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Lu Xu

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    P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.01-09 - Pembrolizumab Plus Ipilimumab or Placebo in 1L Metastatic NSCLC with PD-L1 Tumor Proportion Score (TPS) ≥50%: KEYNOTE-598 (ID 12958)

      16:45 - 18:00  |  Author(s): Lu Xu

      • Abstract
      • Slides


      Pembrolizumab monotherapy significantly prolonged survival vs chemotherapy in previously untreated, advanced NSCLC with PD-L1 expressed on ≥50% of tumor cells (TPS ≥50%) in KEYNOTE-024. Pembrolizumab with chemotherapy led to higher objective response rates (ORRs) vs chemotherapy alone in a similar population in KEYNOTE-021. KEYNOTE-598 (NCT03302234) will evaluate the effects of combination immunotherapy with pembrolizumab and ipilimumab.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Eligibility for this randomized, double-blind phase 3 study requires patients be ≥18 years of age and have histologically/cytologically confirmed stage IV metastatic NSCLC, PD-L1 TPS ≥50% per IHC analysis on archival/newly obtained tumor sample, measurable disease per RECIST v1.1, ECOG PS 0/1, absence of EGFR/ALK aberration, and no prior systemic therapy. Patients will be randomized 1:1 to up to 35 administrations of pembrolizumab 200 mg Q3W with 18 cycles of either ipilimumab 1 mg/kg or placebo Q6W. Patients may be eligible for 17 and 9 additional administrations of pembrolizumab and ipilimumab/placebo, respectively. Treatment may be discontinued due to disease progression, intolerable toxicity, or consent withdrawal. Randomization is stratified by ECOG PS (0 vs 1), geography (East Asia vs non–East Asia), and histology (squamous vs nonsquamous). Response is assessed every 9 weeks through week 54, then every 12 weeks per RECIST v1.1 by BICR. Treatment-based decisions may utilize modified RECIST v1.1 for immune-based therapy (iRECIST). Site-assessed progression is verified by BICR before treatment discontinuation. AEs are graded per CTCAE v4.0. Primary endpoints are overall survival and progression-free survival. Secondary endpoints are ORR and duration of response by BICR; time to true deterioration in the composite endpoint of cough, pain in chest, and shortness of breath assessed by EORTC QLQ-LC13 and EORTC QLQ-C30; and safety. Approximately 548 patients will be enrolled. Enrollment began on December 18, 2017; as of April 13, 2018, 33 patients have been enrolled.

      4c3880bb027f159e801041b1021e88e8 Result

      "Section not applicable"

      8eea62084ca7e541d918e823422bd82e Conclusion

      "Section not applicable"


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