UPDATE 2-Pfizer lung cancer drug fails in two large studies

Mon Jan 27, 2014 10:39am EST

By Ransdell Pierson
    Jan 27 (Reuters) - Pfizer Inc 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 1009, patients
given Pfizer's once-daily pill did not show improved survival
without the cancer worsening, compared with Roche Holding AG'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
Plc. Results from that study are expected in 2015.
    Pfizer shares were little changed in morning trading on the
New York Stock Exchange.