The European Commission (EC) has approved a Type II extension for Johnson and Johnson (J&J)’s immunotherapy Rybrevant (amivantamab), which was submitted in February of this year. Rybrevant in with chemotherapy is the first combination to significantly improve progression-free survival (PFS) versus chemotherapy alone.
The European designation follows a similar approval in the US, where the Food and Drug Administration (FDA) granted full approval to Rybrevant plus chemotherapy to treat NSCLC in March this year, upgrading a prior accelerated approval given in May 2021. This label extension describes Rybrevant's use in combination with carboplatin and pemetrexed to treat NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletion (ex19del) or exon 21 L958R substitution following prior EGFR TKI therapy.
Last week, the FDA also approved Rybrevant plus Lazcluze (lazertinib) combination to treat certain groups of metastatic non-small cell lung cancer (NSCLC).
Rybrevant’s latest label expansion was based on data from the Phase III MARIPOSA-2 trial (NCT04988295). The trial investigated the efficacy and safety of Rybrevant plus chemotherapy versus chemotherapy alone for 657 NSCLC patients with certain EGFR mutations for whom osimertinib treatment had failed. Osimertinib is an EGFR TKI marketed as Tagrisso by AstraZeneca.
The MARIPOSA-2 trial met its primary endpoint, with Rybrevant reducing the risk of disease progression or death by 52% versus chemotherapy. Patients receiving Rybrevant had a median PFS of 6.3 months compared to 4.2 months for chemotherapy-treated patients, with an objective response rate 64% compared to 36% with the comparator arm.
The EGFR+ NSCLC treatment space is highly competitive. GlobalData estimates that Rybrevant will generate $356m in global revenue during 2024, and projects this will increase to $2.4bn annually by 2030.
GlobalData is the parent company of Pharmaceutical Technology.
Lung cancers account for the greatest mortality of all cancers, killing an estimated 1.8 million people globally in 2020, as per the World Health Organization. NSCLC makes up 85% of lung cancer cases, and of these some of the most common drivers are EGFR mutations. For patients with advanced NSCLC with EGFR mutation who are treated with TKIs, fewer than 20% survive for five years or more.
Dr. Henar Hevia, Senior Director of Oncology at Johnson & Johnson, stated that the approval, “addresses a major unmet need for those whose disease has progressed following treatment with an EGFR TKI and who, until now, have faced limited treatment options”.
