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ESMO 2025 | CS1003-305: nofazinlimab and lenvatinib in first-line HCC
Lorenza Rimassa, MD, Hunimed University, Milan, Italy, reviews the Phase III CS1003-305 study (NCT04194775) of nofazinlimab plus lenvatinib versus placebo plus lenvatinib as first-line therapy for unresectable or metastatic hepatocellular carcinoma (HCC). The investigational combination showed a favorable trend toward improved overall survival but the primary endpoint was not met. Manageable safety and no new safety signals were additionally observed. This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.
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Transcript
This is a phase three study conducted in China that tested a new combination of immune checkpoint inhibitor plus lenvatinib versus lenvatinib. The trial is very well conducted, classical phase three, and the baseline characteristics are typical for a study conducted in China. So most of the patients were younger compared to global studies. Indeed, most of the patients were less than 65 years, and most of the patients, more than 80%, had the HBV etiology...
This is a phase three study conducted in China that tested a new combination of immune checkpoint inhibitor plus lenvatinib versus lenvatinib. The trial is very well conducted, classical phase three, and the baseline characteristics are typical for a study conducted in China. So most of the patients were younger compared to global studies. Indeed, most of the patients were less than 65 years, and most of the patients, more than 80%, had the HBV etiology. The trial is negative, so the trial did not meet its primary endpoint of overall survival, even if the combination arm performed well with a 22-month overall survival, but the lenvatinib arm had a median overall survival of 19 months. And these results are pretty much in line with the results of the LEAP002 trial that was a phase 3 trial conducted globally that compared pembrolizumab plus lenvatinib versus lenvatinib. And even if in a different population, so Chinese population versus global population, the results are very similar. So one of the reasons that can explain these results, the negative results, can be the good performance of lenvatinib single agent. For progression-free survival and response rate, we have quite similar results in the two trials. So once again, the combination arm performed well, but also the lenvatinib single arm performed well. And so there is no difference between the two arms. There is another important point. There is another Chinese study that is the Apollo trial that tested a different immune checkpoint inhibitor plus tyrosine kinase inhibitor combination in a Chinese population and the control arm was represented by sorafenib and even if the combination arm had a shorter median overall survival compared to the two trials we are discussing about the sorafenib arm performed in had a shorter even shorter median overall survival so So the trial is positive, even if the results are less impressive compared to the results presented at ESMO 2025. In terms of safety, no new safety signals were observed. So in the end, the trial is negative. This will not be a new therapeutic option for the patients, but the results confirm what we already knew from the LEAP002 trial.
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