NECITUMUMAB TRIAL STOPPED FOR SAFETY REASONS

February 2, 2011 — A phase 3 trial of necitumumab, an investigational agent for the first-line treatment of advanced nonsmall cell lung cancer (NSCLC), has stopped enrolling patients because of safety concerns related to thromboembolism in the experimental group of the study.
Eli Lilly and Bristol-Myers Squibb — the sponsors of the trial and codevelopers of the agent — made the announcement today in a press statement.
The INSPIRE trial compares necitumumab, a fully human IgG1 monoclonal antibody, in combination with pemetrexed (Alimta; Eli Lilly) and cisplatin with a control regimen of the latter 2 drugs for patients with advanced nonsquamous NSCLC.
No new safety issues were seen in the control group.
According to the press statement, the decision to stop enrollment followed a recommendation by the independent Data Monitoring Committee that no new or recently enrolled patients continue treatment in the trial because of safety concerns.
Notably, the Data Monitoring Committee said that patients who have received 2 or more cycles of necitumumab appear to have a lower ongoing risk for thromboembolism. These patients might choose to remain in the trial after being informed of the potential risks. Investigators will continue to assess patients after 2 cycles to determine if there is a benefit from treatment, says the statement.
Meanwhile, another phase 3 trial of necitumumab — SQUIRE — continues on with no concerns about thromboembolism at this time. In that trial, necitumumab is being studied as a potential treatment for squamous NSCLC in combination with gemcitabine (Gemzar; Lilly) and cisplatin. "The same independent Data Monitoring Committee recommended that this trial continue because no safety concerns have been observed," according to the press statement.
"Patient safety is paramount. While stopping enrollment in 1 of the 2 phase 3 trials is disappointing, the SQUIRE phase 3 study of necitumumab in lung cancer continues," said Richard Gaynor, MD, vice president of oncology product development and medical affairs at Eli Lilly.