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A Bioluminescent and Fluorescent Orthotopic Syngeneic Murine Model of Androgen-dependent and Castration-resistant Prostate Cancer
07:25

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Ceralasertib Monotherapy in Patients with ATM-Altered Advanced Solid Tumors or Metastatic Castration-Resistant

Rahul R Aggarwal1, Antoine Italiano2,3, Susan M Domchek4

  • 1Division of Hematology/Oncology, University of California, San Francisco, California.

Cancer Research Communications
|June 1, 2026
PubMed
Abstract

Insights

Ceralasertib showed limited efficacy as a monotherapy in patients with ATM-altered cancers. Further research will explore alternative patient selection and combination therapies for better outcomes.

Area of Science:

  • Oncology
  • Pharmacology
  • Genetics

Background:

  • Ceralasertib is an oral ataxia telangiectasia and Rad3-related (ATR) inhibitor.
  • Preclinical studies showed ceralasertib has activity in ataxia-telangiectasia mutated (ATM)-altered cancers.

Purpose of the Study:

  • The PLANETTE study evaluated ceralasertib in patients with previously treated advanced solid tumors or metastatic castration-resistant prostate cancer with ATM alterations.
  • The study assessed efficacy and safety of ceralasertib monotherapy.

Main Methods:

  • Patients received ceralasertib 160 mg BID for 14 days every 28-day cycle.
  • Efficacy was assessed by objective response rate (ORR) in advanced solid tumors and composite response rate (CRR) in prostate cancer.
  • Progression-free survival (PFS) and safety were secondary endpoints.

Main Results:

  • The study included 30 patients in Cohort A (solid tumors) and 15 in Cohort B (prostate cancer).
  • ORR in Cohort A was 7.1% and CRR in Cohort B was 7.7%.
  • In patients with ATM protein loss, ORR was 18.2% (Cohort A) and CRR was 0% (Cohort B). Median PFS was 3.7 months for both cohorts. Grade ≥3 adverse events occurred in approximately 50% of patients.

Conclusions:

  • Ceralasertib monotherapy was tolerated but demonstrated limited responses in this patient population.
  • Future strategies may involve improved patient selection and combination therapies to enhance efficacy.

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