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Ref Type

Journal Article

PMID

(32343890)

Authors

de Bono J, Mateo J, Fizazi K, Saad F, Shore N, Sandhu S, Chi KN, Sartor O, Agarwal N, Olmos D, Thiery-Vuillemin A, Twardowski P, Mehra N, Goessl C, Kang J, Burgents J, Wu W, Kohlmann A, Adelman CA, Hussain M

Title

Olaparib for Metastatic Castration-Resistant Prostate Cancer.

Journal	Vol	Issue	Date	Pages	Journal Short Title
The New England journal of medicine			2020 Apr 28	2091-2102	N Engl J Med

URL

Abstract Text

Multiple loss-of-function alterations in genes that are involved in DNA repair, including homologous recombination repair, are associated with response to poly(adenosine diphosphate-ribose) polymerase (PARP) inhibition in patients with prostate and other cancers.We conducted a randomized, open-label, phase 3 trial evaluating the PARP inhibitor olaparib in men with metastatic castration-resistant prostate cancer who had disease progression while receiving a new hormonal agent (e.g., enzalutamide or abiraterone). All the men had a qualifying alteration in prespecified genes with a direct or indirect role in homologous recombination repair. Cohort A (245 patients) had at least one alteration in BRCA1, BRCA2, or ATM; cohort B (142 patients) had alterations in any of 12 other prespecified genes, prospectively and centrally determined from tumor tissue. Patients were randomly assigned (in a 2:1 ratio) to receive olaparib or the physician's choice of enzalutamide or abiraterone (control). The primary end point was imaging-based progression-free survival in cohort A according to blinded independent central review.In cohort A, imaging-based progression-free survival was significantly longer in the olaparib group than in the control group (median, 7.4 months vs. 3.6 months; hazard ratio for progression or death, 0.34; 95% confidence interval, 0.25 to 0.47; P<0.001); a significant benefit was also observed with respect to the confirmed objective response rate and the time to pain progression. The median overall survival in cohort A was 18.5 months in the olaparib group and 15.1 months in the control group; 81% of the patients in the control group who had progression crossed over to receive olaparib. A significant benefit for olaparib was also seen for imaging-based progression-free survival in the overall population (cohorts A and B). Anemia and nausea were the main toxic effects in patients who received olaparib.In men with metastatic castration-resistant prostate cancer who had disease progression while receiving enzalutamide or abiraterone and who had alterations in genes with a role in homologous recombination repair, olaparib was associated with longer progression-free survival and better measures of response and patient-reported end points than either enzalutamide or abiraterone. (Funded by AstraZeneca and Merck Sharp & Dohme; PROfound ClinicalTrials.gov number, NCT02987543.).

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Molecular Profile	Treatment Approach
CDK12 S785fs	Olaparib
ATM H2554D	Olaparib
ATM Q1636Rfs*10	Olaparib
ATM C353fs	Olaparib
ATM I1581Nfs*5	Olaparib
ATM I2629fs	Olaparib
ATM D2708N	Olaparib
ATM V1941L	Olaparib
CDK12 G909R	Olaparib
ATM T1743I	Olaparib
ATM dec exp	Olaparib
ATM W57*	Olaparib
ATM T2333Nfs*40	Olaparib
CDK12 T212fs	Olaparib
CDK12 K1021*	Olaparib
ATM F2732V	Olaparib
ATM Q628Pfs*7	Olaparib
ATM K1807E	Olaparib
ATM S333F	Olaparib
ATM L1239fs	Olaparib
ATM D1682H	Olaparib
ATM I10fs	Olaparib
CDK12 R701*	Olaparib
ATM G2718_K2756del	Olaparib
CDK12 V387*	Olaparib
ATM S2017fs	Olaparib
ATM D1682Y	Olaparib
ATM P1069fs	Olaparib
ATM S214fs	Olaparib
ATM L2338P	Olaparib
CDK12 P58fs	Olaparib
CDK12 L996F	Olaparib
ATM I2701Nfs*17	Olaparib
ATM M1484Rfs*15	Olaparib
ATM F1025L	Olaparib
CDK12 del	Olaparib
ATM W2109*	Olaparib
ATM N765Kfs*12	Olaparib
ATM E2977Rfs*2	Olaparib
ATM L15fs	Olaparib
ATM E277*	Olaparib
ATM Q2972*	Olaparib
ATM L2572fs	Olaparib
ATM K468fs	Olaparib
ATM E390*	Olaparib
ATM H1380Y	Olaparib
ATM F2827C	Olaparib
CDK12 S343fs	Olaparib
CDK12 Q944*	Olaparib
ATM W412*	Olaparib
ATM W2104*	Olaparib
ATM G2765S	Olaparib
ATM S2761Vfs*41	Olaparib
ATM S1599*	Olaparib
ATM S2394L	Olaparib
CDK12 Y319fs	Olaparib
ATM S1135_K1192del	Olaparib
CDK12 F89Sfs*3	Olaparib
ATM S131*	Olaparib
ATM R2138Kfs*8	Olaparib
ATM E1072*	Olaparib
ATM S421*	Olaparib
ATM S214Pfs*16	Olaparib
ATM K293*	Olaparib
ATM P2974L	Olaparib
CDK12 Y279*	Olaparib
ATM R2849*	Olaparib
ATM A59S	Olaparib
CDK12 R204fs	Olaparib
ATM F2571Yfs*4	Olaparib
ATM R337S	Olaparib
ATM P960H	Olaparib
CDK12 Y901C	Olaparib
CDK12 W719*	Olaparib
ATM E2187*	Olaparib
ATM E1666*	Olaparib
CDK12 Q602*	Olaparib
ATM C2488Y	Olaparib
ATM A2602fs	Olaparib
ATM S1455R	Olaparib
ATM L1956H	Olaparib
ATM A2062V	Olaparib
ATM R2506_N2543del	Olaparib
ATM L2890V	Olaparib
ATM V278fs	Olaparib
ATM V566Ifs*6	Olaparib
ATM R1618*	Olaparib
ATM negative	Olaparib
ATM R250Sfs*3	Olaparib
ATM L2452P	Olaparib
ATM Q1627*	Olaparib
CDK12 E1024*	Olaparib
CDK12 G879V	Olaparib
CDK12 K756R	Olaparib
ATM A2067D	Olaparib
ATM S2407*	Olaparib
ATM Y2019C	Olaparib
ATM S824F	Olaparib
ATM Q2800*	Olaparib
ATM E2272*	Olaparib
ATM S2855_V2856delinsRI	Olaparib
ATM E2039K	Olaparib
ATM N2326_K2363del	Olaparib
ATM E2304Gfs*69	Olaparib
CDK12 P683Qfs*70	Olaparib
CDK12 S62fs	Olaparib
ATM E1978*	Olaparib
CDK12 R271*	Olaparib
ATM E473*	Olaparib
CDK12 K46fs	Olaparib
CDK12 L122*	Olaparib
ATM R2598*	Olaparib
ATM Q1970*	Olaparib
ATM S751*	Olaparib
ATM V1268fs	Olaparib
ATM R2034P	Olaparib
ATM R3008H	Olaparib
ATM Q1906*	Olaparib
ATM R2691C	Olaparib
ATM S2592C	Olaparib
ATM E343*	Olaparib
ATM V2119fs	Olaparib
ATM W2300*	Olaparib
ATM P2699S	Olaparib
ATM N81Tfs*20	Olaparib
CDK12 S587Ffs*54	Olaparib
ATM R1466*	Olaparib
ATM R1898*	Olaparib
CDK12 H111fs	Olaparib
ATM G1676fs	Olaparib
ATM V1538fs	Olaparib
ATM L2738*	Olaparib
ATM K2756*	Olaparib
ATM P604S	Olaparib
ATM K1410*	Olaparib
CDK12 E72fs	Olaparib
ATM G2083*	Olaparib
ATM E522*	Olaparib
ATM Q284*	Olaparib
ATM L2953Tfs*3	Olaparib
ATM L1465P	Olaparib
ATM L2427P	Olaparib
ATM I1849fs	Olaparib
ATM H2038Y	Olaparib
ATM Q1171Tfs*8	Olaparib
CDK12 D877N	Olaparib
ATM R250*	Olaparib
ATM L2427_R2428del	Olaparib
ATM R2832C	Olaparib
ATM V2716A	Olaparib
ATM E2039*	Olaparib
ATM S1403fs	Olaparib
ATM A1742P	Olaparib
CDK12 R882L	Olaparib
ATM W524*	Olaparib
ATM Q1579fs	Olaparib
ATM T2902fs	Olaparib
CDK12 S133Kfs*24	Olaparib
ATM inact mut	Olaparib
ATM E518fs	Olaparib
ATM R2227C	Olaparib
ATM I1294Nfs*8	Olaparib
CDK12 inact mut	Olaparib
ATM R2547_S2549del	Olaparib
ATM V2424G	Olaparib
ATM Q2730P	Olaparib
ATM M2520fs	Olaparib
ATM S719*	Olaparib
ATM R1304*	Olaparib
ATM Q2397*	Olaparib
ATM loss	Olaparib
ATM S978fs	Olaparib
ATM R3047*	Olaparib
ATM L804fs	Olaparib
ATM R805*	Olaparib
ATM V2288fs	Olaparib
ATM I1681V	Olaparib
ATM Y1961C	Olaparib
ATM R2912Efs*26	Olaparib
ATM S1455Vfs*3	Olaparib
ATM L1449*	Olaparib
CDK12 A88fs	Olaparib
ATM K2811fs	Olaparib
ATM Y54*	Olaparib
ATM E668*	Olaparib
ATM N3033*	Olaparib
ATM S1993Rfs*23	Olaparib
ATM V1268*	Olaparib
ATM A302fs	Olaparib
ATM R1875*	Olaparib
ATM Q2522fs	Olaparib
ATM S1993fs	Olaparib
ATM K468Efs*18	Olaparib
CDK12 E647Kfs*8	Olaparib
ATM I1453fs	Olaparib
ATM R2993*	Olaparib
CDK12 K975E	Olaparib
ATM R2849P	Olaparib
ATM R1882*	Olaparib
ATM Y1442*	Olaparib
ATM T2333fs	Olaparib
ATM G2867R	Olaparib
CDK12 P335fs	Olaparib
ATM L1874F	Olaparib
ATM V519I	Olaparib
ATM T1200Lfs*7	Olaparib
ATM K2749I	Olaparib
CDK12 loss	Olaparib
ATM L762Qfs*4	Olaparib
ATM P2699L	Olaparib
ATM R3008C	Olaparib
ATM S1905Ifs*25	Olaparib
ATM R1730*	Olaparib
ATM Y2371*	Olaparib
ATM R2034*	Olaparib
ATM Q2277*	Olaparib
ATM I1441fs	Olaparib
ATM P292L	Olaparib
ATM T2947S	Olaparib
ATM Y1229*	Olaparib
ATM T2666A	Olaparib
ATM del	Olaparib
ATM N1650S	Olaparib
ATM S2812Vfs*3	Olaparib
ATM Q2297*	Olaparib
CDK12 E928fs	Olaparib
ATM W1058*	Olaparib
ATM C540*	Olaparib

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
ATM P292L	prostate cancer	sensitive	Olaparib	FDA approved - On Companion Diagnostic	Actionable	In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved progression-free survival (7.4 vs 3.6 mo, HR 0.34, p<0.001), objective response rate (33% vs 2%, OR 20.86, p<0.001), and median overall survival (18.5 vs 15.1 mo, HR 0.64, p=0.02) over control in metastatic prostate cancer patients harboring inactivating BRCA/ATM mutations as detected by approved assays, including ATM P292L, HR was 1.04 in ATM-mutant group (PMID: 32343890; NCT02987543).	detail... 32343890 detail...
CDK12 inact mut	prostate cancer	sensitive	Olaparib	FDA approved - On Companion Diagnostic	Actionable	In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in metastatic castration-resistant prostate cancer patients harboring deleterious or suspected deleterious mutations in homologous recombination repair genes who progressed on hormone therapy, HR for progression or death was 0.74 in CDK12-mutant patients (PMID: 32343890; NCT02987543).	detail... 32343890 detail...
ATM D2913Y	prostate cancer	sensitive	Olaparib	FDA approved - On Companion Diagnostic	Actionable	In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved progression-free survival (7.4 vs 3.6 mo, HR 0.34, p<0.001), objective response rate (33% vs 2%, OR 20.86, p<0.001), and median overall survival (18.5 vs 15.1 mo, HR 0.64, p=0.02) over control in metastatic prostate cancer patients harboring inactivating BRCA/ATM mutations as detected by approved assays, including ATM D2913Y, HR was 1.04 in ATM-mutant group (PMID: 32343890; NCT02987543).	detail... 32343890 detail...
ATM R2547_S2549del	prostate cancer	sensitive	Olaparib	FDA approved - On Companion Diagnostic	Actionable	In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved progression-free survival (7.4 vs 3.6 mo, HR 0.34, p<0.001), objective response rate (33% vs 2%, OR 20.86, p<0.001), and median overall survival (18.5 vs 15.1 mo, HR 0.64, p=0.02) over control in metastatic prostate cancer patients harboring inactivating BRCA/ATM mutations as detected by approved assays, including ATM R2547_S2549del, HR was 1.04 in ATM-mutant group (PMID: 32343890; NCT02987543).	detail... 32343890 detail...
ATM R2832C	prostate cancer	sensitive	Olaparib	FDA approved - On Companion Diagnostic	Actionable	In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved progression-free survival (7.4 vs 3.6 mo, HR 0.34, p<0.001), objective response rate (33% vs 2%, OR 20.86, p<0.001), and median overall survival (18.5 vs 15.1 mo, HR 0.64, p=0.02) over control in metastatic prostate cancer patients harboring inactivating BRCA/ATM mutations as detected by approved assays, including ATM R2832C, HR was 1.04 in ATM-mutant group (PMID: 32343890; NCT02987543).	detail... 32343890 detail...
ATM R3008C	prostate cancer	sensitive	Olaparib	FDA approved - On Companion Diagnostic	Actionable	In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved progression-free survival (7.4 vs 3.6 mo, HR 0.34, p<0.001), objective response rate (33% vs 2%, OR 20.86, p<0.001), and median overall survival (18.5 vs 15.1 mo, HR 0.64, p=0.02) over control in metastatic prostate cancer patients harboring inactivating BRCA/ATM mutations as detected by approved assays, including ATM R3008C, HR was 1.04 in ATM-mutant group (PMID: 32343890; NCT02987543).	32343890 detail... detail...
ATM F2827C	prostate cancer	sensitive	Olaparib	FDA approved - On Companion Diagnostic	Actionable	In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved progression-free survival (7.4 vs 3.6 mo, HR 0.34, p<0.001), objective response rate (33% vs 2%, OR 20.86, p<0.001), and median overall survival (18.5 vs 15.1 mo, HR 0.64, p=0.02) over control in metastatic prostate cancer patients harboring inactivating BRCA/ATM mutations as detected by approved assays, including ATM F2827C, HR was 1.04 in ATM-mutant group (PMID: 32343890; NCT02987543).	detail... detail... 32343890
ATM D2708N	prostate cancer	sensitive	Olaparib	FDA approved - On Companion Diagnostic	Actionable	In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved progression-free survival (7.4 vs 3.6 mo, HR 0.34, p<0.001), objective response rate (33% vs 2%, OR 20.86, p<0.001), and median overall survival (18.5 vs 15.1 mo, HR 0.64, p=0.02) over control in metastatic prostate cancer patients harboring inactivating BRCA/ATM mutations as detected by approved assays, including ATM D2708N, HR was 1.04 in ATM-mutant group (PMID: 32343890; NCT02987543).	detail... 32343890 detail...
ATM R2227C	prostate cancer	sensitive	Olaparib	FDA approved - On Companion Diagnostic	Actionable	In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved progression-free survival (7.4 vs 3.6 mo, HR 0.34, p<0.001), objective response rate (33% vs 2%, OR 20.86, p<0.001), and median overall survival (18.5 vs 15.1 mo, HR 0.64, p=0.02) over control in metastatic prostate cancer patients harboring inactivating BRCA/ATM mutations as detected by approved assays, including ATM R2227C, HR was 1.04 in ATM-mutant group (PMID: 32343890; NCT02987543).	detail... 32343890 detail...
ATM V2716A	prostate cancer	sensitive	Olaparib	FDA approved - On Companion Diagnostic	Actionable	In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved progression-free survival (7.4 vs 3.6 mo, HR 0.34, p<0.001), objective response rate (33% vs 2%, OR 20.86, p<0.001), and median overall survival (18.5 vs 15.1 mo, HR 0.64, p=0.02) over control in metastatic prostate cancer patients harboring inactivating BRCA/ATM mutations as detected by approved assays, including ATM V2716A, HR was 1.04 in ATM-mutant group (PMID: 32343890; NCT02987543).	detail... 32343890 detail...
ATM A2622V	prostate cancer	sensitive	Olaparib	FDA approved - On Companion Diagnostic	Actionable	In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved progression-free survival (7.4 vs 3.6 mo, HR 0.34, p<0.001), objective response rate (33% vs 2%, OR 20.86, p<0.001), and median overall survival (18.5 vs 15.1 mo, HR 0.64, p=0.02) over control in metastatic prostate cancer patients harboring inactivating BRCA/ATM mutations as detected by approved assays, including ATM A2622V, HR was 1.04 in ATM-mutant group (PMID: 32343890; NCT02987543).	detail... detail... 32343890
ATM A2067D	prostate cancer	sensitive	Olaparib	FDA approved - On Companion Diagnostic	Actionable	In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved progression-free survival (7.4 vs 3.6 mo, HR 0.34, p<0.001), objective response rate (33% vs 2%, OR 20.86, p<0.001), and median overall survival (18.5 vs 15.1 mo, HR 0.64, p=0.02) over control in metastatic prostate cancer patients harboring inactivating BRCA/ATM mutations as detected by approved assays, including ATM A2067D, HR was 1.04 in ATM-mutant group (PMID: 32343890; NCT02987543).	detail... detail... 32343890
ATM inact mut	prostate cancer	sensitive	Olaparib	FDA approved - On Companion Diagnostic	Actionable	In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved progression-free survival (7.4 vs 3.6 mo, HR 0.34, p<0.001), objective response rate (33% vs 2%, OR 20.86, p<0.001), median overall survival (18.5 vs 15.1 mo, HR 0.64, p=0.02) over control in prostate cancer patients harboring inactivating BRCA/ATM mutations as detected by approved assays, including nonsense, frameshift, rearrangement, splice site variants, HR was 1.04 in ATM-mutant group (PMID: 32343890; NCT02987543).	detail... 32343890 detail...
ATM S2855_V2856delinsRI	prostate cancer	sensitive	Olaparib	FDA approved - On Companion Diagnostic	Actionable	In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved progression-free survival (7.4 vs 3.6 mo, HR 0.34, p<0.001), objective response rate (33% vs 2%, OR 20.86, p<0.001), and median overall survival (18.5 vs 15.1 mo, HR 0.64, p=0.02) over control in metastatic prostate cancer patients harboring inactivating BRCA/ATM mutations as detected by approved assays, including ATM S2855_V2856delinsRI, HR was 1.04 in ATM-mutant group (PMID: 32343890; NCT02987543).	32343890 detail... detail...
ATM R3008H	prostate cancer	sensitive	Olaparib	FDA approved - On Companion Diagnostic	Actionable	In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved progression-free survival (7.4 vs 3.6 mo, HR 0.34, p<0.001), objective response rate (33% vs 2%, OR 20.86, p<0.001), and median overall survival (18.5 vs 15.1 mo, HR 0.64, p=0.02) over control in metastatic prostate cancer patients harboring inactivating BRCA/ATM mutations as detected by approved assays, including ATM R3008H, HR was 1.04 in ATM-mutant group (PMID: 32343890; NCT02987543).	32343890 detail... detail...
ATM G2765S	prostate cancer	sensitive	Olaparib	FDA approved - On Companion Diagnostic	Actionable	In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved progression-free survival (7.4 vs 3.6 mo, HR 0.34, p<0.001), objective response rate (33% vs 2%, OR 20.86, p<0.001), and median overall survival (18.5 vs 15.1 mo, HR 0.64, p=0.02) over control in metastatic prostate cancer patients harboring inactivating BRCA/ATM mutations as detected by approved assays, including ATM G2765S, HR was 1.04 in ATM-mutant group (PMID: 32343890; NCT02987543).	32343890 detail... detail...
ATM R2032K	prostate cancer	sensitive	Olaparib	FDA approved - On Companion Diagnostic	Actionable	In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved progression-free survival (7.4 vs 3.6 mo, HR 0.34, p<0.001), objective response rate (33% vs 2%, OR 20.86, p<0.001), and median overall survival (18.5 vs 15.1 mo, HR 0.64, p=0.02) over control in metastatic prostate cancer patients harboring inactivating BRCA/ATM mutations as detected by approved assays, including ATM R2032K, HR was 1.04 in ATM-mutant group (PMID: 32343890; NCT02987543).	detail... 32343890 detail...
ATM Y2470D	prostate cancer	sensitive	Olaparib	FDA approved - On Companion Diagnostic	Actionable	In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved progression-free survival (7.4 vs 3.6 mo, HR 0.34, p<0.001), objective response rate (33% vs 2%, OR 20.86, p<0.001), and median overall survival (18.5 vs 15.1 mo, HR 0.64, p=0.02) over control in metastatic prostate cancer patients harboring inactivating BRCA/ATM mutations as detected by approved assays, including ATM Y2470D, HR was 1.04 in ATM-mutant group (PMID: 32343890; NCT02987543).	detail... 32343890 detail...
ATM D2016G	prostate cancer	sensitive	Olaparib	FDA approved - On Companion Diagnostic	Actionable	In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved progression-free survival (7.4 vs 3.6 mo, HR 0.34, p<0.001), objective response rate (33% vs 2%, OR 20.86, p<0.001), and median overall survival (18.5 vs 15.1 mo, HR 0.64, p=0.02) over control in metastatic prostate cancer patients harboring inactivating BRCA/ATM mutations as detected by approved assays, including ATM D2016G, HR was 1.04 in ATM-mutant group (PMID: 32343890; NCT02987543).	detail... 32343890 detail...