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Ref Type | Journal Article | ||||||||||||
PMID | (39085400) | ||||||||||||
Authors | Piha-Paul SA, Tseng C, Leung CH, Yuan Y, Karp DD, Subbiah V, Hong D, Fu S, Naing A, Rodon J, Javle M, Ajani JA, Raghav KP, Somaiah N, Mills GB, Tsimberidou AM, Zheng X, Chen K, Meric-Bernstam F | ||||||||||||
Title | Phase II study of talazoparib in advanced cancers with BRCA1/2, DNA repair, and PTEN alterations. | ||||||||||||
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Abstract Text | 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. |