May 26 (Reuters) - An experimental Mirati Therapeutics Inc
drug that targets a specific genetic mutation shrank
tumors in 44% of advanced lung cancer patients in clinical
trials, but also caused serious side effects in 43% of them, the
company said on Thursday.
Details from studies of the drug, adagrasib, were released
ahead of the early June annual meeting of the American Society
of Clinical Oncology (ASCO), sending shares of Mirati down more
than 21% in after hours trading.
The oral drug is designed to target a mutated form of a gene
known as KRAS that occurs in about 13% of non-small cell lung
cancers (NSCLC), the most common type of lung cancer.
The first drug in this class, Amgen Inc's Lumakras,
was approved by the U.S. Food and Drug Administration last
year. Amgen in April reported data showing that its drug shrank
tumors in 41% of advanced NSCLC patients.
The drugs are part of a growing trend of medicines that
target gene mutations driving cancer regardless of which organ
the disease originated.
The FDA is slated to make an approval decision on Mirati's
drug by mid-December.
Mirati on Thursday said updated data from the Phase II study
under review at the FDA shows that 43% of trial participants
experienced serious treatment-related side effects, including
increased levels of liver enzymes and anemia.
Two treatment-related deaths were reported and 7% of trial
participants discontinued the treatment.
Mirati at the ASCO meeting is scheduled to present
additional data on how effective adagrasib is at treating NSCLC
that has spread to the brain.
The California-based company is also testing the drug as an
initial treatment for NSCLC, both alone and in combination with
Merck & Co's immunotherapy Keytruda.
Shares of Mirati, which closed at $58.76 in regular trading,
were down $12.46, or 21.3%, at $46 after hours.
(Reporting By Deena Beasley; Editing by Bill Berkrot and
Richard Pullin)