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

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

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

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.Legal entity responsible for the study The authors."

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

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

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.Legal entity responsible for the study M. You."

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

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

Comparison of immunotherapy regimens in locally advanced or metastatic gastric or gastroesophageal junction cancer: A systematic review and Bayesian network meta-analysis (KINGCA Week 2025) - "For PFS (14 trials, 9489 patients), cadonilimab plus chemotherapy [HR 0.53, 95% credible interval 0.39-0.73], sintilimab plus chemotherapy [HR 0.64, 0.47-0.88], sugemalimab plus chemotherapy [HR 0.66, 0.48-0.91], pembrolizumab plus chemotherapy [HR 0.77, 0.65-0.91], and nivolumab plus chemotherapy [HR 0.79, 0.67-0.98] were among the most effective regimens...The overall risk of bias was low to some concerns. CONCLUSIONS : Our findings indicate that cadonilimab plus chemotherapy achieved the best PFS and OS for patients with advanced GC or GEJC."

Metastases • Retrospective data • Review • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Cost-effectiveness analysis of Cadonilimab in first-line treatment of advanced HER2-negative gastric cancer or gastroesophageal junction cancer. (PubMed, Therap Adv Gastroenterol) - "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."

HEOR • Journal • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

Subcutaneously administered anti-PD-(L)1 antibodies are predominantly absorbed via the lymphatic system, resulting in high drug exposure to draining lymph nodes. (PubMed, J Pharm Sci) - "The current study aimed to examine the absorption route of widely used anti-PD-(L)1 mAbs following SC injection, and four marketed products (Pembrolizumab, Tislelizumab, Envafolimab, Sugemalimab) were selected as the model drugs...In addition, markedly different lymphatic absorption profiles were observed following SC administration at different sites, reflecting specific draining routes associated with certain anatomical regions in the rat. Our data suggested that the food pad is likely the optimal SC injection site for quantitative studies of lymphatic transport, whereas injection to the lower hind leg (a common SC injection site in previous studies) appeared to underestimate the absolute extent of lymphatic drug transport in the thoracic lymph-duct cannulated rat model, as these sites are drained by lymphatic networks that cannot be fully captured by the thoracic lymph-duct cannulation model."

Journal

A phase Ib trial of CS5001 (ROR1-ADC) as a single agent and in combination with systemic therapies in patients with advanced solid tumours and lymphomas (ESMO 2025) - P1 | "Table: 1316eTiP Monotherapy cohorts (≥2 prior LoT) Combination therapy cohorts A CLL and other indolent B-cell non- Hodgkin lymphoma E DLBCL, ≥1 prior LoT CS5001 + R-GemOx B r/r DLBCL F DLBCL, ≥1 prior LoT CS5001 + R2 C r/r follicular lymphoma G untreated DLBCL CS5001 + R-CHOP D r/r classical Hodgkin lymphoma H solid tumour, ≥1 prior LoT CS5001 + sugemalimab I ROR1-positive solid tumour Abbreviations: LoT: line of therapies; CLL: chronic lymphocytic leukemia; r/r: relapsed/refractory; DLBCL: Diffused Large B Cell Lymphoma; R-GemOx: rituximab, gemcitabine and oxaliplatin; R2: rituximab and lenalidomide; R-CHOP: rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone. Legal entity responsible for the study CStone Pharmaceuticals Co., Ltd. Funding CStone Pharmaceuticals Co., Ltd."

Clinical • Combination therapy • Metastases • P1 data • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Classical Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • ROR1

The Cost-Effectiveness of Sugemalimab Plus CAPOX in Treating Advanced Gastric Cancer: Analysis from the GEMSTONE-303 Trial. (PubMed, Cancers (Basel)) - "Sugemalimab plus CAPOX is not cost-effective for advanced or metastatic G/GEJ adenocarcinoma from the Taiwan payer's perspective. Achieving cost-effectiveness would require a 20-30% price reduction for sugemalimab (to USD 1204-USD 1376 per 600 mg), assuming first-line therapy is administered for the median treatment duration observed in the GEMSTONE-303 trial. If reimbursement continued until disease progression, a reduction of approximately 68% would be required (USD 550 per 600 mg)."

HEOR • Journal • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Oral Cancer • Solid Tumor

CStone Announces CHMP Positive Opinion for Sugemalimab in Stage III NSCLC, Expanding Its Potential Use to Cover Both Stage III and IV NSCLC in Europe (CStone Pharma Press Release) - "CHMP’s recommendation for sugemalimab’s new indication is primarily based on the compelling results from the pivotal Phase III GEMSTONE-301 study, a multicenter, randomized, double-blind clinical trial that demonstrated dual benefits of sugemalimab in progression-free survival and overall survival among patients with stage III NSCLC."

CHMP • Non Small Cell Lung Cancer

The Cost-Effectiveness of Sugemalimab Plus CAPOX in Treating Advanced Gastric Cancer: Analysis from the GEMSTONE-303 Trial (Multidisciplinary Digital Publishing Institute) - "Compared to capecitabine and oxaliplatin (CAPOX) alone, adding sugemalimab yielded an incremental gain of 0.39 QALYs at an additional cost of USD 47,020, resulting in an incremental net monetary benefit of −USD 7478."

HEOR • Gastric Cancer

PRAC adopted an extension of indication for Cejemly to include adults with unresectable stage III NSCLC without sensitising EGFR or ALK/ROS1 aberrations whose disease has not progressed after platinum-based chemoradiotherapy. The decision is based on final results from Phase 3 study CS1001-301 evaluating sugemalimab as consolidation therapy. (European Medicines Agency) - Pharmacovigilance Risk Assessment Committee (PRAC)-Draft agenda for the meeting on 29 Sep - 2 Oct 2025: Updates were made to SmPC sections 4.1, 4.2, 4.4, 4.8, 5.1, 5.2, the Package Leaflet, and RMP version 2.0. [AI generated summary]

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

Treatment Strategies for First-Line PD-L1-Unselected Advanced NSCLC: A Comparative Review of Immunotherapy-Based Regimens by PD-L1 Expression and Clinical Indication. (PubMed, Diagnostics (Basel)) - " PD-1-targeted therapies demonstrated superior OS compared to PD-L1-based regimens, with cemiplimab monotherapyranking highest for OS benefit (posterior probability: 90%), followed by sintilimab plus platinum-based chemotherapy (PBC) and pemetrexed-PBC. PFS atezolizumab plus bevacizumab and PBC, and camrelizumab plus PBC were the most effective regimens...The most favorable safety profiles were observed with cemiplimab, nivolumab, and avelumab monotherapy, while atezolizumab plus PBC and sugemalimab plus PBC carried the highest toxicity burdens...Balancing efficacy with safety remains critical, especially in the absence of predictive biomarkers. These findings support a patient-tailored approach to immunotherapy and highlight the need for further biomarker-driven and real-world investigations to optimize treatment selection."

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

Sugemalimab plus chemotherapy versus chemotherapy for advanced gastric cancer in China: a cost-effectiveness analysis. (PubMed, Sci Rep) - "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."

HEOR • Journal • Gastric Cancer • Oncology • Solid Tumor • PD-L1

Safety and Efficacy of NK510 to Treat NSCLC (clinicaltrials.gov) - P1 | N=9 | Recruiting | Sponsor: Base Therapeutics (Shanghai) Co., Ltd. | Trial completion date: Jul 2024 ➔ Jul 2026 | Trial primary completion date: Jul 2024 ➔ Jul 2026

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

Long Progression-Free Survival With Sunvozertinib in EGFRm NSCLC Patients After Third-Generation EGFR TKI Failure: Case Series (IASLC-WCLC 2025) - "After relapsing in Jun 2010, he received various chemotherapy regimens until Aug 2012, followed by icotinib, then osimertinib (found T790M mutation) was administered as fifth-line therapy (Dec 2017-May 2023) combined with anlotinib from 2020, and nab-paclitaxel plus sugemalimab as sixth-line (May-Oct 2023). For seventh-line treatment, sunvozertinib 150 mg QD with vinorelbine maintained for over 12 months...After relapsing in 2016, she received gefitinib...Table 1. Case summary (Data cutoff: Dec 11, 2024)"

Clinical • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

PSUR review confirmed benefit-risk remains unchanged; SmPC to add coeliac disease and exocrine pancreatic insufficiency under immune checkpoint inhibitor class effects, noting reports with other ICIs may also apply to sugemalimab; variation to MA required, next PSUR to follow EURD submission schedule. (European Medicines Agency) - Pharmacovigilance Risk Assessment Committee (PRAC) Minutes of meeting on 7 – 10 Jul 2025: [AI generated summary]

PRAC • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Phase I Study of Low-Dose Radiotherapy Plus Chemotherapy and Sugemalimab and Olaparib for First-Line Treatment of SLFN-11 positive Extensive Stage Small Cell Lung Cancer (ChiCTR) - P1 | N=45 | Recruiting | Sponsor: West China Hospital of Sichuan University; West China Hospital of Sichuan University | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • SLFN11

Cost-effective analysis of sugemalimab plus chemotherapy as first-line treatment for advanced gastric or gastroesophageal junction adenocarcinoma with PD-L1 CPS ≥5. (PubMed, Front Public Health) - "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."

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

Cost-effectiveness analysis of sugemalimab combined with chemotherapy as first-line treatment for advanced gastric cancer. (PubMed, Front Public Health) - "Based on findings from the GEMSTONE-303 trial, the sugemalimab plus capecitabine and oxaliplatin regimen showed superior clinical efficacy compared to chemotherapy alone in advanced gastric cancer patients. Probabilistic sensitivity analysis demonstrated stable results, with a 0% probability that the sugemalimab combination regimen was cost-effective. Under the current economic conditions in China, sugemalimab combined with chemotherapy as a first-line treatment for advanced gastric cancer is not cost-effective."

HEOR • Journal • Gastric Cancer • Oncology • Solid Tumor