Johnson & Johnson Announces Updated Phase III MARIPOSA Data Showing Rybrevant (amivantamab) Plus Lazertinib Significantly Improves PFS Versus Osimertinib in First-Line High-Risk EGFR-Mutated NSCLC

Jun 02, 2024 10:43 CST Updated 10:43

Johnson & Johnson

Healthcare Product Manufacturers, Health Service Providers

Source: PharmaCube Info

On May 31, Johnson & Johnson announcedLatest Data from the Phase III MARIPOSA Study: EGFR/c-MET Bispecific Antibody Rybrevant (Amivantamab) Combined with Third-Generation EGFR Inhibitor Lazertinib Shows Significant Improvement in Progression-Free Survival (PFS) Compared to Osimertinib as First-Line Treatment for High-Risk EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC).

This study included treatment-naive patients.EGFR Exon 19 Deletion or Exon 21 (L858R) Substitution MutationPatients with NSCLC, 89% of whom had one or more high-risk diseases or clinical features at baseline, such as 41% with brain metastases, 16% with liver metastases, 54% with TP53 co-mutations, and 70% withctDNA, 15% of patients still detected ctDNA after two cycles of treatment.

The results showed that the Rybrevant+Lazertinib combination therapy significantly reduced the risk of disease progression or death across all high-risk subgroups. Specifically:

1) In patients with a history of brain metastases, the combination therapy of Rybrevant reduced the risk compared to the osimertinib group.31%Risk(18.3 months vs 13.0 months; HR, 0.69; [95% CI, 0.53-0.92]; P=0.010);

2) In baseline liver metastasis patients, Rybrevant combination therapy reduced more than the osimertinib group.42%Risk (18.2 months vs 11.0 months; HR, 0.58 [95% CI, 0.37-0.91]; P=0.017);

3）In patients with TP53 co-mutations, the combination therapy of Rybrevant reduced more than the osimertinib group.35%Risk (18.2 months vs 12.9 months; HR, 0.65 [95% CI, 0.48-0.87]; P=0.003);

4) In patients with ctDNA detected at baseline, Rybrevant combination therapy reduced the risk compared to the osimertinib group.32%Risk (20.3 months vs 14.8 months; HR, 0.68 [95% CI, 0.53-0.86]; P=0.002）；

5) In patients who did not clear ctDNA at C3D1, Rybrevant combination therapy reduced compared to the osimertinib group51%Risk (16.5 months vs 9.1 months; HR, 0.49 [95% CI, 0.27-0.87]; P = 0.015).

In terms of safety, the combination of Rybrevant and Lazertinib demonstrated a safety profile consistent with each individual drug, with most adverse events being Grade 1 or Grade 2.

In addition to this study,Rybrevant CombinationLazertinib and ChemotherapyThe Phase III MARIPOSA-2 study for the treatment of osimertinib resistance also met its primary endpoint of PFS.MARIPOSA-2 is also the first Phase III study to demonstrate a clinically meaningful improvement in PFS with osimertinib in later-line treatment.

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