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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
CHEK2 K244R Olaparib
CHEK2 G370E Olaparib
ATM K1030* Olaparib
ATM L2659* Olaparib
RAD54L inact mut Olaparib
ATM R2993* Olaparib
ATM Y2437* Olaparib
ATM K742* Olaparib
ATM H2554D Olaparib
ATM E2164D Olaparib
CHEK2 E321K Olaparib
ATM L442P Olaparib
ATM D2448H Olaparib
CHEK2 K135Nfs*26 Olaparib
ATM N765Kfs*12 Olaparib
ATM T1200Lfs*7 Olaparib
RAD51D G112A Olaparib
CHEK2 I160M Olaparib
ATM V2119fs Olaparib
RAD54L P85A Olaparib
ATM L1449* Olaparib
RAD54L del Olaparib
CHEK2 M304T Olaparib
CHEK2 T387S Olaparib
ATM C2021Y Olaparib
ATM R1466* Olaparib
CHEK2 K253* Olaparib
ATM M2520fs Olaparib
ATM E390* Olaparib
ATM E2295* Olaparib
ATM K102* Olaparib
ATM S83* Olaparib
CHEK2 L236P Olaparib
ATM E1724K Olaparib
RAD51B del Olaparib
ATM Q2800* Olaparib
CHEK2 R95* Olaparib
ATM W164* Olaparib
ATM Q2397* Olaparib
ATM R2034* Olaparib
ATM S978fs Olaparib
ATM A2626T Olaparib
ATM P1526L Olaparib
ATM E1892* Olaparib
ATM S1455Vfs*3 Olaparib
ATM R2459S Olaparib
ATM E1707* Olaparib
ATM K331E Olaparib
ATM L2445P Olaparib
ATM N2326_K2363del Olaparib
CHEK2 D293fs Olaparib
CHEK2 C385R Olaparib
ATM M1484Rfs*15 Olaparib
ATM R2032K Olaparib
RAD51D V200* Olaparib
CHEK2 E321* Olaparib
RAD54L loss Olaparib
ATM G1672V Olaparib
CHEK2 Q34Vfs*42 Olaparib
ATM Q2522H Olaparib
CHEK2 R181C Olaparib
CHEK2 W93Gfs*17 Olaparib
ATM S214Ffs*40 Olaparib
ATM R329T Olaparib
ATM P1680R Olaparib
RAD51C R237P Olaparib
ATM S131* Olaparib
RAD51C G114V Olaparib
CHEK2 P85R Olaparib
CHEK2 D162G Olaparib
ATM T2947S Olaparib
ATM P1069fs Olaparib
ATM R1973I Olaparib
ATM Q2066R Olaparib
ATM V1268fs Olaparib
ATM L436P Olaparib
ATM L2623F Olaparib
CHEK2 D82_E86del Olaparib
CHEK2 D409N Olaparib
ATM F1025L Olaparib
CHEK2 T410fs Olaparib
ATM W2091* Olaparib
CHEK2 T367Mfs*15 Olaparib
RAD54L Q90* Olaparib
ATM V1268* Olaparib
ATM R2691C Olaparib
ATM Q654Rfs*10 Olaparib
RAD51D E37* Olaparib
ATM E277* Olaparib
ATM R2138Kfs*8 Olaparib
ATM W308* Olaparib
ATM A2602fs Olaparib
ATM G330V Olaparib
ATM H2038Y Olaparib
CHEK2 E122Dfs*8 Olaparib
CHEK2 H371Y Olaparib
ATM L100* Olaparib
CHEK2 H143R Olaparib
ATM P604S Olaparib
ATM W2104* Olaparib
RAD51C del Olaparib
ATM W2483* Olaparib
ATM D1637N Olaparib
ATM Q1171Tfs*8 Olaparib
ATM H2075L Olaparib
RAD51C S163R Olaparib
ATM L2051P Olaparib
ATM Y2627C Olaparib
RAD51C R312W Olaparib
ATM R1466G Olaparib
ATM H2125Y Olaparib
ATM A2635D Olaparib
CHEK2 Y139* Olaparib
ATM E2039K Olaparib
ATM P292L Olaparib
RAD51C K131I Olaparib
ATM S333F Olaparib
ATM L2738* Olaparib
ATM R2486* Olaparib
ATM G2072R Olaparib
ATM G2083* Olaparib
CHEK2 T366fs Olaparib
ATM S2190* Olaparib
ATM L1078P Olaparib
ATM A2626V Olaparib
ATM Q2297* Olaparib
CHEK2 F125S Olaparib
ATM Q2414* Olaparib
ATM D2085H Olaparib
ATM del Olaparib
ATM V1941F Olaparib
CHEK2 R474C Olaparib
ATM P955S Olaparib
ATM T2333Nfs*40 Olaparib
CHEK2 C420T Olaparib
CHEK2 W93R Olaparib
CHEK2 Q27* Olaparib
CHEK2 C108R Olaparib
RAD51C E80* Olaparib
CHEK2 R117G Olaparib
CHEK2 D265_H282del Olaparib
ATM Q1839* Olaparib
ATM D2016N Olaparib
RAD51C T121R Olaparib
CHEK2 N352D Olaparib
ATM E522* Olaparib
RAD51D K91fs Olaparib
ATM R3047* Olaparib
ATM R2832C Olaparib
CHEK2 del Olaparib
ATM E2272* Olaparib
ATM H1380Y Olaparib
ATM W412L Olaparib
ATM I1294Nfs*8 Olaparib
ATM L145R Olaparib
CHEK2 A392V Olaparib
ATM G2020C Olaparib
ATM R2547_S2549del Olaparib
ATM Q675* Olaparib
ATM R2263* Olaparib
CHEK2 H143Y Olaparib
CHEK2 F475Lfs*7 Olaparib
ATM G2718_K2756del Olaparib
ATM Q1579fs Olaparib
ATM K1057* Olaparib
CHEK2 I160T Olaparib
RAD54L F82S Olaparib
ATM A2308V Olaparib
CHEK2 K287fs Olaparib
ATM L1718V Olaparib
ATM L2051R Olaparib
ATM G2891D Olaparib
ATM R1898* Olaparib
CHEK2 R318H Olaparib
CHEK2 F169Lfs*2 Olaparib
ATM Y1216* Olaparib
ATM E2294Q Olaparib
ATM D1637Y Olaparib
ATM A416E Olaparib
ATM Q91* Olaparib
ATM R3008C Olaparib
ATM Y731* Olaparib
ATM F2732V Olaparib
ATM S1947P Olaparib
ATM P2699L Olaparib
ATM S2761Vfs*41 Olaparib
ATM Y54* Olaparib
ATM L2427P Olaparib
ATM L2447W Olaparib
ATM E1666* Olaparib
ATM W164C Olaparib
CHEK2 inact mut Olaparib
ATM C1674Y Olaparib
ATM R2461P Olaparib
ATM R1618* Olaparib
ATM K468Efs*18 Olaparib
ATM Y2019C Olaparib
ATM R2912Efs*26 Olaparib
ATM V723G Olaparib
RAD51C C135Y Olaparib
ATM H2125R Olaparib
RAD51C G302V Olaparib
CHEK2 loss Olaparib
ATM L2452P Olaparib
ATM L1019P Olaparib
ATM S719* Olaparib
ATM I1581Nfs*5 Olaparib
ATM Q501* Olaparib
ATM V278fs Olaparib
ATM Y1938H Olaparib
ATM Q1531* Olaparib
ATM L2447F Olaparib
ATM W2638* Olaparib
CHEK2 R117A Olaparib
CHEK2 R145W Olaparib
ATM S2394L Olaparib
RAD51C T132R Olaparib
ATM Q1310* Olaparib
RAD51C T287A Olaparib
ATM V2424G Olaparib
ATM F1767V Olaparib
ATM E968* Olaparib
ATM W2491C Olaparib
ATM G1676fs Olaparib
ATM L1524R Olaparib
CHEK2 L216* Olaparib
RAD51C R258H Olaparib
RAD51C R214C Olaparib
ATM E958* Olaparib
ATM L2427_R2428del Olaparib
CHEK2 R474H Olaparib
ATM P1288Q Olaparib
RAD51D inact mut Olaparib
ATM W524* Olaparib
RAD51C V140G Olaparib
ATM L1936S Olaparib
CHEK2 L174V Olaparib
ATM I2076S Olaparib
CHEK2 D347N Olaparib
ATM Q2066H Olaparib
ATM L1322P Olaparib
ATM F2571Yfs*4 Olaparib
CHEK2 G306A Olaparib
ATM Q14P Olaparib
ATM Y2080C Olaparib
ATM T2902fs Olaparib
CHEK2 I189V Olaparib
ATM G1746R Olaparib
ATM Q1117* Olaparib
ATM W2300L Olaparib
RAD51D V203E Olaparib
ATM I2701Nfs*17 Olaparib
RAD51D Q41* Olaparib
ATM Q1970* Olaparib
ATM R2105S Olaparib
ATM Q2269* Olaparib
CHEK2 R180H Olaparib
ATM C2349F Olaparib
RAD51C A155E Olaparib
ATM Q628Pfs*7 Olaparib
ATM L2659S Olaparib
ATM K331N Olaparib
ATM S2407* Olaparib
RAD54L R75* Olaparib
RAD51D del Olaparib
RAD51B R8* Olaparib
ATM F2393I Olaparib
ATM W2300* Olaparib
ATM Q684* Olaparib
RAD51C inact mut Olaparib
ATM L15fs Olaparib
ATM K2749I Olaparib
ATM E2621* Olaparib
RAD51B loss Olaparib
ATM G2072E Olaparib
CHEK2 G414E Olaparib
ATM S2017fs Olaparib
CHEK2 S140N Olaparib
ATM R2227C Olaparib
ATM Y1938C Olaparib
CHEK2 E273K Olaparib
CHEK2 P85L Olaparib
ATM S1993fs Olaparib
ATM S2812Vfs*3 Olaparib
ATM L1647P Olaparib
CHEK2 F202fs Olaparib
ATM S1905Ifs*25 Olaparib
CHEK2 L183S Olaparib
CHEK2 L309P Olaparib
ATM K1807E Olaparib
ATM E1342* Olaparib
ATM L1956H Olaparib
ATM Q1906* Olaparib
ATM W1058C Olaparib
RAD51C loss Olaparib
RAD51C E146* Olaparib
ATM Q1709* Olaparib
ATM I1849fs Olaparib
RAD54L Y309* Olaparib
RAD51C L265* Olaparib
ATM K2413Q Olaparib
CHEK2 S428F Olaparib
CHEK2 S372F Olaparib
ATM C458Y Olaparib
RAD54L K189R Olaparib
ATM P2665S Olaparib
ATM K241* Olaparib
ATM G2020D Olaparib
ATM I2629fs Olaparib
ATM R2642I Olaparib
ATM M946I Olaparib
RAD51C Q133K Olaparib
RAD54L E436* Olaparib
CHEK2 V198Ffs*7 Olaparib
ATM R1730* Olaparib
ATM negative Olaparib
ATM R1875* Olaparib
ATM Q2972* Olaparib
ATM Y2371* Olaparib
ATM R2506_N2543del Olaparib
ATM Y175* Olaparib
ATM S214Pfs*16 Olaparib
ATM R2849P Olaparib
ATM S751* Olaparib
ATM E2164K Olaparib
ATM C353R Olaparib
ATM R2459P Olaparib
RAD51C R12W Olaparib
CHEK2 E351K Olaparib
ATM D2708N Olaparib
ATM N2632K Olaparib
ATM L186* Olaparib
ATM R1917G Olaparib
CHEK2 K373E Olaparib
ATM N2494Y Olaparib
RAD51C G125V Olaparib
ATM K2811fs Olaparib
ATM K2431* Olaparib
CHEK2 E149Ifs*6 Olaparib
ATM Q1116* Olaparib
ATM Q401* Olaparib
ATM G2765S Olaparib
ATM N3033* Olaparib
ATM L2255I Olaparib
ATM V2716A Olaparib
RAD54L S49E Olaparib
CHEK1 del Olaparib
ATM P960H Olaparib
ATM S824F Olaparib
ATM V2288fs Olaparib
CHEK2 E161del Olaparib
ATM R2060H Olaparib
CHEK2 G306E Olaparib
ATM L944R Olaparib
ATM V1678G Olaparib
CHEK2 L326P Olaparib
ATM L2953Tfs*3 Olaparib
ATM R248* Olaparib
CHEK2 C284Y Olaparib
ATM R447* Olaparib
CHEK2 A237T Olaparib
ATM R2453P Olaparib
ATM K293* Olaparib
ATM K792N Olaparib
ATM G335E Olaparib
ATM Q2177* Olaparib
ATM Q1636Rfs*10 Olaparib
ATM Q513* Olaparib
ATM S698* Olaparib
CHEK2 A392P Olaparib
ATM Q2522fs Olaparib
RAD51C V156D Olaparib
RAD51C R193* Olaparib
ATM E518fs Olaparib
ATM W412* Olaparib
ATM Q2637E Olaparib
ATM Q2637* Olaparib
RAD51D S207L Olaparib
RAD51C A279P Olaparib
CHEK2 T476M Olaparib
ATM L1255* Olaparib
CHEK2 G386R Olaparib
CHEK2 A247D Olaparib
RAD51D K91Ifs*13 Olaparib
ATM V2441D Olaparib
ATM S712* Olaparib
ATM E836* Olaparib
CHEK2 H54Pfs*6 Olaparib
ATM L745* Olaparib
ATM F2393S Olaparib
ATM A2062V Olaparib
ATM E1979* Olaparib
ATM G2536* Olaparib
ATM Y1442* Olaparib
ATM D2016H Olaparib
ATM E2052K Olaparib
CHEK2 H345Y Olaparib
CHEK2 R474L Olaparib
CHEK2 E275* Olaparib
ATM N81Tfs*20 Olaparib
RAD51D E157* Olaparib
ATM Q1015* Olaparib
ATM R250* Olaparib
RAD51C D159Y Olaparib
CHEK2 Q209* Olaparib
CHEK2 R382* Olaparib
ATM L1078R Olaparib
CHEK2 H483R Olaparib
ATM K468fs Olaparib
ATM L1874F Olaparib
ATM Q852* Olaparib
ATM S1487* Olaparib
ATM L1465P Olaparib
ATM V519I Olaparib
ATM L2427R Olaparib
ATM E1346* Olaparib
RAD51C L138F Olaparib
ATM S601I Olaparib
ATM G1522R Olaparib
ATM L2572fs Olaparib
ATM E2014G Olaparib
ATM L2490F Olaparib
CHEK2 Y390S Olaparib
CHEK2 S372Y Olaparib
ATM E343* Olaparib
RAD54L L381Cfs*8 Olaparib
RAD51D loss Olaparib
ATM E73* Olaparib
ATM Q1500* Olaparib
ATM S1455R Olaparib
ATM K2440N Olaparib
ATM V2664del Olaparib
RAD51C L219S Olaparib
ATM N1719D Olaparib
RAD51B inact mut Olaparib
RAD51C G130A Olaparib
ATM A2622V Olaparib
ATM E473* Olaparib
ATM C1674R Olaparib
ATM S214fs Olaparib
ATM L991* Olaparib
ATM M1755I Olaparib
CHEK2 I157T Olaparib
ATM K1904* Olaparib
ATM E2539* Olaparib
ATM Y1229* Olaparib
RAD51C L226P Olaparib
RAD51C F103V Olaparib
ATM K2440E Olaparib
ATM A59S Olaparib
ATM Q2651* Olaparib
CHEK2 P426R Olaparib
CHEK2 G229S Olaparib
ATM L1239fs Olaparib
ATM R2849* Olaparib
ATM E2039* Olaparib
ATM E668* Olaparib
ATM S83L Olaparib
ATM T2333fs Olaparib
ATM P1829R Olaparib
CHEK2 G14Afs*47 Olaparib
ATM W2042L Olaparib
RAD51C D108G Olaparib
CHEK2 S357F Olaparib
RAD51C R366Q Olaparib
ATM inact mut Olaparib
ATM A2067V Olaparib
ATM Q446* Olaparib
ATM T554M Olaparib
CHEK2 E239K Olaparib
ATM E2977Rfs*2 Olaparib
ATM Q2028* Olaparib
CHEK2 E64K Olaparib
ATM E71* Olaparib
ATM W1058R Olaparib
ATM L762Qfs*4 Olaparib
ATM R805* Olaparib
RAD51C Q133E Olaparib
ATM E2164Q Olaparib
ATM Q14* Olaparib
ATM Y332H Olaparib
RAD51C L27P Olaparib
ATM C2337R Olaparib
RAD51C C135R Olaparib
ATM E1978* Olaparib
CHEK2 T59K Olaparib
ATM T1953A Olaparib
CHEK2 N185fs Olaparib
ATM I1453fs Olaparib
ATM E2014K Olaparib
ATM Q2641* Olaparib
ATM L2001S Olaparib
RAD51C G150E Olaparib
ATM L2492F Olaparib
ATM A2346T Olaparib
ATM G1202* Olaparib
CHEK2 W485G Olaparib
CHEK2 Y424H Olaparib
ATM S677N Olaparib
ATM dec exp Olaparib
RAD51B L103* Olaparib
RAD51C T132P Olaparib
CHEK2 E107_K197del Olaparib
CHEK2 S422Vfs*15 Olaparib
ATM Q2277* Olaparib
ATM L1562* Olaparib
ATM E2181K Olaparib
ATM S1403fs Olaparib
ATM R2151K Olaparib
CHEK2 Y220C Olaparib
ATM G2024W Olaparib
CHEK2 D347A Olaparib
ATM L419* Olaparib
RAD51C Q143R Olaparib
RAD51C V140E Olaparib
ATM W2109* Olaparib
CHEK2 A392S Olaparib
ATM G330* Olaparib
ATM E2039G Olaparib
ATM Q781* Olaparib
ATM S1599* Olaparib
ATM R3008H Olaparib
ATM Y2627H Olaparib
CHEK2 M381* Olaparib
ATM S421* Olaparib
ATM S1655F Olaparib
ATM K2756* Olaparib
CHEK2 R406Vfs*8 Olaparib
ATM W57* Olaparib
ATM T2666A Olaparib
ATM L427* Olaparib
ATM L1176fs Olaparib
ATM W1058* Olaparib
ATM W1710* Olaparib
ATM Y1961C Olaparib
ATM T1743I Olaparib
ATM D1682H Olaparib
ATM L1764I Olaparib
ATM E739* Olaparib
ATM L804fs Olaparib
CHEK1 R379* Olaparib
ATM A302fs Olaparib
CHEK2 Y390C Olaparib
ATM V566Ifs*6 Olaparib
ATM D2016G Olaparib
ATM E1072* Olaparib
ATM L2338P Olaparib
ATM Q1627* Olaparib
CHEK2 T367fs Olaparib
ATM D2448N Olaparib
ATM E2245* Olaparib
CHEK2 L183F Olaparib
CHEK2 K224E Olaparib
ATM R76* Olaparib
ATM N2501S Olaparib
ATM G197E Olaparib
ATM F2827C Olaparib
RAD51C D348V Olaparib
ATM C353fs Olaparib
ATM Q1537L Olaparib
ATM I352N Olaparib
ATM K2237* Olaparib
CHEK2 E394K Olaparib
ATM V1538fs Olaparib
RAD51C T102I Olaparib
ATM R1095I Olaparib
ATM K1410* Olaparib
RAD54L K189A Olaparib
RAD51C G162Efs*9 Olaparib
ATM R250Sfs*3 Olaparib
ATM S2855_V2856delinsRI Olaparib
ATM R2598* Olaparib
CHEK1 inact mut Olaparib
CHEK2 T323P Olaparib
RAD51C G153D Olaparib
ATM Q284* Olaparib
ATM E2096* Olaparib
RAD51C S105* Olaparib
ATM R337S Olaparib
CHEK2 R148G Olaparib
ATM R1304* Olaparib
ATM A2602E Olaparib
ATM Q2730P Olaparib
CHEK2 I160R Olaparib
CHEK2 A230P Olaparib
ATM loss Olaparib
ATM L663* Olaparib
CHEK2 G167R Olaparib
ATM C540* Olaparib
CHEK2 N166S Olaparib
ATM S2592C Olaparib
ATM H2125L Olaparib
RAD51D D206A Olaparib
ATM Y2627* Olaparib
RAD51D G107V Olaparib
ATM P1379R Olaparib
ATM R1882* Olaparib
ATM K2363N Olaparib
ATM R2105W Olaparib
ATM C907* Olaparib
ATM E2187* Olaparib
CHEK2 Q10fs Olaparib
CHEK2 D438Y Olaparib
ATM V1941L Olaparib
RAD51D G96C Olaparib
ATM G2867R Olaparib
ATM G2063V Olaparib
ATM S853* Olaparib
ATM G2477* Olaparib
ATM I1441fs Olaparib
CHEK2 N290Ifs*15 Olaparib
ATM S1993Rfs*23 Olaparib
ATM A2067D Olaparib
ATM Q2220* Olaparib
ATM E2444K Olaparib
ATM L2345F Olaparib
ATM G1746E Olaparib
CHEK2 K249R Olaparib
ATM L233* Olaparib
CHEK2 T476K Olaparib
ATM D1053N Olaparib
ATM P2353R Olaparib
CHEK2 F169L Olaparib
CHEK2 E87* Olaparib
CHEK2 F292fs Olaparib
ATM G294* Olaparib
CHEK2 S412R Olaparib
RAD51B Y46* Olaparib
ATM E2304Gfs*69 Olaparib
RAD54L E297* Olaparib
RAD51C D159A Olaparib
ATM I10fs Olaparib
ATM Q466* Olaparib
ATM C2488Y Olaparib
ATM P2974L Olaparib
ATM E2126* Olaparib
ATM S2549fs Olaparib
ATM R1917T 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
RAD51D inact mut prostate cancer sensitive Olaparib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) treatment significantly improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer who progressed on hormone therapy and harbored deleterious or suspected deleterious mutations in homologous recombination repair genes, including RAD51D (PMID: 32343890; NCT02987543). detail... detail... 32343890
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 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 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 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 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 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 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 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 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 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...
CHEK1 inact mut prostate cancer sensitive Olaparib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) treatment significantly improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer who progressed on hormone therapy and harbored deleterious or suspected deleterious mutations in homologous recombination repair genes, including CHEK1 (PMID: 32343890; NCT02987543). detail... detail... 32343890
CHEK2 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 0.87 in CHEK2-mutant patients (PMID: 32343890; NCT02987543). detail... detail... 32343890
RAD54L 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 0.33 in RAD54L-mutant patients (PMID: 32343890; NCT02987543). detail... detail... 32343890
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...
RAD51B inact mut prostate cancer sensitive Olaparib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) treatment significantly improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer who progressed on hormone therapy and harbored deleterious or suspected deleterious mutations in homologous recombination repair genes, including RAD51B (PMID: 32343890; NCT02987543). detail... detail... 32343890
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 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...
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 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 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 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 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...
RAD51C inact mut prostate cancer sensitive Olaparib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) treatment significantly improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer who progressed on hormone therapy and harbored deleterious or suspected deleterious mutations in homologous recombination repair genes, including RAD51C (PMID: 32343890; NCT02987543). detail... detail... 32343890
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...