Cejemly (sugemalimab) / SteinCares, Mediolanum Pharma, CStone Pharma, Pfizer, Ewopharma, Pharmalink - LARVOL DELTA

Economic value, affordability, and scale-up of adjuvant immunotherapies in lung cancer treatment: From cost-effectiveness decision to budget impact analysis. (PubMed, J Cancer Policy) - "Adjuvant immunotherapies for lung cancer deliver meaningful clinical benefits, but their economic value and affordability are highly context-specific. While several strategies are cost-effective at the individual patient level, health system affordability is strongly influenced by the pace and scale of adoption. Scenario-based budget impact analyses demonstrate that accelerated uptake can impose substantial short-term fiscal pressure, whereas phased or restricted implementation markedly improves affordability without altering cost-effectiveness conclusions. These findings underscore the importance of integrating cost-effectiveness evidence with explicit consideration of budget impact, adoption strategies, and managed entry mechanisms to support sustainable and equitable scale-up of adjuvant immunotherapies in routine clinical practice."

HEOR • IO biomarker • Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • PD-L1

Comparative Risks of Pneumonitis Amongst Immune Checkpoint Inhibitors in Patients with Lung Cancer: A Network Meta-Analysis of Randomized Clinical Trials. (PubMed, Pharmaceuticals (Basel)) - "Pembrolizumab was associated with a significantly increased risk of pneumonitis compared to placebo (odds ratio [OR] = 2.67, 95% confidence interval [CI]: 1.70-4.17), with similar elevated risk observed for sugemalimab (odds ratio [OR] = 2.45, 95% confidence interval [CI]: 1.52-3.95). Nivolumab was associated with increased odds of pneumonitis, although with unstable point estimate (odds Ratio [OR] = 2.69, 95% confidence interval [CI]: 0.64-11.35)...Atezolizumab and ipilimumab demonstrated modest or uncertain risk...Although the absolute incidence is low, the potential severity of pneumonitis warrants vigilant monitoring. These results should guide clinicians in risk stratification and treatment planning, and they should support the development of standardized reporting criteria and further comparative research."

Checkpoint inhibition • Clinical • Journal • Retrospective data • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Small Cell Lung Cancer • Solid Tumor

Sugemalimab Receives [I, A] Recommendation in ESMO Guideline for Consolidation Therapy in Patients with Stage III NSCLC (CStone Pharma Press Release) - "As per the latest ESMO guideline update: Sugemalimab consolidation therapy is recommended for patients with EGFR wild-type and no ALK or ROS1 genomic tumour aberrations, stage III NSCLC who have not progressed after concurrent or sequential chemoradiotherapy, for a duration of up to 24 months. This [I, A] recommendation applies to patients whose tumours express PD-L1 on ≥1% of tumour cells (TC) [ESMO-MCBS v2.0 score: 3; approved by European Medicines Agency (EMA)]. This recommendation is based on the results from the pivotal Phase III GEMSTONE-301 clinical trial..."

Clinical guideline • Non Small Cell Lung Cancer

First-Line Serplulimab versus Other Anti-PD-1/PD-L1 Antibodies Plus Chemotherapy for Esophageal Squamous Cell Carcinoma: A Systematic Review with Benefit-Risk Assessment via Matching-Adjusted Indirect Comparison. (PubMed, Biologics) - "The pooled adjusted OS HR was 0.98 (95% CI, 0.87-1.11), with numerically favorable OS versus nivolumab (HR, 0.76; 95% CI 0.47-1.24) and comparable OS versus pembrolizumab (HR, 0.93; 95% CI, 0.71-1.22) and camrelizumab (HR, 0.93; 95% CI, 0.70-1.24). The pooled adjusted PFS HR was 0.91 (95% CI, 0.81-1.02), significantly favoring serplulimab over nivolumab (HR, 0.56; 95% CI, 0.33-0.96), with favorable trends versus pembrolizumab (HR, 0.83; 95% CI, 0.63-1.10) and sugemalimab (HR, 0.86; 95% CI, 0.63-1.16)...This indirect comparison provides comparative benefit-risk evidence to inform first‑line treatment selection for locally advanced or metastatic ESCC. Serplulimab plus chemotherapy demonstrated a clinically meaningful PFS benefit, comparable OS after matching, and a manageable safety profile consistent with the PD-1/PD-L1 inhibitor class."

Benefit-risk assessment • Journal • Review • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Sugemalimab for Post-PD-1 Progression in Non-small Cell Lung Cancer. (PubMed, J Immunother) - "Hypothyroidism was the most common treatment-related adverse event, while grade 3/4 events were uncommon. These findings indicate measurable activity of sugemalimab-based rechallenge in a pre-enriched population and support prospective validation with biomarker-informed stratification."

IO biomarker • Journal • Endocrine Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-1 • PD-L1

Sugemalimab as monotherapy for unresectable stage III non-small cell lung cancer with PD-L1 expression≥1%, without oncogenic driver alterations and without progression after chemoradiation (PubMed, Bull Cancer) - No abstract available

IO biomarker • Journal • Monotherapy • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Cost-effectiveness of sugemalimab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced oesophageal squamous cell carcinoma in China. (PubMed, BMJ Open) - "From a Chinese healthcare system perspective, sugemalimab plus chemotherapy as first-line treatment for advanced ESCC might not be a cost-effective treatment option at the WTP threshold of $38 024.68/QALY."

HEOR • Journal • Esophageal Squamous Cell Carcinoma • Gastrointestinal Disorder • Oncology • Squamous Cell Carcinoma

Model-Informed Dosing Regimen of Sugemalimab for European Patients With Non-Small Cell Lung Cancer: Bridging From Asian Clinical Data. (PubMed, CPT Pharmacometrics Syst Pharmacol) - "The proposed regimen of 1500 mg Q3W for patients weighing over 115 kg ensures consistent therapeutic exposure, efficacy, and safety across diverse populations. The MIDD strategy for bridging dose regimens, substantiated by this study, enabled regulatory approval by the European Medicines Agency (EMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) without the need for additional dedicated clinical trials."

Clinical data • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

CStone Pharmaceuticals…announced that the UK MHRA has granted a new indication for sugemalimab as a monotherapy for adult patients with unresectable stage III NSCLC with PD-L1 expression on ≥1% of tumour cells and no sensitising EGFR mutations, or ALK, ROS1 genomic aberrations and whose disease has not progressed following platinum-based chemoradiotherapy (CRT) (PRNewswire) - "This approval is based on the GEMSTONE-301 study, a multicenter, randomized, double-blind Phase III trial."

MHRA approval • Non Small Cell Lung Cancer

Cejemly: “Extension of indication to include the treatment of unresectable stage III non‑small‑cell lung cancer with no sensitising EGFR mutations, or ALK, ROS1 genomic tumour aberrations in adults …based on final results from study CS1001-301…as a consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC are updated” (European Medicines Agency) - CHMP Final Minutes of the meeting on 21 - 24 Jul 2025: “The committee adopted a request for supplementary information with a specific timetable”

CHMP • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Study of Sugemalimab (or Placebo) Plus PGemOx Regimen in Participants With Extranodal NK/T-Cell Lymphoma (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: CStone Pharmaceuticals | Trial completion date: Jun 2029 ➔ Dec 2029 | Trial primary completion date: Jun 2028 ➔ Dec 2028

Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

GEMSTONE-304: A phase 3 study of sugemalimab plus chemotherapy versus chemotherapy as first-line treatment of patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) (ESMO-GI 2023) - P3 | "Sugemalimab (Suge), an anti-PD-L1 monoclonal antibody, plus fluorouracil and cisplatin (FP) regimen demonstrated preliminary anti-tumor activity in a phase 1b cohort of patients (pts) with advanced ESCC. Suge plus FP demonstrated statistically significant and clinically meaningful prolongation of PFS and OS, and improvement of ORR compared with Pbo plus FP. The safety profile was manageable with no new safety signals detected. These results support the use of Suge plus FP as 1L treatment for unresectable locally advanced, recurrent or metastatic ESCC."

Clinical • IO biomarker • Metastases • P3 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Oncology

Sugemalimab Monotherapy for Patients With Relapsed or Refractory Extranodal Natural Killer/T-Cell Lymphoma (GEMSTONE-201): Results From a Single-Arm, Multicenter, Phase II Study. (PubMed, J Clin Oncol) - "Sugemalimab showed robust and durable antitumor activity in R/R ENKTL. Treatment was well tolerated with expected safety profile for this drug class."

Journal • Monotherapy • P2 data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Sugemalimab versus placebo, in combination with platinum-based chemotherapy, as first-line treatment of metastatic non-small-cell lung cancer (GEMSTONE-302): 4-year outcomes from a double-blind, randomised, phase 3 trial. (PubMed, Lancet Oncol) - P3 | "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."

IO biomarker • Journal • P3 data • Hematological Disorders • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1

First-Line Sugemalimab Plus Chemotherapy for Advanced Gastric Cancer: The GEMSTONE-303 Randomized Clinical Trial. (PubMed, JAMA) - P3 | "To evaluate the efficacy of sugemalimab in combination with capecitabine and oxaliplatin (CAPOX) compared with placebo plus CAPOX as first-line treatment for patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with PD-L1 combined positive score (CPS) of 5 or greater. Sugemalimab plus chemotherapy significantly prolonged overall survival and progression-free survival with a manageable safety profile in previously untreated patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. ClinicalTrials.gov Identifier: NCT03802591."

Clinical • Journal • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Cost-effectiveness analysis of sugemalimab plus chemotherapy for the first-line treatment of advanced gastric cancer or gastroesophageal junction cancer. (PubMed, Hum Vaccin Immunother) - "Subgroup analyses indicated that S + C was more cost-effective in patients with advanced GC/GEJC with programmed cell death ligand 1 combined positive score ≥10. Compared to P + C, S + C is currently not an economically viable option for first-line treatment of advanced GC/GEJC in China."

HEOR • Journal • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • PD-L1

Efficacy and safety of immune checkpoint inhibitors for advanced squamous non-small cell lung cancer: a systematic review and network meta-analysis. (PubMed, Front Immunol) - "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) [OR = 2.0, 95% CI:(1.5-2.7)]. https://www.crd.york.ac.uk/prospero/, identifier CRD420251027447."

Checkpoint inhibition • Clinical • IO biomarker • Journal • Retrospective data • Review • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Efficacy and safety of first-line treatments in HER2-negative advanced gastric and gastroesophageal junction cancer (GC/GEJC): A systematic review and Bayesian network meta-analysis (ESMO-IO 2025) - "Among these regimens, cadonilimab +chemo and SHR-1701 +chemo achieved similar OS improvement, ranking first (HR 0.66; 95% Crl 0.54, 0.81) and second (HR 0.66; 95% Crl 0.53, 0.81) respectively, followed by zolbetuximab + chemo (HR 0.76; 95% Crl 0.65, 0.89), sintilimab + chemo (HR 0.77; 95% Crl 0.63, 0.94) and other regimens...Similar results were observed in patients with PD-L1 CPS ≥ 5. Regarding grade ≥3 TRAEs, compared with chemo alone, sugemalimab + chemo (OR 1.145; 95% Crl 0.804, 1.627), SHR-1701 + chemo (OR 1.165; 95% Crl 0.863, 1.557), and tislelizumab + chemo (OR 1.174; 95% Crl 0.919, 1.51)showed better safety profile than other regimens.Conclusions Considering the balance between efficacy and safety, SHR - 1701 + chemo might be considered the preferred first-line treatment for patients with HER2-negative advanced GC/GEJC, particularly those with PD-L1 CPS ≥1 or CPS ≥5."

Metastases • Retrospective data • Review • Esophageal Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2 • PD-L1

Sugemalimab-based combination therapy in treatment-naïve advanced and locally advanced non-small cell lung cancer (NSCLC): Outcomes from a real-world dual-cohort study (ESMO-IO 2025) - "Median PFS was 21.3 months (95% CI, 12.9–NR), with 12- and 18-month PFS rates of 71.6% and 59.6% respectively.Conclusions Sugemalimab-based combination therapy showed durable efficacy and manageable safety in both advanced and locally advanced NSCLC. Real-world outcomes were consistent with pivotal trials, with notable survival benefits in stage IV and promising PFS rates in stage III with induction immunochemotherapy followed by radiotherapy and immunotherapy consolidation."

Clinical • Combination therapy • Metastases • Real-world • Real-world evidence • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Exploration of immunotherapy modalities in stage III unresectable non-small cell lung cancer (Review). (PubMed, Oncol Lett) - "Durvalumab consolidation therapy extended the median progression-free survival (mPFS) from 5.6 to 16.9 months [hazard ratio (HR)=0.55] and the median overall survival from 29.1 to 47.5 months (HR=0.72), thus increasing the 5-year survival rate by ~10%. Sugemalimab demonstrated similar benefits (mPFS, 9.0 vs. 5.8 months; HR=0.64)...Furthermore, emerging therapeutic modalities such as antibody-drug conjugates and bispecific antibodies are potentially expected to further reshape the treatment landscape in the future. The present review aimed to provide an evidence-based framework for individualized precision treatment for stage III unresectable NSCLC."

Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Cost-effectiveness of sugemalimab plus chemotherapy as first-line therapy in advanced gastric cancer and gastroesophageal junction cancer. (PubMed, Ann Med) - "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."

HEOR • IO biomarker • Journal • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • PD-L1

Real-world First-line Sugemalimab-Chemotherapy in Advanced NSCLC (clinicaltrials.gov) - P=N/A | N=150 | Recruiting | Sponsor: Peking Union Medical College

New trial • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Sugemalimab Achieves New Global Milestone (CStone Pharma Press Release) - "CStone Pharmaceuticals...announced that the European Commission (EC) has approved a new indication for sugemalimab as a monotherapy for adult patients with unresectable stage III non-small cell lung cancer (NSCLC) with PD-L1 expression on ≥1% of tumour cells and no sensitising EGFR mutations, or ALK, ROS1 genomic aberrations and whose disease has not progressed following platinum-based chemoradiotherapy (CRT)."

EMA approval • Non Small Cell Lung Cancer

PRAC adopted an extension of indication for CEJEMLY to treat adults with unresectable stage III NSCLC without EGFR/ALK/ROS1 alterations whose disease has not progressed after platinum-based chemoradiotherapy, based on final CS1001-301 results. SmPC sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2, the Package Leaflet, and RMP version 2.0 were updated. (European Medicines Agency) - Pharmacovigilance Risk Assessment Committee (PRAC) Minutes of meeting on 29 Sep - 2 Oct 2025: [AI generated summary]

PRAC • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Systematic Literature Review and Bayesian Network Meta-Analysis of Sugemalimab Plus Chemotherapy vs. Other First-Line Treatments for Metastatic Non-Small Cell Lung Cancer Without Sensitizing eGFR, ALK, ROS1, or RET Alterations (ISPOR-EU 2025) - "Sugemalimab plus chemotherapy demonstrated comparable efficacy and safety to other 1L PD-1/PD-L1-based regimens in mNSCLC patients without oncogenic drivers, supporting its use across a broad patient population."

IO biomarker • Metastases • Retrospective data • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1