“The addition of bevacizumab to adjuvant chemotherapy failed to improve survival outcomes in patients with surgically resected early-stage non–small-cell lung cancer (NSCLC), according to a new randomized trial. The agent “does not have a role” in this setting, the investigators concluded.
” ‘In the setting of advanced-stage NSCLC, the first agent to improve survival when added to a platinum doublet was bevacizumab,’ wrote authors led by Heather A. Wakelee, MD, of the Stanford Cancer Institute at Stanford University in California. The researchers tested whether the VEGF-targeted agent would be similarly effective in the early-stage NSCLC adjuvant setting, where patients remain at high risk of relapse despite chemotherapy.”
“The combination of the CD122-biased cytokine NKTR-214 and the PD-1 inhibitor nivolumab (Opdivo) demonstrated target lesion reductions of 72% for patients with advanced cancers, according to findings from the phase Ib PIVOT-02 trial presented at the 2017 SITC Annual Meeting.
“The dose escalation trial enrolled patients in the first- or second-line setting with advanced non–small cell lung cancer (NSCLC), renal cell carcinoma (RCC), and melanoma. The objective response rates (ORR) by RECIST criteria ranged from 46% to 75% across tumor types. Additionally, the combination was tolerable, with no discontinuations attributed to adverse events (AEs).”
“Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Alecensa® (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. The approval is based on results from the phase III ALEX study, which showed Alecensa significantly reduced the risk of disease worsening or death (progression-free survival, PFS) by 47% (HR=0.53, 95% CI: 0.38, 0.73, p<0.0001) compared to crizotinib as assessed by independent review committee (IRC). Median PFS was 25.7 months (95% CI: 19.9, not estimable) for people who received Alecensa compared with 10.4 months (95% CI: 7.7, 14.6) for people who received crizotinib. The safety profile of Alecensa was consistent with that observed in previous studies. The study also showed that Alecensa significantly reduced the risk of the cancer spreading to or growing in the brain or central nervous system (CNS) compared to crizotinib by 84% (HR=0.16, 95% CI: 0.10, 0.28, p<0.0001). This was based on a time to CNS progression analysis in which there was a lower risk of progression in the CNS as the first site of disease progression for people who received Alecensa (12%) compared to people who received crizotinib (45%).”
“Osimertinib (Tagrisso) has impressed researchers in the field of EGFR-mutant non–small cell lung cancer (NSCLC), most recently with results from the phase III FLAURA trial solidifying its benefit.
“In FLAURA, treatment with frontline osimertinib led to a median progression-free survival (PFS) of 18.9 months (95% CI, 15.2-21.4). This represented a 54% risk reduction in progression or death compared with a standard EGFR tyrosine kinase inhibitor (TKI) for patients with locally advanced or metastatic EGFR-mutant NSCLC.”
“While immunotherapy with programmed death receptor 1 (PD-1) inhibiting antibodies has revolutionized the treatment of non-small cell lung cancer (NSCLC), use of these agents comes at the cost of potential serious immune-related adverse events (irAEs). In melanoma, development of cutaneous irAEs, such as rash and vitiligo, during treatment with PD-1 inhibitors has been shown to be associated with survival benefit, suggesting that early onset of irAEs may predict treatment outcomes. However, in NSCLC, the predictive value of immunotherapy-related toxicity as a clinical marker for efficacy to PD-1 inhibition is unknown. A multi-institution retrospective study investigated the relation between the development of irAEs and efficacy of PD-1 inhibitors in 134 patients with advanced or recurrent NSCLC who received second-line treatment with nivolumab. The primary outcome for this analysis was progression-free survival (PFS) according to the development of irAEs in a 6-week landmark analysis.”
“While several targeted therapies have emerged in recent years for treatment of non-small cell lung cancer (NSCLC) carrying the anaplastic lymphoma kinase (ALK) gene fusion, development of resistance to ALK inhibitors is an increasing problem. Furthermore, only one tyrosine kinase inhibitor (TKI), crizotinib, is currently approved for patients with ROS proto-oncogene 1 (ROS1) rearrangements. Lorlatinib, a novel, highly selective ALK and ROS1 targeting third-generation TKI has shown preclinical activity against known ALK resistance mutations and can penetrate the central nervous system (CNS), a common site of metastasis in ALK-positive or ROS1-positive NSCLC.”
“In a phase 2 clinical trial, the drug poziotinib has shrunk tumors by at least 30 percent in eight of 11 (73 percent) non-small cell lung cancer patients whose cancer includes an epidermal growth factor receptor (EGFR) mutation called an exon 20 insertion. Shrinkage ranged from 30 percent to 50 percent among the eight patients reaching partial response. One patient has progressed on the clinical trial, which began in March. All patients experienced some tumor shrinkage.”
International Association for the Study of Lung Cancer | Oct 18, 2017
“As non-small cell lung cancer (NSCLC) survival rates have increased over time, new research sheds light on how NSCLC outcomes are significantly influenced by the type of treatment facility where patients undergo care. Dr. Bhagirathbhai Dholaria of the Moffitt Cancer Center in the United States presented these findings at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer (WCLC) in Yokohama, Japan.”
“Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of updated overall survival (OS) findings, a secondary endpoint, from the phase 3 KEYNOTE-024 trial evaluating KEYTRUDA®(pembrolizumab), the company’s anti-PD-1 therapy, as a first-line monotherapy in patients with non-small cell lung cancer (NSCLC) whose tumors express high levels of PD-L1 (tumor proportion score [TPS] of 50 percent or more). The study included patients with squamous and nonsquamous NSCLC with no EGFR or ALK genomic tumor aberrations. Findings – which are based on more than two years of follow-up – will be presented in an oral presentation at the 18th World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer in Yokohama, Japan (Abstract OA 17.06).”