Andrew Zhu, MD, PhD, director, Liver Cancer Research, Massachusetts General Hospital, professor of medicine, Harvard Medical School, discusses the final overall survival (OS) results from the phase 3 ClarIDHy trial in previously treated patients with 

According to findings presented during the 2021 Gastrointestinal Cancers Symposium, the median OS was 10.3 months with ivosidenib (Tibsovo) versus 7.5 months with placebo in this patient population, reflecting a hazard ratio (HR) of 0.79 (

Notably, crossover was permitted to the ivosidenib arm if patients experienced radiographic progression with placebo. In total, 70% of patients receiving placebo crossed over to ivosidenib. According to the rank-preserving structural failure time model, the crossover-adjusted OS was 5.1 months with placebo, reflecting an HR of 0.49 (

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Andrew Zhu, MD, PhD, discusses the final overall survival results from the phase 3 ClarIDHy trial in previously treated patients with IDH1-mutated cholangiocarcinoma.  



Dr. Zhu on the OS Results of the ClarIDHy Trial in IDH1+ Cholangiocarcinoma 

Andrew Zhu, MD, PhD, director, Liver Cancer Research, Medicine, Massachusetts General Hospital, discusses the findings of KEYNOTE-224 in hepatocellular carcinoma (HCC).

KEYNOTE-224 evaluated pembrolizumab (Keytruda) in patients with advanced HCC who had been previously treated with sorafenib (Nexavar). Treatment with the PD-1 inhibitor pembrolizumab elicited promising progression-free survival (PFS) and overall survival (OS) results, according to phase II evidence presented at the 2018 Gastrointestinal Cancers Symposium.

Of 105 patients enrolled in the single-arm, open-label phase II KEYNOTE-224 study, the objective response rate with pembrolizumab was 16.3% (95% CI, 9.8%-24.9%), with 1 complete response (CR). The median PFS was 4.8 months (95% CI, 3.4-6.6) and the median OS has not been reached at the time of data presentation, although the OS at 6 months was 77.9%.

Dr. Zhu Discusses Findings of the KEYNOTE-224 in HCC

Andrew Zhu, MD, PhD, Associate Professor, Medicine, Harvard Medical School Director, Liver Cancer Research, Medicine, Massachusetts General Hospital, discusses the REACH study, which looks at ramucirumab in advanced hepatocellular carcinoma (HCC).

Since the approval of sorafenib, which is currently the only approved drug for HCC, there have been many attempts to find a therapy that can be used for patients that are refractory to sorafenib, says Zhu. The REACH study investigated sorafenib versus placebo plus best supportive card for patients that progressed on sorafenib or could not tolerate the therapy.

Despite a numeric improvement in median overall survival , the primary endpoint for the overall intent-to-treat population was not met, says Zhu. However in a subgroup with high alpha-fetoprotein levels, which is about 40-50% of the population, there was a highly statistically significant improvement in median overall survival.

View more from the 2015 World GI Congress

Andrew Zhu, MD, PhD, Associate Professor, Medicine, Harvard Medical School Director, Liver Cancer Research, Medicine, Massachusetts General Hospital, discusses the REACH study, which looks at ramucirumab in advanced hepatocellular carcinoma.

Andrew Zhu, MD, PhD

Articles

Dr. Zhu on the OS Results of the ClarIDHy Trial in IDH1+ Cholangiocarcinoma

Dr. Zhu Discusses Findings of the KEYNOTE-224 in HCC

Dr. Andrew Zhu on Ramucirumab for HCC