Keystone Pharmaceuticals Shugli single-resistance first-line data debuted at ESMO.

Esophageal cancer is also a common gastroesophageal tumor, the incidence rate of malignant tumors in the world ranked 7th, the mortality rate ranked 6th;
China's esophageal cancer to esophageal squamous cell carcinoma (ESCC) mainly, accounting for more than 90% of esophageal cancer, treatment options are limited and poor prognostic, the overall five-year survival rate of less than 30%.
75% of patients were diagnosed with advanced stages or with long-term metastasis, and the medium survival time of patients after the failure of first-line treatment was nearly 5 to 10 months, and new treatments were urgently needed.
years, immunotherapy has broken the treatment bottleneck of many malignant tumors and ushered in new breakthroughs.
Shugli monoanti (CS1001) is an all-human full-length anti-PD-L1 monoclonal antibody developed by Keystone Pharmaceuticals, which has a unique advantage in terms of safety compared to similar drugs, the immunogenicity of Shugli monoantigen and the associated toxicity in patients.
Early preclinical studies have shown that CS1001, in addition to blocking the interaction between PD-L1 and PD-1 to revitalise abnormally functioning tumor immersion effect T cells and inhibit tumor cell proliferation, can also induce antibody-dependent cell-based phagocytosphagy (ADCP)-mediated tumor killing and enhance T-cell initiation by interlinking PD-L1-positive tumor cells with macrophages.
CS1001 combined chemotherapy first-line treatment GC/GEJ and ESCC are under the leadership of Professor Shen Lin and Professor Li Jin to carry out the domestic multi-center clinical Phase III trial.
ESMO 2020 conference, Keystone Pharmaceuticals brought the latest effectiveness and safety data for the GC/GEJ and ESCC queues in CS1001 Ib clinical studies.
study designed the GC/GEJ(1L) queue to include patients with endogenous advanced or metastatic gastric or gastroesophageal combined cancer identified in histology who had not received systematic treatment and could not be surgically removed.
ESCC (1L) queue: includes local advanced, relapsed, or metastatic esophageal squamous cell carcinoma that has been confirmed by histology as non-surgically removable.
study, patients were injected with 1200mg fixed dose CS1001 every 3 weeks, and the GC/GEJ (1L) queue received up to 6 cycles of oxalipalin (130mg/m2, given once every 3 weeks) and carpedabin (1000mg/m2; oral, 2 times daily, d1-14); ESCC (1L) queues receive 5-fluorouracil (800 mg/m2/d, intravenous drips, 1 cycle every 3 weeks) and cisplatin (80 mg/m2, intravenous drips, 1 cycle every 3 weeks), and all cohort patients are given medication until the condition worsens or is not acceptable.
study endpoint was the therapeutic effect of CS1001 combined chemotherapy on GC/GEJ or ESCC evaluated according to RECISTv1.1 standard, and the secondary endpoint was the safety and tolerance of CS1001 combined chemotherapy.
29 and 39 patients, respectively, were recruited in the GC/GEJ and ESCC queues as of February 19, 2020.
baselines for patients are shown in the table below: GC/GEJ cohort patients have a medium age of 60 years, 89.7% of patients are GC, and the vast majority of patients are in advanced cancer (96.6%, Stage IV.); The middle age of ESCC queue patients was 61 years old, and 89.7% of patients were in advanced stage tumors (Stage IV.).
29 patients in the GC/GEJ queue were analyzed for effectiveness as of February 19, 2020.
18 (62.1%) patients achieved partial remission (PR), including 17 confirmed PR and 1 undiagnosed PR;
medium mitigation duration (mDoR) is 11.3 months, the medium non-progression lifetime (mPFS) is 8.3 months, and the medium total lifetime (mOS) is 17.0 months.
as of February 19, 2020, 37 patients from the ESCC queue (2 patients who had not reached the first tumor assessment time after treatment) had been analyzed effectively, and 25 (67.6%) patients had reached PR, including 20 cases PR and 5 cases of unrefirmed PR were confirmed; 8 patients with SD (21.6%), 2 cases (5.4%) PD, and 2 patients (5.4%) stopped treatment (i.e. not applicable) at the time of tumor assessment after the baseline was not reached.
orR is 68%, mPFS is 9.0 months, mDoR and mOS are still not reached.
19 February 2020, the mid-range time for CS1001 treatment in the GC/GEJ and ESCC queues was 232 days (range: 21-523) and 172 days (range: 21-488), respectively.
security, in the GC/GEJ queue, the rates of all grades associated with CS1001 and level 3 AEs were 96.6% and 48.3%, respectively.
, the most common (n-2 cases) associated with CS1001 was a decrease in plate plate count (n=6), a decrease in white blood cell count (n=3), a decrease in the neutral granulocyte count (n=3), anemia (n=3) and fatigue (n=2).
in the ESCC queue, all levels associated with CS1001 and level 3 adverse events (AEs) were 87.2% and 41.0%, respectively.
the most common (n-2 cases) - 3 levels of CS1001-related AEs include anemia (n-6), reduced white blood cell count (n=3), reduced neutral granulocyte count (n=3), increased blood amylase (n=3), decreased plateboard count (n=2), hyponamicemia (n=2) and fatigue (n=2).
, we expect that, under the leadership of Professors Shen Lin and Li Jin, two first-line double-blind, randomized clinical Phase III studies of CS1001 Combined Standard Chemotherapy (SoC) will be CONDUCT-303 (CS1001-303, NCT03802591) and GEMSTONE-304 (CS1001-304, NCT04187352) have been successful early, providing patients with better first-line treatment options.
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