Pfizer has dropped its Phase III trial evaluating figitumumab (CP-751,871) as an addition to paclitaxel and carboplatin therapy in patients with advanced nonadenocarcinoma non-small-cell lung cancer (NSCLC). The decision followed an analysis by the trial’s independent data safety monitoring committee (DSMC), which found that the treatment would be unlikely to improve overall survival.
In September the DSMC put a halt on new patient enrolment to the study after observing an apparent increase in serious adverse events including deaths in the patient cohort randomized to receive figitumumab.
Pfizer admits that having to discontinue the trial is disappointing but says it hopes to identify a subset of NSCLC patients who would benefit from the addition of figitumumab to chemotherapy. Future trials would then target this group of patients specifically. “We remain strongly committed to the figitumumab clinical development program in NSCLC in addition to other cancers where treatment options are desparately needed,” asserts Garry Nicholson, svp and GM of Pfizer’s oncology business unit.
Figitumumab is a fully human mAb targeting the insulin growth factor-1 receptor pathway. The drug’s Phase III trial program includes an ongoing study of the antibody as an addition to erlotinib in patients with refractory, advanced nonadenocarcinoma NSCLC. Another Phase III trial being planned will assess the addition of figitumumab to cisplatin and gemcitabine as a first-line treatment for advanced NSCLC. Pfizer says that it will use data from the discontinued trial to help optimize the new Phase III study. Figitumumab is also being evaluated in clinical trials against breast and prostate cancers and Ewing’s sarcoma.