On September 13, 2021 EQRx, a new type of pharmaceutical company committed to developing and delivering important new medicines to patients at radically lower prices, reported a late-breaking mini oral presentation of updated data from its partner CStone Pharmaceuticals’ Phase 3 GEMSTONE-302 study at the International Association for the Study of Lung Cancer 2021 World Conference on Lung Cancer (IASLC 2021 WCLC) (Press release, EQRx, SEP 13, 2021, View Source [SID1234587636]). GEMSTONE-302 is a placebo-controlled Phase 3 trial evaluating the efficacy and safety of the anti-PD-L1 antibody sugemalimab in combination with chemotherapy as a first-line treatment for patients with Stage IV non-small cell lung cancer (NSCLC).
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Positive results were previously reported on the use of sugemalimab in Stage IV NSCLC1, demonstrating that sugemalimab plus standard-of-care chemotherapy prolonged progression-free-survival (PFS) and was well-tolerated as compared to chemotherapy and placebo regardless of PD-L1 expression level or pathologic subtype of NSCLC. Updated data with longer follow-up being presented at IASLC 2021 WCLC include final PFS, preliminary overall survival (OS), and safety data as follows:
As of the March 2021 data cutoff, sugemalimab plus chemotherapy continued to provide longer PFS (9.0 vs 4.9 months, HR=0.48, P<0.0001) compared to chemotherapy alone.
Although the pre-defined interim analysis for OS has not yet been reached, preliminary median OS was 22.8 months in the sugemalimab plus chemotherapy arm compared to 17.7 months in the chemotherapy plus placebo arm.
Clinical benefit continued to be observed across all the subgroups including different pathologic subtypes and PD-L1 expression levels.
No new safety signals were observed with longer follow-up.
"These updated Stage IV data combined with previous positive Phase 3 results in Stage III NSCLC continue to underscore the potential of sugemalimab to treat a broad range of NSCLC patient populations and lend credence to our mission of developing and delivering high-quality medicines at radically lower prices so patients can access the treatments that they need," said Vincent Miller, MD, physician-in-chief at EQRx. "We look forward to more mature OS data from GEMSTONE-302 as well as continued regulatory discussions for sugemalimab in multiple countries."
Details of the presentation are as follows:
Presentation Title: GEMSTONE-302: Randomized, Double-Blind, Phase 3 Study of Sugemalimab or Placebo Plus Platinum-Based Chemotherapy as First-Line Treatment for Metastatic NSCLC
Date: Monday, September 13, 2021
Time: 8:05 PM – 8:10 PM EDT
Track: Immunotherapy (Phase II/III Trials)
Format: Mini Oral Presentation
Session: MA13 – Building on the Past: What Will Be the Next Immunotherapy Combination?
Abstract Number: MA13.07
Presenter: Caicun Zhou, PhD, MD, Director of the Department of Oncology, Shanghai Pulmonary Hospital
About Lung Cancer
Every 15 seconds, a person across the world is diagnosed with lung cancer, and every 18 seconds, a person dies of the disease, making it the second most commonly diagnosed cancer and leading cause of cancer death worldwide. In 2020, an estimated 2.2 million people were diagnosed with lung cancer.2 NSCLC is the most common type of lung cancer, accounting for 84% of all lung cancer diagnoses.3
About GEMSTONE-302
GEMSTONE-302 is a randomized, double-blind, placebo-controlled Phase 3 study to evaluate the efficacy and safety of sugemalimab or placebo in combination with carboplatin-based chemotherapy as a first-line treatment in patients with Stage IV squamous or non-squamous NSCLC. The study was led by CStone Pharmaceuticals and conducted in China. The primary endpoint was investigator-assessed PFS. Secondary endpoints include OS, BICR-assessed PFS and safety.
In August 2020, the GEMSTONE-302 study met its primary endpoint and data was presented at ESMO (Free ESMO Whitepaper) Asia 2020, demonstrating that sugemalimab in combination with chemotherapy significantly prolonged PFS and reduced the risk of disease progression or death by 50% compared to placebo in combination with chemotherapy, as assessed by IDMC at the planned interim analysis. Subgroup analysis showed clinical benefit regardless of PD-L1 expression level or pathologic subtype in patients with Stage IV NSCLC. Sugemalimab in combination with chemotherapy was well-tolerated and no new safety signals were identified.
About Sugemalimab
Sugemalimab is an investigational monoclonal antibody targeting programmed death-ligand 1 (PD-L1) discovered by CStone Pharmaceuticals. As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab mirrors the natural G-type immunoglobulin 4 (IgG4) human antibody, which reduces the risk of immunogenicity and potential toxicities in patients, a potential advantage during treatment. Currently, sugemalimab is being investigated in a number of ongoing clinical trials including four Phase 3 registration studies in Stage III NSCLC (GEMSTONE-301), Stage IV NSCLC (GEMSTONE-302), gastric cancer and esophageal cancer. The National Medical Products Administration (NMPA) of China accepted New Drug Applications for sugemalimab combined with chemotherapy for the first-line treatment of advanced squamous and non-squamous NSCLC patients and for sugemalimab as a consolidation therapy in patients with unresectable Stage III NSCLC without disease progression after concurrent or sequential chemoradiotherapy. EQRx holds the development and commercialization rights to sugemalimab outside of Greater China and plans to pursue regulatory discussions in multiple countries.