Diagnosis of adenocarcinoma of the lung, a major subtype of non-small lung cancer (NSCLC), nowadays triggers mandatory testing of tumor tissue for alterations in four genes: EGFR, ALK, ROS1, and more recently, BRAF. If present, these alterations predict sensitivity to specific targeted drugs approved by the U.S. Food and Drug Administration (FDA) that work better and often longer than standard chemotherapy, and are better tolerated.
However, there are many more targetable/actionable genomic alterations (also known as “drivers”) in NSCLC. This blog post will briefly discuss most of them, with the goal of promoting molecular testing for more than the four “usual suspects” mentioned above. Some patients with these alterations may benefit from FDA-approved drugs or from enrollment in clinical trials that are testing additional drugs and drug combinations. Continue reading…
“Clinical trials of new anti-cancer therapies have often excluded patients whose disease has spread to the brain or central nervous system (CNS) or, if such patients were allowed on trial, trials have often failed to clearly capture information on the drug’s effect in the brain. Today new guidelines from an international, multidisciplinary group published in the journal Lancet Oncology describe how to most appropriately address cancer patients with CNS involvement within clinical trials of anti-cancer drugs.”
“The FDA has granted a priority review to a supplemental new drug application (sNDA) for the use of osimertinib (Tagrisso) as a first-line treatment for patients with non–small cell lung cancer (NSCLC) whose tumors harbor EGFR mutations (exon 19 deletions or exon 21 [L858R] substitution mutations).
“The sNDA is based on the phase III FLAURA study, in which frontline osimertinib reduced the risk of progression or death by 54% versus standard TKI therapy—erlotinib (Tarceva) or gefitinib (Iressa). In the double-blind study, the median progression-free survival (PFS) was 10.2 months (95% CI, 9.6-11.1) for standard therapy and 18.9 months (95% CI, 12.5-21.4) with osimertinib (HR, 0.46; 95% CI, 0.37-0.57; P <.0001).”
“When 29-year-old Carly Bastiansen was diagnosed in January 2016 with advanced pancreatic cancer, doctors told her a clinical trial was her best shot at slowing the notoriously quick-killing and hard-to-treat disease. She found one that appeared promising and went through the screening process. But the trial would not accept her.
“ ‘Participating in a clinical trial is really my only chance at living longer,’ Bastiansen, a children’s librarian in Baltimore, said this fall as she was growing weaker. ‘To have had that option taken off the table was devastating.’ ”
“Smokers are less likely than non-smokers to have lung cancers caused by targetable genetic changes. But a study published this week in the journal Clinical Cancer Research shows that when they do, smokers benefit just as much as non-smokers from targeted treatments.
” ‘A smoker or former smoker with a targetable alteration has the same probability of benefitting from targeted therapy as a never-smoker with a targetable alteration,’ says Dara Aisner, PhD, investigator at the University of Colorado Cancer Center and molecular pathologist at CU School of Medicine.”
“A new combination therapy for the first line treatment of advanced non-squamous non-small-cell lung cancer (NSCLC) improves progression-free survival (PFS), according to results of the phase III IMpower150 trial presented at the ESMO Immuno Oncology Congress 2017.
” ‘This is the first phase III trial to report on the combination of chemotherapy, antiangiogenic treatment and immunotherapy as first line treatment for advanced non-squamous NSCLC,’ said lead author Professor Martin Reck, chief oncology physician, Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Germany. ‘The trial met its co-primary endpoint of PFS and the preliminary results of the co-primary endpoint of overall survival (OS), although immature, look encouraging.’ ”
“U.S. regulators have approved a first-of-a-kind test that looks for mutations in hundreds of cancer genes at once, giving a more complete picture of what’s driving a patient’s tumor and aiding efforts to match treatments to those flaws.
“The U.S. Food and Drug Administration approved Foundation Medicine’s test for patients with advanced or widely spread cancers, and the Centers for Medicare and Medicaid Services proposed covering it.
“The dual decisions, announced late Thursday, will make tumor-gene profiling available to far more cancer patients than the few who get it now and will lead more insurers to cover it.”
“Adding Tecentriq (atezolizumab) to a treatment of Avastin (bevacizumab) and chemotherapy significantly prolonged the time to disease progression or death in people with previously untreated advanced non-squamous non-small cell lung cancer (NSCLC).
“The results stem from a Phase 3 trial of 1,202 people, with data also indicating better overall survival in patients treated with Tecentriq. Improved progression-free and overall survival were the two main trial outcome measures.”
“The Food and Drug Administration wants to help patients get faster access to promising cancer treatments.
“The agency is preparing proposals that would expand an accelerated-approval program for lifesaving medications, FDA Commissioner Scott Gottlieb told House lawmakers on Thursday.
“Drugmakers can seek rapid conditional approval for treatments for cancer or other serious diseases based on evidence that a drug is likely to extend patient survival. Later trials once such a drug is on the market are necessary to prove the survival benefit.”