New Data From Phase III MARIPOSA Study Presented at ASCO Show Groundbreaking Results for RYBREVANT Combination in NSCLC Patients

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Johnson & Johnson has announced new data from the Phase III MARIPOSA study of RYBREVANT (amivantamab-vmjw) in combination with lazertinib in patients with high-risk disease or clinical features, which occur in nearly 85% of patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.¹

These new results show the RYBREVANT combination consistently and significantly improved progression-free survival (PFS) compared to osimertinib in patients with NSCLC with EGFR exon 19 deletion (ex19del) or L858R mutations. This groundbreaking data was presented earlier at ASCO 2024.

The Phase III MARIPOSA trial (NCT04487080) enrolled 1,074 patients and is a randomized study. The primary endpoint is PFS (using RECIST v1.1 guidelines) as assessed by BICR. Secondary endpoints include overall survival (OS), overall response rate (ORR), duration of response (DOR), second progression-free survival (PFS2) and intracranial PFS.

“These new data demonstrate the efficacy of RYBREVANT plus lazertinib, showing a significant reduction in the risk of disease progression or death compared to osimertinib in several high-risk subgroups of patients with EGFR-mutated NSCLC,” Byoung Chul Cho, MD, PhD, medical oncologist and professor in the division of medical oncology at Yonsei Cancer Center, Yonsei University College of Medicine in Seoul, Republic of Korea said in a press release. “These findings support the potential of this combination as an important first-line option for these patients who face significant unmet needs.”

According to the press release, results showed treatment with RYBREVANT plus lazertinib significantly reduced the risk of disease progression or death consistently across all high-risk subgroups:

• 31% compared to osimertinib in patients with a history of brain metastases (18.3 vs 13.0 months; hazard ratio [HR], 0.69; [95% confidence interval [CI], 0.53-0.92]; P=0.010)
• 42% compared to osimertinib in patients with liver metastases at baseline (18.2 vs 11.0 months; HR, 0.58 [95% CI, 0.37-0.91]; P=0.017)
• 35% compared to osimertinib among patients with TP53 co-mutations (18.2 vs 12.9 months; HR, 0.65 [95% CI, 0.48-0.87]; P=0.003)
• 32% compared to osimertinib in patients with detectable ctDNA at baseline (20.3 vs 14.8 months; HR, 0.68 [95% CI, 0.53-0.86]; P=0.002)
• 51% compared to osimertinib in patients without cleared ctDNA at C3D1 (16.5 vs 9.1 months; HR, 0.49 [95% CI, 0.27-0.87]; P=0.015)

In the same press release, Craig Tendler, MD, vice president, late development and global medical affairs, Johnson & Johnson Innovative Medicine added: “With the majority of patients with EGFR-mutated lung cancer having high-risk disease and clinical features, ensuring that all patients receive the most appropriate treatment in the first-line setting is critical. The results presented at ASCO suggest RYBREVANT plus lazertinib offer a new standard of care in this patient population. These new findings continue to demonstrate how RYBREVANT-based regimens are transforming treatment for patients with EGFR-mutated non-small cell lung cancer and add to the growing body of evidence that supports the promise of this chemotherapy-free approach.”

Reference

1. RYBREVANT® (amivantamab-vmjw) plus lazertinib is the only chemotherapy-free regimen showing longer progression-free survival versus osimertinib in first-line treatment of patients with high-risk EGFR-mutated non-small cell lung cancer. News release. May 31, 2024. Accessed June 5, 2024. https://www.jnj.com/media-center/press-releases/rybrevant-amivantamab-vmjw-plus-lazertinib-is-the-only-chemotherapy-free-regimen-showing-longer-progression-free-survival-versus-osimertinib-in-first-line-treatment-of-patients-with-high-risk-egfr-mutated-non-small-cell-lung-cancer