Author of

• 36267

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  P75 - Immunotherapy (Phase II/III Trials) - Misc. Topics (ID 248)

  • Event: WCLC 2020
  • Type: Posters
  • Track: Immunotherapy (Phase II/III Trials)
  • Presentations: 1
  • Moderators:
  • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall

  • 36270

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    P75.03 - KEYNOTE-U01: A Phase 2 Umbrella Study of Investigational Agents Plus Pembrolizumab-Based Therapy for Advanced NSCLC (ID 3308)

    00:00 - 00:00  |  Presenting Author(s): Suman Rao
    • Abstract
    • Slides

    Introduction
    

    Pembrolizumab, an anti‒PD-1 antibody, has shown improvements in clinical outcomes versus platinum-based chemotherapy in patients with advanced non–small-cell lung cancer (NSCLC) as monotherapy in both the first- and second-line settings among patients with PD-L1‒positive NSCLC, and in combination with chemotherapy in the first-line setting, irrespective of tumor PD-L1 expression. KEYNOTE-U01 (NCT04165798) is an ongoing phase 2 umbrella study to evaluate the efficacy and safety of investigational agents in combination with pembrolizumab monotherapy or pembrolizumab plus chemotherapy in patients with advanced NSCLC using an adaptive design. Treatment arms evaluating investigational agents will be added on a rolling basis to the study based on the agents’ mechanism of action and their toxicity profile observed in phase 1 studies.

    Methods
    

    KEYNOTE-U01 is a phase 2, multicenter, open-label, adaptive design study that is enrolling patients with histologically or cytologically confirmed stage IV squamous or nonsquamous NSCLC, measurable disease per RECIST version 1.1, with no EGFR or ALK aberrations, and with a tumor sample available for the evaluation of PD-L1 expression. Patients are being enrolled in 1 of 3 substudies based on PD-L1 tumor proportion score (TPS) and prior treatment history. Substudy 1 includes patients with previously untreated squamous or nonsquamous NSCLC. Patients receive 4 cycles of pembrolizumab 200 mg plus chemotherapy (squamous, carboplatin area under the concentration-time curve (AUC) 6 mg/mL/min plus paclitaxel 200 mg/m²; nonsquamous, carboplatin AUC 5 mg/mL/min plus pemetrexed 500 mg/m²) plus an investigational agent Q3W, followed by pembrolizumab plus the same investigational agent (plus maintenance pemetrexed 500 mg/m² for patients with nonsquamous histology) Q3W for up to a combined total of 35 cycles (approximately 2 years). Substudy 2 includes patients with previously untreated squamous or nonsquamous NSCLC and PD-L1 TPS ≥1%. Patients receive pembrolizumab 200 mg Q3W plus an investigational agent or combination of investigational agents for up to 35 cycles (approximately 2 years). Substudy 3 includes patients with squamous or nonsquamous NSCLC previously treated with an anti‒PD-(L)1 therapy. Patients are randomly assigned to pembrolizumab 200 mg Q3W and either an investigational agent or combination of investigational agents for up to 35 cycles (approximately 2 years). Patients are stratified by histology (squamous vs nonsquamous) and PD-L1 TPS (<1% vs ≥1%) in substudy 1 and by histology in (squamous vs nonsquamous) in substudy 2. There is no stratification in substudy 3. In each substudy, treatment will continue until radiographic disease progression, unacceptable adverse events, intercurrent illness that prevents further administration of treatment, investigator’s decision, or patient withdrawal. The primary endpoint for all substudies is ORR as assessed by the investigator according RECIST version 1.1. Secondary endpoints are PFS (per RECIST version 1.1) and safety. Enrollment began on December 19, 2019 and is ongoing.

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