ASTRIDE: FIRST-OF-ITS-KIND, DESCRIPTIVE, HEAD-TO-HEAD TRIAL COMPARING PD-1 VERSUS PD-L1 INHIBITORS1

Building on results from the international phase 3 ASTRUM-005 trial

Fosun has initiated a complementary registrational trial to confirm the applicability of the results to ES-SCLC patients in the United States. ASTRUM-005 is a multinational, double-blind, phase 2 randomized clinical trial conducted in China, Georgia, Poland, Russia, Turkey, and Ukraine.

DISCOVER THE ASTRUM-005 TRIAL

585

patients were randomized 2:1 to the serplulimab plus chemotherapy group or placebo plus chemotherapy group

  • Key inclusion criteria:
    • Histologically or cytologically confirmed ES-SCLC
    • No prior systemic therapy for ES-SCLC
    • 1 or more measurable lesions assessed using RECIST version 1.1
    • An ECOG PS Scale score of 0 or 1
    • Adequate organ function and life expectancy of 12 weeks or longer
  • Patients received either 4.5 mg/kg of serplulimab or placebo via intravenous infusions every 3 weeks until disease progression, death, unacceptable toxicity, withdrawal of consent, or other reasons specified in the trial protocol
  • All patients received 100 mg/m2 of etoposide on days 1, 2, and 3 and carboplatin within the area under the serum drug concentration time curve of 5 mg/mL/min (up to 750 mg) on day 1 of each cycle for up to 4 cycles via intravenous infusions

ASTRIDE: SERPLULIMAB + CHEMOTHERAPY VERSUS ATEZOLIZUMAB + CHEMOTHERAPY IN TREATING ES-SCLC1

ASTRIDE TRIAL DESIGN1

  • ASTRIDE is a randomized open-label study of serplulimab plus chemotherapy compared with atezolizumab plus chemotherapy in previously untreated patients in the United States with ES-SCLC1
  • Atezolizumab was selected as the comparator arm because it is approved for first-line treatment of ES-SCLC in combination with chemotherapy and is considered a current standard of care in the U.S.2,3
    • Retaining atezolizumab as a comparator arm provides an important opportunity to observe treatment activity with PD-1 and PD-L1 side-by-side in the same trial1
  • Key inclusion criteria1:
Key inclusion criteria including 18 years and older, diagnosed with ES-SCLC, and more
  • Patients are randomized 1:1 to receive serplulimab or atezolizumab intravenously every 3 weeks until disease progression, intolerable toxicity, or death. All patients receive chemotherapy with intravenous etoposide and carboplatin every 3 weeks for up to 4 cycles
ASTRIDE Trial design for adults with untreated ES-SCLC

Diversity Plan

  • White
  • African American
  • Other

Exclusion

  • Histologically or cytologically confirmed mixed-stage SCLC
  • Prior systemic SCLC treatments
  • Grade ≥2 peripheral neuropathy
  • Ejection fraction <50% or NYHA class III to IV cardiac insufficiency
  • Pregnant or breastfeeding females

FOSUN IS COMMITTED TO ADDRESSING HEALTH DISPARITIES AND IMPROVING HEALTH EQUITY

  • The ASTRIDE trial inclusion and recruitment policy has been designed to be inclusive of underserved communities and to reflect the diverse population in the U.S.
  • Patient population:
    • As enrollment continues, ASTRIDE will aim to include a higher percentage of minority patients in proportion to Caucasian patients to ensure a more equitable representation and to better understand serplulimab’s effectiveness across different demographic groups
    • With specific patient demographics in mind, the ASTRIDE trial recruitment was designed to target patients who are most susceptible to lung cancer4
LEARN HOW THE ASTRIDE TRIAL STRIVES FOR INCLUSIVITY

AEs=adverse events; ES-SCLC=extensive-stage small-cell lung cancer; ORR=objective response rate; OS=overall survival; PD=pharmacodynamic; PD-1=programmed cell death 1; PD-L1=programmed cell death ligand 1; PFS=progression-free survival; PK=pharmacokinetic; QoL=quality of life.

References: 1. Dowlati A, Wu E, Puri S, et al. Serplulimab vs atezolizumab added to chemotherapy in patients with treatment-naive ES-SCLC in the United States – ASTRIDE trial. Post in progress. 2023. 2. TECENTRIQ Prescribing Information. Genentech, Inc. 3. Cheng Y, Han L, Wu L, et al. Effect of first-line serplulimab vs placebo added to chemotherapy on survival in patients with extensive-stage small cell lung cancer: the ASTRUM-005 randomized clinical trial. JAMA. 2022;328(12)1223-1232. 4. Wang Q, et al. SCLC: epidemiology, risk factors, genetic susceptibility, molecular pathology, screening, and early detection. J Thorac Oncol. 2023;18(1):31-46.

ES-SCLC: MORE SURVIVAL TIME NEEDED
Downloadable Resources