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Biomarkers Require Refining in Lung Cancer Paradigm

Ellie Leick
Published: Wednesday, Sep 25, 2019

Hossein Borghaei, DO, chief of Thoracic Oncology at Fox Chase Cancer Center

Hossein Borghaei, DO, MS

Upfront genomic testing has become the standard of care upon a non–small cell lung cancer (NSCLC) diagnosis. Now, researchers must work on finding and determining what biomarkers, beyond PD-L1, are best predictive of response to immunotherapy, explained Hossein Borghaei, DO, MS.

Recent studies have demonstrated the effects of immunotherapy alone and in combination with chemotherapy. For example, the KEYNOTE-024 trial explored chemotherapy versus pembrolizumab (Keytruda) in previously untreated patients with advanced NSCLC with PD-L1 expression ≥50%. In an updated analysis of the study, the median overall survival (OS) was 30.0 months for pembrolizumab versus 14.2 months in the chemotherapy group (HR, 0.63; 95% CI, 0.47-0.86).1 Based on earlier data from this study, the FDA approved pembrolizumab in 2016, for the frontline treatment of patients with metastatic NSCLC whose tumors have ≥50% PD-L1 expression.

The phase III KEYNOTE-189 trial examined frontline chemotherapy combined with pembrolizumab in patients with metastatic nonsquamous NSCLC without EGFR or ALK alterations. At a median follow-up of 18.7 months, updated results showed that patients in the pembrolizumab/chemotherapy arm had a median OS of 22.0 months versus 10.7 months for those who received placebo/chemotherapy (HR, 0.56; 95% CI, 0.45-0.70; P <.00001).2 In August 2018, the FDA granted a full approval to the combination of pembrolizumab plus chemotherapy in this patient population, based on preliminary data from this study.

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