Cejemly (sugemalimab)

In comparison, other ICIs approved in China-Pembrolizumab, Nivolumab, Sintilimab, Tislelizumab, and Sugemalimab-incurred total costs of $11,735, $13,970, $16,346, $10,765, and $14,857, respectively, generating 0.68 QALYs (1.04 LYs), 0.69 QALYs (1.04 LYs), 0.73 QALYs (1.12 LYs), 0.82 QALYs (1.26 LYs), and 0.81 QALYs (1.25 LYs)...Cadonilimab is not a cost-effective option for the first-line treatment of advanced HER2-negative GC/GEJC. In comparison to other ICIs approved in China, Tislelizumab appears to be a more favorable option.

Compared with chemotherapy, except for ipilimumab+chemo [HR = 0.92,95%CI: (0.59-1.40)], atezolizumab+chemo [HR = 0.88, 95%CI: (0.56-1.40)], and durvalumab+chemo [HR = 0.84, 95% CI: (0.52-1.40)], durvalumab+ tremelimumab+chemo [HR = 0...Cemiplimab [HR = 0.48, 95% CI: (0.34-0.67)] showed the best OS benefit...Sugemalimab+chemo provided the best survival benefit [HR = 0.34, 95% CI: (0.24-0.48)]. For PD-L1≥50% tumors, penpulimab showed excellent OS and PFS; for PD-L1 1-49% tumors, pembrolizumab+chemo and camrelizumab+chemo achieved the best OS and PFS, respectively; for PD-L1≥1% tumors, the tislelizumab+chemo and camrelizumab+chemo showed the best OS and PFS results, while for tumors with PD-L1 <1%, both nivolumab and serplulimab+chemo provided significant survival benefit...Ipilimumab+chemo had the highest incidence of adverse events (AEs) &lsqb;OR = 2.0, 95% CI:(1.5-2.7)]. https://www.crd.york.ac.uk/prospero/, identifier CRD420251027447.

Both ICERs exceeded the willingness-to-pay (WTP) threshold of $40,343.68 per QALY.Probabilistic sensitivity analysis demonstrated that the probability of sugemalimab plus chemotherapy being cost-effective at the WTP threshold was 0% and 1.5% for the PD-L1 CPS ≥ 5 and CPS ≥ 10 subgroups, respectively.Sensitivity analyses showed that the results were robust to parameter variations. The findings suggest that sugemalimab plus chemotherapy was not a cost-effective treatment option for advanced gastric cancer compared to chemotherapy alone in China.

P1, N=9, Recruiting, Base Therapeutics (Shanghai) Co., Ltd. | Trial completion date: Jul 2024 --> Jul 2026 | Trial primary completion date: Jul 2024 --> Jul 2026

Results from the GEMSTONE-303 trial indicate that compared with placebo plus capecitabine and oxaliplatin (PLA-CAP), sugemalimab plus capecitabine and oxaliplatin (SUG-CAP) as first-line therapy provides clinical benefits for patients with advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with programmed cell death ligand 1 (PD-L1) combined positive score (CPS) ≥5. The parameters that significantly affected the model were the cost of sugemalimab, progression-free survival (PFS) utility, and discount rate. From the perspective of China's healthcare system, SUG-CAP as first-line therapy for advanced G/GEJ adenocarcinoma with PD-L1 CPS ≥5 is not cost-effective compared with chemotherapy alone.

P1, N=45, Recruiting, West China Hospital of Sichuan University; West China Hospital of Sichuan University | Not yet recruiting --> Recruiting

P3, N=479, Active, not recruiting, CStone Pharmaceuticals | Trial completion date: Jun 2025 --> Jun 2027

P3, N=150, Not yet recruiting, CStone Pharmaceuticals | Trial completion date: Nov 2028 --> Jun 2029 | Trial primary completion date: Nov 2027 --> Jun 2028

P2, N=25, Recruiting, Shanghai Pulmonary Hospital, Shanghai, China | Not yet recruiting --> Recruiting

Current pricing renders sugemalimab combination therapy economically unfavorable as first-line ESCC treatment in China. Strategic price adjustments could enhance cost-effectiveness potential.

Sugemalimab with chemotherapy showed a superior long-term overall survival benefit compared with placebo with chemotherapy, as a first-line treatment for patients with NSCLC with no known sensitising EGFR, ALK, ROS1, or RET genomic alterations. These results underscore the efficacy of sugemalimab plus platinum-based chemotherapy as a standard first-line treatment option for both squamous and non-squamous metastatic NSCLC while maintaining a manageable safety profile.

P2, N=25, Not yet recruiting, Shanghai Pulmonary Hospital, Shanghai, China