risvutatug rezetecan (GSK5764227) / Jiangsu Hansoh Pharma, GSK - LARVOL DELTA

Risvutatug Rezetecan (a B7-H3-Directed ADC) Versus Topotecan in Relapsed SCLC: Primary Results of Phase 3 ARTEMIS-008 (IASLC-WCLC 2026) - P3 | "Conclusions : Ris-Rez 8.0 mg/kg Q3W demonstrated a statistically significant and clinically meaningful OS benefit over topotecan in pts with SCLC that progressed after platinum-based therapy, with a favorable safety profile. These results suggest the potential of Ris-Rez to define a new standard of care in relapsed SCLC."

ADC • Late-breaking abstract • P3 data • Lung Cancer • Small Cell Lung Cancer • Solid Tumor • CD276

Risvutatug Rezetecan (Ris-Rez) versus Gemcitabine and Docetaxel (GD) in Heavily Pretreated Patients (pts) with Relapsed or Refractory (R/R) Osteosarcoma: Primary Results from the Phase 3 ARTEMIS-011 Study (ESMO 2026) - No abstract available

Clinical • Late-breaking abstract • P3 data • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=83 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Sep 2028 ➔ May 2030 | Trial primary completion date: Jul 2026 ➔ Feb 2028

Trial completion date • Trial primary completion date • Colon Adenocarcinoma • Colon Cancer • Oncology • Prostate Cancer • Solid Tumor

EMBOLD-SCLC-301: A global, Phase 3, randomised study assessing Risvutatug Rezetecan (Ris-Rez) versus standard of care in patients with relapsed small cell lung cancer (SCLC) (ESMO 2026) - No abstract available

Clinical • P3 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

EMBOLD PanTumor-101: Risvutatug Rezetecan (Ris-Rez) dose optimisation in patients with extensive-stage small cell lung cancer (ES-SCLC) (ESMO 2026) - No abstract available

Clinical • Pan tumor • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

EMBOLD PanTumor-101: Safety and efficacy of Risvutatug Rezetecan (Ris-Rez) monotherapy during dose escalation in a global patient population with advanced/metastatic (A/M) solid tumours (ST) (ESMO 2026) - No abstract available

Clinical • Metastases • Monotherapy • Pan tumor • Oncology • Solid Tumor

Pooled analysis of interstitial lung disease (ILD) cases among patients (pts) with advanced solid tumours who received Risvutatug Rezetecan (Ris-Rez) monotherapy (ESMO 2026) - No abstract available

Metastases • Monotherapy • Retrospective data • Oncology • Solid Tumor

A Study of Risvutatug Rezetecan in Combination With Ivonescimab in Participants With Advanced Solid Tumors (EMBOLD PanTumour-103) (clinicaltrials.gov) - P1/2 | N=184 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Pan tumor • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276

Risvutatug rezetecan for injection (HS-20093) for osteosarcoma included in priority review and approval procedure of the NMPA (HKEXnews) - "Hansoh Pharmaceutical...is pleased to announce that, on September 14, 2026, based on the positive results from the pivotal Phase III ARTEMIS-011 trial on HS-20093 for injection (risvutatug rezetecan for injection) (the 'Product'), the Product’s indication for the treatment of osteosarcoma patients aged 12 years and above who have failed at least two prior lines of therapy has been included in the Priority Review and Approval Procedure of the National Medical Products Administration (the 'NMPA') of China."

China filing • Priority review • Osteosarcoma

Combination of risvutatug rezetecan and adebrelimab in previously treated advanced nsq-NSCLC without actionable genomic alterations: Results from ARTEMIS-101, a phase 1 study (AACR 2026) - P1 | "Based on the efficacy of Ris-Rez monotherapy, the combination with adebrelimab showed a trend toward improved efficacy in previously treated patients with nsq-NSCLC without AGAs and no new safety signals were observed."

First-in-human • Metastases • P1 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

HS-20093, a B7-H3-targeted antibody-drug conjugate in lung cancer: Results from the ARTEMIS-001 phase 1a/b trial. (PubMed, Cancer Cell) - P1 | "Among response-evaluable patients, the confirmed objective response rate was 52.3% (95% CI: 39.5, 64.9) for extensive-stage SCLC (ES-SCLC, N = 65) and 22.4% (95% CI: 16.0, 29.8) for non-small cell lung cancer (NSCLC, N = 152) patients, with comparable rates between 8.0 mg/kg and 10.0 mg/kg dose cohorts across both groups. These results support further development of HS-20093, with 8.0 mg/kg selected for phase 3 trials."

Journal • P1 data • Hematological Disorders • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor

A Phase II Study of HS-20093 Injection Combined With Adebrelimab Versus HS-20093 Injection in Previously Treated Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (clinicaltrials.gov) - P2 | N=76 | Not yet recruiting | Sponsor: Hansoh BioMedical R&D Company

New P2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

ARTEMIS-002: A phase II study of HS-20093 in patients with relapsed or refractory sarcomas (ESMO 2025) - P2 | "Table: 2684O Efficacy Osteosarcoma (39 Adults and 5 adolescents) Other Sarcomas 8.0 mg/kg (N=15) 12.0 mg/kg (N=29) 12.0 mg/kg (N=20) ORR, % 6.7 17.2 25.0 DCR, % 66.7 86.2 85.0 mDoR, months NA NA 5.7 mPFS, months 4.0 8.4 8.2 6 months PFS, % 33.3 59.7 62.3 Median F/U, months 16.4 10.8 15.4 * Cut-off date: 3 March, 2025; ORR=Objective response rate; DCR=Disease control rate; F/U=Follow-up; mDoR=Median duration of response; mPFS=Median progression-free survival; mOS=Median overall survival; NA=Not available. Conclusions HS-20093 demonstrated promising emerging efficacy with manageable safety profile in heavily pretreated R/R sarcomas pts, supporting further clinical development."

Clinical • P2 data • Oncology • Osteosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Efficacy and Safety of HS-20093 in Extensive Stage Small Cell Lung Cancer in A Multicenter, Phase 1 Study (ARTEMIS-001) (IASLC-WCLC 2024) - P1, P3 | "All pts received platinum plus etoposide, 73.2% received immunotherapy (IO), and 23.2% received topoisomerase 1 inhibitor (TOPO1i). A phase 3 study is currently ongoing in China to compare the efficacy and safety of HS-20093 with standard-of-care chemotherapy in pts with relapsed SCLC (NCT06498479). The clinical development program of HS-20093 is planned to be expanded into US, EU, and rest of the world."

Clinical • IO biomarker • P1 data • Anemia • Hematological Disorders • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Study of Risvutatug Rezetecan in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P3 | N=684 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P3 trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Hansoh Pharmaceutical Group announced that risvutatug rezetecan for injection (HS-20093), targeted at small cell lung cancer patients whose disease has progressed after prior platinum-based chemotherapy, has been accepted into the National Medical Products Administration’s Priority Review and Approval Procedure. (TipRanks)

China filing • Priority review • Lung Neuroendocrine Carcinoma • Small Cell Lung Cancer

Hansoh Pharmaceutical…is pleased to announce that, on September 2, 2026, the biologics license application of the Group’s innovative medicine HS-20093 for injection has been accepted by the…NMPA of China, for the treatment of adult patients with small cell lung cancer (SCLC) after the failure of prior platinum-based chemotherapy (HKEXnews)

China filing • Small Cell Lung Cancer

ARTEMIS-001: Phase 1 study of HS-20093, a B7-H3–targeting antibody-drug conjugate, in patients with advanced solid tumor. (ASCO 2023) - P1 | "The safety profile of HS-20093 was acceptable. HS-20093 demonstrated promising antitumor activity in several tumor types, especially in SCLC. The further dose expansion study on efficacy and safety of HS-20093 in selected tumor types is ongoing."

Clinical • Metastases • P1 data • Anemia • Fatigue • Hematological Disorders • Interstitial Lung Disease • Leukopenia • Lung Cancer • Neuroendocrine Tumor • Neutropenia • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Sarcoma • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia

Anti-B7-H3 ADCs Take Center Stage against SCLC at WCLC. (PubMed, Cancer Discov) - "Separate phase III trials of the anti-B7-H3 antibody-drug conjugates tambotatug pelitecan and risvutatug rezetecan significantly improved overall survival, progression-free survival, and objective response rates compared with topotecan in patients with relapsed small-cell lung cancer. In a third trial, the combination of the investigational PD-L1 x VEGF-A bispecific antibody pumitamig plus the anti-B7-H3 ADC elfetabart drozuntecan showed encouraging early efficacy in SCLC across lines of therapy and doses. The studies were presented at the 2026 World Congress on Lung Cancer in Seoul, Republic of Korea."

Journal • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276

ARTEMIS-002: Phase 2 study of HS-20093 in patients with relapsed or refractory osteosarcoma. (ASCO 2024) - P1, P2 | "Twenty-six pts (76.5%) had received 4 types of standard chemotherapies consisting of platinum, anthracyclines, ifosfamide and methotrexate. The data has demonstrated that HS-20093 exhibited promising antitumor activity with acceptable toxicity in pts of heavily-pretreated R/R osteosarcoma. The enrollment of ARTEMIS-002 is continuing."

Clinical • P2 data • Anemia • Hematological Disorders • Leukopenia • Neutropenia • Oncology • Osteosarcoma • Sarcoma • Solid Tumor • Thrombocytopenia

Phase III ARTEMIS-008 Trial Shows Risvutatug Rezetecan Significantly Improves Overall Survival in Relapsed Small-Cell Lung Cancer (PRNewswire) - "The findings were presented today at the IASLC 2026 World Conference on Lung Cancer (WCLC)....A total of 461 patients in China were randomized....At the June 6, 2026 data cutoff, after a median follow-up of 12.2 months, median overall survival was 18.5 months with Ris-Rez compared with 10.3 months with topotecan. Ris-Rez reduced the risk of death by 54% (HR 0.46; 95% CI, 0.35–0.62; P<0.0001), with consistent overall survival benefits across relevant subgroups.....Median progression-free survival was 7.2 months with Ris-Rez versus 3.0 months with topotecan (HR 0.33; 95% CI, 0.25–0.42). The objective response rate was 58.3% versus 12.6%, respectively, and the disease control rate was 90.4% versus 60.2%."

P3 data • Lung Neuroendocrine Carcinoma • Small Cell Lung Cancer

ARTEMIS-001: Data from a phase 1a/b study of HS-20093 in patients with relapsed small cell lung cancer (SCLC). (ASCO 2024) - P1 | "All pts received platinum plus etoposide and 73.2% (41/56) received immunotherapy. HS-20093 demonstrated promising antitumor activity and manageable safety in pts with previously-treated SCLC. Phase 3 study is planned to compare the efficacy and safety of HS-20093 with standard-of-care chemotherapy in relapsed SCLC."

Clinical • IO biomarker • P1 data • Anemia • Hematological Disorders • Leukopenia • Lung Cancer • Neutropenia • Oncology • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia

A Pan-RAS Inhibitor in Combination With Anti-Tumor Therapy in Participants With Advanced Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=80 | Not yet recruiting | Sponsor: Zhejiang University

IO biomarker • New P1/2 trial • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

GSK plc…announced that ARTEMIS-011, its pivotal phase III trial evaluating risvutatug rezetecan (Ris-Rez) in patients with osteosarcoma who have progressed or relapsed after receiving at least two prior lines of systemic therapy, met its primary endpoint of progression-free survival (PFS). (GSK Press Release) - "In the trial, conducted in patients in China, Ris-Rez, a B7-H3-targeted antibody-drug conjugate (ADC), demonstrated statistically significant and clinically meaningful improvements in PFS compared with chemotherapy. Consistent benefit was also observed across secondary endpoints, including overall survival. The safety profile of ARTEMIS-011 is consistent with prior findings in this tumour type, and no new safety signals were identified. These data will be used by Hansoh Pharma for regulatory submission in China."

P3 data • Osteosarcoma

A Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Advanced Sarcomas (EMBOLD Sarcoma-202) (clinicaltrials.gov) - P1/2 | N=113 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Sarcoma • Solid Tumor