Johnson & Johnson: RYBREVANT OS and tolerability updates at WCLC 2026
- Final overall survival analysis from Phase 3 PAPILLON (PL.03.03)—first-line RYBREVANT plus chemotherapy in EGFR exon 20 insertion NSCLC—selected for the Presidential Symposium.
- Longer follow-up from Phase 2 COPERNICUS (MO12.09) reporting low rates of key treatment‑related events with RYBREVANT FASPRO plus lazertinib when prophylactic strategies are used.
- Updated Phase 2 PALOMA-2 findings on first-line RYBREVANT FASPRO plus lazertinib presented (PT2.03.06).
- RYBREVANT FASPRO received U.S. FDA approval in December 2025 and is the only approved subcutaneous therapy for EGFR‑mutated NSCLC, offering monthly dosing after initial weekly dosing.
WCLC 2026 presentations
Johnson & Johnson will present multiple RYBREVANT‑based datasets at IASLC WCLC 2026, including the final overall survival analysis from Phase 3 PAPILLON (Late‑breaking Abstract PL.03.03) evaluating first‑line RYBREVANT plus chemotherapy in NSCLC with EGFR exon 20 insertions, selected for the Presidential Symposium. Additional presentations include longer follow‑up from Phase 2 COPERNICUS (Mini Oral Abstract MO12.09) and updated PALOMA‑2 Phase 2 data (Late‑breaking Poster Tour Abstract PT2.03.06), plus real‑world evidence on resistance mechanisms (Poster P2.184).
Tolerability and prophylactic strategies
Johnson & Johnson highlights new findings showing low rates of key treatment‑related events with subcutaneous RYBREVANT FASPRO when used with prophylactic measures in patients with common EGFR mutations. Safety topics to be addressed across abstracts include administration‑related/infusion reactions, ILD/pneumonitis, venous thromboembolic events, dermatologic and ocular adverse events, and recommended monitoring and prophylaxis approaches described in trial reports.
Regulatory, mechanism and clinical positioning
RYBREVANT FASPRO (amivantamab and hyaluronidase‑lpuj) received U.S. FDA approval in December 2025 and is approved in multiple markets for EGFR‑mutated NSCLC, including exon 19 deletions, exon 21 L858R and exon 20 insertions; it provides a subcutaneous dosing option after initial weekly dosing. RYBREVANT is a bispecific antibody targeting EGFR and MET. NCCN guidelines include amivantamab‑based regimens, with IV amivantamab plus lazertinib a Category 1 preferred first‑line option for common EGFR mutations and subcutaneous substitution where appropriate.
Source: J&J