Eli Lilly said Wednesday that a Phase III study of Cyramza (ramucirumab) in the second-line treatment of people with hepatocellular carcinoma (HCC) met its primary endpoint of overall survival, as well as its secondary goal of progression-free survival. The company noted that it intends to initiate regulatory submissions for the VEGF receptor 2 antagonist in this indication in mid-2018.
The REACH-2 trial randomised 292 patients with HCC who were intolerant to, or that had disease progression while on or following treatment with, Bayer's Nexavar (sorafenib) and had high levels of the glycoprotein alpha-fetoprotein (AFP) to receive Cyramza or placebo, both in combination with best supportive care. Eli Lilly noted that this is the first positive late-stage study in a biomarker-selected HCC population.
Levi Garraway, senior vice president of global development and medical affairs at Lilly Oncology, remarked "advanced liver cancer is an aggressive disease that has a poor prognosis – and for those that have elevated AFP levels, the prognosis is even more dismal." Garraway continued "for this reason, Lilly is encouraged by the results of REACH-2 and the potential for Cyramza to benefit patients in this setting." The drugmaker indicated that results will be submitted for presentation at a future medical meeting.
Eli Lilly explained that the design of the REACH-2 trial was based on findings from the Phase III REACH study. In the trial, the results of which were unveiled in 2014, Cyramza failed to significantly improve survival in the entire patient cohort, while key secondary endpoints were met in a pre-specified subgroup of patients with high AFP levels.
Cyramza was initially approved in the US in 2014 for use in certain patients with unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma, later gaining clearance for use in combination with paclitaxel. The drug is also authorised in the US for patients with metastatic non-small-cell lung cancer.
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