Pfizer drops figitumumab in NSCLC on disappointing Ph III; FDA delays Prevnar 13 and rejects Basilea/J&J's ceftobiprole for cSSSI

Global drug behemoth Pfizer has discontinued the development of A4021016 (also known as ADVIGO 1016), in a Phase III trial examining the effects of investigational compound figitumumab (CP-751,871) as first-line treatment in patients with advanced non-adenocarcinoma non-small cell lung cancer (NSCLC) due to the study meeting pre-defined boundaries for early termination.

An analysis by an independent Data Safety Monitoring Committee (DSMC) showed that the addition of figitumumab to paclitaxel plus carboplatin would be unlikely to meet the primary endpoint of improving overall survival compared to paclitaxel plus carboplatin alone. This discontinuation follows a halt in new patient enrollment to A4021016 in September 2009 when the DSMC observed an apparent imbalance of certain serious adverse events between the treatment arms with more events, including fatalities, occurring in patients who were randomized to receive figitumumab.

"While these findings are disappointing, Pfizer is committed to using information gained from this study to refine the design of future trials of figitumumab in non-small cell lung cancer,' said Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer's Oncology Business Unit. "We are hopeful that we will be able to identify a subset of patients who may have derived benefit from the addition of figitumumab to chemotherapy. If this can be done, then future trials will focus on this group of patients in our efforts to deliver this drug to the right patient," Dr Rothenberg added.