Amgen on Thursday said its KRAS-blocking drug Lumakras succeeded in a late-stage clinical trial, delaying progression of a certain kind of colon cancer.
According to the biotechnology company, both tested doses of Lumakras met the trial’s main goal measuring what’s known as progression-free survival. Dubbed CodeBreak 300, the study pitted a combination of Lumakras and a drug called Vectibix against physicians’ choice of one of two older colorectal cancer therapies in patients who had previously received chemotherapy.
Amgen disclosed the study’s results alongside its second quarter earnings, but did not divulge further details. The company will present specific data at an upcoming medical meeting, and said it would discuss the findings with regulators.
The Food and Drug Administration approved Lumakras in early 2021 for treating lung cancer, making it the first drug available to target tumors driven to growth by an often-mutated gene called KRAS. These mutations are also commonly found in colon and pancreatic cancers.
Although an early study found Lumakras didn’t work as well by itself in colon cancer, Amgen pushed forward with testing that combined it with Vectibix, an antibody drug it also sells. Results in the fall of 2021 showed some promise, spurring Amgen to begin the Phase 3 study that’s now read out.
In its short update Thursday, Amgen said Lumakras’ efficacy in the trial was “consistent” with those 2021 data and showed no new safety signals.
While Lumakras’ approval was viewed as a research landmark, Amgen hasn’t had as much success selling the drug as some analysts once envisioned. Between April and June, sales of the drug reached $77 million, about equal to what it earned during the same period last year.
Amgen said lower net selling prices and inventory stocking offset growth in Lumakras prescription volume.
Also on Thursday, Amgen revealed it halted enrollment in a study testing Lumakras together with a common type of immunotherapy for lung cancer. Prior data had shown such combinations could result in lung toxicity.
Amgen is working to convert Lumakras’ lung cancer approval from accelerated to full, and told investors Thursday that the FDA will make a decision by December 24. That application is based on findings from a Phase 3 study comparing Amgen’s drug to chemotherapy in people with non-small cell lung cancer.
Meanwhile, the company revealed Thursday that another of its cancer drugs, the bispecific antibody tarlatamab, showed promise in a Phase 2 study of people with the less common small cell form of lung cancer.