Disease Progression or Death Risk Reduced by 52%! Janssen's EGFR/c-Met Bispecific Antibody Rybrevant Plus Chemotherapy Approved for Second-Line Treatment of NSCLC

On September 20, Johnson & Johnson announced that the FDA had approved its EGFR/c-Met bispecific antibody Rybrevant (amivantamab-vmjw,Amivantamab) in combination with standard chemotherapy (carboplatin + pemetrexed) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletion (ex19del) or L858R substitution mutations, whose disease has progressed during or after treatment with EGFR tyrosine kinase inhibitors (TKIs).

The 5-year survival rate for all patients with advanced EGFR-mutant NSCLC is less than 20%. The mechanisms of acquired resistance after TKI monotherapy are diverse and complex, making targeted therapy after progression more challenging and limiting its efficacy. Adding immunotherapy to chemotherapy has also failed to demonstrate clinically meaningful improvement.

FDA Approval Based on Phase III MARIPOSA-2 (NCT04988295) Study Results: Rybrevant Plus Chemotherapy for Locally Advanced or Metastatic NSCLC Patients with EGFR ex19del or L858R Substitution Mutations After Osimertinib ProgressionThe FDA's approval was based on the results of the Phase III MARIPOSA-2 (NCT04988295) study, which evaluated the efficacy and safety of Rybrevant in combination with chemotherapy for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletion or L858R substitution mutations following progression on osimertinib. The results showed that, compared to chemotherapy alone, the combination of Rybrevant and chemotherapy reduced the risk of disease progression or death (progression-free survival, PFS) by 52%, which was the primary endpoint of the study. The median PFS for patients receiving Rybrevant plus chemotherapy was 6.3 months, compared to 4.2 months for those receiving chemotherapy alone. Additionally, the objective response rate (ORR) was 53% for the Rybrevant plus chemotherapy group, versus 29% for the chemotherapy-only group.

The safety of Rybrevant in combination with chemotherapy is consistent with the established profile of individual treatments. Rybrevant was permanently discontinued in 11% of patients due to adverse reactions.

Amivantamab-vmjw (Rybrevant) combined with chemotherapy is the only Category 1 treatment option recommended by the NCCN guidelines for EGFR-mutated NSCLC patients who have progressed after osimertinib treatment and present with multiple lesions.

Rybrevant is a fully human bispecific antibody targeting EGFR and MET, with immune cell-directed activity. This approval marks the third new indication for Rybrevant this year, following the FDA's approval in March for its use in combination with chemotherapy (carboplatin + pemetrexed) as a first-line treatment for locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, and the FDA's approval in August for its use in combination with the third-generation EGFR inhibitor Lazcluze (lazertinib) as a first-line treatment for locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.

Kiran Patel, M.D., Vice President of Clinical Development at Johnson & Johnson Innovative Medicine, stated:"This milestone reinforces Rybrevant as a critical treatment option for patients with EGFR-mutated NSCLC, who continue to face significant unmet needs after disease progression during or after TKI therapy."”

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