Talazoparib in patients with BRCA mutant metastatic breast or ovarian carcinoma: results of early access program

Talazoparib is a strong PARP inhibitor with significant catalytic inhibition as well as the ability to cause PARP entrapment at DNA damage sites. It is one of the recommended treatments for individuals with BRCA-mutant advanced breast cancer, although research on its efficacy in advanced ovarian cancer is limited. The purpose of this study was to evaluate the efficacy of talazoparib in advanced breast and ovarian cancer patients with BRCA mutations. Patients with advanced breast (HR + or TNBC) and ovarian cancer who had germline BRCA mutations were included in this multicenter, retrospective study. There were no exclusion criteria regarding treatment-line, metastatic sites or performance status. All patients received talazoparib treatment via early-access programme. The primary endpoint was PFS. Secondary endpoints were OS and ORR. There were 47 and 42 patients in the breast cancer (BC) and ovarian cancer (OC) cohorts, respectively. In BC cohort, after median 13.6 months follow-up the median PFS was 6.5 months (5.0–8.1 months, 95% CI). In this heavily pretreated cohort, the ORR was 31.9% and the estimated 12-month OS rate was 73.6%. In OC cohort, the median follow up period was 13.7 months and the median PFS was 9.1 months (7.3–10.8 months, 95% CI). The ORR was 47.6% and the estimated 12-month OS rate was 75.9% in OC patients. Talazoparib may be an effective therapy option for patients with advanced BRCA-mutant breast cancer. In the absence of prospective phase 2/3 data, the outcomes of OC cohort may also considerably contribute to the literature on BRCA-mutant ovarian cancer.

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Publication Details

Journal
BMC Cancer
Published
2025-11-22
DOI
https://doi.org/10.1186/s12885-025-15287-2
Primary Topic
PARP inhibition in cancer therapy
Type
article
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article

Talazoparib in patients with BRCA mutant metastatic breast or ovarian carcinoma: results of early access program

Semra Paydaş, Nuriye Özdemir, Gülcan Bulut, Cihan Erol et al.
BMC Cancer
PARP inhibition in cancer therapy
article

Talazoparib in patients with BRCA mutant metastatic breast or ovarian carcinoma: results of early access program

Semra Paydaş, Nuriye Özdemir, Gülcan Bulut, Cihan Erol, İsmail Ertürk, Kerem Oruç, Serkan Değirmencioğlu, Atakan Demir, Kerem Okutur, Necla Demir, Zafer Arık, Fatih Köse, Meral Günaldı, Oktay Halit Aktepe, Çağlayan Geredeli, Ömer Fatih Ölmez, Sema Sezgin Göksu, Mehmet Alı Nahıt Şendur, Sercan Aksoy, Mutlu Hızal, Nuri Karadurmuş, Burcu Çakar, Naziye Ak, Umut Demırcı, Mehmet Artaç, Umut Dişel, Başak Oyan Uluç, Ferhat Ekinci, Hacı Mehmet Türk, Erhan Gökmen, Emrah Eraslan, Muhammed Bülent Akıncı, Serkan Menekşe, Abdullah Sakin, Leyla Özer, Di̇lek Erdem, Metin Özkan, Bülent Yalçın, Alper Sevinç, Fatma Şen, Deniz Tural, Nihat Ökten
article en

Abstract

Talazoparib is a strong PARP inhibitor with significant catalytic inhibition as well as the ability to cause PARP entrapment at DNA damage sites. It is one of the recommended treatments for individuals with BRCA-mutant advanced breast cancer, although research on its efficacy in advanced ovarian cancer is limited. The purpose of this study was to evaluate the efficacy of talazoparib in advanced breast and ovarian cancer patients with BRCA mutations. Patients with advanced breast (HR + or TNBC) and ovarian cancer who had germline BRCA mutations were included in this multicenter, retrospective study. There were no exclusion criteria regarding treatment-line, metastatic sites or performance status. All patients received talazoparib treatment via early-access programme. The primary endpoint was PFS. Secondary endpoints were OS and ORR. There were 47 and 42 patients in the breast cancer (BC) and ovarian cancer (OC) cohorts, respectively. In BC cohort, after median 13.6 months follow-up the median PFS was 6.5 months (5.0–8.1 months, 95% CI). In this heavily pretreated cohort, the ORR was 31.9% and the estimated 12-month OS rate was 73.6%. In OC cohort, the median follow up period was 13.7 months and the median PFS was 9.1 months (7.3–10.8 months, 95% CI). The ORR was 47.6% and the estimated 12-month OS rate was 75.9% in OC patients. Talazoparib may be an effective therapy option for patients with advanced BRCA-mutant breast cancer. In the absence of prospective phase 2/3 data, the outcomes of OC cohort may also considerably contribute to the literature on BRCA-mutant ovarian cancer.

BMC CancerVol. 25(1)
Izmir University (TR), Avrasya University (TR), Selçuk University (TR), Ankara University (TR), Manisa Celal Bayar University (TR), Bilkent University (TR), Başkent University (TR), Dokuz Eylül University (TR), Akdeniz University (TR), Konya Food and Agriculture University (TR), Bezmiâlem Vakıf Üniversitesi (TR), Istanbul Medipol University (TR), Ege University (TR), Gülhane Askerî Tıp Akademisi (TR), Memorial Ankara Hospital (TR), Ankara Onkoloji Eğitim ve Araştırma Hastanesi (TR), Memorial Sisli Hospital (TR), Istanbul University-Cerrahpaşa (TR), Medical Park Gaziantep Hospital (TR), Hacettepe University Hospital (TR), Istinye University (TR), Bakırköy Dr.Sadi Konuk Eğitim ve Araştırma Hastanesi (TR), Sağlık Bilimleri Üniversitesi (TR), Istanbul Memorial Hospital (TR), Acıbadem University Atakent Hospital (TR), Istanbul Eye Hospital (TR), Ankara Yıldırım Beyazıt University (TR), Acıbadem Adana Hospital (TR), Pamukkale University (TR), Cukurova University (TR), Istanbul Medeniyet University (TR), Istanbul University (TR), Erciyes University (TR), Gazi University (TR)
Openalex Percentile: Top 51%
PARP inhibition in cancer therapy
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