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?
Misako Nagasaka, Saihong Ignatius Ou · 2023
Read 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? by Misako Nagasaka, Saihong Ignatius Ou (2023) in the Tower of Babel, a free online library of public-domain works preserved in clean, searchable text. No sign-up. The full text is served as a plain-text file at a predictable URL, where text is present: https://antarctic-labs.com/tower-of-babel/pmc-10725831.txt.
Description
Misako Nagasaka and Saihong Ou questioned a lung cancer drug rule in two thousand twenty-three. Two immune drugs won approval after early lung surgery. The newer approval rests on tumor stage alone. It ignores a key marker level and gene status. It also ignores whether chemotherapy came first. The authors compare the trials behind both approvals.
One trial tested the first drug with marker-based rules. The second tested the newer drug more broadly. Their designs and patient mixes differed importantly. Clinicians may find the two labels confusing side by side. The authors lay out what each trial really showed. They ask if stage alone should gate treatment. The debate affects many patients after lung surgery.
Catalog record
| CREATOR | Misako Nagasaka, Saihong Ignatius Ou |
|---|---|
| YEAR | 2023 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 31 KB |
| VERSION | 1.0 |
| LICENSE | CC BY 4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |