Author of

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  P2.04 - Immunooncology (Not CME Accredited Session) (ID 953)

  • Event: WCLC 2018
  • Type: Poster Viewing in the Exhibit Hall
  • Track:
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall

  • 27006

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    P2.04-29 - Preliminary Results With Tislelizumab in Chinese Patients With Non-Small Cell Lung Cancer (NSCLC) (ID 11319)

    16:45 - 18:00  |  Author(s): Chenlu Wei
    • Abstract
    • Slides

    Background
    

    NSCLC accounts for 80–85% of all lung cancers and has a poor prognosis at later stages. Immune checkpoint inhibitors have shown efficacy in patients (pts) with advanced NSCLC. Tislelizumab is a humanized IgG4 monoclonal antibody with high affinity/specificity for PD-1. Tislelizumab was specifically engineered to minimize F_cϒR binding on macrophages that, based on preclinical evidence, is believed to minimize potentially negative interactions with other immune cells. In a phase 1 study, tislelizumab was generally well tolerated and showed antitumor activity in NSCLC pts; 200 mg IV Q3W was established as the recommended tislelizumab dose.

    a9ded1e5ce5d75814730bb4caaf49419 Method
    

    In the ongoing indication-expansion phase of this study, Chinese pts with histologically confirmed NSCLC were enrolled into PD-L1-high (PD-L1⁺; ≥10% tumor cells expressing PD-L1) and PD‑L1‑low (PD-L1^–) cohorts. Antitumor activity (RECIST v1.1) and safety/tolerability (NCI-CTCAE v4.03) were assessed.

    4c3880bb027f159e801041b1021e88e8 Result
    

    As of 8 Dec 2017, 42 NSCLC pts (median age 54 yr [range 37–72]) were enrolled; 17 were PD-L1⁺ and 25 were PD-L1^–. Most pts were male (69%), former/current smokers (57%), and had received prior therapy (95%). Adenocarcinoma was the most prevalent histology (57%). Median follow-up was 4.5 mo and 23 pts remain on treatment. Of the 39 response-evaluable pts, 4 (n=2/14, PD-L1⁺; n=2/25, PD-L1^–) achieved confirmed PR and 20 (n=6/14, PD-L1⁺; n=14/25, PD‑L1^–) achieved SD, including 4 (n=2, PD-L1⁺; n=2, PD‑L1^–) with unconfirmed PR. Across the study population, ORR was 10% and DCR was 61.5%. ORRs by cohort were 14% (PD‑L1⁺) and 8% (PD-L1^–), respectively. Common treatment-related AEs were increased AST (24%), increased ALT (19%), hypothyroidism (12%), and rash (12%). Five grade ≥3 treatment-related AEs occurred in 4 pts (increased AST [n=2], hyperglycemia, increased ALT, and increased GGT [n=1 each]). No treatment-related grade 5 events were reported.

    8eea62084ca7e541d918e823422bd82e Conclusion
    

    Tislelizumab was generally well tolerated and demonstrated antitumor activity in previously treated pts with advanced NSCLC. A global phase 3 study (NCT03358875) of tislelizumab vs docetaxel as potential second/third-line therapy in NSCLC pts who progressed after a platinum-based regimen is ongoing.

    6f8b794f3246b0c1e1780bb4d4d5dc53

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