In a recent announcement, Eli Lilly and Company disclosed that its phase 3 RAINFALL trial of the drug Cyramza (ramucirumab) for the treatment of HER2-negative metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma achieved mixed results. While the trial met its primary endpoint of progression-free survival (PFS), it did not improve overall survival (OS), a key secondary endpoint.

Details of the RAINFALL Trial

The RAINFALL trial, a global, randomized, double-blinded, placebo-controlled study initiated in 2015, involved 645 patients across 19 countries. It evaluated the efficacy of ramucirumab combined with cisplatin and either capecitabine or 5-fluorouracil (5-FU) in a first-line setting. Despite achieving a halt in disease progression, the trial failed to extend the overall survival of patients, a critical measure of effectiveness in cancer treatment.

Expert Commentary on Trial Outcomes

Commenting on the findings, Levi Garraway, Senior Vice President of Lilly Oncology Global Development and Medical Affairs, expressed a tempered response: “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. 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.”

Implications for Regulatory Approval and Future Research

In light of the results, Lilly has decided not to pursue regulatory approval for the ramucirumab combination therapy based on the current outcomes of the RAINFALL trial. However, the company reassured that these results do not affect the current approvals of ramucirumab for gastric cancer treatment, which was first approved by the US Food and Drug Administration in 2014 for patients with advanced stages of the disease who had previously undergone chemotherapy.

Safety Profile and Ongoing Commitment

Lilly also confirmed that the safety profile of ramucirumab observed in the RAINFALL trial aligns with that seen in previous trials, indicating no new safety concerns. Despite the setback in overall survival improvement, Lilly remains committed to continuing its research in this challenging area, aiming to better understand and eventually improve the outcomes for patients suffering from advanced gastric cancer.

  Cancer treatment, clinical trials, Cyramza, Eli Lilly, Eli Lilly and Company, gastric cancer, Oncology, RAINFALL trial, ramucirumab, USA