Pfizer has been showcasing its cancer portfolio which it hopes will make it a major force in oncology, and much of that hope will be riding on Sutent and its new compound axitinib.
The New York-based drugs giant met with financial analysts in connection with the American Society of Clinical Oncology meeting in Chicago and noted that it will be pushing three compounds into Phase III trials in the next year. The most prominent will be Sutent (sunitinib) which is already approved, and is already the gold standard of treatment for advanced kidney cancer, and it is showing considerable potential in other indications. Currently in late-stage trials for breast cancer, Phase III studies are set to begin this year for non small-cell lung as well as for colon and liver cancer.
As for axitinib, which is in Phase III for thyroid cancer, Pfizer presented a whole range of data at ASCO, notably from a Phase II trial which showed that the compound, which is an investigational oral, selective inhibitor of vascular endothelial growth factor receptors 1, 2 and 3, when combined with gemcitabine, showed a trend towards prolonged overall survival in patients with advanced pancreatic cancer, compared with the chemotherapy treatment alone.
Results from the randomised Phase II study of 103 previously untreated patients with advanced pancreatic cancer demonstrated median overall survival with axitinib in combination with gemcitabine of 6.9 months compared with 5.6 months with gemcitabine alone and Pfizer’s new compound combined with the latter reduced the risk of death by 26%. “Pancreatic cancer continues to be one of the most life-threatening and difficult-to-treat solid tumours,” said lead study investigator Jean-Philippe Spano, who added that “seeing an agent with this level of activity and tolerability at this stage in development is encouraging news.”
Axitinib will now enter Phase III studies for pancreatic cancer, and Pfizer also presented several other Phase II studies evaluating the efficacy and safety of the compound in metastatic refractory thyroid, renal cell, non-small cell lung (NSCLC) and breast cancer. The company said it also plans to begin late-stage trials this year of its experimental drug CP-751,871 against non-small-cell lung cancer.
Matters away from the ASCO meeting brought worse news for Pfizer as it was revealed that the Nigerian government has filed a civil lawsuit against the company seeking around $7 billion in damages over the company's alleged role in the deaths and injuries of children who received the then-unapproved quinolone antibiotic Trovan (trovafloxacin) in 1996 as part of a clinical study. The allegations in an Abuja lawsuit are similar to allegations in a recent legal challenge against Pfizer, reported in PharmaTimes World News last month, which was filed in the Nigerian state of Kano.
Then, as now, Pfizer denies all the charges that it broke any laws when it administered the drug to children during a following an outbreak of a particularly virulent form of meningitis which ultimately killed 15,000 people. In the Abuja suit, the Nigerian government is seeking $500 million for treatment, compensation and support of the victims, $450 million for damages related to money spent on overcoming "societal misgivings" related to the study, $1 billion for health programmes and $5 billion in “general damages”.