The European Commission has granted approval for the use of Rybrevant (amivantamab) in combination with Lazcluze (lazertinib) as a first-line treatment for adults diagnosed with advanced non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations. This decision introduces a new chemotherapy-free approach, showing superior outcomes compared to osimertinib monotherapy.
Also read: Novartis aims to treat broader patient population with intrathecal onasemnogene abeparvovec
The approval is grounded in findings from the Phase 3 MARIPOSA clinical trial, which assessed the efficacy and safety of combining Rybrevant (amivantamab) with Lazcluze (lazertinib) versus Tagrisso (osimertinib) alone in treating advanced or metastatic NSCLC.
The study achieved its primary goal by demonstrating a significant reduction in the risk of disease progression or death by 30% for patients receiving the combination therapy, as opposed to those on osimertinib alone.
Specifically, the median progression-free survival (PFS) for patients treated with amivantamab and lazertinib was 23.7 months, compared to 16.6 months for the osimertinib group. Additionally, the duration of response (DOR) was extended by nine months (25.8 months versus 16.8 months), reflecting a longer-lasting benefit from the combination therapy.
The MARIPOSA trial enrolled over 1,000 patients and followed a randomized, controlled design. Along with evaluating progression-free survival, secondary endpoints included overall survival (OS), overall response rate (ORR), and second progression-free survival (PFS2). Brain MRI scans were conducted periodically to track the development of brain metastases, a frequent complication in NSCLC cases.
In patients without brain involvement, the combination therapy extended median PFS to 27.5 months compared to 18.5 months for osimertinib.
At a three-year follow-up, 61% of patients receiving the amivantamab-lazertinib combination remained alive, compared to 53% of those on osimertinib.
Median overall survival had not yet been reached for patients treated with the combination, underscoring its potential to significantly improve long-term outcomes.
Amivantamab is a bispecific antibody targeting EGFR and MET mutations, disrupting tumor growth while engaging the immune system to enhance its anti-cancer response. Its dual mechanism of action positions it as a powerful tool in combating resistance mechanisms that often develop in EGFR-mutated NSCLC.
Also read: Bristol Myers Squibb Reports Positive Results from Phase 3 Trials of Deucravacitinib in Psoriatic Arthritis
The combination of amivantamab and lazertinib is now poised to reshape first-line treatment strategies for advanced NSCLC in patients with EGFR mutations, offering a new standard of care aimed at prolonging survival and improving quality of life.
Comments