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Ceralasertib Monotherapy in Patients with ATM-Altered Advanced Solid Tumors or Metastatic Castration-Resistant Prostate Cancer: Data from the Phase 2a PLANETTE Study - PubMed

4 hours ago
  • #ATR inhibitor
  • #Phase 2a trial
  • #ATM alteration
  • Ceralasertib, an oral ATR inhibitor, was studied in patients with ATM-altered advanced solid tumors (Cohort A, n=30) and metastatic castration-resistant prostate cancer (Cohort B, n=15).
  • Objective response rate in Cohort A was 7.1% (2/28 patients) with one complete response and one partial response, while composite response rate in Cohort B was 7.7% (1/13 patients).
  • Limited responses were observed, with higher ORR of 18.2% in patients with centrally confirmed ATM protein loss, but no responses in those with mCRPC with ATM protein loss.
  • Median progression-free survival was 3.7 months in both cohorts, and grade ≥3 adverse events occurred in about 50% of patients, including asthenia/fatigue, nausea, and anemia.
  • Findings suggest ceralasertib monotherapy has limited efficacy, prompting further exploration of patient selection and combination treatments.