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Association details:
| Biomarker: | BRCA2 mutation |
|---|---|
| Cancer: | Prostate Cancer |
| Drug: | Talzenna (talazoparib) (PARP inhibitor) |
| Direction: | Sensitive |
Evidence:
Title:
Regulator OKs Pfizer's BRCA mutation breast cancer treatment
Excerpt:
Pfizer Korea said that the Ministry of Food and Drug Safety has approved Talzenna, its BRCA (Breast Cancer Susceptibility Gene) mutation breast cancer targeted therapy....treatment as monotherapy for germline BRCA (gBRCA) mutations and HER2 (human epithelial cell growth factor receptor 2) negative locally advanced or metastatic breast cancer patients have previously had chemotherapy.
Source:
Title:
Talazoparib, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Aberrations in Genes Involved in DNA Damage Response
Excerpt:
...- Deleterious BRCA1 or BRCA2 mutations...
Trial ID:
Source:
Title:
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Excerpt:
...- Deleterious BRCA1 or BRCA2 mutations...
Trial ID:
Less C2 evidence
Source:
Title:
CT027 - TALAPRO-1 final data: Talazoparib (TALA) monotherapy in men with DNA damage response alterations (DDRalt) and metastatic castration-resistant prostate cancer (mCRPC): Exploration of DDRalt germline/somatic origin and zygosity
Published date:
03/10/2021
Excerpt:
The most common tDDRalt were BRCA2 (14 germline; 10 somatic) and ATM (4 germline; 7 somatic). ORR was 25.9% (7/27) in pts with tDDRalt of germline origin and 9.1% (2/22) in pts with only somatic tDDRalt (P = 0.159, 2-sided Fisher’s exact test). ORR was 50.0% (7/14) in pts with tumor BRCA2alt of germline origin and 20.0% (2/10) in pts with somatic BRCA2alt (not significantly different; P = 0.210)....pts with germline and/or homozygous tDDRalt appeared to be numerically most likely to respond to TALA.
Source:
Title:
138P - TALAPRO-1: Talazoparib (TALA) monotherapy in men with DNA damage response alterations (DDRalt) and metastatic castration-resistant prostate cancer (mCRPC): Exploration of DDRalt germline/somatic origin
Published date:
09/14/2020
Excerpt:
Phase 2 TALAPRO-1...to assess germline/somatic origin of tumor DDRalt (tDDRalt) and associations with efficacy...The most common tDDRalt in the 37 pts were BRCA2 (11 germline; 7 somatic) and ATM (3 germline; 6 somatic). Observed ORR was numerically higher for pts with tDDRalt of germline origin (7/20 [35%]) than with only somatic DDRalt (1/16 [6.3%])...
Trial ID:
Test:
Source:
Title:
TALAPRO-1: Phase II study of talazoparib (TALA) in patients (pts) with DNA damage repair alterations (DDRm) and metastatic castration-resistant prostate cancer (mCRPC) – updated interim analysis (IA).
Published date:
05/13/2020
Excerpt:
TALA monotherapy has encouraging antitumor activity in docetaxel-pretreated mCRPC pts with BRCA1/2 alterations and was generally well tolerated. also Refer table.
DOI:
10.1200/JCO.2020.38.15_suppl.5566
Trial ID:
Source:
Title:
TALAPRO-1: A phase II study of talazoparib (TALA) in men with DNA damage repair mutations (DDRmut) and metastatic castration-resistant prostate cancer (mCRPC)—First interim analysis (IA).
Published date:
02/13/2020
Excerpt:
Overall ORR (95% CI) was 25.6% (13.5–41.2), ORRBRCA1/2 50.0% (27.2–72.8), ORRATM 7.1% (0.2–33.9). Overall median (95% CI) rPFS was 5.6 months (mo) (3.5–8.2), rPFSBRCA1/2 8.2 mo (5.6–NE), rPFSATM 3.5 mo (1.7–8.1).
Trial ID:
