Janssen's EGFR/MET Bispecific Antibody Rybrevant Shows Positive Phase 3 Results in Osimertinib-Resistant NSCLC

Sep 07, 2023 17:56 CST Updated 17:56

Johnson & Johnson

Medical Device R&D and Manufacturer

On September 6, 2023, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, announced positive topline results from the three-arm Phase III MARIPOSA-2 study of Rybrevant, a fully human bispecific antibody targeting EGFR/MET.

This study aims to evaluate the efficacy of Rybrevant in combination with the third-generation oral EGFR-TKI Lazertinib, in combination with chemotherapy (carboplatin and pemetrexed), and with chemotherapy alone.

This clinical trial enrolled participants who, after developing resistance to osimertinib, progressed to locally advanced or metastatic EGFR exon 19 deletion or L858R substitution NSCLC. The study achieved its dual primary endpoints. This demonstrates that both the combination of Lazertinib and chemotherapy treatment groups showed clinically meaningful improvements in PFS compared to chemotherapy alone, with no new safety issues identified.

As the world's first antibody targeting both EGFR and MET, Rybrevant was approved by the FDA for marketing as early as May 2021. The approved indication is for the first-line treatment of adult patients with NSCLC harboring EGFR exon 20 insertion mutations.

On August 25, 2023, Janssen announced that it had submitted a supplemental Biologics License Application to the FDA, seeking to expand the indication for Rybrevant to include its use in combination with chemotherapy as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations. These patients have a very poor prognosis, and there is a significant and urgent need for new treatment options.

NSCLC patients account for nearly 80% of lung cancer patients worldwide. The most common driver mutation in NSCLC is alterations in EGFR. A large number of patients respond to the EGFR target, and with the occurrence of drug resistance, the demand for new therapies among NSCLC patients is significant. Additionally, a substantial portion of patients are resistant to radiotherapy.

Under the influence of various factors, the treatment methods for NSCLC need to be continuously updated to meet patient needs. The expanding indications for Rybrevant also show us another way to increase treatment options.

References:

Johnson & Johnson Official Website
Other Public Information

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