(RTTNews) - Johnson & Johnson (JNJ) on Tuesday announced positive topline results from the Phase 3 MARIPOSA study, highlighting the combination of RYBREVANT and LAZCLUZE as a first-line therapy for patients with EGFR-mutated non-small cell lung cancer or NSCLC.
RYBREVANT is a bispecific antibody targeting EGFR and MET, while LAZCLUZE is a third-generation EGFR TKI.
Both are approved in combination for the treatment of NSCLC with EGFR exon 19 deletions or L858R mutations, and for the treatment of EGFR exon 20 insertion mutations in combination with chemotherapy.
The chemotherapy-free regimen demonstrated a statistically significant and clinically meaningful improvement in median overall survival or OS compared to the current standard of care, osimertinib.
The combination therapy is expected to exceed a one-year improvement in median OS, marking the first survival benefit over existing treatments in EGFR-mutated lung cancer.
The positive results reinforce the potential of RYBREVANT and LAZCLUZE in extending life expectancy for patients with advanced EGFR-mutated NSCLC.
The MARIPOSA trial enrolled 1,074 patients and evaluated the combination regimen against osimertinib in a randomized Phase 3 study. The final OS results add to the previously reported positive progression-free survival or PFS data.
The safety profile of the combination regimen was consistent with individual treatments, and studies showed that the use of oral anticoagulants significantly reduced the risk of venous thromboembolic events associated with the combination.
Dr. Yusri Elsayed, Global Therapeutic Area Head at Johnson & Johnson, emphasized, "These findings can be transformative for patients with EGFR-positive lung cancer, providing more time and hope in their battle against this disease.
RYBREVANT and LAZCLUZE are already approved in the U.S. and Europe for the first-line treatment of EGFR-mutated NSCLC.
The company plans to present the final OS analysis at a major medical meeting and share the data with global health authorities.
The MARIPOSA study paves the way for more options in treating EGFR-mutated NSCLC, addressing a significant unmet need in lung cancer therapeutics.
RYBREVANT and LAZCLUZE are poised to make a major impact in the lung cancer market, with ongoing studies in additional indications such as non-small cell lung cancer or NSCLC.
The combination is expected to help improve survival rates for EGFR-positive patients worldwide.
Currently, JNJ is trading at $146.51 up by 1.98%.
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