A trial assessing the clinical effectiveness of biomarker-based treatments provided additional support for the use of targeted therapeutic options, but also called attention to the need for better biomarker-driven treatment strategies.
The study was a continuation of the BATTLE (Biomarker-Integrated Approaches of Targeted Therapy for Lung Cancer Elimination) trial, which evaluated the feasibility of using real-time lung biopsies to identify potential biomarkers and assign patients treatment strategies specific to the those genetic factors.
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In the BATTLE-2 trial, led by Vassiliki Papadimitrakopoulou, MD, University of Texas MD Anderson Cancer Center (Houston, TX), patients with advanced non-small cell lung cancer (excluding those with epidermal growth factor receptor mutations and anaplastic lymphoma kinase) refractory to more than one prior therapy were stratified by their KRAS mutation status and randomly assigned to 4 arms where they received erlotinib, erlotinib plus MK-2206, MK-2206 plus AZD6244, or sorafenib.
The primary analysis included 200 patients, 27% of whom had KRAS-mutant tumors, and 186 of whom were evaluable for the primary endpoint, 8-week disease control rate (DCR). Among those patients, the 8-week DCR was 50% with erlotinib plus MK-2206, 53% with MK-2206 plus AZD6244, 46% with sorafenib monotherapy, and 32% with erlotinib monotherapy.
In the KRAS-mutant subgroup, DCRs were 20% with erlotinib alone, 25% with erlotinib plus MK-2206, 62% with MK-2206 plus AZD6244, and 44% with sorafenib. In the KRAS-wild type cohort exclusively, the 8-week DCRs were 6%, 57%, 49%, and 47% for these same patient groups, respectively.
Median progression-free survival was 2 months and did not differ based on KRAS status. Median overall survival was 6.5 months, 9 months with erlotinib plus MK-2206, and 5.1 months with MK-2206 plus AZD6244 and sorafenib monotherapy. Additionally, patients with mesenchymal tumors had median survival of 7.5 months versus 5 months among those with epithelial tumors.
Thus, researchers concluded that despite improvement in progression-free survival on therapies that did not contain erlotinib for KRAS-mutation positive patients and better prognosis for mesenchymal tumors, better biomarker driven treatment strategies are still needed.
