Author of

• 20168

  +

  P2.04 - Clinical Design, Statistics and Clinical Trials (ID 705)

  • Event: WCLC 2017
  • Type: Poster Session with Presenters Present
  • Track: Clinical Design, Statistics and Clinical Trials
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)

  • 23333

    +

    P2.04-004 - IMpower010: A Phase III Study of Atezolizumab vs Best Supportive Care Following Adjuvant Chemotherapy in Completely Resected NSCLC (ID 8896)

    09:30 - 09:30  |  Author(s): F. Xia
    • Abstract
    • Slides

    Background:
    Atezolizumab is an anti–PD-L1 mAb that blocks PD-L1 from interacting with its receptors PD-1 and B7.1 and restores anti-cancer immunity. In patients with 2L/3L advanced NSCLC, the OAK trial showed improved mOS in the atezolizumab arm (13.8 mo) vs the docetaxel arm (9.6 mo), with survival benefit observed across all PD-L1 expression levels on tumor cells (TC) or tumor-infiltrating immune cells (IC). In patients with fully resected NSCLC (stages IB [tumors ≥ 4 cm]-IIIA), adjuvant chemotherapy remains the standard of care, but survival benefit is limited. Therefore, more effective therapies are still needed for patients with early-stage NSCLC. IMpower010 (NCT02486718) is a global Phase III, randomized, open-label trial conducted to evaluate the efficacy and safety of atezolizumab vs best supportive care (BSC) following adjuvant cisplatin–based chemotherapy in patients with resected stage IB (tumors ≥ 4 cm)-IIIA NSCLC.
    
    Method:
    Eligibility criteria include complete tumor resection 4-12 weeks prior to enrollment for pathological stage IB (tumors ≥ 4 cm)-IIIA NSCLC, adequate recovery from surgery, ability to receive cisplatin-based adjuvant chemotherapy and ECOG PS 0-1. Patients with other malignancies, autoimmune disease, hormonal cancer or radiation therapy within 5 years and prior chemotherapy or immunotherapy will be excluded. Approximately 1127 patients will be enrolled regardless of PD-L1 status. Patients will receive up to four 21-day cycles of cisplatin-based chemotherapy (cisplatin [75 mg/m[2] IV, day 1] + vinorelbine [30 mg/m[2] IV, days 1, 8], docetaxel [75 mg/m[2] IV, day 1] or gemcitabine [1250 mg/m[2] IV, days 1, 8], or pemetrexed [500 mg/m[2] IV, day 1; only non-squamous NSCLC]). Adjuvant radiation therapy is not permitted. Eligible patients will be randomized 1:1 to receive 16 cycles of atezolizumab 1200 mg q3w or BSC post-adjuvant chemotherapy. Stratification factors include sex, histology (squamous vs non-squamous), disease stage (IB vs II vs IIA) and PD-L1 status by IHC (TC2/3 [≥ 5% expressing PD-L1] and any IC vs TC0/1 [< 5%], and IC2/3 vs TC0/1 and IC0/1 [< 5%]). The primary endpoint is disease-free survival, and secondary endpoints include OS and safety. Exploratory biomarkers will be evaluated, including PD-L1 expression and immune- and tumor-related biomarkers before, during and after treatment with atezolizumab and at radiographic disease recurrence or confirmation of new primary NSCLC.
    
    Result:
    Section not applicable
    
    Conclusion:
    Section not applicable
    
    

    Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.