An experimental Mirati Therapeutics Inc drug that targets a specific genetic mutation shrank tumors in 44% of advanced lung cancer patients in clinical trials, the company said on Thursday.
The 132 patients, who had stopped responding to previous therapy, were given once daily adagrasib in early and mid-stage studies. The oral medication 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 pooled trial 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 also 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's updates were provided in a scientific summary, or abstract, released ahead of the annual meeting of the American Society of Clinical Oncology (ASCO) in early June, where the studies will be presented in more detail.
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.
The KRAS mutation is also found in 1% to 3% of colorectal and other cancers. Both Mirati and Amgen are studying their drugs in these cancers.
