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Based on data from the phase I/II CheckMate-032 trial, nivolumab has been granted a priority review by the FDA for the treatment of patients with small cell lung cancer with disease progression following 2 or more lines of therapy, according to Bristol-Myers Squibb, the manufacturer of the PD-1 inhibitor.

The 1-year progression-free survival rate was more than tripled with the combination of nivolumab and ipilimumab versus chemotherapy in treatment-naïve patients with non–small cell lung cancer with high tumor mutation burden, according to initial findings from the phase III CheckMate-227 trial.

According to results of a pilot study presented at the 2018 AACR Annual Meeting and simultaneously published in the <em>New England Journal of Medicine,</em>&nbsp;neoadjuvant treatment with the PD-1 inhibitor nivolumab (Opdivo) demonstrated a 45% major pathologic response rate in patients with resectable stage I to III non&ndash;small cell lung cancer (NSCLC) irrespective of PD-L1 expression.

Findings from the phase III ALEX trial were consistent with earlier results on efficacy and adverse events. Investigators said there were superior patient-reported outcomes for the next-generation tyrosine kinase inhibitor (TKI) alectinib (Alecensa) compared to the standard of care TKI inhibitor crizotinib (Xalkori) for patients with ALK-positive non&ndash;small cell lung cancer.