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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.
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
ATM Q2800* Olaparib
ATM P2793T Olaparib
ATM F2827C Olaparib
ATM G294* Olaparib
ATM G3030E Olaparib
ATM G2695V Olaparib
ATM D2016G Olaparib
ATM R1466* Olaparib
ATM E2676* Olaparib
CDK12 S785fs Olaparib
ATM L2492F Olaparib
ATM Q1015* Olaparib
ATM R3008C Olaparib
ATM S1487* Olaparib
ATM Y2969* Olaparib
ATM L1078P Olaparib
ATM Q1116* Olaparib
ATM G2024W Olaparib
ATM E2164K Olaparib
ATM R2227C Olaparib
ATM G2891D Olaparib
ATM G2891S Olaparib
ATM C2931W Olaparib
ATM N765Kfs*12 Olaparib
ATM S1993fs Olaparib
ATM R2854L Olaparib
ATM T2902fs Olaparib
ATM V2716A Olaparib
ATM Q2066R Olaparib
CDK12 K975E Olaparib
ATM L1078R Olaparib
ATM R2929K Olaparib
ATM N81Tfs*20 Olaparib
ATM L1562* Olaparib
ATM P1680R Olaparib
CDK12 Q602* Olaparib
ATM I2948F Olaparib
ATM V2892D Olaparib
ATM G3051E Olaparib
ATM I1581Nfs*5 Olaparib
ATM R1898* Olaparib
ATM R2105S Olaparib
CDK12 H111fs Olaparib
ATM T2666I Olaparib
ATM P2699L Olaparib
ATM L762Qfs*4 Olaparib
ATM H2125L Olaparib
ATM S214Ffs*40 Olaparib
ATM D2870N Olaparib
ATM R2060C Olaparib
ATM H2554D Olaparib
ATM Q1171Tfs*8 Olaparib
ATM R248* Olaparib
ATM L991* Olaparib
ATM E1346* Olaparib
ATM D2085H Olaparib
ATM R805* Olaparib
ATM E1892* Olaparib
ATM Y2371* Olaparib
CDK12 V387* Olaparib
ATM E1724K Olaparib
ATM W2042L Olaparib
CDK12 K46fs Olaparib
ATM T2333fs Olaparib
CDK12 P335fs Olaparib
ATM M1484Rfs*15 Olaparib
ATM L15fs Olaparib
ATM R2459P Olaparib
ATM S83L Olaparib
ATM A2626T Olaparib
ATM G1522R Olaparib
ATM L2490F Olaparib
ATM S333F Olaparib
CDK12 Y279* Olaparib
ATM W2960L Olaparib
ATM Y2437* Olaparib
ATM V1268* Olaparib
ATM L1718V Olaparib
ATM S214Pfs*16 Olaparib
ATM L2659* Olaparib
ATM K2440N Olaparib
ATM L419* Olaparib
ATM Q684* Olaparib
ATM Q2730P Olaparib
ATM R250* Olaparib
ATM K468fs Olaparib
ATM G2891C Olaparib
ATM G2020C Olaparib
ATM Q2684* Olaparib
ATM K1410* Olaparib
ATM L2952I Olaparib
ATM V2951I Olaparib
ATM T1953A Olaparib
ATM F2393S Olaparib
ATM L2338P Olaparib
ATM G2919D Olaparib
ATM K1057* Olaparib
ATM G335E Olaparib
ATM R2506_N2543del Olaparib
ATM K2413Q Olaparib
ATM E668* Olaparib
CDK12 Y901C Olaparib
ATM V1941L Olaparib
ATM I10fs Olaparib
ATM K102* Olaparib
ATM D2448N Olaparib
ATM V2906A Olaparib
ATM L1019P Olaparib
ATM Q781* Olaparib
ATM L745* Olaparib
CDK12 F89Sfs*3 Olaparib
ATM S1947P Olaparib
ATM V2757E Olaparib
ATM K468Efs*18 Olaparib
ATM E2126* Olaparib
ATM L2946S Olaparib
ATM N2501S Olaparib
ATM S2407* Olaparib
CDK12 K1021* Olaparib
ATM Q513* Olaparib
ATM R1882* Olaparib
ATM W2960* Olaparib
ATM E2744* Olaparib
ATM S2190* Olaparib
ATM D2448H Olaparib
ATM H2872D Olaparib
ATM Y175* Olaparib
ATM A59S Olaparib
ATM R1095I Olaparib
ATM R2580* Olaparib
ATM S1655F Olaparib
ATM R2461P Olaparib
ATM W2109* Olaparib
CDK12 T212fs Olaparib
ATM E2904Q Olaparib
ATM Y2627H Olaparib
ATM W1710* Olaparib
ATM S978fs Olaparib
ATM P2759H Olaparib
ATM R1304* Olaparib
ATM L1874F Olaparib
ATM R1875* Olaparib
ATM G2867E Olaparib
ATM Q284* Olaparib
ATM K2670* Olaparib
CDK12 A88fs Olaparib
ATM R3008H Olaparib
ATM S2761Vfs*41 Olaparib
ATM S1599* Olaparib
ATM D2720Y Olaparib
ATM D2959N Olaparib
ATM Q2177* Olaparib
ATM E1707* Olaparib
ATM R2486* Olaparib
ATM R2105W Olaparib
ATM K2749I Olaparib
ATM Q2740* Olaparib
ATM C2488Y Olaparib
ATM S719* Olaparib
ATM L804fs Olaparib
ATM Q654Rfs*10 Olaparib
ATM I1294Nfs*8 Olaparib
ATM R2790S Olaparib
ATM R1917T Olaparib
ATM I1849fs Olaparib
ATM L1449* Olaparib
ATM Q1627* Olaparib
CDK12 S62fs Olaparib
ATM R337S Olaparib
ATM L1176fs Olaparib
ATM W412L Olaparib
ATM negative Olaparib
ATM T2333Nfs*40 Olaparib
ATM V2119fs Olaparib
ATM L2767R Olaparib
ATM C2349F Olaparib
ATM Q2277* Olaparib
ATM H2788Y Olaparib
ATM S824F Olaparib
ATM Q2730L Olaparib
ATM I2629fs Olaparib
ATM G1672V Olaparib
ATM M946I Olaparib
ATM R2993* Olaparib
ATM Q1636Rfs*10 Olaparib
ATM L2001S Olaparib
ATM G3051V Olaparib
ATM A2067D Olaparib
ATM W2483* Olaparib
ATM R2138Kfs*8 Olaparib
ATM W2769R Olaparib
ATM L2850F Olaparib
ATM L2445P Olaparib
ATM K2756* Olaparib
ATM R2032K Olaparib
ATM G330* Olaparib
ATM L1936S Olaparib
ATM D2708N Olaparib
ATM S83* Olaparib
CDK12 R271* Olaparib
ATM S712* Olaparib
ATM G330V Olaparib
ATM L2447F Olaparib
ATM K2811fs Olaparib
ATM S2685P Olaparib
ATM L2953Tfs*3 Olaparib
ATM L663* Olaparib
ATM Y1938H Olaparib
ATM E2039K Olaparib
ATM S2549fs Olaparib
ATM L2738* Olaparib
ATM T1200Lfs*7 Olaparib
ATM W2104* Olaparib
ATM E3022* Olaparib
ATM L2051P Olaparib
ATM Q2641* Olaparib
CDK12 K756R Olaparib
ATM Y2755* Olaparib
ATM Q852* Olaparib
ATM G2765C Olaparib
ATM G2536* Olaparib
ATM Q14* Olaparib
ATM R2151K Olaparib
ATM N2494Y Olaparib
ATM G2777D Olaparib
ATM V2892G Olaparib
ATM E522* Olaparib
ATM K792N Olaparib
ATM G2718_K2756del Olaparib
CDK12 E928fs Olaparib
ATM V2951L Olaparib
ATM Q1310* Olaparib
ATM S2592C Olaparib
ATM L186* Olaparib
ATM W412* Olaparib
ATM K1904* Olaparib
ATM W308* Olaparib
ATM R1730* Olaparib
ATM Q1906* Olaparib
ATM C2021Y Olaparib
ATM E2977Rfs*2 Olaparib
ATM F2393I Olaparib
ATM G1676fs Olaparib
ATM V566Ifs*6 Olaparib
ATM E473* Olaparib
ATM V2823F Olaparib
ATM D1053N Olaparib
ATM I2683T Olaparib
ATM W57* Olaparib
ATM E2052K Olaparib
CDK12 Y319fs Olaparib
ATM W2638* Olaparib
ATM V2951D Olaparib
CDK12 E72fs Olaparib
ATM C458Y Olaparib
ATM E836* Olaparib
CDK12 W719* Olaparib
ATM Q1579fs Olaparib
ATM E390* Olaparib
ATM V2926F Olaparib
ATM E2187* Olaparib
ATM K742* Olaparib
ATM Q1117* Olaparib
ATM L1322P Olaparib
ATM S698* Olaparib
ATM T1743I Olaparib
ATM T2947S Olaparib
ATM R2912Efs*26 Olaparib
CDK12 loss Olaparib
ATM L1465P Olaparib
ATM F2571Yfs*4 Olaparib
ATM H2125R Olaparib
ATM L2780I Olaparib
ATM R329T Olaparib
ATM L2868F Olaparib
ATM dec exp Olaparib
ATM R2912T Olaparib
ATM A2602fs Olaparib
ATM P604S Olaparib
ATM A2067V Olaparib
ATM G2925S Olaparib
ATM F2732L Olaparib
ATM E1978* Olaparib
ATM L2427R Olaparib
ATM Q1500* Olaparib
ATM V2664del Olaparib
ATM V2830D Olaparib
ATM R2691C Olaparib
ATM Y332H Olaparib
ATM S214fs Olaparib
ATM E2932K Olaparib
ATM C2931Y Olaparib
ATM W3055* Olaparib
ATM R2419* Olaparib
ATM G3030V Olaparib
ATM Q2762* Olaparib
ATM A302fs Olaparib
ATM V2288fs Olaparib
ATM A2893V Olaparib
ATM C2735F Olaparib
ATM E2181K Olaparib
ATM G2072E Olaparib
ATM Q628Pfs*7 Olaparib
ATM M1628V Olaparib
ATM A2787V Olaparib
ATM R2973W Olaparib
ATM A2626V Olaparib
ATM E3015* Olaparib
ATM K331N Olaparib
ATM L2051R Olaparib
ATM R2263* Olaparib
ATM E1666* Olaparib
ATM G2922V Olaparib
ATM R76* Olaparib
ATM S1905Ifs*25 Olaparib
ATM R2060H Olaparib
ATM L436P Olaparib
ATM S677N Olaparib
ATM E2164D Olaparib
ATM Q1531* Olaparib
ATM K293* Olaparib
ATM H2038Y Olaparib
ATM M1755I Olaparib
ATM E739* Olaparib
ATM S2855R Olaparib
ATM E2039* Olaparib
ATM Q1970* Olaparib
ATM L2427P Olaparib
ATM L2572fs Olaparib
ATM L2952P Olaparib
ATM S751* Olaparib
ATM R2849* Olaparib
ATM E277* Olaparib
ATM C2770G Olaparib
ATM R447* Olaparib
ATM Q2397* Olaparib
ATM V2937G Olaparib
ATM H1380Y Olaparib
ATM I2702M Olaparib
ATM W524* Olaparib
ATM R1618* Olaparib
ATM Y2019C Olaparib
CDK12 S343fs Olaparib
ATM S1993Rfs*23 Olaparib
ATM E73* Olaparib
ATM V2441D Olaparib
ATM L2715R Olaparib
ATM E518fs Olaparib
ATM Q2414* Olaparib
ATM Q2724K Olaparib
CDK12 R204fs Olaparib
ATM V723G Olaparib
ATM G2694E Olaparib
ATM C907* Olaparib
ATM N2632K Olaparib
ATM L1348W Olaparib
ATM F2779C Olaparib
ATM I2876F Olaparib
ATM R1973I Olaparib
ATM E2164Q Olaparib
ATM P1288Q Olaparib
ATM Y2627* Olaparib
ATM I352N Olaparib
ATM F1767V Olaparib
ATM S1455R Olaparib
ATM G2765A Olaparib
ATM Y731* Olaparib
ATM L2952V Olaparib
ATM V2862F Olaparib
ATM R2763* Olaparib
ATM V1268fs Olaparib
ATM H2075L Olaparib
ATM Y2627C Olaparib
ATM D1637N Olaparib
ATM R2871K Olaparib
ATM Q14P Olaparib
ATM N3033* Olaparib
ATM E2295* Olaparib
ATM Y2852C Olaparib
ATM L2659S Olaparib
CDK12 L996F Olaparib
ATM W164C Olaparib
ATM W3052* Olaparib
ATM R2832C Olaparib
ATM K2440E Olaparib
ATM W2300L Olaparib
ATM Q2972* Olaparib
ATM L1524R Olaparib
ATM del Olaparib
ATM L2945M Olaparib
ATM H2125Y Olaparib
ATM K1807E Olaparib
ATM A2602E Olaparib
ATM E2977* Olaparib
ATM R2723* Olaparib
ATM E2304Gfs*69 Olaparib
ATM Q675* Olaparib
ATM Q1839* Olaparib
ATM C1674Y Olaparib
ATM P1069fs Olaparib
ATM L145R Olaparib
ATM Q2220* Olaparib
ATM V2424G Olaparib
ATM inact mut Olaparib
ATM G2765V Olaparib
ATM K2431* Olaparib
ATM W1058* Olaparib
CDK12 E1024* Olaparib
ATM Y1938C Olaparib
ATM Y1216* Olaparib
CDK12 P58fs Olaparib
ATM P1829R Olaparib
ATM R2459S Olaparib
ATM V1941F Olaparib
ATM D2016H Olaparib
ATM Y1229* Olaparib
ATM D2016N Olaparib
ATM S421* Olaparib
ATM K1030* Olaparib
ATM G2869C Olaparib
ATM Y54* Olaparib
ATM T2921M Olaparib
ATM A2346T Olaparib
ATM E2294Q Olaparib
ATM C540* Olaparib
ATM P2759L Olaparib
CDK12 R882L Olaparib
CDK12 G879V Olaparib
ATM A2893P Olaparib
ATM V519I Olaparib
ATM W3052L Olaparib
ATM T2682I Olaparib
ATM P2974L Olaparib
ATM L2345F Olaparib
ATM E2444K Olaparib
ATM L2427_R2428del Olaparib
ATM E2096* Olaparib
ATM T2921R Olaparib
ATM Y1442* Olaparib
ATM E958* Olaparib
ATM S2394L Olaparib
ATM G1746E Olaparib
CDK12 Q944* Olaparib
ATM L1647P Olaparib
ATM W2769* Olaparib
ATM E2444D Olaparib
ATM Q2733* Olaparib
ATM N2326_K2363del Olaparib
CDK12 L122* Olaparib
ATM N1719D Olaparib
ATM G2919S Olaparib
ATM Y2080C Olaparib
ATM T2666A Olaparib
ATM G3030R Olaparib
ATM W2960C Olaparib
ATM S1455Vfs*3 Olaparib
ATM E2014K Olaparib
ATM Q1537L Olaparib
ATM W1058R Olaparib
ATM S2812Vfs*3 Olaparib
ATM R1466G Olaparib
ATM E2837K Olaparib
ATM W2300* Olaparib
ATM K2747N Olaparib
ATM L1239fs Olaparib
ATM G1746R Olaparib
ATM E2895A Olaparib
ATM W2491C Olaparib
ATM A2843D Olaparib
ATM A2635D Olaparib
ATM E1072* Olaparib
ATM Q466* Olaparib
ATM L2452P Olaparib
ATM S601I Olaparib
ATM P2665S Olaparib
ATM P1379R Olaparib
CDK12 E647Kfs*8 Olaparib
ATM Q446* Olaparib
ATM Q2522H Olaparib
ATM C2337R Olaparib
ATM R2973T Olaparib
ATM S2017fs Olaparib
ATM Q2269* Olaparib
ATM V278fs Olaparib
ATM L2623F Olaparib
ATM Y2833D Olaparib
ATM E2272* Olaparib
ATM Q501* Olaparib
ATM D1637Y Olaparib
ATM E2245* Olaparib
ATM G2897S Olaparib
ATM R2973M Olaparib
ATM E1342* Olaparib
ATM loss Olaparib
ATM L2447W Olaparib
ATM Q445* Olaparib
ATM G2083* Olaparib
ATM I2683M Olaparib
ATM E2014G Olaparib
ATM Q91* Olaparib
ATM F1025L Olaparib
ATM R2598* Olaparib
ATM G2020D Olaparib
ATM R2453P Olaparib
ATM T2853R Olaparib
ATM E2039G Olaparib
ATM P955S Olaparib
ATM D2913H Olaparib
ATM R2547_S2549del Olaparib
CDK12 D877N Olaparib
ATM K331E Olaparib
ATM L233* Olaparib
ATM I1441fs Olaparib
ATM V2757M Olaparib
ATM L1255* Olaparib
ATM Q1709* Olaparib
ATM G3051R Olaparib
ATM Q2297* Olaparib
ATM A2308V Olaparib
ATM C353fs Olaparib
ATM E71* Olaparib
ATM T2947N Olaparib
ATM I2076S Olaparib
ATM F2686C Olaparib
ATM Q2028* Olaparib
ATM A2062V Olaparib
ATM R2034* Olaparib
ATM G2867R Olaparib
ATM L427* Olaparib
ATM T554M Olaparib
ATM P1526L Olaparib
ATM R1917G Olaparib
CDK12 P683Qfs*70 Olaparib
ATM S1403fs Olaparib
ATM V1538fs Olaparib
CDK12 del Olaparib
ATM Q1640* Olaparib
ATM M2520fs Olaparib
ATM P2759S Olaparib
ATM K3053* Olaparib
ATM C1674R Olaparib
ATM E2768* Olaparib
ATM F2732V Olaparib
ATM Q401* Olaparib
ATM R3047* Olaparib
ATM R250Sfs*3 Olaparib
ATM W3055L Olaparib
ATM Q2522fs Olaparib
ATM Y1961C Olaparib
ATM G2477* Olaparib
ATM E343* Olaparib
ATM E968* Olaparib
ATM L100* Olaparib
ATM V2937A Olaparib
CDK12 G909R Olaparib
CDK12 R701* Olaparib
ATM P2353R Olaparib
ATM G2765S Olaparib
ATM P960H Olaparib
ATM P2907H Olaparib
ATM P2829L Olaparib
ATM W2091* Olaparib
ATM A2622V Olaparib
ATM Q2637* Olaparib
ATM L442P Olaparib
ATM G197E Olaparib
CDK12 S587Ffs*54 Olaparib
ATM S2685* Olaparib
ATM L1956H Olaparib
ATM K2237* Olaparib
ATM K241* Olaparib
ATM W164* Olaparib
ATM C353R Olaparib
ATM W1058C Olaparib
ATM L2255I Olaparib
ATM V1678G Olaparib
ATM Q2651* Olaparib
CDK12 inact mut Olaparib
ATM P2829S Olaparib
ATM E2539* Olaparib
ATM G2063V Olaparib
ATM A416E Olaparib
ATM L1764I Olaparib
ATM K2363N Olaparib
ATM E1979* Olaparib
ATM T2934N Olaparib
ATM Q2066H Olaparib
ATM R2849P Olaparib
ATM S2855_V2856delinsRI Olaparib
ATM D1682H Olaparib
ATM G2072R Olaparib
ATM G1202* Olaparib
ATM P292L Olaparib
ATM E2621* Olaparib
ATM I2701Nfs*17 Olaparib
CDK12 S133Kfs*24 Olaparib
ATM Q2637E Olaparib
ATM S2859Y Olaparib
ATM R2642I Olaparib
ATM S131* Olaparib
ATM L944R Olaparib
ATM I1453fs Olaparib
ATM S853* 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 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 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 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 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 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 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 D2625_A2626delinsEP 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 D2625_A2626delinsEP, HR was 1.04 in ATM-mutant group (PMID: 32343890; NCT02987543). 32343890 detail... 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 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 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 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...
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 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 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 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 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 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 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 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...