Combination extends survival vs. standard first-line therapy for advanced lung cancer
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Key takeaways:
- The combination of amivantamab-vmjw and lazertinib extended OS by more than 1 year.
- Previously reported results showed a 30% reduction in risk for progression or death with the combination.
A two-drug combination extended OS compared with standard first-line osimertinib for certain patients with advanced lung cancer, according to the agents’ manufacturer.
The OS benefit with amivantamab-vmjw (Rybrevant, Janssen) and lazertinib (Lazcluze; Janssen) is expected to exceed 1 year, according to a press release issued by Johnson & Johnson.
Amivantamab-vmjw is an EGFR-MET bispecific antibody. Lazertinib is a central nervous system-penetrant EGFR tyrosine kinase inhibitor.
The FDA approved the amivantamab-vmjw and lazertinib combination last year for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
The agency based approval on results of the randomized phase 3 MARIPOSA trial, which showed the combination significantly prolonged PFS compared with osimertinib (Tagrisso, AstraZeneca).
Updated topline data revealed the OS benefit with the combination.
“The combination of these two agents previously demonstrated an improvement in progression-free survival, but this does not always capture the impact on the entire treatment course. Evaluation of overall survival can better demonstrate the benefit of a first-line treatment regimen,” Stephen Liu, MD, associate professor of medicine at Georgetown University School of Medicine, as well as director of thoracic oncology and head of developmental therapeutics at Georgetown’s Lombardi Comprehensive Cancer Center, said in a press release issued by Johnson & Johnson. “Seeing this increase in overall survival in a trial with mature data is powerful and reaffirms that first-line treatment with [amivantamab and lazertinib] can lead to better patient outcomes.”
The MARIPOSA trial included 1,074 patients (median age, 63 years; 62% women; 59% Asian).
Researchers randomly assigned 429 patients to amivantamab-lazertinib and 216 patients to lazertinib monotherapy. The other 429 patients received osimertinib (Tagrisso, AstraZeneca).
PFS by blinded independent central review served as the primary endpoint. Secondary endpoints included OS, objective response rate, duration of response, safety and PFS after first subsequent therapy.
Previously reported results showed the combination conferred a 30% reduction in risk for disease progression or death compared with osimertinib (median PFS, 23.7 months vs. 16.6 months; HR = 0.7; 95% CI, 0.58-0.85).
The combination improved PFS regardless of brain metastases history (with history, HR = 0.69; 95% CI, 0.53-0.92; no history, HR = 0.69; 95% CI, 0.53-0.89), and it also improved extracranial PFS (median, 27.5 months vs. 18.5 months; HR = 0.68; 95% CI, 0.56-0.83).
Researchers reported comparable ORRs between the combination and osimertinib monotherapy groups (86% vs. 85%); however, results showed longer median duration of response among confirmed responders in the combination group (25.8 months vs. 16.8 months).
The safety profile of the combination appeared generally consistent with the known profiles of the individual agents, according to the release.
Complete OS results will be presented at a medical meeting.
“Every milestone in clinical trials and every approval of a new drug or regimen brings hope and progress for [patients with EGFR-positive disease] and their families,” Marcia Horn, JD, president of International Cancer Advocacy Network, said in the release. “These topline data from the MARIPOSA trial offer renewed optimism in the journey to extend life for [patients with EGFR mutations], adding another important option for patients and oncologists.”
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