On November 28, 2023 Fosun Pharma USA Inc. ("Fosun Pharma USA") reported its abstract on ASTRIDE (NCT05468489), a phase 3 randomized, open-label study of serplulimab vs atezolizumab both in combination with chemotherapy (Carboplatin-Etoposide) in patients with extensive-stage small-cell lung cancer (ES-SCLC), has been accepted for presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2023 North America Conference on Lung Cancer (NACLC), being held in Chicago, Illinois, Dec. 1 – 3, 2023 (Press release, Fosun Pharma, NOV 28, 2023, View Source [SID1234638024]).

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All abstracts accepted for presentation have been published on the NACLC website.

"Our PIs are excited to present their poster on the design of the ASTRIDE Trial in Progress (TiP), which is an important milestone for the lead investigators and authors," said Stan Lechpammer, Vice President, Medical Affairs, Innovative Medicines, Fosun Pharma USA. "This presentation provides greater insight into the ASTRIDE trial that investigates serplulimab as a potentially new therapeutic option for extensive-stage (ES) small-cell lung cancer patients (SCLC). SCLC is an aggressive malignancy, with the majority of patients presenting with extensive-stage disease at initial diagnosis. There is a high unmet need for this patient population. Beyond the potential of our TiP study design, we have committed to recruiting patients from many medically underserved communities, to address health disparities and improve health equity for ES-SCLC patients in the U.S."

Abstract accepted for presentation’s details and key points about the study design:

Medicine

Abstract Title

Presentation Details

Serplulimab

Serplulimab vs atezolizumab added to chemotherapy in patients with treatment-naive ES-SCLC in the United States – ASTRIDE Trial in Progress

Abstract #: PP01.35

Poster available:

December 2 at 5:40 PM CST/6:40 PM EST

Key Highlights about Study Design

Trial will include approximately 200 adult patients with treatment-naïve ES-SCLC
Study participants are being recruited from over 90 sites across the United States
About Serplulimab
Serplulimab is a novel anti–PD-1 (programmed cell death-1) monoclonal antibody (mAb), with a unique mode of recognition of the PD-1 receptor compared with currently available anti–PD-1 mAbs (Issafras et al. Plos One. 2021).

About the ASTRIDE Phase 3 Trial
ASTRIDE is a randomized, open-label study of serplulimab plus chemotherapy (carboplatin-etoposide) compared with atezolizumab plus chemotherapy in previously untreated patients with extensive-stage small cell lung cancer (ES-SCLC) in the United States. The primary objective for ASTRIDE is to confirm the applicability of the results of ASTRUM-005 (a global, randomized, phase 3 trial) to patients in the United States, with the current standard-of-care as the control arm, based on comments from the U.S. Food and Drug Administration (Serplulimab study protocol 2.0 final. Shanghai Henlius Biotech, Inc.; July 18, 2022).

About Small-cell Lung Cancer
Approximately 30,000-35,000 people are diagnosed with small-cell lung cancer (SCLC) each year in the United States. It is the most aggressive form of lung cancer with approximately 70% of patients presenting with extensive-stage disease (ES-SCLC), with a median overall survival of approximately 12.5 months with standard-of-care treatment.