Keystone Pharmaceuticals announces detailed results of GEMSTONE-302 clinical studies

GEMSTONE-302 is the world's first randomized double-blind Phase III clinical trial of anti-PD-L1 mono-anti-combination chemotherapy as a first-line treatment in patients with stage IV squamous and non-squamous non-small cell lung cancer (NSCLC).
the study was designed to assess the effectiveness and safety of Shugli's monoantigen combination chemotherapy in patients without first-line treatment, phase IV NSCLC, compared to placebo combination chemotherapy.
the main endpoint of the study was the PFS assessed by the researchers, and the secondary endpoints included total lifetime, PFS and safety assessed by the Blind Independent Center Review Committee (BICR).
As of June 8, 2020, the study included 479 patients in the study, and in-period analysis data showed that Shugli single-anti-combination chemotherapy compared to placebo combined chemotherapy significantly prolonged the patient's progression-free survival (PFS), reaching the main endpoint of the study.
in all patients with scaly and non-scaly NSCLC, the researchers assessed a medium PFS of 7.8 months vs. 4.9 months, with a risk ratio of HR to 0.5 (95% CI: 0.39, 0.64), p.lt;0.0001. The mid-PFS assessed by BICR was 8.September vs 4.9, with a risk ratio of HR to 0.54 (95% CI: 0.41, 0.70), p.lt;0.0001. Shugli monotherapy benefits both squamous and non-squamous patients.
patients with squamous cancer, the medium PFS was 7.16 vs 4.70, respectively, and HR was 0.33; In non-squamous patients, the medium PFS was 8.57 vs. 5.16, respectively, and HR was 0.66. Shugli monoantigen combination chemotherapy benefited from PD-L1 expression ≥1% and PD-L1 expression in 1% of patients, PD-L1 expression ≥1% of patients, with a medium PFS of 8.90 months vs 4.90 months, HR of 0.42; PD-L1 Expressions - 1% patients, with a medium PFS of 6.97 months vs 4.93 months, HR of 0.66 The objective remission rate of Shugli monoantigen combination chemotherapy was higher than that of the placebo combination chemotherapy group: 61.4% vs 39.2%, p.lt;0.0001.
duration (DoR) of Sugley monoantigen combination chemotherapy was longer than that of the placebo combination chemotherapy group: 9.69 months (7.43, NR) vs 3.68 (3.48, 5.72) Clinical benefits were observed in patients with poor clinical prognosis for brain transfer and liver metastasis, with the researchers evaluating the medium PFS at 10.January vs 4.5 months vs. 3.9 months, respectively. OS data is not yet mature, but the Shugli monoantigen joint group has shown total survival benefits (HR=0.66, p=0.0338) compared to the placebo joint group. The safety of Shugli monoantigen combination chemotherapy was good, no new safety signals were found, the proportion of adverse reactions was basically the same in Shugli monoantigen combination chemotherapy group and placebo combination chemotherapy group, the most common adverse events of any level of treatment period (TEAE) were anemia 73.8% vs. 70.4%, neutral granulocytes decreased by 56.3% vs 59.1%, and white blood cell count decreased by 55.3% vs. vs. vs. vs. 5 7.9%; ≥3 LEVEL TEAE occurrence rate 61.9% vs 61.6%, resulting in death TAAE 5.6% vs 5.7%: Immune-related adverse reactions have a lower rate, mostly CTCAE 1-2, where the occurrence rate of more than 5% of immuno-related adverse reactions including hyperthyroidism and hypothyroidism.
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