Selumetinib, the first targeted therapy to benefit patients with the most common genetic subtype of lung cancer, performed well across many measures in an international study led by scientists at Dana-Farber Cancer Institute.
The clinical trial included 87 non–small cell lung cancer (NSCLC) patients with tumors harboring a mutation in the KRAS gene. These tumors account for approximately 20% of all NSCLC cases. Selumetinib, the drug under investigation, interferes with a protein called MEK.
Participants in the study received the standard chemotherapy agent docetaxel in combination with either selumetinib or a placebo. They all had advanced stages of the disease.
By many measures, including change in tumor size, the group receiving selumetinib did significantly better than the placebo group. Most clinically significant were the improved rate of response to treatment (37% compared with 0% in the placebo arm) and prolonged progression-free survival (5.3 months compared with 2.1 months in the placebo arm). On average, patients in the selumetinib group also survived longer than those in the placebo group (9.4 months compared with 5.2 months, respectively). However, the improvement was not considered statistically significant.
“This clinical trial demonstrates that a combination of chemotherapy and selumetinib is significantly better than chemotherapy alone for this group of patients – better in terms of tumor response to therapy and in terms of survival times prior to advance of the disease,” says Pasi Jänne, MD, PhD, scientific codirector of Dana-Farber’s Belfer Institute for Applied Cancer Science. “It suggests that for the first time we may have an effective treatment for KRAS-mutant lung cancer, which is the largest single subtype of the disease. These impressive clinical findings not only have implications for the treatment of lung cancer but all cancers that harbor KRAS mutations, including pancreatic and colorectal cancer.”
Some side effects, such as acne, loss of strength, neutropenia, and respiratory problems were more common in the selumetinib group. Yet, the rate of patients discontinuing the study due to severe side effects was comparable for both groups.
Source: Dana-Farber Cancer Institute.