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 Out of 13 lung cancer patients taking a 960-milligram dose of
AMG510, seven had tumors shrink by at least 30%, according to data
presented in Barcelona at the World Conference on Lung Cancer.
Cancer was stabilized in the other six high-dose patients.
Nine of the 13, or 69%, are still taking the daily pill. Two of the
partial responders have died, and another left the study due to
cancer progression. One patient with stable disease also died.
Patients who responded to the drug have been treated for a median of
15 weeks, but the median duration of response has not been reached,
according to Greg Friberg, head of oncology development at Amgen.
He said one patient previously reported as free of lung cancer is
being counted as a partial responder since cancer in lymph nodes or
other tissue cannot be ruled out.
Thirty-four lung cancer patients are enrolled in the Phase 1
dose-ranging trial, but Amgen has moved only the highest dose into a
mid-stage study. The trial enrolled patients with tumors carrying
the targeted mutation whose cancer had worsened despite several
previous treatments - including chemotherapy and checkpoint
inhibitors.
Of the 23 lung cancer patients so far evaluated - at various doses
of AMG510 - 11 had tumor shrinkage of at least 30%.
About a third of trial patients reported mild side effects. More
serious side effects, diarrhea and anemia, were seen in 9%of
patients and no one left the study due to toxicity, the company
said.
Wall Street has taken a keen interest in the Amgen drug that could
become the first approved medicine targeting a mutated form of a
gene known as KRAS - one of the most common mutations found in
non-small cell lung cancer (NSCLC).
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NSCLC accounts for up to 85% of lung cancers, by far the leading
cause of cancer death among men and women, according to the American
Cancer Society.
AMG510 is part of a growing trend of precision medicines that target
gene mutations driving cancer regardless of the organ in which the
disease originated.
The targeted mutation, KRASG12C, occurs in around 13% of NSCLC
cases, as well as 3-5% of colorectal cancers and up to 2% of other
solid tumor cancers, including pancreatic.
Amgen plans to present Phase 1 AMG510 trial results for patients
with colorectal cancer later this month at a separate meeting to be
held in Barcelona, this one by the European Society for Medical
Oncology.
The company is also enrolling patients in an early-stage study of
AMG510 in combination with Keytruda, Merck & Co's checkpoint
inhibitor designed to unleash the body's immune system to attack
cancer cells.
Amgen said the U.S. Food and Drug Administration has granted "fast
track" status to AMG510 for previously treated NSCLC with KRASG12C
mutation.
Rivals such as Mirati Therapeutics Inc are also developing drugs
that target KRAS mutations, but Amgen’s could be first to market.
(Reporting by Deena Beasley in Los Angeles; Editing by Matthew
Lewis)
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