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Phase II study of talazoparib in advanced cancers with BRCA1/2, DNA repair, and PTEN alterations.
Piha-Paul, Sarina A; Tseng, Chieh; Leung, Cheuk Hong; Yuan, Ying; Karp, Daniel D; Subbiah, Vivek; Hong, David; Fu, Siqing; Naing, Aung; Rodon, Jordi; Javle, Milind; Ajani, Jaffer A; Raghav, Kanwal P; Somaiah, Neeta; Mills, Gordon B; Tsimberidou, Apostolia M; Zheng, Xiaofeng; Chen, Ken; Meric-Bernstam, Funda.
Affiliation
  • Piha-Paul SA; Department of Investigational Cancer Therapeutics (A Phase I Clinical Trials Program), University of Texas MD Anderson Cancer Center, Houston, TX, USA. spihapau@mdanderson.org.
  • Tseng C; Department of Investigational Cancer Therapeutics (A Phase I Clinical Trials Program), University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Leung CH; Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Yuan Y; Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Karp DD; Department of Investigational Cancer Therapeutics (A Phase I Clinical Trials Program), University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Subbiah V; Department of Investigational Cancer Therapeutics (A Phase I Clinical Trials Program), University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Hong D; Department of Investigational Cancer Therapeutics (A Phase I Clinical Trials Program), University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Fu S; Department of Investigational Cancer Therapeutics (A Phase I Clinical Trials Program), University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Naing A; Department of Investigational Cancer Therapeutics (A Phase I Clinical Trials Program), University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Rodon J; Department of Investigational Cancer Therapeutics (A Phase I Clinical Trials Program), University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Javle M; Department of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Ajani JA; Department of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Raghav KP; Department of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Somaiah N; Department of Sarcoma Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Mills GB; Knight Cancer Institute, Oregon Health Sciences University, Portland, OR, USA.
  • Tsimberidou AM; Department of Investigational Cancer Therapeutics (A Phase I Clinical Trials Program), University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Zheng X; Department of Bioinformatics and Computational Biology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Chen K; Department of Bioinformatics and Computational Biology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Meric-Bernstam F; Department of Investigational Cancer Therapeutics (A Phase I Clinical Trials Program), University of Texas MD Anderson Cancer Center, Houston, TX, USA.
NPJ Precis Oncol ; 8(1): 166, 2024 Jul 31.
Article in En | MEDLINE | ID: mdl-39085400
ABSTRACT
Cancer cells with BRCA1/2 deficiencies are sensitive to poly (ADP-ribose) polymerase (PARP) inhibitors. We evaluated the efficacy of talazoparib in DNA-Damage Repair (DDR)-altered patients. In this phase II trial, patients were enrolled onto one of four cohorts based on molecular alterations (1) somatic BRCA1/2, (2) other homologous recombination repair pathway, (3) PTEN and (4) germline BRCA1/2. The primary endpoint was a clinical benefit rate (CBR) complete response, partial response or stable disease ≥24 weeks. 79 patients with a median of 4 lines of therapy were enrolled. CBR for cohorts 1-4 were 32.5%, 19.7%, 9.4% and 30.6%, respectively. PTEN mutations correlated with reduced survival and a trend towards shorter time to progression.Talazoparib demonstrated clinical benefit in selected DDR-altered patients. PTEN mutations/loss patients derived limited clinical benefit. Further study is needed to determine whether PTEN is prognostic or predictive of response to PARP inhibitors.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Language: En Journal: NPJ Precis Oncol Year: 2024 Document type: Article Affiliation country: Estados Unidos Country of publication: Reino Unido
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Full text: 1 Collection: 01-internacional Database: MEDLINE Language: En Journal: NPJ Precis Oncol Year: 2024 Document type: Article Affiliation country: Estados Unidos Country of publication: Reino Unido