Lung Cancer

A burning question is whether immunotherapy combinations will further improve outcomes compared with checkpoint inhibitor therapy alone—and if so, which combinations will rise to the top.

The FDA accelerated the approval of brigatinib (Alunbrig), a new generation of oral ALK inhibitor, for the treatment of patients with ALK-positive metastatic NSCLC who do not tolerate or have had an inadequate response to crizotinib..

A post hoc analysis of the phase 2 ALTA trial showed longer overall survival in crizotinib-refractory patients with advanced ALK-positive NSCLC who continued brigatinib versus discontinuing it after disease progression.
In treatment-naïve patients with NSCLC and high tumor mutation burden—regardless of PD-L1 expression—the combination of nivolumab plus ipilimumab showed superior PFS versus chemotherapy in the phase 3 CheckMate-227 trial.
Amid the changing landscape of treatments for ALK-positive NSCLC, sequencing of ALK inhibitors grows more complex and will require an assessment of individual patient’s tumor characteristics.
Seribantumab (MM-121), a drug under investigation in the phase 2 SHERLOC trial for the treatment of heregulin-positive NSCLC, was granted orphan drug designation from the FDA.
The College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology have updated their 2013 molecular analysis guideline for the selection of patients with lung cancer for TKI treatment, to include 18 new recommendations and 3 revisions to the existing guidance.
Based on results from the phase 3 FLAURA trial, the FDA has granted osimertinib (Tagrisso) breakthrough therapy designation for treatment-naïve patients with EGFR-positive non–small-cell lung cancer.
In the pivotal phase 3 KEYNOTE-189 trial of pembrolizumab (Keytruda) combined with pemetrexed and cisplatin or carboplatin for the first-line treatment of patients with metastatic, nonsquamous non–small-cell lung cancer, the regimen showed significant improvements in overall survival and progression-free survival.
The kinase inhibitor alectinib (Alecensa) received FDA approval for the frontline treatment of ALK-positive, metastatic, non–small-cell lung cancer based on results from the phase 3 ALEX trial.
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