PRINCETON, N.J., Nov. 28, 2023 /PRNewswire/ -- Fosun Pharma USA Inc. ("Fosun Pharma USA") announced today 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.
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:
Serplulimab vs atezolizumab added to chemotherapy in patients with treatment-naive ES-SCLC in the United States – ASTRIDE Trial in Progress
Abstract #: PP01.35
December 2 at 5:40 PM CST/6:40 PM EST
Key Highlights about Study Design
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.
About Fosun Pharma USA
Established in 2017 and headquartered in Princeton, New Jersey, Fosun Pharma USA Inc. is a wholly owned subsidiary of Fosun Pharma (Group) co., Ltd. Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun HQ"). Fosun HQ, founded in 1994 and headquartered in Shanghai, is a top global, innovation-driven, pharmaceutical and healthcare industry group.
Created as an entrepreneurial business entity, Fosun Pharma USA is a U.S.-focused specialty pharmaceutical company, innovating through strategic partnerships and building its commercial presence in the United States. Fosun Pharma USA leverages its global parent company, Fosun Pharma Group, as well as a unique R&D model, to advance innovative products to patients in need.
Fosun Pharma USA is led by a team of highly experienced executives, who have a strong track record as leaders at both U.S. and European-based pharma companies, in both commercial operations and R&D. Its current portfolio is comprised of specialty pharmaceutical injectable products and ophthalmics, to build a portfolio of high value, branded innovative products.
The company is continuing to build its pipeline with late development stage (phase 2 and beyond) or commercial stage innovative products for the U.S. market, primarily. While Fosun Pharma USA can facilitate a partnership with Fosun HQ for the Chinese market, the focus is on U.S. rights for innovative biopharmaceutical products. Website: www.fosunpharmausa.com; Follow us on LinkedIn for more company updates: Fosun Pharma USA Inc.
Fosun Pharma USA Forward-Looking Statement
This presentation may include predictions, estimates, current target dates, current target indications, current plans, or other information (hereinafter "prospective information") that might be considered forward-looking. While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially. You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions as to said prospective information only as of the date of this presentation. Please keep in mind that we are not obligating ourselves to revise or publicly release the results of any revision to these forward-looking statements in light of new information, developments, changed circumstances, or future events. During today's discussion, we will attempt to present some important factors relating to our business that may affect our aforementioned prospective information.
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