▎WuXiEdited by Kant Content Team

Johnson & Johnson today announced that the European Commission (EC) has approved its bispecific antibody Rybrevant (amivantamab) in combination with chemotherapy (carboplatin and pemetrexed) for the treatment of patients with epidermal growth factor receptor (EGFR) with exon 19 deletions (ex19del) or L858R substitution mutations in exon 21, advanced non-small cell lung cancer (NSCLC) adult patients who have previously received treatment including EGFR tyrosine kinase inhibitors (TKI) and experienced disease progression. The press release noted,Compared with chemotherapy alone, the combination therapy of amivantamab and chemotherapy is the first treatment regimen that has demonstrated a significant improvement in progression-free survival (PFS) in this patient population.

This approval is mainly based on the results of the Phase 3 clinical study MARIPOSA-2, which evaluated the combination of amivantamab and chemotherapy in patients withEGFR Efficacy and safety in patients with locally advanced or metastatic NSCLC harboring ex19del or L858R substitution mutations who experienced disease progression during or after treatment with osimertinib. The analysis showed that the trial met its primary endpoint.Compared with patients receiving chemotherapy alone, the risk of disease progression or death was significantly reduced by 52% in patients receiving amivantamab combination therapy., PFS was 6.3 months in the treatment group and 4.2 months in the control group (HR=0.48; 95% CI: 0.36–0.64; P<0.001). In addition,The objective response rate (ORR) was 64% in the amivantamab combination therapy group, compared to 36% in the control group.

MARIPOSA-2The data also showed for the first timeamivantamabCombination therapy regimens can provide intracranial activity.Specifically, compared with patients who only received chemotherapy,Amivantamab combination therapy reduced the risk of intracranial progression or death by 45%, with median intracranial progression-free survival of 12.5 months versus 8.3 months (HR=0.55; 95% CI: 0.38-0.79, P=0.001).According to the press release, due to the recent30%Patients with this type of disease may experience brain metastasis of cancer cells, making this discovery crucial for them.

In terms of safety, the safety of the amivantamab combination therapy is consistent with the safety of its individual component drugs.

AmivantamabIt is a humanized EGFR/MET bispecific antibody. It has multiple mechanisms of anticancer action, not only blocking EGFR and MET-mediated signal transduction but also guiding immune cells to target tumors carrying activating and drug-resistant EGFR/MET mutations and amplifications.This therapy received approval from the U.S. FDA in May 2021.Accelerated Approval, used to treat conditions detected by FDA-approved testsEGFRAdult patients with locally advanced or metastatic NSCLC who have exon 20 insertion mutations and whose disease has progressed during or after platinum-based chemotherapy.

References:

[1] European Commission approves RYBREVANT®▼ (amivantamab) in combination with chemotherapy for the treatment of adult patients with advanced EGFR-mutated non-small cell lung cancer after failure of prior therapy. Retrieved August 27, 2024 from https://www.globenewswire.com/news-release/2024/08/27/2935982/0/en/European-Commission-approves-RYBREVANT-amivantamab-in-combination-with-chemotherapy-for-the-treatment-of-adult-patients-with-advanced-EGFR-mutated-non-small-cell-lung-cancer-after-.html

Disclaimer: The content team of WuXi AppTec focuses on introducing the research progress in global biopharmaceuticals and health. This article is for information exchange only, and the views expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article. This article is not a recommendation for treatment plans. If you need guidance on treatment options, please visit a regular hospital.

Copyright Statement: This article is from the content team of WuXi AppTec. Individuals are welcome to share it on their social media circles, but unauthorized reproduction by media or institutions in any form to other platforms is prohibited. For authorization to reproduce, please reply with "reprint" on the WeChat Official Account of "WuXi AppTec" to obtain reprint guidelines.