Phase 3 study in second-line liver cancer patients met overall survival endpoint

Eli Lilly has announced top-line results from its Phase 3 REACH-2 study of its second-line treatment for liver cancer CYRAMZA, as a single agent .

The study has met its primary endpoint of overall survival (OS) as well as the secondary endpoint of progression-free survival (PFS). CYRAMZA has now demonstrated a survival benefit in four aggressive, difficult-to-treat tumor types in Phase 3 studies, including as a single agent in both gastric cancer and hepatocellular carcinoma HCC.

With this positive outcome, the REACH-2 study has confirmed the hypothesis generated by the REACH trial results,1 which showed that a pre-specified subgroup of advanced HCC patients who were AFP-High derived a survival benefit from treatment with CYRAMZA following first-line treatment with sorafenib. This REACH-2 outcome also builds upon Lilly’s efforts and commitment to providing treatment options for people living with HCC and gastrointestinal cancers. In addition to the Phase 3 REACH and REACH-2 trials, Lilly is evaluating CYRAMZA with an immuno-oncology agent in HCC in a Phase 1b study cohort, and is conducting various studies of CYRAMZA in other gastrointestinal cancers, including gastric, colorectal and biliary tract, Lilly said in the announcement.

Levi Garraway, senior vice president, global development and medical affairs, Lilly Oncology, said: “We thank the patients, their caregivers and investigators for their support of and participation in the REACH-2 study. Without their contributions, we could not have achieved today’s milestone – which represents important progress in our efforts to help people living with liver cancer and, more broadly, gastrointestinal cancers.”