▎WuXiEdited by Kant Content Team

Recently, Johnson & Johnson announced that the U.S. FDA has approved its bispecific antibody Rybrevant (amivantamab) in combination with standard 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 locally advanced or metastatic non-small cell lung cancer (NSCLC) adult patients who have experienced disease progression after receiving EGFR tyrosine kinase inhibitor (TKI) therapy.

The approval by the U.S. FDA was primarily based on the results of the Phase 3 MARIPOSA-2 study, which evaluated the efficacy and safety of Rybrevant in combination with chemotherapy for adult patients with locally advanced or metastatic NSCLC who experienced disease progression during or after treatment with Tagrisso (osimertinib). These patients carryEGFRex19del or L858R substitution mutation.

Analysis shows that, compared with chemotherapy alone,Rybrevant in combination with chemotherapy reduced the risk of disease progression or death by 52%, achieving the primary endpoint of the study.The median progression-free survival (PFS) for patients receiving Rybrevant in combination with chemotherapy was 6.3 months, compared to 4.2 months for the chemotherapy alone group. Additionally,The confirmed overall response rate (ORR) was 53% in patients treated with Rybrevant plus chemotherapy, compared to 29% in patients treated with chemotherapy alone.

The safety of Rybrevant in combination with chemotherapy is consistent with the safety observed in previous trials.

Rybrevant is a humanized EGFR/MET bispecific antibody. It has multiple mechanisms of anticancer action, not only blocking EGFR and MET-mediated signaling but also directing immune cells to target tumors carrying activating and drug-resistant EGFR/MET mutations and amplifications.Rybrevant was approved by 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.

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References:

[1] RYBREVANT® (amivantamab-vmjw) plus standard of care approved in the U.S. as first and only targeted regimen to cut risk of disease progression by more than half in second-line EGFR-mutated advanced lung cancer. Retrieved September 20, 2024 from https://www.prnewswire.com/news-releases/rybrevant-amivantamab-vmjw-plus-standard-of-care-approved-in-the-us-as-first-and-only-targeted-regimen-to-cut-risk-of-disease-progression-by-more-than-half-in-second-line-egfr-mutated-advanced-lung-cancer-302253749.html

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