Dr Spira on Updated MARIPOSA Trial Data in EGFR+ Advanced NSCLC - OncLive
Alexander Spira discusses MARIPOSA study findings showing amivantamab-vmjw plus lazertinib significantly improves progression-free survival vs osimertinib in EGFR-mutated NSCLC. FDA approved the combination in 2024. Longer-term data from 2024 IASLC World Conference on Lung Cancer indicates potential overall survival benefit with the doublet.
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FDA approved osimertinib (Tagrisso) for locally advanced, unresectable stage III NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations, not progressed after platinum-based chemoradiation. Efficacy shown in LAURA trial with significant improvement in progression-free survival (39.1 months vs 5.6 months) and no detriment in overall survival. Common adverse reactions include lymphopenia, leukopenia, and interstitial lung disease. Recommended dose is 80 mg once daily. Review conducted under Project Orbis.
FDA approves Rybrevant plus chemotherapy for locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R mutations, based on MARIPOSA-2 trial results showing improved progression-free survival and overall response rate.
Alexander Spira discusses MARIPOSA study findings showing amivantamab-vmjw plus lazertinib significantly improves progression-free survival vs osimertinib in EGFR-mutated NSCLC. FDA approved the combination in 2024. Longer-term data from 2024 IASLC World Conference on Lung Cancer indicates potential overall survival benefit with the doublet.
FDA approved amivantamab-vmjw (Rybrevant) with carboplatin and pemetrexed for advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations, after progression on EGFR tyrosine kinase inhibitor treatment. Efficacy showed median progression-free survival of 6.3 months with amivantamab/CP vs. 4.2 months with CP, and overall response rate of 53% vs. 29%. Common adverse reactions included rash, infusion-related reactions, and fatigue.
FDA approves amivantamab-vmjw (Rybrevant) with chemotherapy for EGFR-mutated NSCLC progressing after EGFR TKI treatment. This combination is the only NCCN category 1 option for patients with multiple lesions after osimertinib failure. Phase 3 MARIPOSA-2 study showed improved progression-free survival and overall response rates compared to chemotherapy alone.
FDA approves amivantamab-vmjw (Rybrevant) with carboplatin and pemetrexed for advanced NSCLC with EGFR mutations, showing improved PFS and ORR in MARIPOSA-2 trial. This combination addresses resistance to EGFR TKIs and offers a new second-line treatment option.
FDA approves osimertinib for locally advanced, unresectable stage III EGFR-mutated NSCLC after chemoradiotherapy, based on phase 3 LAURA trial results showing 84% reduction in progression or death risk. Osimertinib's median PFS was 39.1 months vs 5.6 months for placebo, with 57% ORR vs 33% for placebo. The trial did not compare osimertinib with current immunotherapy standards.
FDA approves amivantamab-vmjw (Rybrevant) plus carboplatin and pemetrexed for advanced/metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations, post-EGFR TKI progression. MARIPOSA-2 trial shows 6.3 months median PFS vs 4.2 months with chemotherapy alone, 53% overall response rate vs 29%. No significant OS difference noted. Common adverse effects include rash, infusion-related reactions, fatigue, and COVID-19 infection.
Amivantamab-lazertinib showed improved OS vs osimertinib in advanced EGFR-mutant NSCLC, with median OS not estimable vs 37.3 months, and 61% vs 53% survival at 3 years. FDA approved amivantamab-lazertinib in 2024 for first-line treatment.
FDA approves amivantamab-vmjw (Rybrevant) in combination with chemotherapy for advanced non-small cell lung cancer with EGFR mutations.
FDA approves amivantamab-vmjw (Rybrevant) plus carboplatin and pemetrexed for locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations, for patients whose disease has progressed following EGFR TKI treatment. MARIPOSA-2 trial supports this approval, showing improved progression-free survival and overall response rate with amivantamab/chemotherapy.
Osimertinib (Tagrisso; AstraZeneca) approved by FDA for treating unresectable, stage III, EGFRm NSCLC not progressed post-platinum-based CRT, based on phase 3 LAURA trial results.
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Johnson & Johnson's Rybrevant (amivantamab) received FDA approval for use with chemotherapy in advanced NSCLC with EGFR exon 19 deletions or L858R mutations, following prior EGFR inhibitor treatment. The MARIPOSA-2 trial showed Rybrevant improved survival rates and progression-free survival compared to chemotherapy alone, though overall survival benefit was not yet statistically significant. Rybrevant aims to address resistance to third-generation EGFR inhibitors like AstraZeneca's Tagrisso.
© 2024 Mashup Media, LLC. All rights reserved.
FDA approves Johnson & Johnson's Rybrevant in combination with chemotherapy for locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R mutations, marking its third approval in 2024.
Osimertinib (Tagrisso) received FDA approval for unresectable stage III non–small cell lung cancer (NSCLC) with EGFR mutations, based on LAURA trial data showing significant benefits, including 39.1-month median progression-free survival.
FDA approves Rybrevant (amivantamab-vmjw) plus chemotherapy for EGFR-mutated NSCLC, showing improved progression-free survival and response rates in MARIPOSA-2 study.
FDA approves osimertinib (Tagrisso) for locally advanced, unresectable stage III NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations, not progressing after chemoradiation. LAURA trial showed osimertinib improved PFS by 84% (HR, 0.16; 95% CI, 0.10-0.24; P < .001) with median PFS of 39.1 months vs 5.6 months in placebo.
FDA approves J&J's Rybrevant with chemotherapy for EGFR-mutated NSCLC, reducing disease progression risk by 52%. Combination therapy showed median PFS of 6.3 months vs. 4.2 months with solo chemotherapy, and overall response rate of 53% vs. 29%. Common AEs included rash, infusion-related reactions, and fatigue.
J&J's Rybrevant approved by FDA for advanced NSCLC with EGFR ex19del or L858R mutations, in combination with carboplatin and pemetrexed chemotherapy. Rybrevant targets EGFR to halt tumor growth, showing 52% reduction in disease progression risk in MARIPOSA-2 study.
FDA approves amivantamab-vmjw (Rybrevant) with carboplatin and pemetrexed for advanced/metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations, post-EGFR TKI progression. MARIPOSA-2 trial showed 6.3 months median PFS (vs 4.2 months with chemotherapy), 53% overall response rate (vs 29% with chemotherapy). No significant difference in overall survival noted. Common adverse effects include rash, infusion-related reactions, fatigue, and COVID-19 infection.
FDA approves osimertinib (Tagrisso) for locally advanced, unresectable stage III NSCLC after chemoradiotherapy, based on LAURA trial data showing 7-fold increase in median PFS to 39.1 months. Osimertinib indicated for EGFR exon 19 deletions or exon 21 L858R mutations.
FDA approves amivantamab-vmjw plus carboplatin and pemetrexed for EGFR-mutated NSCLC after EGFR tyrosine kinase inhibitor treatment failure, based on MARIPOSA-2 trial results showing improved progression-free survival and response rates.
FDA approves osimertinib for advanced non-small cell lung cancer patients with EGFR exon 19 deletions or exon 21 L858R mutations who did not progress after platinum-based chemoradiation.
Johnson & Johnson's Rybrevant approved by FDA for treating locally-advanced or metastatic non-small cell lung cancer in combination with chemotherapy, reducing disease progression risk by 52%.
FDA approves RYBREVANT® (amivantamab-vmjw) with chemotherapy for advanced EGFR-mutated NSCLC, based on MARIPOSA-2 study showing 52% reduced risk of disease progression.
The FDA approved osimertinib (Tagrisso) for stage III EGFR-mutated NSCLC not progressing after platinum-based chemoradiation, supported by the phase 3 LAURA trial showing significant PFS improvements.
FDA approved amivantamab-vmjw (Rybrevant) plus lazertinib (Lazcluze) for first-line treatment of locally advanced or metastatic EGFR-mutant NSCLC, based on MARIPOSA trial data showing improved median PFS (23.7 months vs 16.6 months with osimertinib). The combination targets EGFR mutations, including exon 19 deletions and exon 21 L858R substitutions, addressing suboptimal responses to current third-generation TKIs. Future research will focus on managing toxicities and developing next-generation therapies.
FDA approves Tagrisso (osimertinib) for stage III unresectable NSCLC with EGFR mutations not progressed post-CRT. LAURA trial showed osimertinib reduced progression risk by 84% vs placebo, with median PFS of 39.1 months vs 5.6 months. Adverse reactions include lymphopenia, leukopenia, and COVID-19.
FDA approves osimertinib (Tagrisso) for stage III NSCLC with EGFR mutations after chemoradiation, based on LAURA trial showing 39.1 months median PFS vs. 5.6 months with placebo. Common adverse effects include lymphopenia, leukopenia, and COVID-19 infection.