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.
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.
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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