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Biomarker Testing in NSCLC

CME

Biomarker Testing to Optimize NSCLC Care: Multidisciplinary Perspectives

Physicians: Maximum of 1.00 AMA PRA Category 1 Credit™

Released: July 06, 2022

Expiration: July 05, 2023

Matthew Gubens
Matthew Gubens, MD, MS
Alexander Craig Mackinnon, Jr.
Alexander Craig Mackinnon, Jr., MD, PhD, MSHA
CME/CE Information

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Moving Targeted Therapy and Immunotherapy Earlier in the Disease Course

Craig Mackinnon, MD, PhD:
Historically, biomarker testing was primarily performed on tumors from patients with advanced NSCLC. However, it is becoming increasingly evident that there is a role for biomarker testing in patients with early‑stage NSCLC.

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Phase III IMpower010 Trial: Adjuvant Atezolizumab vs BSC in Resected Stage 1B-IIIA NSCLC After Adjuvant CT

Craig Mackinnon, MD, PhD:
The phase III IMpower010 trial demonstrated that adjuvant atezolizumab after adjuvant chemotherapy prolonged DFS compared with best supportive care after adjuvant chemotherapy in patients with early-stage NSCLC whose tumors expressed a PD-L1 level of ≥1% (HR: 0.66; 95% CI: 0.50-0.88; P = .004).53,54 The greatest DFS benefit with adjuvant atezolizumab was observed in patients with a high PD-L1 expression level of ≥50% (HR: 0.43; 95% CI: 0.27-0.68). There was no DFS benefit with adjuvant atezolizumab after adjuvant chemotherapy compared with best supportive care among patients with resected early-stage NSCLC with a PD-L1 expression level of <1% (HR: 0.97; 95% CI: 0.72-1.31). Based on these results, the FDA approved adjuvant atezolizumab following resection and platinum-based chemotherapy for the treatment of patients with stage II-IIIA NSCLC whose tumors express PD-L1 on ≥1% of tumor cells. So, there is a role for PD-L1 testing in early‑stage NSCLC. 

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Phase III ADAURA Trial: Adjuvant Osimertinib for Early-Stage EGFR-Mutated NSCLC

Craig Mackinnon, MD, PhD:
The phase III ADAURA trial evaluated adjuvant osimertinib vs placebo in patients with completely resected EGFR mutation–positive stage IB-IIIA NSCLC. The trial demonstrated a significantly longer DFS among patients who received adjuvant osimertinib compared with placebo.55 The median DFS was not reached with adjuvant osimertinib vs 27.5 months with placebo (HR: 0.20; 99.12% CI: 0.14-0.30; P <.001). Based on the results of the ADAURA trial, the FDA approved osimertinib as adjuvant therapy following tumor resection in patients with NSCLC harboring EGFR exon 19 deletions or exon 21 L858R mutations.

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Based on currently available evidence, which biomarkers should be tested for in patients with completely resected early-stage NSCLC to guide adjuvant therapy recommendations?
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