Adding Lilly’s biologic Cyramza (ramucirumab) to the chemotherapy paclitaxel significantly boosted median overall survival in patients with advanced gastric (stomach) cancer or gastroesophageal junction (GEJ) adenocarcinoma, a late-stage trials has shown, meeting its primary goals.
The RAINBOW study, data from which is published in The Lancet Oncology online, also hit secondary targets of significant improvements in progression-free survival and objective response rate.
According to the results, patients taking the Cyramza/paclitaxel combo had a median survival benefit of 9.6 months compared to 7.4 months for those in the control arm, while Lilly’s regimen also significantly cut the risk of disease progression or death (by 37%), with a 52% increase in median progression-free survival compared with placebo (4.4 months vs. 2.9 months).
On the safety side, the most frequent side effects that occurred at a higher rate in the Cyramza group were: neutropenia (41% vs. 19%); decreased white blood cell count (17% vs. 7%); high blood pressure (15% vs. 3%); and fatigue/asthenia (12% vs. 5%).
Lilly notes that this is the second Phase III gastric cancer trial in which the drug has demonstrated statistically significant improvements in both overall survival and progression-free survival, following data from the REGARD study which assessed Cyramza as a single-agent treatment.
"We are encouraged by the RAINBOW study results and are pleased that we now have a second Phase III trial of ramucirumab which has demonstrated improved survival in advanced gastric cancer patients,” noted Lilly Oncology’s product development and medical affairs lead Richard Gaynor.
The firm also said that data from RAINBOW trial form the basis for regulatory submissions on both side of the Atlantic, while plans for a submission to Japanese regulatory authorities in the second half of 2014 are on track.