionately known as fostrox—a revolutionary pro-drug meticulously crafted to wage a precise war against liver cancer while sparing patients the burdensome weight of side effects. The promise it holds is nothing short of transformative.
Collaboration and partnership form the backbone of our business model, where drug development takes shape through the hands of Medivir or in tandem with trusted allies. Among our prized assets is birinapant, a powerful SMAC mimetic, exclusively entrusted to the capable hands of IGM Biosciences (Nasdaq: IGMS). Together, they embark on a journey to conquer solid tumors, wielding the potent combination of birinapant and IGM-antibodies.
At Medivir, we believe in the power of innovation to rewrite the narrative of cancer, turning despair into hope and limitations into boundless opportunities.