Amgen Inc. on Sunday announced that a small study conducted on its Lumakras is found to be helpful to 29 percent of advanced lung cancer patients. However, the liver toxicity was high and more study is needed on it, the company said ahead of the data presentation at the World Conference on Lung Cancer in Vienna.
According to a report by the news agency Reuters, the scientists who conducted this study found that almost all of the 58 trial patients treated with the highest dose of genetic-mutation targeting Lumakras experienced elevated liver enzyme levels, and about 20 percent given the lowest dose saw significant liver toxicity.
Meanwhile, the findings of the study revealed the performance of Lumakras in combination with drugs that help the immune system attack cancer – Merck & Co’s (MRK.N) Keytruda and Roche Holding AG’s (ROG.S) Tecentriq.
An oral drug, Lumakras is designed to target a mutated form of a gene called KRAS that occurs in about 13 percent of non-small cell lung cancers, the most common form of the disease, and less frequently in some other solid tumors.
Last year, the drug was approved by the U.S. Food and Drug Administration (USFDA) for advanced lung cancer patients with KRAS mutations whose disease has worsened after treatment with chemotherapy or other medicines, however, Amgen is testing whether the drug could be used as an earlier treatment.
The study found that 17 out of 58 patients with advanced NSCLC – most of whom were previously treated with immunotherapies – had tumor shrinkage. Among the 17 responders, the median duration of response was 17.9 months.
“It is not a slam-dunk success with the combination as we had hoped for … clearly high doses were not tolerable. There still seems to be a path forward,” Dr. Bob Li, an oncologist at Memorial Sloan Kettering Cancer Center and the study’s lead investigator said as quoted by Reuters.
According to reports, Amgen said that the next iteration of the study will enroll only patients not previously treated with immunotherapy. To limit the risk of liver toxicity, it will use a low dose of Lumakras as a lead-in, followed by the combination of Lumakras and Keytruda. Tecentriq will no longer be part of the trial.
“I suspect we will have data sometime next year,” said David Reese, Amgen’s research and development chief as quoted by Reuters.
Amgen said it is also starting a study of Lumakras in combination with chemotherapy as an initial treatment for advanced NSCLC patients who test negative for PD-L1, a protein targeted by drugs like Keytruda that helps cancer cells hide from the body’s immune system.
(With inputs from Reuters)