On August 7, 2022 EQRx, Inc. (Nasdaq: EQRX), a new type of pharmaceutical company committed to developing and delivering innovative medicines to patients at radically lower prices, reported a late-breaking oral presentation of updated data from the Phase 3 GEMSTONE-301 trial of sugemalimab in non-small cell lung cancer (NSCLC) at the International Association for the Study of Lung Cancer (IASLC) 2022 World Conference on Lung Cancer (WCLC), taking place August 6 through August 9, 2022 (Press release, EQRx, AUG 7, 2022, View Source [SID1234618254]). These results are being featured in the WCLC press program.
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"In the updated results from GEMSTONE-301, sugemalimab demonstrated a sustained progression-free survival benefit, underscoring its potential as consolidation therapy for people with locally advanced, unresectable Stage III non-small cell lung cancer," said Vince Miller, MD, physician-in-chief at EQRx. "The inclusion of patients who had received sequential chemoradiotherapy in this trial is of particular importance as patients often cannot tolerate concurrent chemoradiotherapy or cannot access it due to a variety of factors. There is currently no immune checkpoint inhibitor approved as a consolidation option for these patients, estimated to represent as many as 25% of people with unresectable Stage III non-small cell lung cancer in the U.S."
As of the March 2022 data cutoff, the final progression-free survival (PFS) analysis of the Phase 3 GEMSTONE-301 trial showed that sugemalimab continued to demonstrate improvement in PFS compared to placebo as consolidation therapy for patients with locally advanced, unresectable Stage III NSCLC without disease progression after concurrent or sequential chemoradiotherapy. Median PFS was 10.5 months for sugemalimab and 6.2 months for placebo (hazard ratio [HR]=0.65, 95% CI 0.50–0.84, P=0.0012). PFS benefit was observed in the sugemalimab arm over the placebo arm regardless of whether patients received prior concurrent chemoradiotherapy (15.7 vs. 8.3 months; HR=0.71, 95% CI: 0.50, 1.00) or sequential chemoradiotherapy (8.1 vs. 4.1 months; HR=0.57, 95% CI: 0.38, 0.87). Data for overall survival, a secondary endpoint, were encouraging but immature at the time of the analysis. The safety profile for sugemalimab was consistent with previously reported results, and no new safety signals were identified within the follow-up period.
GEMSTONE-301 previously met its PFS primary endpoint in May of 2021 and is the first positive Phase 3 trial of a PD-L1 agent in this Stage III NSCLC patient population setting.1
On Sunday, August 7, these results are being featured in a WCLC press conference at 4:10 a.m. ET and in an oral presentation at 6:22 a.m. ET during WCLC 2022 (abstract #OA02.05, "From Locally Advanced to Unresectable NSCLC: Improvement of Multimodality Treatment session").*
About Non-small Cell Lung Cancer (NSCLC)
Lung cancer is the leading cause of cancer death for men and women worldwide.2 Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 85% of all lung cancer diagnoses. The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma.3 Treatment options for NSCLC include surgery, radiation therapy, chemotherapy, targeted therapy and immunotherapy.4
About the GEMSTONE-301 Trial
GEMSTONE-301 (NCT03728556) is a randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the efficacy and safety of sugemalimab versus placebo as consolidation therapy for patients with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) without disease progression after either concurrent or sequential chemoradiotherapy. The study was conducted by CStone Pharmaceuticals and included 381 patients who were randomized to the sugemalimab group (n=255) or the placebo group (n=126). The study met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to placebo as assessed by blinded independent central review according to Response Evaluation Criteria in Solid Tumors version 1.1. Secondary endpoints include overall survival, investigator-assessed PFS and safety.
About Sugemalimab
Sugemalimab is a monoclonal antibody targeting programmed death-ligand 1 (PD-L1) that is currently being investigated in several ongoing clinical trials, including studies in relapsed or refractory extranodal natural killer/T cell lymphoma (ENKTL), Stage III non-small cell lung cancer (NSCLC), Stage IV NSCLC, gastric cancer and esophageal cancer. In October of 2020, the U.S. Food and Drug Administration (FDA) granted sugemalimab Breakthrough Therapy designation for the treatment of adult patients with relapsed or refractory ENKTL. Sugemalimab is approved by the National Medical Products Administration (NMPA) of China for the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy and in combination with chemotherapy for the first-line treatment of patients with metastatic squamous and non-squamous NSCLC. Sugemalimab was discovered by CStone Pharmaceuticals, and EQRx has partnered with CStone Pharmaceuticals on the global development of sugemalimab with the goal of expanding access worldwide. EQRx holds the development and commercialization rights to sugemalimab outside of Greater China.