Stage as the Sole “Biomarker” for Adjuvant Pembrolizumab in Resected Stage IB to IIIA NSCLC without Considerations for PD-L1 Expression Level, ALK/EGFR Mutational Status, and Prior Adjuvant Chemotherapy per FDA Approval Indications of PEARLS/Keynote-091?

Abstract

One of the most recent advancements in NSCLC was the approval of immunotherapy in the adjuvant setting. Both atezolizumab and pembrolizumab have been approved for the use in early stage NSCLC patients post resection. As it broadens the options for our patients, multiple approvals in the same setting are generally welcomed. However, there were important differences in the two studies that led to the approvals and the data could be confusing. Here we review IMpower010, the study that led to the first approval of atezolizumab in the adjuvant setting with comparison to the Keynote-091 study evaluating pembrolizumab in the adjuvant setting, gaining the most recent FDA approval for adjuvant use in early stage NSCLC.

Keywords:

• post operative therapy
• checkpoint inhibitors
• atezolizumab
• IMpower010
• biomarker

CRediT Authorship Contribution Statement

We confirm that both authors have made a significant contribution to the work reported. Both authors were involved in the conception, study design, execution, acquisition of data, analysis, and interpretation. Both authors drafted and revised the manuscript. Both have agreed on the journal to which the article will be submitted, and reviewed and agreed on all versions of the article before submission, during revision, and the final version accepted for publication. Both authors agree to take responsibility and be accountable for the content of the article.

Disclosure

There was no funding allocated for this research and there are no direct conflicts of interest. Potential COI from all authors are listed below.

MN is on the advisory board for AstraZeneca, Daiichi Sankyo, Takeda, Novartis, EMD Serono, Janssen, Pfizer, Eli Lilly and Company, Bayer, and Genentech; a consultant for Caris Life Sciences (virtual tumor board); a speaker for Blueprint Medicines, Janssen, Mirati and Takeda; and reports travel support from AnHeart Therapeutics.

SHIO has stock ownership and was on the scientific advisory board of Turning Point Therapeutics Inc (until February 28, 2019), is a member of the SAB of Elevation Oncology, and has received speaker honorarium from Merck, Roche/Genentech, Astra Zeneca, Takeda/ARIAD, and Pfizer; and has received advisory fees from Roche/Genentech, Astra Zeneca, Takeda/ARIAD, Pfizer, Foundation Medicine Inc, Spectrum, Daiichi Sankyo, Janssen/JNJ, and Xcovery.