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 Chief Executive Officer Charles Baum told Reuters Mirati plans to
meet with the U.S. Food and Drug Administration in October to
discuss whether it can pursue accelerated approval based on the
combination therapy data.
Adagrasib targets a mutated form of a gene known as KRAS that occurs
in around 13% of non-small cell lung cancers, 3% to 5% of colorectal
cancers and up to 2% of other solid tumor cancers. Like other newer
experimental drugs, it homes in on specific gene mutations driving
cancer regardless of the organ in which the disease originated.
In May, Amgen Inc's Lumakras became the first approved drug in the
class after the U.S. Food and Drug Administration cleared it for use
in patients with advanced non-small cell lung cancer.
At a meeting of the European Society of Medical Oncology (ESMO) on
Sunday, Mirati said that out of 28 evaluated trial patients treated
with adagrasib plus Erbitux, 11, or 39%, experienced tumor
shrinkage. Two patients had tumor growth, but the cancer was
stabilized in the others, Mirati said.
Erbitux is an Eli Lilly & Co drug designed to block one of the
signals that tells a tumor cell to grow by attaching to a structure
on the cell called the epidermal growth factor receptor (EGFR).
At the ESMO meeting earlier this week, Amgen said a trial of
Lumakras in combination with its own EGFR inhibitor Vectibix found
that 7 out of 26 advanced colorectal cancer patients, or 27%,
responded to the combination therapy.
[to top of second column] |
 Mirati said that at the time of
its analysis, with a median follow up of seven
months, 63% of enrolled patients remained on its
combination treatment.
In a segment of the trial where colorectal
cancer patients were given adagrasib alone, 22%
of evaluated patients responded to the drug, the
company said.
Researchers said serious side effects occurred
in 30% of patients treated with adagrasib alone,
and in 16% of patients treated with the
combination. Two patients who received the
combination discontinued treatment after
developing infusion-related reactions.
"It looks like we've gained quite a bit in
efficacy and not really added much significant
toxicity. So that's why, you know, that
combination approach may end up being our
fastest approach for accelerated approval," CEO
Baum said.
Mirati plans to present updated results from a
trial of adagrasib for lung cancer patients at
ESMO on Monday.
Both Amgen and Mirati are also studying their
drugs in combination with Keytruda, Merck & Co’s
blockbuster immunotherapy, for treating lung
cancer.
(Reporting By Deena Beasley; Editing by David
Gregorio)
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