“The investigational small-molecule plinabulin yielded some interesting benefits when added to docetaxel in previously treated patients with stage III/IV non–small cell lung cancer (NSCLC), in a phase II study. Although the benefit of the doublet was modest in the overall study population, the study’s findings were striking in two ways: the duration of response was 7 times that achieved with docetaxel alone, and patients with measurable disease had a 4.6-month improvement in survival.”
“Treatment with pembrolizumab (Keytruda) could elicit long-term survival (LTS) rates of 21% to 25% for previously-treated patients with PD-L1–positive non–small cell lung cancer (NSCLC) compared with 3% to 4% for docetaxel, according to a statistical analysis of findings from the KEYNOTE-010 and -001 trials presented at the 2017 ASCO-SITC Symposium.
“Findings from the analysis shed light on the number of patients with advanced NSCLC expected to benefit for up to 70 months from pembrolizumab. According to survival statistics from the SEER database for 2006 to 2012, the 5-year survival rate was 4.3% for those with lung or bronchus cancer with distant metastases.”
“In the phase III OAK trial reported in The Lancet by Rittmeyer et al, treatment with the anti–programmed cell death ligand 1 (PD-L1) antibody atezolizumab (Tecentriq) improved overall survival vs docetaxel in previously treated non–small cell lung cancer (NSCLC). Results of the trial supported the recent approval of atezolizumab in metastatic NSCLC in patients who have received prior platinum-containing therapy.”
“The first phase III study of PD-L1 inhibitor atezolizumab in previously-treated non-small-cell lung cancer has seen significant improvements in survival compared to standard chemotherapy, researchers reported at the ESMO 2016 Congress in Copenhagen.
“PD-L1 inhibitors are of a class of cancer immunotherapies called checkpoint inhibitors, and work by inhibiting one of the mechanisms of resistance developed by cancer cells in order to evade the immune system.”
“Combined results from subset analyses of the TIGER-X and TIGER-2 clinical trials show that the VeriStrat test stratifies T790M-mutated patients with previously-treated, advanced non-small cell lung cancer (NSCLC) who are more or less likely to experience longer progression-free survival (PFS) when treated with a third-generation EGFR-TKI therapy. Clinical trial data suggesting the test’s potential for identifying better candidates for third-generation EGFR-TKI therapy were presented in Chicago last Friday at the at the IASLC Multidisciplinary Symposium in Thoracic Oncology hosted by the International Association for the Study of Lung Cancer.”
“The FDA granted an accelerated approval to pembrolizumab (Keytruda) as a treatment for patients with pretreated advanced non–small cell lung cancer (NSCLC) across all histologies whose tumors express PD-L1. The PD-1 inhibitor was approved along with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, and is indicated for patients who progressed on or after platinum-containing chemotherapy or EGFR-or ALK-targeted agents in patients harboring those mutations.
“The approval was based on data from the phase I KEYNOTE-001 trial, in which the overall response rate (ORR) with the drug was 41% among a subgroup of 61 patients with pretreated PD-L1–positive advanced NSCLC as determined by the 22C3 pharmDx diagnostic test. Response duration ranged from 2.1 to 9.1 months. A survival improvement has yet to be demonstrated in a clinical trial, and the accelerated approval is contingent upon the eventual outcomes of confirmatory studies.”
“Immunotherapy wasn’t merely the big story of the American Society of Clinical Oncology (ASCO) 2015 meeting; it was the tornado that left a vacuum in its wake, as some of us discussed—the unfortunate side effect of everything that wasn’t immunotherapy being swept aside as last year’s model of quaint anticancer therapy.
“In the world of lung cancer, at least, immunotherapy trials delivered data that merited real excitement. We saw truly practice-changing results that provided a glimpse of a new era in which we might expect lung cancer treatments to be transformed by integrating immunotherapy across many settings. For now, that will start with previously treated advanced non-small cell lung cancer (NSCLC), and we will also see where immunotherapy is heading next.”
“Bristol-Myers Squibb Company (NYSE:BMY) today announced results from CheckMate -017, a Phase III, open-label, randomized study evaluating Opdivo (n=135) versus docetaxel (n=137) in previously treated patients with advanced squamous non-small cell lung cancer. At one year, Opdivo demonstrated an overall survival rate of 42% versus 24% for docetaxel, with a median overall survival of 9.2 months versus 6 months, respectively. In the trial, Opdivo reduced the risk of death by 41%, based upon a hazard ratio of 0.59 (95% CI, 0.44-0.79; P = 0.00025). The safety profile of Opdivo in CheckMate -017 was consistent with prior studies and favorable versus docetaxel. Findings from CheckMate -017 were published today in The New England Journal of Medicine and presented during an oral abstract session at the 51st Annual Meeting of the American Society of Clinical Oncology (Abstract #8009).
“ ‘Historically, treatment options for lung cancer patients have been limited. The Opdivo data presented today offer patients the first major advance in the treatment of squamous non-small cell lung cancer in more than a decade,’ said David Spigel, MD, Sarah Cannon Research Institute. ‘In this study, Opdivo not only demonstrated superior overall survival and objective response rate versus chemotherapy, the standard of care, but these benefits were sustained over time. The study also showed that squamous non-small cell lung cancer has a unique biology that resulted in similar efficacy across levels of PD-L1 expression.’ “