Lumakras Demonstrates Positive Results for Some Patients with KRAS G12C Pancreatic Cancer

Lumakras (sotorasib), a KRAS G12C inhibitor, demonstrated meaningful anticancer activity with an acceptable safety profile in patients KRAS G12C-mutated metastatic pancreatic cancer, who were previously heavily treated, according to study results recently published in The New England Journal of Medicine.

Specifically, there was an objective response rate (the rate of a measurable response to the treatment) of 21.1% and a median time to response of 1.5 months with 84% of patients having disease control. Furthermore, median progression-free survival (time during and after treatment when the patient lives without disease progression) was 4 months and overall survival (time from diagnosis or treatment start when patients are alive) was 6.9 months.

“These are encouraging early data because they point toward establishing that KRAS inhibitors can work in pancreatic cancers, which have been difficult to crack from a targeted therapy standpoint,” said Dr. David S. Hong, lead author on the study and professor of Investigational Cancer Therapeutics at the University of Texas MD Anderson, in a press release. “We look forward to data from larger trials as we continue working to bring much-needed new therapies to these patients.”

Of note, KRAS mutations are common in pancreatic cancers, presenting in 90% of cases. 1% to 2% of cases are KRAS G12 mutations.

Hong also noted that these results could be a forerunner of success for other drugs in the pipeline that target KRAS mutations. Of note, Lumakras is approved by the Food and Drug Administration for patients with KRAAS G12C mutated non-small cell lung cancer.

All patients (38) experienced side effects, with the most common being abdominal pain (36.8%), diarrhea (23.7%) and nausea (23.7%). Severe or worse side effects were reported in 15.8% of patients. The most commonly reported side effects were diarrhea and fatigue.

“It’s gratifying to see results like this, since targeting mutant KRAS seemed virtually impossible just a few years ago. Still, we must continue our research efforts to make progress against other common KRAS mutations found in pancreatic and other cancer types,” Hong said. “Trials have recently begun on drugs targeting KRAS G12D, a much more common mutation in pancreatic cancer, as well as some pan-RAS therapies, which target multiple mutations.”

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