Janssen's Bispecific Antibody Rybrevant Approved by FDA in Combination with Chemotherapy for EGFR-Mutated NSCLC

Sep 24, 2024 16:01 CST Updated 16:01

Johnson & Johnson

Medical Device R&D and Manufacturer

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Recently, Johnson & Johnson, a global healthcare giant, announced a significant advancement: its bispecific antibody drug Rybrevant (amivantamab), when used in combination with standard chemotherapy (carboplatin and pemetrexed), has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with specific types of locally advanced or metastatic non-small cell lung cancer (NSCLC). These patients carry either an epidermal growth factor receptor (EGFR) exon 19 deletion (ex19del) or the L858R substitution mutation, and their condition has progressed after prior treatment with EGFR tyrosine kinase inhibitors (TKIs).

The FDA's approval was based on critical data from the Phase 3 MARIPOSA-2 clinical study, which focused on evaluating the efficacy and safety of Rybrevant in combination with chemotherapy in the aforementioned specific patient population. The study results showed that, compared to chemotherapy alone, the combination of Rybrevant and chemotherapy significantly reduced the risk of disease progression or death by 52%, achieving the primary efficacy endpoint set for the study. Specifically, the median progression-free survival (PFS) in the combination therapy group extended to 6.3 months, compared to only 4.2 months in the chemotherapy-only group. Additionally, the confirmed overall response rate (ORR) in the combination therapy group reached 53%, far exceeding the 29% observed in the chemotherapy group.

In terms of safety, the combination therapy of Rybrevant and chemotherapy has demonstrated a safety profile consistent with previous trials, providing an important safety guarantee for patients' treatment.

Rybrevant, as an innovative humanized EGFR/MET bispecific antibody, features a unique dual mechanism of action that not only effectively blocks the EGFR and MET signaling pathways but also possesses the ability to direct immune cells to precisely target tumor cells with specific EGFR/MET mutations or amplifications. This capability demonstrates significant potential in anti-tumor therapy. The recent additional FDA approval marks an important step for Rybrevant in treating specific types of NSCLC patients, offering these patients a new treatment option and hope. Notably, Rybrevant had already received accelerated FDA approval for treating locally advanced or metastatic NSCLC patients with EGFR exon 20 insertion mutations who are resistant to platinum-based chemotherapy.

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