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RYBREVANT®▼ (amivantamab) plus lazertinib shows longer progression-free survival versus osimertinib in the first-line treatment of patients with high-risk EGFR-mutated non-small cell lung cancer

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Investigational chemotherapy-free regimen of amivantamab plus lazertinib addresses a significant unmet need as most patients with EGFR-mutated NSCLC have high-risk disease1

Landmark Phase 3 MARIPOSA data featured in an oral presentation at ASCO1 

BEERSE, BELGIUM, May 31, 2024 – Janssen-Cilag International NV, a Johnson & Johnson company, today announced new data from the Phase 3 MARIPOSA study demonstrating the efficacy of first-line treatment with RYBREVANT®▼ (amivantamab) in combination with lazertinib in patients with high-risk  disease or clinical features, which occur in nearly 85 percent of patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.1,2 Results from the new analysis show the amivantamab-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.1 These data were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #8504) taking place in Chicago, Illinois from 31 May – 4 June 2024.1

“These new data demonstrate the efficacy of amivantamab 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,” said Byoung Chul Cho, M.D., Ph.D, medical oncologist and professor in the Division of Medical Oncology at Yonsei Cancer Center, Yonsei University College of Medicine in Seoul, Republic of Korea, and the study author.* “These findings support the potential of this combination as an important first-line option for these patients who face significant unmet needs.”

The MARIPOSA study enrolled treatment-naïve patients with EGFR-mutant (ex19del or L858R) advanced NSCLC.1 Overall, results showed amivantamab plus lazertinib resulted in a significant reduction in the risk of disease progression or death compared to osimertinib as previously reported.1 High-risk features, such as liver or brain metastases, baseline TP53 co-mutations, and circulating tumour DNA (ctDNA) shedding are common in patients with EGFR-mutated advanced NSCLC and associated with poor prognoses.3,4,5,6 In the study, 89 percent of enrolled patients had one or more of these high-risk disease or clinical features at baseline. Specifically, 41 percent had brain metastases, 16 percent had liver metastases, 54 percent had TP53 co-mutations, 70 percent had ctDNA present at baseline and 15 percent continued to shed ctDNA after two cycles of treatment.1

Results from the analysis showed treatment with amivantamab plus lazertinib significantly reduced the risk of disease progression or death consistently across all high-risk subgroups:1

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

“High-risk features are incredibly prevalent in first-line EGFR-mutated non-small-cell lung cancer and are associated with a poor prognosis,” said Henar Hevia, Ph.D, Senior Director, EMEA Therapeutic Area Lead, Oncology, Johnson & Johnson Innovative Medicine. “The encouraging findings from this study, demonstrating improved progression-free survival in this critical patient subgroup treated with amivantamab and lazertinib, highlight our commitment to pioneering precision medicine and establishing new standards of care for one of the largest lung cancer patient populations.”

As reported at the European Society for Medical Oncology (ESMO) 2023 Congress, the safety profile of the combination of amivantamab and lazertinib was consistent with the safety profiles of the individual treatments, with mostly Grade 1 or 2 adverse events (AEs) reported.7 Toxicity was largely manageable with dose interruptions and reductions, along with supportive care measures commonly used in the treatment of patients with NSCLC.7 The most common Grade 3 or higher treatment-related AEs were rash and paronychia.7 Amivantamab plus lazertinib had higher rates of EGFR and MET-related AEs (hypoalbuminemia and peripheral oedema) and venous thromboembolism compared to osimertinib, with higher rates of diarrhoea being observed with osimertinib.7 The rate of discontinuation of all study treatments due to treatment-related AEs for the amivantamab combination was 10 percent.7 The rate of interstitial lung disease (including pneumonitis) was less than three percent in both arms.7

“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 amivantamab plus lazertinib may offer a new standard of care in this patient population,” said Craig Tendler, M.D., Vice President, Late Development and Global Medical Affairs, Johnson & Johnson Innovative Medicine. “These new findings continue to demonstrate how amivantamab-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 potential promise of this chemotherapy-free approach.”

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