Olaparib in Patients With Solid Tumors With BRCA1/2 Alterations: Results From The Targeted Agent and Profiling

Tareq Al Baghdadi1, Michael Rothe2, Pam K Mangat2

  • 1Michigan Cancer Research Consortium, IHA Hematology Oncology, Ypsilanti, MI.

JCO Precision Oncology
|October 16, 2025
PubMed
Abstract

Insights

Olaparib demonstrated significant antitumor activity in patients with advanced solid tumors harboring BRCA1/2 mutations. This targeted therapy showed promising disease control rates across multiple cancer types, warranting further investigation.

Area of Science:

  • Oncology
  • Genomics
  • Clinical Trials

Background:

  • The Targeted Agent and Profiling Utilization Registry Study (TAPUR) is a phase II basket trial.
  • Investigating targeted agents in advanced cancers with genomic alterations.

Purpose of the Study:

  • Evaluate the antitumor activity of olaparib in patients with advanced solid tumors and BRCA1/2 mutations.
  • Assess olaparib's efficacy across five distinct cancer cohorts: breast, biliary tract, lung, uterine, and other solid tumors.

Main Methods:

  • Phase II basket trial design with five patient cohorts.
  • Primary endpoint: disease control (DC) rate defined as complete response, partial response, or stable disease (SD) for at least 16 weeks.
  • Utilized Simon two-stage design for histology-specific cohorts and a one-sided exact binomial test for smaller cohorts.

Main Results:

  • Enrolled 119 patients with BRCA1/2-altered advanced solid tumors.
  • Achieved significant disease control rates across all cohorts, exceeding the null hypothesis of 15% DC.
  • Reported DC rates ranged from 41% to 69%, with notable efficacy in breast and biliary tract cancers.

Conclusions:

  • Olaparib demonstrated a signal of clinical activity in patients with various advanced BRCA1/2-altered solid tumors.
  • The study met its prespecified criteria for declaring efficacy.
  • Results support olaparib as a potential targeted therapy for BRCA1/2-mutated solid malignancies.

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