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OASI ALK ASCO 2017

OASI ALK ASCO 2017. A cura di Filippo de Marinis. Alectinib versus crizotinib in treatment-naive advanced ALK-positive non-small cell lung cancer (NSCLC): Primary results of the global phase III ALEX study Alice Tsang Shaw.

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OASI ALK ASCO 2017

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  1. OASI ALK ASCO 2017 A cura di Filippo de Marinis

  2. Alectinib versus crizotinib in treatment-naive advanced ALK-positive non-small cell lung cancer (NSCLC): Primary results of the global phase III ALEX study Alice Tsang Shaw

  3. Background: Alectinib, a TKI targeting ALK, hasshownrobustefficacy in crizotinib-naïve/resistantALK+ NSCLC. J-ALEX showedsuperiority of alectinib 300mg BID vs crizotinib in Japanesepts with crizotinib-naïve ALK+ NSCLC (progression-free survival [PFS] HR 0.34, p<0.0001). We report primaryresults from the ALEX study of first-line alectinib 600mg BID vs crizotinib in advancedALK+ NSCLC (NCT02075840). Methods: This open-labelrandomizedmulticenterphase III studyenrolledpts with stage IIIB/IV ALK+ NSCLC, determined by central IHC testing. Eligibleptshad ECOG PS 0–2 and no priorsystemic therapy for advanced NSCLC. Pts with asymptomatic CNS metastaseswereallowed. Pts (n=303) wererandomized 1:1 to receivealectinib 600mg or crizotinib 250mg BID. Primaryendpoint: Investigator (Inv)-assessed PFS (RECIST v1.1), with systematic CNS imaging in allpts. Secondaryendpointsincludedindependentreviewcommittee (IRC)-assessed PFS, IRC-assessed time to CNS progression (TTP), objectiveresponse rate (ORR), overallsurvival (OS) and safety. Results: At the primary data cut-off (9 Feb 2017), alectinibdemonstratedstatisticallysignificantsuperiority vs crizotinib, reducing risk of progression/death by 53% (HR 0.47, 95% CI 0.34–0.65, p<0.0001); alectinibmedian PFS wasnotreached (95% CI 17.7–NE) vs crizotinib 11.1 months (95% CI 9.1–13.1). Keysecondaryendpointsshowedsuperiority for alectinib vs crizotinib, respectively: IRC PFS, HR 0.50 (95% CI 0.36–0.70; p<0.0001); median PFS 25.7 months (95% CI 19.9–NE) vs 10.4 months (95% CI 7.7–14.6); CNS TTP, cause-specific HR of CNS progression 0.16 (95% CI 0.10–0.28; p<0.0001); ORR (Inv) 83% (95% CI 76–89) vs 76% (95% CI 68–82), p=0.09; OS, based on 25% events, HR 0.76 (95% CI 0.48–1.20; p=0.24). Grade 3/4 AEswerelessfrequent with alectinib, 41%, vs 50% with crizotinib; fatalAEsoccurred in 3% vs 5%, respectively. Rates of AEsleading to discontinuation, dose reduction and interruptionwerelower with alectinib. Conclusions: Alectinibshowedsuperiorefficacy and favorabletolerabilitycompared with crizotinib. ALEX results support alectinibas a new standard of care for treatment-naïve ALK+ NSCLC. Funding: F. Hoffmann-La Roche Clinical trial information: NCT02075840

  4. Alectinib vs crizotinib in treatment-naïve advanced ALK+ NSCLC: primary results of the global phase III ALEX study (LBA9008) Presented By Alice Shaw at 2017 ASCO Annual Meeting

  5. Slide 2 Presented By Alice Shaw at 2017 ASCO Annual Meeting

  6. ALK rearrangement in NSCLC Presented By Alice Shaw at 2017 ASCO Annual Meeting

  7. Alectinib in ALK+ NSCLC Presented By Alice Shaw at 2017 ASCO Annual Meeting

  8. Study rationale Presented By Alice Shaw at 2017 ASCO Annual Meeting

  9. Study design Presented By Alice Shaw at 2017 ASCO Annual Meeting

  10. Statistical considerations Presented By Alice Shaw at 2017 ASCO Annual Meeting

  11. Study conduct Presented By Alice Shaw at 2017 ASCO Annual Meeting

  12. Baseline characteristics Presented By Alice Shaw at 2017 ASCO Annual Meeting

  13. Baseline CNS disease Presented By Alice Shaw at 2017 ASCO Annual Meeting

  14. Primary endpoint: PFS, investigator-assessed Presented By Alice Shaw at 2017 ASCO Annual Meeting

  15. Secondary endpoint: PFS, IRC-assessed Presented By Alice Shaw at 2017 ASCO Annual Meeting

  16. PFS: analysis by subgroups* Presented By Alice Shaw at 2017 ASCO Annual Meeting

  17. PFS by baseline CNS metastases status* Presented By Alice Shaw at 2017 ASCO Annual Meeting

  18. Secondary endpoint: <br />Time to CNS progression (by IRC, ITT) Presented By Alice Shaw at 2017 ASCO Annual Meeting

  19. Objective response rate* Presented By Alice Shaw at 2017 ASCO Annual Meeting

  20. CNS objective response rate* Presented By Alice Shaw at 2017 ASCO Annual Meeting

  21. Secondary endpoint: OS Presented By Alice Shaw at 2017 ASCO Annual Meeting

  22. Safety summary and exposure Presented By Alice Shaw at 2017 ASCO Annual Meeting

  23. Adverse events, ≥10% between treatment arms Presented By Alice Shaw at 2017 ASCO Annual Meeting

  24. Summary Presented By Alice Shaw at 2017 ASCO Annual Meeting

  25. Conclusions Presented By Alice Shaw at 2017 ASCO Annual Meeting

  26. Acknowledgments Presented By Alice Shaw at 2017 ASCO Annual Meeting

  27. Slide 24 Presented By Alice Shaw at 2017 ASCO Annual Meeting

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