随机、安慰剂对照的奥拉帕尼维持治疗转移性胰腺癌和种系BRCA突变患者的III期试验
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of the 2019 ASCO Annual Meeting; May 31 - June 4, 2019; Chicago, Illinois
*CCO is an independent medical education company that provides state-of-the-art medical information to healthcare professionals through conference coverage and other educational programs.
Olaparib 300 mg BID (n = 92)
Placebo (n = 62)
*n = 195 received treatment.
3315 patients screened; 247 had germline BRCA mutation (7.5%)
Continue until PD or unacceptable toxicity
This activity is supported by educational grants from Blueprint Medicines, Celgene Corporation, and Taiho Oncology Inc.
About These Slides
Please feel free to use, update, and share some or all of these slides in your noncommercial presentations to colleagues or patients
In single-arm phase II trial in patients with advanced solid tumors and germline BRCA mutations, PARP inhibitor olaparib associated with 22% ORR and median PFS of 4.6 mos in patients with metastatic pancreatic cancer (n = 23)[3]
POLO: Background
Among patients with metastatic pancreatic cancer, 4% to 7% harbor germline BRCA1/2 mutation[1]
‒ These patients have obtained increased benefit from platinum-based chemotherapy[2]
‒ Currently no phase III data to validate targeted treatments for a biomarker-selected population with pancreatic cancer
Current phase III POLO trial evaluated efficacy, safety of maintenance olaparib vs placebo in patients with metastatic pancreatic cancer and germline BRCA mutation who had first-line platinum-based chemotherapy[4,5]
1. Friedenson. MedGenMed. 2005;7:60. 2. Waddell. Nature. 2015;518:495. 3. Kaufman. JCO. 2015;33:244. 4. Kindler. ASCO 2019. Abstr LBA4. Golan. NEJM. 2019;[Epub].
Primary endpoint: PFS by blinded independent central review (modified RECIST v1.1)
Slide credit: clinicaloptions.com
POLO: Study Design
wenku.baidu.com
International, randomized, double-blind phase III trial
Patients with pancreatic cancer and
Randomized 3:2
POLO: Randomized, Placebo-Controlled Phase III Trial of Maintenance Olaparib in Patients With Metastatic Pancreatic Cancer and Germline BRCA Mutation
CCO Independent Conference Highlights*
p(P4dmaldawt≥-teBnsh8meutli1Rdieoelttnwweo6ahCtfrugteiaskoAtpetwmire(shtpou1rilNk(aorirtf-yn/oNmPserbut2,=p,oiuaconsSClr≥m=msi1/sefounRseR5gnu2gfm2euldi4earttr9ssoep)ars-Bstpte5mbtstrthhre-Rirsi)aeoldePolociiiCosnrnorntruRaaeene,seAlspdipedno1y)yOen/2sC
When using our slides, please retain the source attribution:
Slide credit: clinicaloptions.com
These slides may not be published, posted online, or used in commercial presentations without permission. Please contact permissions@clinicaloptions.com for details
*CCO is an independent medical education company that provides state-of-the-art medical information to healthcare professionals through conference coverage and other educational programs.
Olaparib 300 mg BID (n = 92)
Placebo (n = 62)
*n = 195 received treatment.
3315 patients screened; 247 had germline BRCA mutation (7.5%)
Continue until PD or unacceptable toxicity
This activity is supported by educational grants from Blueprint Medicines, Celgene Corporation, and Taiho Oncology Inc.
About These Slides
Please feel free to use, update, and share some or all of these slides in your noncommercial presentations to colleagues or patients
In single-arm phase II trial in patients with advanced solid tumors and germline BRCA mutations, PARP inhibitor olaparib associated with 22% ORR and median PFS of 4.6 mos in patients with metastatic pancreatic cancer (n = 23)[3]
POLO: Background
Among patients with metastatic pancreatic cancer, 4% to 7% harbor germline BRCA1/2 mutation[1]
‒ These patients have obtained increased benefit from platinum-based chemotherapy[2]
‒ Currently no phase III data to validate targeted treatments for a biomarker-selected population with pancreatic cancer
Current phase III POLO trial evaluated efficacy, safety of maintenance olaparib vs placebo in patients with metastatic pancreatic cancer and germline BRCA mutation who had first-line platinum-based chemotherapy[4,5]
1. Friedenson. MedGenMed. 2005;7:60. 2. Waddell. Nature. 2015;518:495. 3. Kaufman. JCO. 2015;33:244. 4. Kindler. ASCO 2019. Abstr LBA4. Golan. NEJM. 2019;[Epub].
Primary endpoint: PFS by blinded independent central review (modified RECIST v1.1)
Slide credit: clinicaloptions.com
POLO: Study Design
wenku.baidu.com
International, randomized, double-blind phase III trial
Patients with pancreatic cancer and
Randomized 3:2
POLO: Randomized, Placebo-Controlled Phase III Trial of Maintenance Olaparib in Patients With Metastatic Pancreatic Cancer and Germline BRCA Mutation
CCO Independent Conference Highlights*
p(P4dmaldawt≥-teBnsh8meutli1Rdieoelttnwweo6ahCtfrugteiaskoAtpetwmire(shtpou1rilNk(aorirtf-yn/oNmPserbut2,=p,oiuaconsSClr≥m=msi1/sefounRseR5gnu2gfm2euldi4earttr9ssoep)ars-Bstpte5mbtstrthhre-Rirsi)aeoldePolociiiCosnrnorntruRaaeene,seAlspdipedno1y)yOen/2sC
When using our slides, please retain the source attribution:
Slide credit: clinicaloptions.com
These slides may not be published, posted online, or used in commercial presentations without permission. Please contact permissions@clinicaloptions.com for details