Support for First-Line Erlotinib in NSCLC with EGFR Mutations

“For patients with non-small-cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations, erlotinib is active, and treatment beyond progression is feasible and may delay salvage therapy in selected patients, according to a study published online Dec. 30 in JAMA Oncology.

“Keunchil Park, M.D., from the Sungkyunkwan University School of Medicine in Seoul, South Korea, and colleagues examined the efficacy of first-line erlotinib therapy in  with NSCLC with activating EGFR mutations in the Asian Pacific trial of Tarceva as first-line in EGFR mutation (ASPIRATION). Patients received 150 mg/day erlotinib until ; after this point, therapy could be continued at the discretion of the patient and/or investigator. Patients were followed for a median of 11.3 months.”


Afatinib a Better Choice for EGFR-Mutated Lung Cancer in First-Line Treatment

“Patients with EGFR-activating mutations in advanced lung cancer seem to benefit more from afatinib than gefitinib as first-line treatment, researchers report at the first ESMO Asia 2015 Congress in Singapore.

“In the global, randomised, open-label Phase IIb LUX-Lung 7 (LL7) trial, the irreversible ErbB family blocker afatinib significantly improved efficacy versus gefitinib across a range of clinically relevant endpoints, such as progression-free survival, time-to- failure and objective response rate. ‘Based on these results I would consider afatinib as the EGFR (TKI) of choice for the first-line treatment for patients with EGFR mutation-positive non-small-cell (NSCLC),’ lead author, Professor Keunchil Park, head of the Division of Hematology/Oncology at Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea, said.”


Lung Cancer Patients Gain Access to New Treatment for Fourth Time in Two Months

“The International Association for the Study of Lung Cancer (IASLC) is pleased to hear of another approval by the U.S. Food and Drug Administration (FDA) that helps in the fight against lung cancer—the fourth in two months. The FDA approved necitumumab (Portrazza) in combination with standard chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for their advanced disease.

“Necitumumab binds to the epidermal growth factor receptor (EGFR), a protein commonly found on squamous NSCLC tumors, and blocks EGFR from binding its ligands, thus preventing tumor growth. Necitumumab is the first monoclonal antibody type of EGFR inhibitor to be approved in lung cancer, whereas there are a number of tyrosine kinase type of EGFR inhibitors (TKI) already FDA approved and used in clinical practice. These TKIs include gefitinib, erlotinib, afatinib, and osimertinib.”


AZD9291 Shows Clinical Activity in Non-Small Cell Lung Cancer Patients with Leptomeningeal Disease

“The epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) AZD9291 crossed the blood-brain barrier and showed clinical activity in heavily pretreated non-small cell lung cancer (NSCLC) patients with leptomeningeal disease, a disease in which lung cancer cells spread to the membranes surrounding the brain and spinal cord, according to data from a phase I BLOOM clinical trial presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, held Nov. 5–9.

” ‘Leptomeningeal disease at initial diagnosis of NSCLC is rare; however, as their lung cancer progresses, up to 15 percent of patients will develop this devastating complication. Additionally, an increased risk of central nervous system [CNS] involvement has been reported among patients with EGFR-mutant NSCLC, in particular those treated with a first-generation EGFR-TKI,’ said Dae Ho Lee, MD, PhD, associate professor in the Department of Oncology in the University of Ulsan College of Medicine and Asan Medical Center, Seoul, Korea.”


Adding Tivantinib to Standard Erlotinib Treatment Improved Outcomes for Specific Subgroup of Patients with Lung Cancer

“Adding the investigational anticancer therapeutic tivantinib to standard erlotinib treatment substantially increased progression-free survival for patients with advanced nonsquamous non–small cell lung cancer (NSCLC) who had tumors positive for epidermal growth factor receptor (EGFR) gene mutations, according to a subset analysis of data from the phase III MARQUEE clinical trial presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, held Nov. 5–9.

” ‘EGFR inhibitors like erlotinib are effective treatments for patients with advanced NSCLC with and without EGFR mutations,’ said Wallace Akerley, MD, director of thoracic oncology at the Huntsman Cancer Institute at the University of Utah in Salt Lake City. ‘However, tumors invariably develop resistance. MET overexpression is associated with resistance to EGFR therapy, and the phase III MARQUEE clinical trial set out to investigate whether adding the MET inhibitor tivantinib to erlotinib treatment could improve patient outcomes.’ “


Super Patient: Janet Freeman-Daily Joins a Clinical Trial—and Beats the Odds on Lung Cancer


In March 2011, Janet Freeman-Daily was about to take a long family trip to China. She’d been coughing for a while, so she asked her doctor for an antibiotic as a precaution before leaving. Even so, she came back in May with a respiratory infection that wouldn’t go away.

Her doctor ordered an X-ray and then a CT scan. “Before I got home, they called and said they’d like to do a bronchoscopy,” Janet says. The scan revealed a 7-cm mass in her left lung, and biopsies showed it was non-small cell lung cancer (NSCLC) and that it had spread to several lymph nodes. Continue reading…


Bristol-Myers Squibb’s Opdivo (nivolumab) Receives Expanded FDA Approval in Previously-Treated Metastatic Non-Small Cell Lung Cancer (NSCLC), Offering Improved Survival to More Patients

Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR mutation or ALK translocation should have disease progression on appropriate targeted therapy prior to receiving Opdivo. In a Phase 3 trial, CheckMate -057, Opdivodemonstrated superior overall survival (OS) in previously treated metastatic non-squamous NSCLC compared to chemotherapy, with a 27% reduction in the risk of death (hazard ratio: 0.73 [95% CI: 0.60, 0.89; p=0.0015]), based on a prespecified interim analysis. The median OS was 12.2 months in the Opdivo arm (95% CI: 9.7, 15.0) and 9.4 months in the docetaxel arm (95% CI: 8.0, 10.7). This approval expands Opdivo’s indication for previously treated metastatic squamous NSCLC to include the non-squamous patient population. Squamous and non-squamous NSCLC together represent approximately 85% to 90% of lung cancer cases.”


FDA Grants Priority Review to Rociletinib for Advanced NSCLC

“The FDA granted priority review to a new drug application for rociletinib.

“Rociletinib (Clovis Oncology) — a novel, oral, targeted covalent mutant-selective epidermal growth factor receptor inhibitor — is intended for patients with advanced EGFR-mutant, T790M-positive non–small cell lung cancer who already received EGFR-targeted therapy.

“The FDA is expected to make a decision about the agent’s status by March 30, 2016.”


JUNIPER Trial Branches Out in KRAS Mutation-Positive Advanced NSCLC

“In 2008 Linardou et al published results of a meta-analysis of studies in advanced non–small cell lung cancer (NSCLC) and metastatic colorectal cancer. They extracted data on 1008 patients; 165 from 17 manuscripts for the NSCLC portion of the meta-analysis had KRAS mutations. They sought to establish whether or not KRAS mutations could be candidate predictive biomarkers for antiepidermal growth factor (EGFR) treatments. The analysis yielded empirical evidence that KRAS mutations are highly specific negative predictors of response to EGFR tyrosine kinase inhibitors (TKIs) when given as single agents to patients with advanced NSCLC. Further implicating an association of KRAS mutations with poor outcomes, a retrospective analysis of data from 1036 patients with stage IV lung adenocarcinoma and KRAS mutation evaluated between 2002 and 2009, found the presence of KRAS mutations to be associated with shorter survival (HR, 1.21; P = .48).”