Johnson & Johnson’s (J&J) Rybrevant (amivantamab) in combination with chemotherapy, has been recommended by the European Medicines Agency’s human medicines committee as a first-line treatment for advanced non-small cell lung cancer (NSCLC).
The fully-human epidermal growth factor receptor (EGFR)-MET bispecific antibody has been recommended to treat adults with NSCLC with activating EGFR exon 20 insertion mutations, in combination with carboplatin and pemetrexed.
In 2022, it was estimated that there were 484,306 new cases of lung cancer in Europe, with 85% accounted for by NSCLC, which includes adenocarcinoma, squamous cell carcinoma and large cell carcinoma.
One of the biggest driver mutations in NSCLC are alterations in EGFR. Currently, the third most prevalent activating EGFR mutation, EGFR exon 20 mutations, have a five-year overall survival of 8%, which is lower than for patients with the most common EGFR mutations, EGFR ex19del or L858R.
The Committee for Medicinal Products for Human Use’s (CHMP) recommendation was supported by positive data from the phase 3 Papillon study, which evaluated the efficacy and safety of Rybrevant in combination with chemotherapy and versus chemotherapy in 308 newly diagnosed patients with advanced or metastatic NSCLC characterised by EGFR exon 20 insertion mutations.
Meeting its primary endpoint, the results demonstrated a statistically significant and clinically meaningful improvement in progression-free survival in patients receiving Rybrevant in combination with chemotherapy compared to chemotherapy alone.
The combination also demonstrated a safety profile consistent with the safety profiles of the individual agents, with lower rates of treatment-related discontinuations.
“[The] positive opinion represents the culmination of years of work and our team’s commitment to the lung cancer community,” said Kiran Patel, vice president, clinical development, solid tumours, J&J research and development, LLC.
“We will continue to focus on redefining treatment paradigms, starting from the very first line of therapy, with [the] goal of improving survival rates and overall patient outcomes,” Patel said.
Rybrevant was approved by the US Food and Drug Administration in March, alongside carboplatin and pemetrexed chemotherapy, for the first-line treatment of locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.
It also received traditional approval in patients whose disease has progressed on or after platinum-based chemotherapy.