Janssen's EGFR/c-Met Bispecific Antibody Rybrevant Receives FDA Approval for Second-Line Treatment of EGFR-Mutated NSCLC

Sep 21, 2024 07:20 CST Updated 07:20

Johnson & Johnson

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September 21, 2024

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On September 19 local time, Johnson & Johnson announced that the FDA had approved its EGFR/c-Met bispecific antibody Rybrevant (amivantamab-vmjw) in combination with standard chemotherapy (carboplatin + pemetrexed) for the treatment of patients with epidermal growth factor receptor (EGFR) exon 19 deletion mutations.ex19del) orL858RAdult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring substitution mutations, who have progressed during or after treatment with EGFR tyrosine kinase inhibitors (TKIs).

EGFRMutations are the most common driver mutations in NSCLC. According to literature reports, 10%~15% of Western adenocarcinoma NSCLC patients and 40%~50% of Asian patients have EGFR mutations. EGFRex19delor EGFRL858RMutation is the most common EGFR mutation.

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 varied and complex, making targeted therapy after progression more challenging and limiting its efficacy post-progression. The addition of immunotherapy to chemotherapy has also failed to demonstrate clinically meaningful improvement.

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The FDA's approval this time is based on the results of the Phase III MARIPOSA-2 (NCT04988295) study, which evaluated Rybrevant in combination with chemotherapy for the treatment of patients with EGFR mutations whose disease had progressed after treatment with osimertinib.ex19delOrL858REfficacy and Safety of Rybrevant in Adult Patients with Locally Advanced or Metastatic NSCLC Harboring Substitution Mutations. The results showed that, compared with chemotherapy, 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 group.

In addition to diffuse gastric cancer, the preclinical efficacy also characterizes this targeted drug as having superior single-agent efficacy in malignant metastatic cancers such as ovarian cancer, triple-negative breast cancer, and pancreatic cancer, as well as in combination with chemotherapy orKRAS mutation and the combination of targeted drugs for EGFR mutations have demonstrated superior therapeutic effects. With the progress of clinical research, they are expected to play a role in more treatment areas.

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) in combination 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 harboring 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 significant treatment option for patients with EGFR-mutated NSCLC, who continue to face a high level of unmet need following disease progression during or after TKI therapy."

References:

1. Publicly Available Information on the Internet

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