J&J posts late-stage trial win for PARP inhibitor combo in prostate cancer

Johnson & Johnson (NYSE:JNJ) said on Tuesday that niraparib, a cancer treatment from a group of drugs called PARP inhibitors, successfully met its main goal in a Phase 3 trial for prostate cancer when used with other medications.

The ongoing trial named AMPLITUDE was designed to evaluate niraparib developed by JNJ with GSK (GSK) with abiraterone acetate plus prednisone in metastatic castration-sensitive prostate cancer ((mCSPC).

696 patients whose tumors expressed BRCA and other recombination repair (HRR) genetic alterations were selected for the placebo-controlled trial.

Citing its initial data, J&J (NYSE:JNJ) said AMPLITUDE reached the primary endpoint of radiographic progression-free survival (rPFS), indicating a clinically meaningful and statistically significant improvement.

Patients with BRCA alterations showed the highest potential, as median rPFS was not reached for the niraparib arm compared to 26 months for the placebo arm, with a reduction of risk of radiographic progression or death by 48%.

As for those with any HRR alterations, median rPFS was also not reached in comparison to 29.5 months in the comparator arm, reducing the risk of progression or death by 37%.

Meanwhile, 75% and 59% of patients in the niraparib arm and placebo arm developed Grade 3/4 adverse events, and treatment discontinuations due to adverse events in the groups stood at 14.7% and 10.3%.

Niraparib, marketed by JNJ with abiraterone acetate as Akeeba, is already available in the U.S. in combination with abiraterone acetate for adults with BRCA-positive mCRPC.