European Commission Approves Johnson & Johnson Non-Small Cell Lung Cancer Treatment

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Johnson & Johnson company Janssen-Cilag International NV, based in Belgium, announced on Jan. 21, 2025 that the European Commission (EC) approved a marketing authorization for Lazcluze (lazertinib) in combination with Rybrevant (amivantamab) for first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC), with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations (1).

This approval from the EC comes the same week that the National Institute for Health and Care Excellence gave positive recommendations for treatment of lung cancer patients in England and Wales to two AstraZeneca products, Imfinzi (durvalumab) and Tagrisso (osimertinib), the latter of which Antonio Passaro, MD, PhD, medical oncologist of the Division of Thoracic Oncology, European Institute of Oncology in Milan, Italy, referenced in a Johnson & Johnson press release (1,2).

A Phase III study (MARIPOSA) evaluated lazertinib in combination with amivantamab, in comparison to osimertinib as a first-line treatment (1).

“This chemotherapy-free regimen has already demonstrated significant progression-free survival improvements, and new topline data suggest it is expected to extend life by a median of one year or more, in patients with untreated EGFR-mutated NSCLC versus the current standard of care, osimertinib,” Passaro said (1). “These results mark a significant step forward in the treatment of EGFR-mutated NSCLC. Extending life expectancy is a critical indicator of a treatment’s impact. The MARIPOSA study reaffirms the potential of first-line treatment with this combination therapy to redefine the standard of care and offer clinically meaningful improvements in outcomes for patients.”

As Passaro mentioned, the Phase III study met its primary endpoint of progression-free survival, adding to Johnson & Johnson’s disclosure earlier in January 2025 that amivantamab plus lazertinib, according to topline overall survival results, met a final, pre-specified secondary endpoint of overall survival (OS), demonstrating clinically meaningful and statistically significant improvement in OS—the median length of which is expected to exceed one year—versus osimertinib monotherapy (1).

“Currently, the five-year survival rate for patients with advanced NSCLC and EGFR mutations treated with EGFR tyrosine kinase inhibitors is less than 20 percent,” Henar Hevia, PhD, senior director, Europe, Middle East and Africa therapeutic area lead, oncology, for Johnson & Johnson, said in the press release. “Today’s approval marks an important moment in lung cancer care, bringing a new option to patients through a chemotherapy-free regimen, and potentially offering more time with their loved ones.”

After presenting data from the Phase III study at the 2023 European Society of Medical Oncology Congress and the International Association for the Study of Lung Cancer 2024 World Conference on Lung Cancer, Johnson & Johnson intends to detail the latest OS data at an upcoming medical meeting, which was not further specified in the release (1).

References

1. Johnson & Johnson. European Commission Approves Lazcluze (lazertinib) in Combination with Rybrevant (amivantamab) for the First-Line Treatment of Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer. Press Release. Jan. 21, 2025.
2. AstraZeneca. AstraZeneca Receives Two Positive NICE Recommendations for Lung Cancer Patients Across England and Wales. Press Release. Jan. 22, 2025.