Author of

• 25921

  +

  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

  • 26314

    +

    P1.01-83 - IMpower150: Impact of Chemotherapy Cycles in 1L Metastatic NSCLC in Patients Treated With Atezolizumab + Bevacizumab (ID 12180)

    16:45 - 18:00  |  Author(s): Mayank Gandhi
    • Abstract
    • Slides

    Background
    

    In the randomized Phase III IMpower150 study, atezolizumab (anti–programmed death-ligand 1 [PD-L1]) + bevacizumab + chemotherapy (Arm B) showed statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) over bevacizumab + chemotherapy (Arm C) in patients with first-line (1L) nonsquamous non-small cell lung cancer (NSCLC). The study protocol allowed investigator choice of 4 or 6 chemotherapy cycles. The objective of this exploratory analysis was to assess the impact of chemotherapy cycles on safety and efficacy outcomes.

    a9ded1e5ce5d75814730bb4caaf49419 Method
    

    Patients were categorized based on actual chemotherapy cycles received in Arm B. Landmark analysis of PFS was performed to assess the benefit of 4 vs 6 chemotherapy cycles. Sensitivity analyses were performed to adjust the numerically imbalanced baseline factors.

    4c3880bb027f159e801041b1021e88e8 Result
    

    A total of 356 patients were randomized in Arm B; 188 patients (53%) were planned to receive 4 cycles, and 168 patients (47%) were planned to receive 6 cycles of chemotherapy. Within these 2 groups, 143 (76%) and 98 patients (58%) completed 4 and 6 chemotherapy cycles, respectively. The demographic and baseline disease characteristics were balanced, except for race (Asian vs other), smoking status, and PD-L1 status (TC3 or IC3 vs other). The landmark PFS analysis showed no difference between patients who completed 4 vs 6 cycles (HR 0.83 [95% CI: 0.59, 1.17). The sensitivity analyses, which adjusted for race, smoking status, or PD-L1, showed comparable results (adjusted HRs of 0.80, 0.85, or 0.91, respectively).

    8eea62084ca7e541d918e823422bd82e Conclusion
    

    In the atezolizumab + bevacizumab + chemotherapy arm, patients who received 4 cycles of chemotherapy appeared to have similar PFS benefit as those who received 6 cycles of chemotherapy. Detailed analyses of varying chemotherapy cycles, safety analyses, and impact on OS will be presented.

    6f8b794f3246b0c1e1780bb4d4d5dc53

    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.

• 25971

  +

  P3.17 - Treatment of Locoregional Disease - NSCLC (Not CME Accredited Session) (ID 983)

  • Event: WCLC 2018
  • Type: Poster Viewing in the Exhibit Hall
  • Track:
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall

  • 27804

    +

    P3.17-12 - Phase II Trial of Atezolizumab Before and After Chemoradiation for Unresectable Stage III NSCLC (AFT-16): Trial in Progress (ID 13929)

    12:00 - 13:30  |  Author(s): Mayank Gandhi
    • Abstract
    • Slides

    Background
    

    Cure is possible for a substantial minority of stage III NSCLC patients, but most will relapse after conventional chemoradiation (CRT). Combining checkpoint inhibition through PD-L1 blockade with CRT may attenuate tumor related immunosuppression via depletion of Tregs and clonal expansion of effector T-cells, thereby improving tumor immunogenicity. Further, CRT may reveal hidden antigens that can present additional targets to the reconstituting immune system. Whether anti-PD-L1 therapy before CRT will improve outcomes in this setting is the subject of this trial.

    a9ded1e5ce5d75814730bb4caaf49419 Method
    

    This phase II single arm Alliance Foundation Trials study (AFT-16, NCT03102242) explores safety and efficacy of atezolizumab before and after definitive CRT. 63 patients with stage III NSCLC, PS 0-1, no active autoimmune disease and no significant organ dysfunction will enroll at 15 Alliance sites. Participants receive 4 cycles of neoadjuvant atezolizumab 1200 mg IV q 21 days with restaging after cycles 2 and 4. Non-progressing patients undergo carboplatin and paclitaxel (C/P) weekly with 60 Gy RT followed by 2 cycles of C/P consolidation and adjuvant atezolizumab to complete one year of therapy. The primary endpoint is disease control rate (CR+PR+SD) after neoadjuvant atezolizumab. Secondary endpoints include ORR, PFS, OS, safety and QoL by the EORTC QLQ-30.

    Correlatives include the role of PD-L1 and tumor mutation burden as predictive biomarkers. Tumor tissue is obtained at study entry, and plasma and immune cells are isolated at study entry, post neoadjuvant atezolizumab, post CRT, during adjuvant atezolizumab and at study end. Explorative endpoints include potential predictive biomarkers development that may define how atezolizumab affects the proportions of immunologic subtypes and immune activation using flow cytometry and T cell receptor immunophenotyping, multiplex immunohistochemistry and cytokine analysis.

    The trial was activated on 11/1/17. As of 5/4/18, the trial is open at 8 centers with 14 patients enrolled.

    4c3880bb027f159e801041b1021e88e8 Result
    

    Section not applicable

    8eea62084ca7e541d918e823422bd82e Conclusion
    

    Section not applicable

    6f8b794f3246b0c1e1780bb4d4d5dc53

    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.