EC Approves Expanded Use of J&J's Rybrevant Combo for Lung Cancer

Johnson & Johnson’s (J&J’s) Rybrevant (amivantamab) has received approval from the European Commission (EC) for use as a combination treatment in a subset of advanced lung cancer patients. The bispecific antibody is now authorized to be used alongside carboplatin and pemetrexed chemotherapy for treating advanced non-small cell lung cancer (NSCLC) in adults who have either epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations.

This treatment is designated for patients who have not responded to prior therapies, including an EGFR tyrosine kinase inhibitor (TKI). Lung cancer diagnoses in Europe reached approximately 484,306 cases in 2022, with NSCLC constituting up to 85% of these cases. Among NSCLC patients, those with EGFR ex19del or EGFR L858R mutations have historically faced a dire prognosis and had limited treatment options following disease progression on an EGFR TKI.

Rybrevant is engineered to inhibit EGFR on the cell surface, preventing tumor growth. It is already approved in the European Union as a monotherapy and in combination with chemotherapy for specific adults with advanced NSCLC characterized by activating EGFR exon 20 insertion mutations.

The EC’s recent approval is based on positive outcomes from the late-stage MARIPOSA-2 study. This study assessed Rybrevant in combination with chemotherapy in patients with locally-advanced or metastatic EGFR ex19del or L858R substitution NSCLC, whose disease had progressed after treatment with AstraZeneca’s TKI Tagrisso (osimertini). The Rybrevant combination arm achieved its primary endpoint by significantly reducing the risk of disease progression or death by 52% compared to chemotherapy alone. Additionally, the combination therapy showed an objective response rate of 64% versus 36% for chemotherapy alone and lessened the risk of intracranial progression or death by 45%.

Henar Hevia, senior director and EMEA therapeutic area lead for oncology at J&J Innovative Medicine, emphasized the importance of this approval. He stated, “The approval of [Rybrevant] in combination with chemotherapy 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. This milestone further reinforces the critical role of precision medicine in driving enhanced outcomes for patients living with lung cancer.”

The advanced approval of Rybrevant offers significant hope for patients who have exhausted other treatment options, highlighting the importance of targeted therapies in managing serious illnesses like lung cancer. The combination of Rybrevant and chemotherapy provides a new line of defense, improving both survival rates and quality of life for those affected by this aggressive form of cancer.