Lumakras, a lung cancer drug developed by Amgen, performed better than chemotherapy in a clinical trial, keeping patients' tumors from getting worse with fewer side effects—but without improving overall death rates, according to a presentation Monday at the European Society for Medical Oncology Congress in Paris.

Study details

Lumakras is the first drug approved by FDA that targets the KRAS genetic mutation that is commonly found in cancers. When FDA approved the drug last year, it required Amgen to conduct another study to confirm its encouraging early-stage results, which the company reported on Sunday.

In the study of 345 lung cancer patients who had been previously treated, researchers found that those who took Lumakras went 5.6 months without their cancer getting worse compared to 4.5 months for patients who took the chemotherapy docetaxel. In total, a quarter of patients who took Lumakras lived at least one year without their cancers worsening compared to just 10% of patients who took docetaxel.

Lumakras also presented fewer side effects, the study found. Among patients who took Lumakras, 11% experienced serious side effects related to their treatment compared to 23% among those who took docetaxel.

However, the study did not find that Lumakras improved death rates. Patients who took Lumakras had a 63.7% death rate during the study compared to 54% among patients who took docetaxel. However, the researchers said the difference was not statistically significant. Lumakras patients survived a median 10.6 months while those taking docetaxel survived a median of 11.3 months.

Amgen noted the study was not statistically designed to measure an overall survival benefit, and that the study allowed patients who received docetaxel to also take Lumakras if their tumors got worse, meaning it would be difficult to determine a survival benefit.

Discussion

Given Lumakras' advantage over chemotherapy, the drug succeeded in its primary goal and will likely be granted full approval from FDA, said Brian Skorney, a biotechnology analyst at Robert W. Baird.

Similarly, Pasi Jänne, a physician and director of the lung cancer center at the Dana-Farber Cancer Institute, said Lumakras is likely to receive approval from FDA based on the results of this study.

"It was nice to see that this was a positive trial against standard-of-care chemotherapy," he said. "Although the progression-free survival was superior, I would have liked to have seen a bit more from Lumakras."

Benjamin Levy, a lung cancer physician and clinical director of medical oncology at Johns Hopkins Sidney Kimmel Cancer Center, said the results of the study were "very surprising and disappointing."

"I want to be fair, so the pros with this study are that Lumakras met the primary endpoint and the drug is better tolerated overall than docetaxel, which can be just brutal on patients," he said. "But if you had asked any lung cancer specialist what was going to happen when you compare Lumakras to docetaxel, none would have told you that there'd be no survival benefit. The Lumakras story is not over by any means, but these results are going to disappoint the field, there's no doubt about that."

Skorney also said the drug's failure to prove a survival benefit could cause some insurers and oncologists to avoid using Lumakras, especially given its list price of $17,900 a month compared to docetaxel's monthly cost of $1,700.

"Payers could say, 'Why should we pay hundreds of thousands of dollars more for a drug that does not provide a survival benefit?'" he said. (Walker, Wall Street Journal, 9/12; Feuerstein, STAT+ [subscription required], 9/12)