Cejemly (sugemalimab)

The GEMSTONE-303 trial demonstrated that sugemalimab combined with capecitabine and oxaliplatin (CAPOX) improved survival benefit in patients with advanced gastric/gastroesophageal junction cancer (GC/GEJC) and a programmed death-ligand 1 (PD-L1) combined positive score (CPS) ≥5. It is essential to adopt a combination of targeted patient selection, price negotiation, and broader PAP access to bring the ICER below the WTP threshold. These findings inform reimbursement negotiations and highlight the need for stratified pricing strategies to optimize accessibility in economically diverse populations.

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.