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CStone to present updated results from pivotal study of sugemalimab in patients with stage III NSCLC in a presentation at WCLC 2022

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Suzhou, China (ots/PRNewswire) – * The results of the GEMSTONE-301 trial were presented at the
IASLC World Conference 2022 on Lung Cancer. In addition, the lead investigator, Professor Yi-Long Wu, was invited to present the key data in a press conference

* In the final progression-free survival analysis, sugemalimab showed sustained clinical benefit compared to placebo in patients with unresectable stage III non-small cell lung cancer, whose disease had not progressed after concurrent or sequential chemoradiotherapy

* Sugemalimab was approved in China for the treatment of patients with unresectable stage III non-small cell lung cancer whose disease had not progressed after concurrent or sequential chemoradiotherapy

CStone Pharmaceuticals (“CStone”, HKEX: 2616), a leading biopharmaceutical company focused on the discovery, development and commercialization of innovative immuno-oncology therapies and precision medicines today announced the presentation of final progression-free survival (PFS) analysis results from the pivotal GEMSTONE-301 study of sugemalimab as consolidation therapy in patients with unresectable stage III non-small cell lung cancer (NSCLC) whose disease had not progressed following concurrent or sequential chemoradiotherapy at the IASLC 2022 World Conference on Lung Cancer. The data showed that sugemalimab maintained a statistically significant and clinically meaningful improvement in PFS, as assessed by blinded independent central review (BICR). A subgroup analysis showed clinical benefits in patients who had received either concurrent or sequential chemoradiotherapy prior to sugemalimab treatment.

The GEMSTONE-301 trial is a multicenter, randomized, double-blind Phase 3 clinical trial designed to evaluate the efficacy and safety of sugemalimab as consolidation therapy in patients with unresectable stage III non-small cell lung cancer whose disease had not progressed following concurrent or subsequent chemoradiotherapy. In May 2021, the GEMSTONE-301 trial met its primary endpoint at a pre-planned interim analysis. Results showed that sugemalimab demonstrated a statistically significant and clinically meaningful improvement in PFS compared with placebo. Subgroup analyses showed that sugemalimab was associated with clinical benefits regardless of whether patients received concurrent or sequential chemoradiotherapy prior to treatment with sugemalimab.

The results presented at WCLC 2022 were based on data from the final PFS analysis. As of March 1, 2022, the key outcomes of this study are as follows:

* BICR-estimated median PFS: 10.5 months for sugemalimab vs. 6.2 months for placebo (HR= 0.65, 95% CI 0.50-0.84)

– In patients who received sequential chemoradiotherapy:
median PFS was 8.1 months vs. 4.1 months, HR=0.57

– In patients receiving concurrent chemoradiotherapy, median PFS was 15.7 months vs. 8.3 months, HR=0.71

* Preliminary overall survival data showed a trend in favor
of sugemalimab, median overall survival (OS): Not reached
for sugemalimab versus 25.9 months for placebo (HR= 0.69, 95% CI 0.49-0.97)

– For patients who received sequential chemoradiotherapy:
Median OS was not achieved (24.1 months, HR=0.60)

– For patients receiving concurrent chemoradiotherapy, median OS was not achieved (32.4 months, HR=0.75)

* Objective response rate (ORR) was similar for sugemalimab and placebo, but duration of overall response (DoR) was longer for sugemalimab

– ORR: 24.5% vs 25.2%

– DoR: 24.1 months vs. 6.9 months

* Sugemalimab had a well-tolerated safety profile; no new safety signals were observed in the final PFS analysis

Professor Yi-Long Wu, director of Guangdong Provincial People’s Hospital and principal investigator of the GEMSTONE-301 trial, said: “The final PFS results of GEMSTONE-301 show that sugemalimab has PFS and OS benefits as consolidation therapy in patients with unresectable stage III NSCLC after concurrent or sequential chemoradiotherapy. The overall benefit was consistent with that seen in the PACIFIC trial. Sugemalimab could be used safely and effectively after concurrent or sequential chemoradiotherapy and become a standard of care for unresectable stage III NSCLC in this setting. Sugemalimab is approved in China for the treatment of patients with stage III NSCLC and is recommended as a preferred treatment option in the 2022 Chinese Society of Clinical Oncology (CSCO) clinical guidelines for primary NSCLC.”

Jason Yang, M.D., Chief Medical Officer of CStone, said, “We are pleased that the updated GEMSTONE-301 results will be presented at WCLC 2022 and highlighted in the press conference. In the final PFS analysis, sugemalimab demonstrated clinical benefits in patients receiving either concurrent or sequential chemoradiotherapy, while preliminary OS benefits were also observed. The preliminary PFS data were published in The Lancet Oncology. We are working with our partner to engage regulatory authorities worldwide and bring sugemalimab, with its robust efficacy and safety profile, to more cancer patients.”

About the GEMSTONE-301 Study

The GEMSTONE-301 study (registration number clinicaltrials.gov:
NCT03728556; clinicaltrials registration number:
CTR20181429) is a multicenter, randomized, double-blind Phase 3 clinical trial designed to evaluate the efficacy and safety of sugemalimab as consolidation therapy in patients with unresectable stage III NSCLC whose disease has not progressed after concurrent or sequential chemoradiotherapy. The primary endpoint of the study was PFS, assessed by BICR according to RECIST v1.1; secondary endpoints included OS, PFS as assessed by investigators, and safety.

In May 2021, the GEMSTONE-301 trial met its primary endpoint at a pre-planned interim analysis reviewed by the iDMC. Results showed that sugemalimab demonstrated a statistically significant and clinically meaningful improvement in BICR-assessed PFS. The investigator-assessed PFS showed consistent results as those of the primary endpoint. Sugemalimab was well tolerated, with no new safety signals. Subgroup analyses showed that sugemalimab was associated with clinical benefit regardless of whether patients received concurrent or sequential chemoradiotherapy prior to sugemalimab treatment. The data were presented in a Late Breaking Abstract (LBA) at the 2021 ESMO Annual Meeting and published in The Lancet Oncology in January 2022.

About Sugemalimab

The anti-PD-L1 monoclonal antibody sugemalimab was developed by CStone using the OmniRat® transgenic animal platform, which enables the generation of fully human antibodies in a single step. Sugemalimab is a fully human anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody that can reduce the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs.

Currently, the National Medical Products Administration of China has approved sugemalimab (Cejemly®):

* In combination with pemetrexed and carboplatin as a first-line treatment for patients with metastatic non-squamous non-small cell lung cancer (NSCLC) without genomic EGFR and ALK tumor aberrations; and in combination with
paclitaxel and carboplatin as first-line treatment of patients with metastatic non-small cell lung cancer

* For the treatment of patients with unresectable stage III non-small cell lung cancer, whose disease has not progressed after concurrent or sequential platinum-based chemoradiotherapy

Based on its proven therapeutic benefits, sugemalimab is recommended in the 2022 Chinese Society of Clinical Oncology (CSCO) clinical guidelines for the diagnosis and treatment of non-small cell lung cancer (NSCLC), in combination with chemotherapy as first-line treatment for patients with stage IV non-squamous/squamous NSCLC without driver changes; or as consolidation therapy in patients with stage III NSCLC after concurrent or sequential platinum-based chemoradiotherapy.

CStone entered into a strategic collaboration agreement with EQRx, under which EQRx licensed exclusive rights to sugemalimab for development and commercialization outside Greater China.

Julia Gao,
+86-18221656386,
[email protected]

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The post CStone presents updated results from pivotal study of sugemalimab in patients with stage III NSCLC in a presentation at WCLC 2022 appeared first on TOP News Austria – News from Austria and around the World.

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