Johnson & Johnson challenges AstraZeneca with new lung cancer survival data

USA – Johnson & Johnson (J&J) has strengthened its case for using its drug combination Rybrevant and Lazcluze to treat patients with EGFR-mutated non-small cell lung cancer (NSCLC).

New data from the MARIPOSA trial, presented at the European Lung Cancer Congress (ELCC), shows that the combination reduces the risk of death by 25% compared to AstraZeneca’s Tagrisso (osimertinib).

The MARIPOSA trial followed patients for nearly 38 months and revealed a significant difference in survival between the two groups after 24 months.

According to trial investigator Professor Nicolas Girard of Institut Curie and Paris-Saclay University, “We see the gap between the survival curves continue to widen, which is exactly what we want to see in lung cancer treatment to improve outcomes for patients.”

Girard also noted that the median overall survival (OS) is projected to be around a year longer than the three-year survival seen with Tagrisso.

“These results reinforce that we are entering a new era for EGFR-mutated non-small cell lung cancer; with this evidence in hand, we need to ensure every patient gets the most effective treatment in the first line for the best possible chance at longer survival,” he added.

Rybrevant (amivantamab) is an EGFRxMET bispecific antibody, while Lazcluze (lazertinib) is a third-generation EGFR tyrosine kinase inhibitor.

The U.S. Food and Drug Administration (FDA) approved the combination for first-line use in locally advanced or metastatic NSCLC with exon 19 deletions or exon 21 L858R substitutions in August.

This approval was based on previous progression-free survival (PFS) data from the MARIPOSA trial.

However, the new overall survival data is expected to challenge AstraZeneca’s Tagrisso, which earned nearly US $6.6 billion in sales last year, a 16% increase.

Tagrisso has been the standard first-line therapy for this type of lung cancer since 2018 and was approved for use with chemotherapy last year.

J&J’s combination treatment may face some challenges, including the need for a two-weekly infusion with Rybrevant, which could be less convenient for patients.

Additionally, there is a risk of clotting side effects, which could impact broader acceptance of the regimen.

However, J&J has already taken steps to address these concerns. The company has filed for approval of a subcutaneous version of Rybrevant to improve convenience.

Although the injectable version was initially rejected by the FDA in December due to manufacturing compliance issues, it has recently been recommended for approval in the European Union.

J&J has high hopes for Rybrevant, projecting it to eventually generate US $5 billion annually. Early sales figures have not yet been disclosed, but the company plans to share them during its first-quarter 2025 earnings report on April 15th.