fizer says it has placed “a temporary halt” on new patient enrollment for one of its Phase III trials examining the investigational compound figitumumab as a treatment for non-small cell lung cancer.
The company sent a statement to PharmaTimes World News that the suspension of the trial following a “a routine review of serious adverse events” by an independent data safety monitoring committee. The study was looking at patients with NSCLC treated with figitumumab in combination with carboplatin plus paclitaxel or carboplatin plus paclitaxel alone.
However, the DSMC’s review of the data from the study, known as Advigo 1016, “indicated an apparent imbalance between the treatment arms with more events, including fatalities”, in patients who were randomized to receive figitumumab, Pfizer noted. The New York-based drugs giant added that currently enrolled patients (over 680 out of a target of 820) may continue their treatment in consultation with their doctors.
Pfizer added that it has notified all clinical trial investigators and regulatory agencies and will work closely with the DSMC to conduct a “thorough data analysis” before issuing further guidance. It noted that another Phase III trial, Advigo 1018, evaluating figitumumab in combination with Roche/OSI Pharmaceuticals' lung cancer drug Tarceva (erlotinib) is continuing to enroll new patients.
The news is a blow for Pfizer, and Seamus Fernandez, an analyst at Leerink Swann, had previously forecasting global revenues of $1.2 billion by 2015 for figitumumab. However he has removed any potential sales of the drug from his models and issued an investment note saying that “despite trials in other types of cancer such as breast and prostate, we...were most enthusiastic about prospects for this drug in lung cancer based on Phase II efficacy responses”.
He added that “this is a disappointment, but not unrecoverable for Pfizer”.