- In the ongoing GEMSTONE-301 Phase 3 study, sugemalimab, administered after treatment with either concurrent or sequential chemoradiotherapy, demonstrated a statistically significant improvement in progression-free survival versus placebo in patients with unresectable Stage III non-small cell lung cancer (NSCLC)
- There are currently no immunotherapy consolidation treatments in the U.S. or Europe approved for patients with unresectable Stage III NSCLC who have received sequential chemoradiotherapy
CAMBRIDGE, Mass., Aug. 07, 2022 (GLOBE NEWSWIRE) -- EQRx, Inc. (Nasdaq: EQRX), a new type of pharmaceutical company committed to developing and delivering innovative medicines to patients at radically lower prices, today announced 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. These results are being featured in the WCLC press program.
“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.
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.
EQRx is a new type of pharmaceutical company committed to developing and delivering innovative medicines to patients at radically lower prices. Launched in January 2020, EQRx is purpose-built, at scale, with a growing catalog of medicines in development in high-cost drug categories and emerging partnerships with leading payers and health systems. Leveraging cutting-edge science and technology and strategic partnerships with stakeholders from across the healthcare system, EQRx aims to provide innovative, patent-protected medicines more efficiently and cost-effectively than ever before. To learn more, visit www.eqrx.com and follow us on social media: Twitter: @EQRxInc, LinkedIn, Instagram: @eqrxinc.
EQRx™ and Remaking Medicine™ are trademarks of EQRx.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of the federal securities laws. These forward-looking statements may be identified by the use of words such as “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “design,” “strategy,” “future,” “opportunity,” “continue,” “aim,” “goal,” “plan,” “may,” “look forward,” “should,” “will,” “would,” “will be,” “will likely result,” and similar expressions. These forward-looking statements include, but are not limited to, express or implied statements regarding sugemalimab’s potential as a treatment option for NSCLC and other diseases, EQRx’s ability to expand access to sugemalimab worldwide with its partner CStone Pharmaceuticals, and EQRx’s ability to develop and deliver innovative medicines at radically lower prices. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to the inherent risks in pharmaceutical development, including with respect to the conduct of clinical trials; delays of any current and future clinical trials or the development of sugemalimab or EQRx’s other drug candidates; risks that the results of prior clinical trials may not be predictive of future results; risks associated with successfully demonstrating the efficacy, safety and tolerability of sugemalimab and obtaining regulatory approvals therefor; EQRx’s ability to obtain, maintain and protect its intellectual property; expectations regarding EQRx’s existing collaborations with CStone Pharmaceuticals and its other existing and future collaboration partners; risks associated with EQRx’s ability to otherwise implement its business plans; changes in the competitive and highly regulated industries in which EQRx operates, including laws and regulations affecting EQRx’s business; and other risks associated with its plans to create a new kind of pharmaceutical company, among others. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section in EQRx’s most recent Annual Report on Form 10-K as well as any other filings with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and EQRx assumes no obligation, and does not intend, to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.
Investors and others should note that we communicate with our investors and the public using our website www.eqrx.com, including, but not limited to, company disclosures, investor presentations and FAQs, SEC filings, press releases, public conference call transcripts and webcast transcripts. The information that we post on our website could be deemed to be material information. As a result, we encourage investors, the media and other interested parties to review the information that we post there on a regular basis. The contents of our website shall not be deemed incorporated by reference in any filing with the SEC.
* EQRx and CStone Pharmaceuticals have partnered on the global development of sugemalimab. This presentation will be shared by CStone Pharmaceuticals and its collaborators.
1 Zhou Q, et al. The Lancet Oncology. Published January 14, 2022. doi: https://doi.org/10.1016/S1470-2045(21)00630-6.
2 Sung H, et al. CA Cancer J Clin. 2021;71(3):209-249. doi: https://doi.org/10.3322/caac.21660
3 American Cancer Society. ”What is Lung Cancer?” Accessed May 3, 2022. Available at: https://www.cancer.org/cancer/lung-cancer/about/what-is.html.
4 American Cancer Society. “Treating Non-Small Cell Lung Cancer.” Accessed May 4 2022. Available at: https://www.cancer.org/cancer/lung-cancer/treating-non-small-cell.html