Unknown MAH — Rybrevant EMA EPAR variation assessment report (EMEA/H/C/005454, 2021)
Unknown MAH · 2021 · EMA EPAR variation assessment report
Report summary
This report details a Type II variation application for Rybrevant (amivantamab) in combination with lazertinib for first-line treatment of advanced EGFRm NSCLC, based on the Phase 3 MARIPOSA study. This global trial (1074 participants) compared amivantamab + lazertinib against osimertinib and lazertinib monotherapy. The MARIPOSA study demonstrated a statistically significant Progression-Free Survival (PFS) benefit for the amivantamab + lazertinib combination over osimertinib (HR 0.70) and lazertinib (HR 0.72), with a numerical trend towards improved Overall Survival (OS). The combination also showed improved PFS after first subsequent therapy (PFS2) and Time to Symptomatic Progression (TTSP), with similar intracranial Objective Response Rate (iORR). Safety data indicated higher rates of Grade 3+ treatment-related adverse events and venous thromboembolism (VTE) with the combination, prompting recommendations for prophylactic anticoagulation.
Key findings — cited to the page
| Hypokalaemia (Any Grade) (%) | 14 % | MARIPOSA · p.77 |
| Paraesthesia (Any Grade) (%) | 34 % | MARIPOSA · p.77 |
| Decreased appetite (Any Grade) (%) | 24 % | MARIPOSA · p.77 |
| Hypocalcaemia (Grade 3-4) (%) | 2.1 % | MARIPOSA · p.77 |
| Hypomagnesaemia (Any Grade) (%) | 5.0 % | MARIPOSA · p.77 |
| Hypomagnesaemia (Grade 3-4) (%) | 0 % | MARIPOSA · p.77 |
| Hypoalbuminaemia (Any Grade) (%) | 48 % | MARIPOSA · p.77 |
| Hypoalbuminaemia (Grade 3-4) (%) | 5 % | MARIPOSA · p.77 |
| Decreased appetite (Grade 3-4) (%) | 1.0 % | MARIPOSA · p.77 |
| Hypocalcaemia (Any Grade) (%) | 21 % | MARIPOSA · p.77 |
| Hypokalaemia (Grade 3-4) (%) | 3.1 % | MARIPOSA · p.77 |
| Paraesthesia (Grade 3-4) (%) | 1.7 % | MARIPOSA · p.77 |
Source: Unknown MAH ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →