Pfizer lung cancer drug fails in two large studies

By Ransdell Pierson

Jan 27 (Reuters) - Pfizer Inc (NYSE: PFE - news) on Monday said one of

its experimental drugs had failed to meet its goals in two

late-stage studies among patients who had received prior

treatment for advanced non-small cell lung cancer, the most

common form of the disease.

Although Pfizer continues to test the drug, called

dacomitinib, in another Phase III study, hopes for its success

have now largely faded, according to ISI Group analyst Mark

Schoenebaum.

"We believe consensus expectations (for the drug) will be

close to zero given today's readout" of unsuccessful trial

results, Schoenebaum said in a research note.

In one of the failed trials, called ARCHER (Frankfurt: 8SW.F - news) 1009, patients

given Pfizer's once-daily pill did not show improved survival

without the cancer worsening, compared with Roche Holding AG (Other OTC: RHHBF - news) 's

widely used Tarceva (erlotinib).

Tarceva is the current standard of care in patients with

mutated forms of a protein called Epidermal Growth Factor

Receptor (EGFR). The protein plays a role in normal regulation

of cell growth, but when mutated is believed to cause cells to

proliferate and thereby help spur various types of cancer.

Dacomitinib is designed to block several types of Epidermal

Growth Factor receptors, while Tarceva and similar treatments

for lung cancer target only one type of receptor.

Cowen and Co had forecast annual sales of $500 million by

2020 for dacomitinib, if it were approved for lung cancer. That

would make it a moderate-sized product for Pfizer, the largest

U.S. drugmaker, which has annual revenue of $50 billion.

Schoenebaum said there has been little investor interest in

the drug and that Wall Street had expected it to generate annual

sales of only $300 million by 2018.

The second failed trial, named BR.26, involved patients that

previously had failed to benefit from chemotherapy as well as

from treatment with an EGFR inhibitor.

Overall survival of patients taking the Pfizer drug was not

prolonged in the study, compared with patients given a placebo.

Pfizer said adverse events seen with dacomitinib were

consistent with those seen in smaller earlier studies.

In the meantime, Pfizer said dacomitinib is also being

tested in a third late-stage trial, called ARCHER 1050, among

patients with advanced non-small cell lung cancer who have not

received prior treatment. The study will compare dacomitinib

with Iressa (gefitinib), an EGFR inhibitor sold by AstraZeneca (EUREX: AZNF.EX - news)

Plc. Results from that study are expected in 2015.

Pfizer shares were little changed in morning trading on the

New York Stock Exchange.