Lilly’s ramucirumab fails to crack phase 3 gastric cancer trial


Eli Lilly and Company, which is better known as Lilly, says that a late-stage trial of Cyramza (ramucirumab) for the treatment of a form of gastric cancer met its primary goal of stopping the disease from advancing, but failed in improving overall survival.

An antiangiogenic therapy, ramucirumab in combination with cisplatin and capecitabine or 5-FU (5-fluorouracil) was evaluated by the global pharmaceutical company in a first-line setting for the treatment of HER2-negative metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

The phase 3 trial named as RAINFALL did meet its primary endpoint of progression-free survival (PFS). However, it couldn’t meet overall survival, one of the key secondary endpoints in the RAINFALL trial part from objective response rate and safety.

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Commenting on the gastric cancer trial, Levi Garraway – Senior Vice President of Lilly Oncology Global Development and Medical Affairs, said: “While we hoped that the positive PFS outcome would have translated into an OS benefit, these RAINFALL results highlight the challenges associated with improving outcomes for people with advanced gastric cancer.

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“This is underscored by the fact that there have been no major advances over standard chemotherapy in the first-line HER2-negative gastric cancer treatment setting in the last decade.”

Eli Lilly and Company

Eli Lilly and Company. Photo courtesy of Guanaco152003/

Lilly would not be going ahead to try for a regulatory approval of the ramucirumab combination therapy with the results of the RAINFALL gastric cancer trial.

The global pharmaceutical company advises that the RAINFALL trial results do not have any impact on current approvals of the gastric cancer drug ramucirumab.

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Lilly revealed the ramucirumab safety profile that was observed in the RAINFALL trial was identical to what was observed in previous trials of the gastric cancer drug.

RAINFALL is a global, randomized, double-blinded, placebo-controlled trial which was initiated in 2015. The late-stage gastric cancer trial enrolled 645 patients and was held in 19 countries.

Ramucirumab was approved by the US Food and Drug Administration in 2014 for gastric cancer treatment in patients in whom the disease is in the advanced stage and who had prior chemotherapy.

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