It was mixed news for Pfizer yesterday after Sutent failed to hit its primary goal in a non-small cell lung cancer trial, but pneumococcal vaccine Prevnar 13 won approval by the World Health Organisation.
The world’s number one drugmaker Pfizer announced clinical trial results yesterday showing that its flagship cancer drug Sutent (sunitinib) failed to hit its primary endpoint in patients with non-small cell lung cancer.
Data from the SUN 1087 study assessing Sutent in combination with Roche’s Tarceva (erlotinib) versus Tarveca alone showed no significant improvement in overall survival. On the plus side, however, the study did meet its secondary endpoint, as the drug significantly improved progression-free survival in patients with previously treated NSCLC.
“While this trial did not demonstrate a statistically significant improvement in overall survival for patients treated with sunitinib plus erlotinib, we believe that the statistically significant improvement in progression free survival is an important finding,” said Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer's Oncology Business Unit.
The company will be conducting an in-depth analysis of the data over the next few months to determine whether Sutent - which is approved for the treatment of gastrointestinal stromal tumours and advanced kidney cancer - could be tested in one or more subgroups of NSCLC patients with either previously untreated or recurrent disease.
Prevnar 13 gets WHO nod
Meanwhile, in a more positive note for the drug giant the World Health Organisation has granted prequalification to its pneumococcal vaccine Prevnar 13 for active immunisation of infants and children from six weeks to five years of age against invasive disease, pneumonia and otitis media, caused by the 13 pneumococcal serotypes.
The move allows the vaccine’s procurement by United Nations agencies, including UNICEF, governments and other organisations, for use in national immunisation programs against the illnesses.
Emilio Emini, chief scientific officer of Vaccine Research at Pfizer, said the company is pleased with the decision, “as recognition that Prevenar 13 meets the organisation's high standards for quality”.
“This is an important step towards our goal of making Prevenar 13, which offers the broadest serotype coverage of any pneumococcal conjugate vaccine, available to infants and young children globally,” she added.
Pfizer also said that it would ramp up its manufacturing capabilities in order to meet growing global demand for its vaccine, through a combination of capital investment, process improvements and efficiency measures throughout its supply network.
In addition, the firm noted that it is currently working on the development of a preserved, multi-dose vial which, subject to WHO prequalification, could offer an alternative option for developing world countries.