Pfizer ended the year with some disappointing clinical news after the firm called a halt to a late-stage trial of its investigational lung cancer treatment figitumumab.
Specifically, Pfizer has discontinued a Phase III trial looking at figitumumab as a first-line treatment for advanced non-adenocarcinoma non-small-cell lung cancer. The termination follows a review by an independent data safety monitoring committee which showed that the addition of the drug to paclitaxel plus carboplatin “would be unlikely to meet the primary endpoint of improving overall survival” compared to the aforementioned chemotherapy alone.
The discontinuation follows a halt in new patient enrolment to the trial in September 2009 when the committee observed “an apparent imbalance of certain serious adverse events between the treatment arms with more events, including fatalities”, occurring in patients randomised to receive figitumumab, an insulin growth factor-1 receptor.
Mace Rothenberg at Pfizer’s oncology business unit, acknowledged that these findings are disappointing, the company is not giving up on the compound. He said Pfizer is “hopeful that we will be able to identify a subset of patients who may have derived benefit from the addition of figitumumab to chemotherapy” and “this can be done, then future trials will focus on this group of patients”.
The trial was part of a larger late-stage programme for figitumumab that includes an ongoing trial in patients with refractory advanced non-adenocarcinoma NSCLC who are receiving the compound in combination with erlotinib (Roche’s Tarceva) or the latter alone, A Phase III trial evaluating figitumumab, in combination with another chemotherapy regimen – cisplatin and Eli Lilly’s Gemzar (gemcitabine) is in the planning stages.
Figitumumab is also being studied as a treatment for other cancers, including prostate and breast, and sarcoma.
FDA review of Prevnar 13 not finished
Pfizer was also hit by the news that regulators in the USA said again that they need more time before they make a decision on whether to give the green light to a new version of the blockbuster childhood vaccine Prevnar.
The US Food and Drug Administration was due to give its final decision on Prevnar 13 for the immunisation of infants and young children for the prevention of invasive disease and otitis media caused by the 13 Streptococcus pneumoniae serotypes in the vaccine by December 30. The agency had already extended its review by 90 days from an original action date of September 30, based on the submission of additional manufacturing data.
The FDA’s Vaccines and Related Biological Products Advisory Committee voted 10 to one in favour of approval in November and Emilio Emini, chief scientific officer of vaccine research at Pfizer, says the firm has confidence in the the data contained in the Biologics License Application for Prevnar 13, which was acquired through the merger with Wyeth. Last month, the European Commission approved the vaccine for immunisation in children aged six weeks to five-years old.
