Eli Lilly is dropping plans to seek expanded FDA approval for ramucirumab (Cyramza) in stomach cancer after the drug missed a key goal in a late-stage study.
The Lilly (NYSE: LLY) drug is already approved, in combination with the drug paclitaxel, as a second-line treatment for patients whose stomach cancer has progressed despite chemotherapy. The current Phase 3 study tested the drug, also in combination with chemotherapies, as a first-line treatment. Ramucirumab blocks a protein produced by some tumors called VEGF. Blocking this protein interferes with the process of forming new blood vessels that provide cancer the blood supply that helps it grow and spread.
The study, started in 2015, enrolled 645 patients in 19 different countries. Patients were randomized to receive the Lilly drug plus chemotherapy, or a placebo plus chemotherapy. In early results from the clinical trial released late Friday, Indianapolis-based Lilly said the study met its main goal of improving progression-free survival, or the length of time a patient continues to live without the cancer worsening.
But the trial missed its second goal of improving overall survival, the length of time measured from when patients in the trial were randomized into different groups until the time of death. The side effects of the drug—hypertension, hand-foot syndrome (redness, swelling, pain, on the palms of the hands and soles of the feet, and sometimes blistering of the skin), and fatigue—were the same as those observed in earlier trials.
Based on the early results of the ramucirumab trial, Lilly said that it won’t seek FDA approval of the drug as a first-line treatment for stomach cancer. Lilly said that the latest results don’t affect the approved applications of the drug.
In addition to its approval in 2014 as a second-line stomach cancer treatment, ramucirumab also won the regulatory nod that year as a second-line treatment for advanced non-small cell lung cancer. In 2015, the FDA approved the drug as a second-line treatment for advanced colorectal cancer. Last year, ramucirumab accounted for more than $614 million in global sales, according to Lilly’s annual report.
The company has also been trying to expand use of the drug to more cancers. Lilly has already reported early data from a Phase 3 study showing that it met its main goal of progression-free survival as a second-line bladder cancer treatment. Overall survival data from that study are expected in mid-2018.
The Lilly drug is also in separate ongoing Phase 3 studies as a treatment for cancers of the liver and the lung. In liver cancer, ramucirumab is being tested as a second-line treatment. In lung cancer, the drug is being tested as a first-line treatment in patients whose tumors over express a protein that helps them grow and divide. Data from those studies are expected in 2018.
Lilly plans to present full results from the stomach cancer study at a future, unspecified medical meeting.