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

Safety and Efficacy of NK510 to Treat NSCLC (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Base Therapeutics (Shanghai) Co., Ltd. | Trial completion date: Jul 2026 ➔ Jul 2028 | Trial primary completion date: Jul 2026 ➔ Jul 2027

First-in-human • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1

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 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

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

First-line sugemalimab plus chemotherapy for metastatic non-small-cell lung cancer: an updated cost-effectiveness analysis based on 4-year survival data. (PubMed, Expert Rev Pharmacoecon Outcomes Res) - "Sugemalimab plus chemotherapy may not be a cost-effective option as first-line treatment for metastatic NSCLC compared with chemotherapy, despite its clinical benefits. Implementing a PAP or reducing the price of sugemalimab could improve its cost-effectiveness."

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

GEMSTONE-302: A Study of CS1001 in Subjects With Stage IV Non-Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=479 | Completed | Sponsor: CStone Pharmaceuticals | Active, not recruiting ➔ Completed | Trial completion date: Jun 2027 ➔ Jul 2026

IO biomarker • Trial completion • Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

SCOPE: Phase II Study of Induction Chemoimmunotherapy Followed by Radiotherapy and Organ Preservation in Resectable ESCC (clinicaltrials.gov) - P2 | N=140 | Active, not recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

CStone Pharmaceuticals Enters into Exclusive Commercialization Agreement with Arrotex for Sugemalimab across Australia and New Zealand (PRNewswire) - "Under the terms of the agreement, CStone will receive an upfront payment from Arrotex and is eligible for additional regulatory and commercial milestone payments. CStone will supply sugemalimab to Arrotex and recognize a profit share arrangement. Arrotex will hold exclusive commercialization rights for sugemalimab in Australia and New Zealand across all approved and future indications, including stage III and IV non-small cell lung cancer (NSCLC), gastric cancer (GC), esophageal squamous cell carcinoma (ESCC), and extranodal NK/T-cell lymphoma (ENKTL), subject to regulatory approval by Australia's Therapeutic Goods Administration (TGA). Arrotex will be responsible for regulatory submissions and commercialization activities in the licensed territory."

Licensing / partnership • Esophageal Squamous Cell Carcinoma • Extranodal Natural Killer/T-cell Lymphoma • Gastric Cancer • Non Small Cell Lung Cancer

Consolidation PD-(L)1 inhibitor after definitive chemoradiotherapy for unresectable stage III NSCLC: Systematic review and meta-analysis of randomized controlled trials. (ASCO 2026) - "Sugemalimab is approved for NSCLC indications in China and the UK but is not FDA-approved in the US... Consolidation PD-(L)1 inhibition after definitive CRT significantly improves PFS in unresectable stage III NSCLC, with an OS signal that requires longer follow-up. Discontinuation due to AEs is increased. Longer follow-up is needed to clarify long-term survival outcomes and infrequent safety events."

Retrospective data • Review • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

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: Dec 2029 ➔ Dec 2030 | Trial primary completion date: Dec 2028 ➔ Dec 2029

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

Immunotherapy combined with chemotherapy as first-line treatment for HER2-negative advanced gastric or gastroesophageal junction cancer: systematic review and Bayesian network meta-analysis based on specific PD-L1 expression levels. (PubMed, BMC Cancer) - "In conclusion, these findings support immunotherapy-combination chemotherapy as a superior first-line strategy for HER2-negative advanced G/GEJC. Different optimal regimens can be selected based on PD-L1 expression levels, providing evidence-based guidance for clinical decision-making."

Biomarker • IO biomarker • Journal • Retrospective data • Review • Gastric Cancer • Oncology • Solid Tumor • HER-2 • PD-L1

SCS-Lung01: Safety and Tolerability of LDRT+Sugemalimab+Chemotherapy+Olaparib for First-Line Treatment of SLFN-11 Positive ES-SCLC (clinicaltrials.gov) - P1/2 | N=45 | Recruiting | Sponsor: Sichuan University | Trial completion date: Mar 2027 ➔ Oct 2028 | Trial primary completion date: Jun 2026 ➔ Oct 2027

Trial completion date • Trial primary completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Efficacy of first-line immune checkpoint inhibitors in advanced non-small-cell lung cancer with or without brain metastases: a systematic review and network meta-analysis. (PubMed, Front Oncol) - "Bayesian rankings favor cemiplimab, sugemalimab, or camrelizumab plus chemotherapy for patients with brain metastases, and pembrolizumab or sintilimab plus chemotherapy for those without. These findings, currently limited by low-certainty indirect evidence, warrant validation in adequately powered, head-to-head trials. https://www.crd.york.ac.uk/prospero/, identifier CRD420251236228."

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

First-line treatments for metastatic non-small-cell lung cancer with sugemalimab plus chemotherapy: a China-based cost-effectiveness analysis. (PubMed, Immunotherapy) - "Sugemalimab plus platinum-based chemotherapy offers long-term clinical benefits for metastatic NSCLC but is not cost-effective at current prices in China. Improving cost-effectiveness may require targeting patients with high PD-L1 expression, adjusting reimbursement policies, and reducing drug prices."

HEOR • IO biomarker • Journal • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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