Johnson & Johnson RYBREVANT reaches 34.3-month survival

• Johnson & Johnson (NYSE:JNJ) reported median overall survival of 34.3 months with RYBREVANT plus chemotherapy versus 27.9 months with chemotherapy alone.
• A crossover-adjusted analysis showed a 43% reduction in the risk of death, while PFS through second progression reached 28.3 months versus 17.5 months.
• Johnson & Johnson described the 34.3-month result as the longest reported median overall survival in this EGFR exon 20 insertion-mutated NSCLC population.

Johnson & Johnson (NYSE:JNJ) reported final Phase 3 PAPILLON results showing median overall survival of 34.3 months with first-line IV RYBREVANT plus carboplatin-pemetrexed versus 27.9 months with chemotherapy alone.

The survival difference was observed despite 76% of eligible patients initially receiving chemotherapy crossing over to second-line RYBREVANT after disease progression.

A prespecified analysis adjusting for crossover showed a 43% reduction in the risk of death with the RYBREVANT combination, with a hazard ratio of 0.57, 95% confidence interval of 0.39 to 0.82, and nominal P=0.003.

Progression-free survival through second progression reached 28.3 months with RYBREVANT plus chemotherapy versus 17.5 months with chemotherapy alone, corresponding to a hazard ratio of 0.59 and nominal P<0.0001.

Johnson & Johnson described the 34.3-month median overall survival as the longest reported in advanced NSCLC with EGFR exon 20 insertion mutations and said it was nearly twice historical median survival levels.

At the data cutoff, 12% of patients remained on first-line RYBREVANT plus chemotherapy, while patient-reported outcomes also favored the combination over chemotherapy alone.

Johnson & Johnson said safety remained consistent with previous experience, with no new signals and common treatment-related events including paronychia and neutropenia at 60% each and rash at 58%.