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Dr Cheng on the Safety and Efficacy of Irpagratinib Plus Atezolizumab in Advanced HCC

Qi Cheng, MD, discusses the safety and efficacy of irpagratinib plus atezolizumab in advanced hepatocellular carcinoma.

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    "The tumor response was deep and durable in most cases, and the median progression-free survival was at least 7 months in both [the treatment-naive and pretreated] groups.”

    Qi Cheng, MD, a physician at Huazhong University of Science and Technology, discussed updated findings from the ongoing phase 2 ABSK-011-201 trial (NCT05441475) evaluating the investigational FGFR4 inhibitor irpagratinib (ABSK-011) in combination with atezolizumab (Tecentriq) in patients with advanced hepatocellular carcinoma (HCC) harboring FGF19 overexpression. The analysis focused on both treatment-naive patients and those previously treated with systemic therapy.

    As of the data cutoff and a median follow-up of 7.1 months, the combination regimen was reported to be well tolerated with irpagratinib given at a dose of 220 mg twice per day, and no new safety signals were observed.

    Irpagratinib plus atezolizumab demonstrated antitumor activity across both cohorts. In the treatment-naive population (n = 15), the objective response rate (ORR) was 50.0%; patients in the pretreated cohort (n = 18) achieved an ORR of 52.9%. The confirmed ORRs were 33.3% and 41.2%, respectively. Across both cohorts, the median duration of response had not been reached at the time of analysis.

    The median progression-free survival was 7.0 months observed in the treatment-naive group and 8.3 months in the pretreated cohort. Overall survival data remained immature, with only 6 deaths reported among the 33 patients enrolled.

    Cheng noted that these findings support the potential clinical utility of dual FGFR4 and PD-L1 blockade in FGF19-positive advanced HCC, a molecularly defined subgroup with a poor prognosis with limited targeted treatment options. He also noted that the safety and efficacy profile of the combination may warrant further evaluation in larger studies, particularly given the observed depth and durability of response in both frontline and pretreated settings.


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