Results From phase III PROpel trial of Lynparza + abiraterone in first-line metastatic castration-resistant prostate cancer published in NEJM Evidence.
AstraZeneca and Merck announced that the results from the Phase III PROpel trial have been published in NEJM Evidence.
Results from the trial showed that Lynparza in combination with abiraterone plus prednisone significantly improved radiographic progression-free survival (rPFS) versus abiraterone plus prednisone, a standard of care, as first-line treatment for patients with metastatic castration-resistant prostate cancer (mCRPC) with or without homologous recombination repair (HRR) gene mutations.
As previously reported, in the Phase III PROpel trial, Lynparza in combination with abiraterone plus prednisone (n=399) reduced the risk of disease progression or death by 34% (HR=0.66 [95% CI, 0.54-0.81]; p<0.0001) versus abiraterone plus prednisone and placebo (n="397)." median rpfs was 24.8 months for lynparza plus abiraterone versus 16.6 months for abiraterone. the most common adverse events (aes) (?20%) for lynparza plus abiraterone were anemia (46%), fatigue (37%) and nausea (28%). grade ?3 aes were anemia (15%), hypertension (4%), urinary tract infection (2%), fatigue (2%), decreased appetite (1%), vomiting (1%), back pain (1%), diarrhea (1%) and nausea (0.3%). approximately 14% of patients who received lynparza in combination with abiraterone discontinued treatment due to an ae.
Lynparza is approved in the U.S. for patients with HRR gene-mutated mCRPC (BRCA-mutated and other HRR gene mutations) who have progressed following prior treatment with enzalutamide or abiraterone and in the European Union, Japan and China for patients with BRCA-mutated mCRPC who have progressed following prior therapy that included a new hormonal agent (NHA)
See-"Abiraterone and Olaparib for Metastatic Castration-Resistant Prostate Cancer"; N.W. Clarke and Others 10.1056/EVIDoa2200043 .NEJM Evidence.
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