Niraparib, abiraterone acetate, prednisone combination
Janssen announced the initial results from the Phase 3 MAGNITUDE study evaluating the combination of niraparib, abiraterone acetate, and prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC). The patients might or not have the homologous recombination repair (HRR) gene mutation.
MAGNITUDE is a randomized, double-blind, placebo-controlled trial. At 18.6 months, in patients with HRR alternations, the risk of progression or death was reduced by 27%. In patients with BRCA1/2 gene mutations, the risk of progression or death was reduced by 47%.
Janssen announced real-world evidence data of Erleada (apalutamide), demonstrating that most patients achieved PSA90 response after six months of treatment. After six months of treatment, 69.3% of patients on Erleada achieved PSA90 response, 55.6% of patients on enzalutamide achieved PSA90 response. After nine months, 70.4% of patients on Erleada and 62.5% on enzalutamide achieved PSA90 response.
The company also announced Phase 3 SPARTAN and TITAN studies, where PSA90 response showed improvement in quality of life, physical well-being, pain, and fatigue.
Lynparza plus abiraterone acetate
Merck announced the Phase 3 trial results of Lynparza (olaparib) plus abiraterone acetate in patients with metastatic castration-resistant prostate cancer (mCRPC), with or without homologous recombination repair (HRR) gene alterations.
PROpel study is a Phase 3 trial in which Lynparza met the primary endpoint. The risk of progression or death was decreased by 34% compared to placebo plus abiraterone acetate combination. Radiographic progression-free survival (rPFS) was 24.8 months in Lynparza + abiraterone arm versus 16.6 months in the placebo plus abiraterone arm. There was no statistically significant difference in the overall survival at the analysis time.
Opdivo + Cabometyx
Bristol Myers Squibb and Exelixis, Inc. announced two-year results of the Phase 3 CheckMate -9ER trial.
Opdivo (nivolumab) and Cabometyx (cabozantinib) combination resulted in the sustained survival rate health-related quality of life improvements, compared to sunitinib in patients with renal cell carcinoma as first-line therapy.
The risk of death was reduced by 30% in Opdivo + Cabometyx arm compared to sunitinib.
Median progression-free survival was 16.6 months in Opdivo + Cabometyx arm vs. 8.3 months in patients on sunitinib.
12.4 showed complete response in the combination arm versus 5.2% in patients on sunitinib.
Bayer presented the Phase III ARASENS trial of Nubeqa (darolutamide) in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
The combination of darolutamide plus androgen deprivation therapy and docetaxel improved overall survival by 32% compared to androgen deprivation therapy and docetaxel.