New data from the Phase 3 PAPILLON study presented at the 2023 ESMO Congress highlights the potential of RYBREVANT® (amivantamab-vmjw) combined with chemotherapy as a first-line treatment for advanced or metastatic non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations. The study reveals a remarkable 60 percent reduction in the risk of disease progression or death, indicating the effectiveness of RYBREVANT® compared to chemotherapy alone. This promising news, along with improved objective response rates and progression-free survival, was presented at ESMO 2023 and published in The New England Journal of Medicine.
RYBREVANT®, when used in combination with chemotherapy, offers patients longer progression-free survival, with a median of 11.4 months compared to 6.7 months with chemotherapy alone. This translates to a significant PFS benefit, even at the 18-month mark. Notably, 73 percent of patients receiving the RYBREVANT® and chemotherapy combination exhibited an objective response rate, in contrast to 47 percent among patients receiving chemotherapy alone. Median PFS2 was also more prolonged with the RYBREVANT® combination, supporting its potential as a first-line treatment option. An interim overall survival analysis displayed a favorable trend for RYBREVANT® plus chemotherapy, with 72 percent and 54 percent of patients alive at two years, respectively.
Although there were EGFR and MET-related toxicities associated with the RYBREVANT® and chemotherapy combination, they were mainly Grade 1 and 2, such as paronychia, rash, hypoalbuminemia, and peripheral edema. Chemotherapy-associated hematologic and gastrointestinal toxicities were comparable across both treatment arms, except for higher rates of neutropenia in the RYBREVANT® combination group, which were reversible. Importantly, the safety profile for RYBREVANT® plus chemotherapy was consistent with the individual agent profiles.
These findings have been submitted to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for their respective reviews, potentially opening the door for a game-changing first-line treatment for patients with EGFR exon 20 insertion mutation-positive NSCLC.
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