On September 17, 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 data from its partner CStone Pharmaceuticals’ Phase 3 GEMSTONE-301 study at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 (Press release, EQRx, SEP 17, 2021, View Source [SID1234587875]). GEMSTONE-301 is a placebo-controlled Phase 3 trial evaluating the efficacy and safety of the anti-PD-L1 antibody sugemalimab as consolidation therapy in patients with locally advanced/unresectable Stage III non-small cell lung cancer (NSCLC) without disease progression after concurrent or sequential chemoradiotherapy. GEMSTONE-301 is the first positive Phase 3 trial of a PD-(L)1 agent in this broad Stage III NSCLC patient population setting.

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In May 2021, EQRx, along with its partner CStone Pharmaceuticals, announced that the GEMSTONE-301 study met its primary endpoint of prolonged progression-free survival (PFS). Detailed results of the study to be presented at ESMO (Free ESMO Whitepaper) 2021 on Saturday, September 18, are as follows:

Sugemalimab, as a consolidation therapy, demonstrated statistically significant and clinically meaningful improvement in PFS vs. placebo as assessed by blinded independent central review (BICR).
Median PFS was 9.0 months vs. 5.8 months (HR=0.64, P=0.0026).
Clinical benefits were observed in patients who received either concurrent or sequential chemoradiotherapy prior to sugemalimab.
For patients who received prior concurrent chemoradiotherapy (cCRT), median PFS was 10.5 months vs. 6.4 months (HR=0.66).
For patients who received prior sequential chemoradiotherapy (sCRT), median PFS was 8.1 months vs. 4.1 months (HR=0.59).
Overall survival (OS) data were immature, but an encouraging trend for a survival benefit with sugemalimab vs. placebo was observed with follow-up of patients ongoing.
Median OS was not reached for sugemalimab vs. 24.1 months for placebo (HR=0.44).
Sugemalimab had a well-tolerated safety profile and no new safety signals were observed.
"GEMSTONE-301 is a unique trial in that it enrolled a highly heterogenous population of patients with Stage III NSCLC reflective of everyday practice across a range of tumor pathologic subtypes, performance status and those treated with either sequential or concurrent chemoradiotherapy," said Vincent Miller, MD, physician-in-chief at EQRx. "Sequential chemoradiotherapy is a widely used alternative for those who cannot tolerate or access concurrent chemoradiotherapy and there remains a high unmet need to improve outcomes for these patients. These data suggest sugemalimab may have the potential to treat a broad population of patients with Stage III NSCLC."

The upcoming presentation at ESMO (Free ESMO Whitepaper) 2021 in Stage III NSCLC builds upon the recent presentation of updated data from the GEMSTONE-302 study in Stage IV NSCLC at the IASLC 2021 World Conference on Lung Cancer, positioning sugemalimab as a potential treatment option to address both Stage III and IV NSCLC.

Separately, a poster is also being presented at ESMO (Free ESMO Whitepaper) 2021 on the final results of the Phase 2 APOLLO study, conducted by EQRx’s partner Hansoh Pharma, of EGFR inhibitor aumolertinib in second-line NSCLC. Data demonstrate an encouraging OS benefit with a median OS of 30.2 months in patients with EGFR T790M-positive advanced NSCLC after disease progression on first-/second-generation EGFR TKI therapies.

Details of the presentations are as follows:

Presentation Title: GEMSTONE-301: A randomized, double-blind, placebo-controlled, phase III study of sugemalimab in patients with unresectable stage III non-small cell lung cancer (NSCLC) who had not progressed after concurrent or sequential chemoradiotherapy (CRT)
Date: Saturday, September 18, 2021
Time: 5:50 p.m. CEST / 11:50 a.m. EDT
Session: Mini oral session – Non-metastatic NSCLC and other thoracic malignancies
Abstract Number: LBA43
Presenter: Yi-Long Wu (Guangdong Provincial People’s Hospital, China)

Presentation Title: Final results of APOLLO study: Overall survival (OS) of aumolertinib in patients with pretreated EGFR T790M-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)
Format: On-demand ePoster
Presentation Number: 1208P
Presenter: Shun Lu (Shanghai, China)

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.1 NSCLC is the most common type of lung cancer, accounting for 84% of all lung cancer diagnoses.2

About GEMSTONE-301

GEMSTONE-301 is a randomized, double-blind, placebo-controlled Phase 3 study to evaluate the efficacy and safety of sugemalimab as consolidation therapy in patients with locally advanced/unresectable Stage III NSCLC without disease progression after concurrent or sequential chemoradiotherapy. The study was conducted in China and the primary endpoint was PFS as assessed by BICR according to RECIST v1.1. Secondary endpoints include OS, PFS as assessed by the investigators and safety. In May 2021, EQRx, along with its partner CStone Pharmaceuticals, announced that GEMSTONE-301 met its primary endpoint of prolonged PFS.

About Sugemalimab

Sugemalimab is an investigational monoclonal antibody targeting programmed death-ligand 1 (PD-L1) discovered by CStone Pharmaceuticals. Authorized by the U.S.-based Ligand Corporation, sugemalimab is developed by the OmniRat transgenic animal platform, which can generate fully human antibodies in one stop. 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. In November 2020, the National Medical Products Administration (NMPA) of China accepted the New Drug Application for sugemalimab combined with chemotherapy for the first-line treatment of advanced squamous and non-squamous NSCLC patients. EQRx holds the development and commercialization rights to sugemalimab outside of Greater China and plans to pursue regulatory discussions in multiple countries.