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Johnson & Johnson receives positive CHMP opinion for RYBREVANT▼ (amivantamab) in combination with chemotherapy for the first-line treatment of patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations

April 29, 2024 – Clinical Trials, Pharmaceutical – CHMP, EMA, Janssen, Johnson & Johnson, NSCLC

This positive CHMP opinion establishes amivantamab as a new option, and the first fully-human EGFR-MET bispecific antibody, in the first-line treatment of EGFR exon 20 insertion-mutated NSCLC
The recommendation is supported by data from the Phase 3 PAPILLON study, which showed amivantamab plus chemotherapy significantly improved progression-free survival in adult patients, versus chemotherapy alone.

26 April 2024 — Beerse, Belgium — Janssen-Cilag International, a Johnson & Johnson company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of RYBREVANT▼ (amivantamab) in combination with chemotherapy (carboplatin and pemetrexed) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

“The PAPILLON study results represent an important advancement in the EGFR exon 20 insertion NSCLC treatment landscape, demonstrating significantly improved progression-free survival (PFS) with first-line amivantamab plus chemotherapy, versus chemotherapy alone,” said trial investigator Professor Nicolas Girard, head of Medical Oncology, Institut Curie, and Professor of Thoracic Oncology and Respiratory Medicine at the Paris Saclay University, France. “Notably, we observed improvements in functional status and reduction in lung cancer-related symptoms, underscoring the potential of this regimen to redefine standards of care for these patients, offering hope for improved quality of life and patient-relevant treatment outcomes.”

An urgent need exists for innovative treatments in NSCLC, particularly for patients with EGFR exon 20 insertion driver mutations, due to the significant disease burden. EGFR exon 20 insertion mutations are the third most common activating EGFR mutation and are associated with real-world five-year overall survival rates as low as 8%. This reinforces the critical demand for targeted therapeutic approaches, tailored to address the unique complexities of EGFR exon 20 insertion mutations, aiming to substantially improve patient survival and quality of life outcomes.

“Lung cancer remains the leading cause of cancer-related mortality in Europe. As patients living with EGFR exon 20 insertion-mutated NSCLC face a particularly poor prognosis, the need for innovative combinations in the frontline setting is vital,” said Henar Hevia, senior director, EMEA Therapeutic Area lead, Oncology, Johnson & Johnson Innovative Medicine. “At Johnson & Johnson, we are dedicated to the development and delivery of novel, targeted therapies aimed to address specific disease pathways, with the ultimate goal of ensuring each patient receives the right treatment at the right time.”

The PAPILLON study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in PFS (PFS; as measured by blinded independent central review [BICR]) in patients receiving amivantamab in combination with chemotherapy, versus chemotherapy alone (hazard ratio [HR]=0.395; 95% confidence interval [CI], 0.30–0.53; P<0.0001). An interim overall survival (OS) analysis showed a favourable trend for patients treated with amivantamab plus chemotherapy, compared to those treated with chemotherapy alone (HR=0.675; 95% CI, 0.42–1.09; P=0.106). The combination of amivantamab and chemotherapy demonstrated a safety profile consistent with the safety profiles of the individual agents, with low rates of treatment-related discontinuations (7%). The rates of overall adverse events (AEs) and AEs leading to death were comparable between both treatment arms. The rate of Grade ≥3 AEs was higher with amivantamab and chemotherapy, compared to chemotherapy alone (75% vs 54%). Serious AEs (SAEs) occurred in 37% of patients with amivantamab and chemotherapy, compared to 31% with chemotherapy alone. EGFR and MET-related AEs were increased with amivantamab-chemotherapy (primarily grade 1-2). Chemotherapy-associated haematologic and gastro-intestinal toxicities were comparable, except for neutropenia, which was transient. Pneumonitis was reported in 3% of patients in the amivantamab-chemotherapy arm.

“Today’s positive opinion represents the culmination of years of work and our team’s commitment to the lung cancer community. We will continue to focus on redefining treatment paradigms, starting from the very first line of therapy, with a goal of improving survival rates and overall patient outcomes.” said Kiran Patel MD, vice president, Clinical Development, Solid Tumours, Johnson & Johnson Research & Development, LLC. “Through our extensive research and development efforts, we are pioneering novel approaches and targeting key pathways implicated in lung cancer progression, with the ultimate goal of transforming clinical outcomes for patients with EGFR-mutated NSCLC.”

About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at www.janssen.com/emea.