Eli Lilly has announced the results of two separate Phase III trials with its cancer mAb ramucirumab – and there’s good news and bad news. The drug failed to reach its primary endpoint in the breast cancer indication, yet successfully met its goal in a separate late-stage trial for the gastric cancer indication, the company has announced.
Ramucirumab, an antiangiogenic mAb, was tested in the ROSE trial as an initial treatment in patients with advanced breast cancer. However, ramucirumab combined with docetaxel did not improve survival without progression of the cancer when compared to placebo and docetaxel.
The results for the gastric cancer indication were quite the opposite, however. Last October, Lilly announced that the Phase III REGARD trial in patients with metastatic gastric cancer showed that single-agent ramucirumab improved overall survival and prolonged progression-free survival. Now there are also positive results from the RAINBOW trial where the drug was used in conjunction with paclitaxel.
With the results in hand, Eli Lilly now plans to file for regulatory approval in gastric cancer but doesn’t plan to move forward with the breast cancer indication, according to the Wall Street Journal.
“We are disappointed that this breast cancer trial did not meet its primary endpoint. However, now with two positive gastric cancer trials, Lilly remains confident in the overall ramucirumab development program. We are looking forward to additional Phase III results for ramucirumab in colorectal, hepatocellular and lung cancer, expected in 2014,” said Richard Gaynor, vice president, product development and medical affairs for Lilly Oncology.