What happened
Shares of Mirati Therapeutics (MRTX) were skyrocketing 37.2% this week as of the market close on Thursday, according to data from S&P Global Market Intelligence. This huge gain came after the company presented data at the 2022 American Society of Clinical Oncology annual meeting on Monday.
So what
For a biotech stock to soar as much as Mirati has on the presentation of clinical data, that data has to be exceptionally positive. That was definitely the case this week.
Mirati presented data from a phase 1b cohort of its Krystal-1 study evaluating adagrasib in treating KRAS G12C-mutated non-small cell lung cancer with active and untreated central nervous system metastases. The company reported that 32% of the 19 evaluable patients had an intracranial response to the drug.
Also, the overall intracranial disease control rate was 84%. Three patients achieved full remission, while three other patients achieved partial remission.
Mirati stated that there weren't any Grade 4 (requiring hospitalization) or Grade 5 (fatal) treatment-related adverse events (TRAEs). Thirty-six percent of patients experienced Grade 3 (serious) TRAEs. Grade 1 (mild) and Grade 2 (bothersome) TRAEs occurred in 60% of the patients.
Now what
The U.S. Food and Drug Administration expects to make an approval decision on adagrasib as a second-line treatment for non-small cell lung cancer by Dec. 14, 2022. Mirati hopes to win accelerated approval, though. If approved, adagrasib would compete against Amgen's Lumakras.
