AMPLITUDE Trial: What Community Oncologists Should Know
Discover the groundbreaking AMPLITUDE trial results, showcasing niraparib's effectiveness in treating metastatic prostate cancer with minimal safety concerns.
Gerhardt Attard, MD, PhD, FRCP, a professor of medical oncology in University College London in the UK, discusses what a community oncologist should know about the double-blind, placebo-controlled AMPLITUDE trial (NCT04497844) of niraparib and abiraterone acetate plus prednisone (AAP) vs placebo plus AAP in patients with metastatic castration-sensitive prostate cancer (mCSPC) harboring certain homologous recombination repair (HRR) pathway gene mutations who were given a PARP inhibitor combined with an androgen receptor pathway inhibitor.
“The AMPLITUDE trial met its primary end point, and that's an end point of radiographic progression-free survival [rPFS]. That efficacy is also supported by a significant delay in time to symptomatic progression, which is a patient-centric end point, and I think of big value. The interim analysis for overall survival is currently mature but trending in the right direction,” says Attard.
AMPLITUDE is the first study to demonstrate improved rPFS. The risk of radiographic progression or death was reduced by 37% with the niraparib combination vs placebo plus AAP.
Looking at safety findings, there were no new safety signals. Grade 3 or 4 adverse events (AEs) occurred in 75.2% of patients in the niraparib and AAP arm vs 58.9% of patients in the AAP arm. Most commonly, these AEs consisted of anemia (29.1% vs 4.6%) and hypertension (26.5% vs 18.4%). Treatment discontinuations due to AEs were low, at 11.0% in the niraparib combination arm and 6.9% in the AAP arm.
"The side effect profile is in keeping with results. For this combination, we have reported in castration-resistant prostate cancer, primarily [adverse events] involving the hematological and cardiovascular systems. We had anemia, grade 3 or 4, in 29% of patients, but importantly, at least in my view, the difference in treatment discontinuation between the niraparib and the placebo group was less than 5%. So just over 10% in the placebo group discontinued treatment due to toxicity, and just under 15% in the niraparib [group] discontinued due to toxicity,” adds Attard.
