Pneumologie 2022; 76(S 01): S49-S50
DOI: 10.1055/s-0042-1747800
Abstracts

Durvalumab+ Tremelimumab + Platin-Etoposide in first-line extensive-stage SCLC (ES-SCLC): 36-month Overall Survival from the Phase 3 CASPIAN study

Authors

  • H Bischoff

    1   Thoraxklinik

  • L Paz-Ares

    2   Hospital Universitario 12 de Octobre

  • Y Chen

    3   Cancer & Hematology Centers of Western Michigan

  • N Reinmuth

    4   Asklepios Lung Clinic

  • K Hotta

    5   5okayama University Hospital

  • D Trukhin

    6   Odesa Regional Oncological Dispensary

  • G Statsenko

    7   Omsk Regional Cancer Center

  • M J Hochmair

    8   Karl Landsteiner Institute of Lung Research and Pulmonary Oncology

  • M Özgüroğlu

    9   9istanbul University−cerrahpaşa

  • J H Li

    10   Samsung Changwon Hospital

  • O Voitko

    11   Kyiv City Clinical Oncological Centre

  • A Poltoratskiy

    12   Petrov Research Institute of Oncology

  • F Verderame

    13   Ao Ospedali Riuniti Po Vincenzo Cervello

  • L Havel

    14   Thomayer Hospital

  • I Bondarenko

    15   Dnipropetrovsk Medical Academy

  • G Losonczy

    16   Semmelweis University

  • N Conev

    17   Medical Oncology

  • H Broadhurst

    18   Plus-Project Ltd

  • T Dalvi

    19   Astrazeneca

  • H Jiang

    19   Astrazeneca

  • J W Golgman

    20   David Geffen School of Medicine at Ucla

  • J Alt

    21   University Medical Center Mainz
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    Background In the Phase 3 CASPIAN study of etoposide + cisplatin/carboplatin (EP) ± durvalumab (D) ± tremelimumab (T) as first-line treatment of ES-SCLC, D + EP demonstrated a statistically significant improvement in OS vs EP alone (data cut-off [DCO]: 11 Mar 2019; HR 0.73 [95% CI 0.59–0.91; p=0.0047]). In a subsequent analysis after a median follow-up of 25.1 mo (DCO 27 Jan 2020), OS benefit with D + EP vs EP was sustained (HR 0.75 [95% CI 0.62–0.91; nominal p=0.0032]), and D + T + EP numerically improved OS vs EP (HR 0.82 [95% CI 0.68–1.00; p=0.0451]), but did not reach statistical significance (p≤0.0418). Here we report updated OS data after a median follow-up of >3 years.

    Methods Pts with treatment-naïve ES-SCLC (WHO PS 0/1) were randomised 1:1:1 to D 1500 mg + EP q3w, D 1500 mg + T 75 mg + EP q3w, or EP q3w. Pts in the IO arms received 4 cycles of EP + D ± T, followed by maintenance D 1500 mg q4w until disease progression. Pts in the EP arm received up to 6 cycles of EP, and optional PCI (investigator’s discretion). The two primary endpoints were OS for D + EP vs EP and for D + T + EP vs EP. Serious adverse events (SAEs) were assessed during long-term follow up.

    Results 268, 268 and 269 pts were randomized to D + EP, D + T + EP and EP, respectively. At a DCO of 27 Mar 2021, median follow-up was 39.4 mo, 86% maturity. D + EP continued to demonstrate improved OS vs EP: HR 0.71 (95% CI 0.60–0.86; nominal p=0.0003). Median OS was 12.9 vs 10.5 mo; 22.9% vs 13.9% of pts were alive at 24 mo; and 17.6% vs 5.8% of pts were alive at 36 mo with D + EP vs EP, respectively. D + T + EP continued to numerically improve OS vs EP: HR 0.81 (95% CI 0.67–0.97; nominal p=0.02); median OS was 10.4 mo, and 15.3% of pts were alive at 36 mo. 46 pts remained on treatment with D at DCO (27 in the D + EP arm and 19 in the D + T + EP arm). In D + EP, D + T + EP and EP arms, respectively, incidences of SAEs (all cause) were 32.5%, 47.4% and 36.5%; and AEs leading to death (all cause) were 5.3%, 10.9% and 6.0%.

    Conclusions D + EP demonstrated sustained OS benefit over EP with a well-tolerated safety profile, consistent with previous analyses. After a median follow-up of >3 years, 10% of pts in the D + EP arm are still receiving D therapy, further establishing the CASPIAN regimen as standard of care for first-line treatment of ES-SCLC.


     

    Publication History

    Article published online:
    11 May 2022

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