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 In the 61-patient study, about 30 percent of those with Merkel skin
cell carcinoma treated with Merck's avelumab saw their tumors shrink
or disappear.
Avelumab, which German Merck is developing with Pfizer Inc <PFE.N>,
belongs to a class of drugs called PD-L1 inhibitors that block a
mechanism tumors use to hide from the immune system, allowing it to
recognize and attack the cancer. They are closely related to the
PD-1 drugs already on the market from Bristol-Myers Squibb <BMY.N> (Opdivo)
and Merck & Co <MRK.N> (Keytruda) seen as major advances against
melanoma, lung cancer and other malignancies.
Roche's <ROG.S> Tecentriq earlier on Wednesday became the first
approved PD-L1 drug, gaining U.S. approval to treat advanced bladder
cancer.
Patients in the avelumab skin cancer study had not been helped by
prior treatment with standard chemotherapy, leaving them without
further treatment options, known as second-linetherapy.
"As there are no approved treatments for second-linemetastatic
Merkel cell carcinoma and the standard of care isparticipating in
clinical trials, these data represent apotential breakthrough for
these patients," said LucianoRossetti, head of research for Merck's
biopharma business.
The drug was not tested against another medicine or placebo. But
researchers concluded from an interim analysis that avelumab
demonstrated "a manageable safety profile withdurable responses."
Six patients, or about 10 percent, experienced complete responses
with no signs of cancer, while 12 others saw significant tumor
shrinkage. The data will be presented at the American Society of
Clinical Oncology meeting in Chicago next month, and could be used
as a basis for seeking U.S. approval.
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The U.S. Food and Drug Administration awarded avelumabits
breakthrough designation, which is given to drugs seen as a
potentially important advance for specific diseases and can speed up
the approval process.
For Merck, which also makes chemicals for display screens and lab
supplies, avelumab could help to revive its fortunes in
pharmaceuticals after a string of setbacks. For Pfizer, seen as
lagging the leaders in the immuno-oncology field, avelumab could be
its first significant entry.
The drug is also being tested against lung, breast, gastric and
ovarian cancers, and in combination with other medicines.
(Reporting by Ludwig Burger; editing by Bill Berkrot and Nick
Zieminski)
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