Johnson & Johnson (NYSE:JNJ) on Monday announced new clinical results from its Phase 2b COPERNICUS study evaluating subcutaneous RYBREVANT FASPRO combined with LAZCLUZE in patients with previously untreated advanced non-small cell lung cancer (NSCLC) harboring common EGFR mutations.
COPERNICUS Study Demonstrates Improved Safety Profile
The trial evaluated 214 U.S. patients receiving the combination alongside prophylactic measures to mitigate blood clots and skin-related side effects.
At a median follow-up of 8.3 months, key treatment-related side effects remained low, with 8% of participants discontinuing treatment due to adverse events.
Skin rash occurred in 25% of patients, while administration-related reactions and venous thromboembolism each affected 3%.
No patients discontinued due to administration-related reactions, while 1% stopped therapy due to rash or blood clots. These findings reflect lower numerical event rates than the intravenous regimen tested in the Phase 3 MARIPOSA study.
PAPILLON Study Shows Survival Advantage
On Sunday, the company shared final overall survival results from the Phase 3 PAPILLON study, which evaluated intravenous RYBREVANT plus chemotherapy against chemotherapy alone for advanced NSCLC patients with EGFR exon 20 insertion mutations.
Patients on the combination regimen achieved a median overall survival of 34.3 months, compared to 27.9 months for chemotherapy alone, extending median survival by over six months.
A prespecified analysis accounting for the 76% of chemotherapy patients who crossed over to second-line RYBREVANT indicated a 43% reduction in the risk of death.
The combination also extended progression-free survival through a second disease progression to 28.3 months, compared to 17.5 months for chemotherapy alone.
JNJ Price Action: Johnson & Johnson shares were down 0.74% to $264.35 at the time of publication on Tuesday, according to Benzinga Pro data.
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