Olaparib in Patients With Solid Tumors With
Document Type
Article
Publication Date
10-1-2025
Original Citation
Al Baghdadi T,
Rothe M,
Mangat P,
Garrett-Mayer E,
Crysler O,
Mileham K,
Farrington L,
Adesunloye B,
Dublis S,
Astsaturov I,
Calfa C,
Bleeker J,
Khalil M,
Thota R,
Cannon T,
Alese O,
Gold P,
Hafez N,
Baron A,
Meric-Bernstam F,
Hobbs E,
Marr A,
Rueter J,
Tawfik B,
Hinshaw D,
Gregory A,
Grantham G,
Halabi S,
Schilsky R.
Olaparib in Patients With Solid Tumors With JCO Precis Oncol. 2025;9:e2500649.
Keywords
JMG, Adult, Aged, Female, Humans, Male, Middle Aged, Antineoplastic Agents, BRCA1 Protein, BRCA2 Protein, Neoplasms, Phthalazines, Piperazines, Poly(ADP-ribose) Polymerase Inhibitors, Registries
JAX Source
JCO Precis Oncol. 2025;9:e2500649.
ISSN
2473-4284
PMID
41100773
DOI
https://doi.org/10.1200/po-25-00649
Abstract
PURPOSE: The Targeted Agent and Profiling Utilization Registry Study is a phase II basket trial evaluating the antitumor activity of targeted agents in patients with advanced cancer and genomic alterations. Results of five cohorts of patients with
METHODS: Eligible patients had advanced tumors, measurable disease (RECIST), Eastern Cooperative Oncology Group performance status 0-2, adequate organ function, and no standard treatment options. The primary end point was disease control (DC), defined as complete or partial response or stable disease (SD) of at least 16-weeks duration. For histology-specific cohorts, Simon two-stage design is based on a null DC rate of 15% versus 35% (power = 0.85; α = .10). Cohorts that were closed before achieving the planned stage II sample size were analyzed using a one-sided exact binomial test. For the HP cohort, the hypothesized null DC rate of 15% was rejected if the lower limit of a one-sided 90% CI was >15%. Secondary end points were objective response, progression-free survival, overall survival, duration of response or SD, and safety.
RESULTS: Patients with BC (n = 28), BTC (n = 19), LC (n = 25), UC (n = 15), or other advanced cancers (n = 32) with
CONCLUSION: Olaparib met prespecified criteria to declare a signal of activity in patients with various advanced