Johnson & Johnson’s (J&J) Rybrevant (amivantamab-vmjw) has been approved by the US Food and Drug Administration (FDA) as part of a combination treatment for a subset of non-small cell lung cancer (NSCLC) patients.
The bispecific antibody has been authorised for use alongside carboplatin and pemetrexed chemotherapy to treat locally advanced or metastatic NSCLC in adults with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.
Patients eligible for the targeted regimen will also have experienced disease progression on or after treatment with an EGFR tyrosine kinase inhibitor (TKI).
NSCLC accounts for up to 85% of all lung cancer cases, and alterations in EGFR are among the most common driver mutations in patients with this form of the disease.
The five-year survival rate for advanced EGFR-mutated NSCLC is less than 20%, with acquired resistance mechanisms after TKI monotherapy making subsequent treatment more difficult.
J&J’s Rybrevant is designed to directly block EGFR on the outside of the cell to stop tumours from growing and is already approved in the US to treat certain cases of the disease, including NSCLC with EGFR exon 20 insertion mutations.
The FDA’s latest decision on the therapy was supported by positive results from the late-stage MARIPOSA-2 study, which evaluated Rybrevant plus chemotherapy in patients with locally-advanced or metastatic EGFR ex19del or L858R substitution NSCLC whose disease had progressed on or after treatment with AstraZeneca’s third-generation EGFR TKI Tagrisso (osimertinib).
Results showed that the Rybrevant combination reduced the risk of disease progression or death by 52% compared to chemotherapy alone, meeting the study’s primary endpoint.
The median progression-free survival for patients receiving Rybrevant plus chemotherapy was 6.3 months versus 4.2 months for chemotherapy alone, and J&J’s regimen also showed a confirmed overall response rate of 53% compared to 29%.
Kiran Patel, vice president, clinical development, solid tumours, J&J Innovative Medicine, said: “This milestone reinforces Rybrevant as an important treatment option for patients with EGFR-mutated NSCLC who continue to face high unmet needs after disease progression on or after TKI therapy. Patients need and deserve effective, targeted approaches across all lines of therapy.”
The approval comes just one month after Rybrevant in combination with J&J’s third-generation EGFR TKI, Lazcluze (lazertinib), was approved by the FDA as a first-line treatment for adults with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.