Eli Lilly and Co. (LLY) Thursday said a global Phase III study of ramucirumab or IMC-1121B in advanced gastric cancer met its primary endpoint of improved overall survival and a secondary endpoint of improved progression-free survival.
However, a separate global Phase III study of ramucirumab in women with locally recurrent or metastatic breast cancer did not meet its primary endpoint of progression-free survival. The stock is down more than 4 percent in pre-market activity.
A global Phase III study of ramucirumab in combination with paclitaxel in patients with advanced gastric cancer, known as the RAINBOW trial, met its primary endpoint of improved overall survival and a secondary endpoint of improved progression-free survival.
The global, randomized, double-blind RAINBOW trial compared ramucirumab and paclitaxel to placebo and paclitaxel in patients with advanced gastric cancer that was refractory to or progressive after initial chemotherapy.
The most common adverse events occurring at a higher rate on the ramucirumab-plus-paclitaxel arm compared to the control arm included neutropenia, leukopenia, hypertension, fatigue/asthenia and abdominal pain.
REGARD, the first positive study, showed that single-agent ramucirumab improved overall survival and progression-free survival in patients with advanced gastric cancer who had disease progression after initial chemotherapy. There are no agents specifically approved in the U.S. or EU for advanced gastric cancer patients in this setting.
Lilly plans to present data from the RAINBOW trial at an upcoming scientific meeting and intends to submit an application for ramucirumab in combination with paclitaxel to regulators.
Richard Gaynor, vice president, product development and medical affairs for Lilly Oncology, said, ''We are excited to see a second positive Phase III trial of ramucirumab in gastric cancer demonstrating an improvement in both overall survival and progression-free survival, as stomach cancer is a difficult-to-treat disease that remains a major health problem worldwide and the prognosis for patients diagnosed with advanced gastric cancer is poor."
Meanwhile, Lilly said a separate global Phase III study of ramucirumab in women with locally recurrent or metastatic breast cancer, called ROSE, did not meet its primary endpoint of progression-free survival. This trial is being conducted with the international cancer research group Translational Research in Oncology or TRIO.
The randomized, double-blind trial, also known as TRIO-012, compared ramucirumab and docetaxel to placebo and docetaxel as a first-line treatment in patients with unresectable, locally recurrent or metastatic HER2-negative breast cancer.
The primary endpoint of progression-free survival in this study favored ramucirumab, but was not statistically significant. The interim analysis for overall survival showed no benefit for ramucirumab.
The most common adverse events occurring at a higher rate on the ramucirumab-plus-docetaxel arm compared to the control arm included fatigue/asthenia, neutropenia, febrile neutropenia, hypertension and stomatitis.
Lilly and TRIO will work together to determine the future course for patients enrolled in this ramucirumab breast cancer study. The drugmaker plans to present data from this trial at an upcoming scientific meeting.
LLY, which closed at $52.61 on Wednesday, is losing 4.1 percent in pre-market activity.
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