Author of

• 30844

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  P1.04 - Immuno-oncology (ID 164)

  • Event: WCLC 2019
  • Type: Poster Viewing in the Exhibit Hall
  • Track: Immuno-oncology
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall

  • 30877

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    P1.04-28 - COAST: Durvalumab Alone or with Novel Agents for Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (ID 174)

    09:45 - 18:00  |  Author(s): Peng He
    • Abstract
    • Slides

    Background
    

    The standard of care for patients with unresectable stage III non-small cell lung cancer (NSCLC) is platinum-based chemotherapy with concurrent radiotherapy, followed by durvalumab consolidation for 12 months. When administered after completion of concurrent chemoradiotherapy (cCRT) in patients with unresectable NSCLC in the PACIFIC study, durvalumab demonstrated superior clinical outcomes vs placebo in terms of progression-free survival (PFS; hazard ratio [HR] 0.51; 95% CI: 0.41, 0.63) and overall survival (OS; HR 0.68; 99.73% CI 0.47, 0.997; p=0.0025).¹ Comparing durvalumab with placebo, the 24‑month OS rate (95% CI) was 66.3% (61.7, 70.4) vs 55.6% (48.9, 61.8), median PFS was 17.2 months (13.1, 23.9) vs 5.6 months (4.6, 7.7) and objective response rate was 30.0% (25.8, 34.5) vs 17.8% (13.0, 23.6).^1,2 However, despite cCRT followed by durvalumab, most patients with unresectable stage III NSCLC relapse and eventually die from NSCLC. The COAST study (NCT03822351) is a platform trial that aims to identify potential combinations of durvalumab with novel agents to improve response rates over monotherapy.

    Method
    

    This multidrug, randomized, phase 2 trial is evaluating the clinical activity and safety of durvalumab alone or in combination with the novel agents oleclumab (MEDI9447) and monalizumab (IPH2201) in patients with unresectable, stage III NSCLC who have not progressed following definitive cCRT. New treatment arms evaluating other durvalumab combinations may be added based on emerging preclinical and clinical data. The primary endpoint is objective response per RECIST v1.1 with monotherapy and combination therapy. Secondary endpoints include safety, efficacy (duration of response, disease control, PFS, 12-month PFS rate, OS), pharmacokinetics and immunogenicity. The COAST study is open for accrual with an estimated total target enrollment of up to 60 patients per treatment arm.

    References

    ¹Antonia SJ, et al. N Engl J Med 2018;379:2342–50.

    ²Antonia SJ, et al. N Engl J Med 2017;377:1919–29.

    Result
    

    Section not applicable

    Conclusion
    

    Section not applicable

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• 30943

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  P2.04 - Immuno-oncology (ID 167)

  • Event: WCLC 2019
  • Type: Poster Viewing in the Exhibit Hall
  • Track: Immuno-oncology
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall

  • 30973

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    P2.04-28 - NeoCOAST: Neoadjuvant Durvalumab Alone or with Novel Agents for Resectable, Early-Stage (I–IIIA) Non‑Small Cell Lung Cancer (ID 56)

    10:15 - 18:15  |  Author(s): Peng He
    • Abstract
    • Slides

    Background
    

    Resectable, early‑stage non‑small cell lung cancer (NSCLC) is a potentially curable disease.The current standard of care is surgery with or without adjuvant or neoadjuvant platinum‑based doublet chemotherapy. However, over half of patients eventually relapse after surgery and die from NSCLC. Clinical studies have shown that neoadjuvant programmed cell death-1/programmed cell death ligand-1 (PD-1/PD-L1) checkpoint inhibitors may yield clinically meaningful pathological responses in patients with resectable NSCLC.^1–3 The NeoCOAST trial is a multidrug platform study to assess the PD-L1 checkpoint inhibitor durvalumab alone or in combination with novel agents, with the goal of identifying new treatment strategies to improve clinical outcomes of patients with resectable, early-stage NSCLC.

    Method
    

    NeoCOAST (NCT03794544) is a phase 2, open-label, randomized trial that will initially evaluate the clinical activity and safety of neoadjuvant durvalumab alone or in combination with the novel agents oleclumab (MEDI9447), monalizumab (IPH2201) and danvatirsen (AZD9150), in patients with resectable, stage I (>2 cm) to IIIA NSCLC. New treatment arms evaluating other durvalumab combinations may be added based on emerging preclinical and clinical data. The primary endpoint is major pathological response rate in the resected tumor specimen after treatment with neoadjuvant durvalumab alone or in combination with novel agents. Secondary objectives include feasibility of tumor resection surgery within 14 days of the end of the 4-week treatment period, safety, pathological complete response rate, pharmacokinetics and immunogenicity. Correlative translational analyses include tumor genomics, changes in the tumor microenvironment, and T cell populations. NeoCOAST is open for accrual with an estimated total target enrollment of up to 40 patients per treatment arm.

    References

    ¹Forde PM, et al. N Engl J Med. 2018;378:1976–86.

    ²Rusch V, et al. MA04.09. Presented at IASLC 19th World Conference on Lung Cancer, 23–26 September 2018, Toronto, Canada.

    ³Cascone T, et al. LBA49. Presented at European Society of Medical Oncology Congress, 19–23 October 2018, Munich, Germany 2018.

    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.