Stephen V. Liu, MD, of the Georgetown University School of Medicine and Georgetown’s Lombardi Comprehensive Cancer Center in Washington, DC, joined Lung Cancers Today to discuss the recent announcement that the COCOON study met its primary endpoint. The randomized phase 2 study is evaluating a prophylactic dermatologic regimen to reduce the incidence of skin and nail adverse reactions in patients receiving first-line treatment with amivantamab plus lazertinib. ...
EGFR+ Non-Small Cell Lung Cancer
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The CHMP positive opinion is supported by results from the phase 3 PALOMA-3 study.
Pending discussions with the FDA, officials say there are plans to submit for regulatory approval in the second half of 2025.
Dr. Liu discusses remaining questions, key considerations, and how the data might shape the field moving forward.
The approval is for the first-line treatment of advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitutions.
The ORR of the external control group was 3%, while it was 36.8% in those who received amivantamab for NSCLC.
The FDA action date for its regulatory decision is anticipated during the third quarter of this year.
Dr. Liu shares his insights on the recent announcement that the phase 3 trial met its secondary endpoint of overall survival.
The phase 2 trial included patients who had advanced or metastatic NSCLC with actionable genomic alterations.
Sunvozertinib is an irreversible EGFR inhibitor that targets a wide spectrum of EGFR mutations.
The results may establish osimertinib as the new standard of care for EGFR-mutated NSCLC in a certain setting.
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