The largest U.S. drugmakers said the combination study will begin in
2015 and be conducted by Pfizer. Financial terms of the deal were
not disclosed.
Xalkori, which has annual sales of $400 million and is also known by
its chemical name, crizotinib, was approved in 2011 for lung cancer
patients who have a specific mutation in the so-called ALK gene, as
determined by an approved diagnostic test.
The mutation occurs in a small percentage of patients with non small
cell lung cancer, the most common form of lung cancer. It makes them
good candidates for treatment with Xalkori, a targeted drug that can
help shrink or slow tumor growth for these patients.
Pembrolizumab works by removing the brakes from the immune system,
allowing it to detect and destroy cancer cells.
The differing mechanisms of action from combination therapy are
meant to deliver a one-two punch to cancer cells.
The Merck drug, called a PD-1 inhibitor, is expected to be approved
within months in the United States and to become a blockbuster
treatment for melanoma, and possibly later for lung cancer and other
types of cancer, depending on results of ongoing clinical trials.
Merck, Bristol-Myers Squibb, Swiss drugmaker Roche and AstraZeneca
Plc are leading the charge in developing PD-1 inhibitors or similar
immunotherapies. Some industry analysts believe the medicines will
capture combined annual sales of up to $30 billion by 2025.
Merck and Pfizer previously said they would collaborate in
combination trials of pembrolizumab both with Pfizer's approved
Inlyta (axitinib) treatment for kidney cancer, and with an
experimental drug called PF-2566 that Pfizer is evaluating in
numerous cancer types. PF-2566 stimulates activity of 4-1BB
(CD-137), a protein involved in regulation of immune cell
proliferation.
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"For Pfizer, these collaborations help secure their drugs in a
market that is going under a paradigm shift" toward immunotherapies,
said Morningstar analyst Damien Conover. "I see it more of a
defensive move to make sure Pfizer's drugs are being used in the
anti-PD-1 space, instead of being bypassed."
Merck is not studying pembrolizumab in combination with its own
experimental drugs, but has other combination studies planned or
underway with a growing number of drugmakers, including Amgen.
Merck is also conducting a study of its PD-1 inhibitor in
combination with its own older melanoma drug, Sylatron.
Shares of Pfizer and Merck were both up about 0.6 percent in morning
trading on the New York Stock Exchange.
(Editing by Bernadette Baum and Dan Grebler)
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