Shan Ke Yu (socazolimab) / Lee's Pharm, Sorrento - LARVOL DELTA

First line PD-L1/1 inhibition based therapies in elderly patients with ES-SCLC: a Systematic Literature Review and Network Meta-Analysis (ESMO-IO 2025) - "Currently, PD-1/PD-L1 inhibitors with platinum and etoposide (EP) have been adopted as standard first-line therapy and idemonstrated survival benefits in the overall population, while the magnitude of benefit and optimal agent in elderly patients remain unclear.Methods Following PRISMA-NMA guidelines, PubMed and ClinicalTrials.gov were searched up to 29 August 2025. Eligible RCTs compared first-line PD-L1 or PD-1 inhibitors—atezolizumab, durvalumab, serplulimab, adebrelimab, tislelizumab, pembrolizumab, socazolimab, benmelstobart(+anlotinib), nivolumab, or toripalimab with or without EP in ES-SCLC...Atezolizumab-EP ranked highest for OS (SUCRA=0.88), followed by Benmelstobart + anlotinib -EP (SUCRA = 0.86) and serplulimab-EP (SUCRA = 0.77), whereas durvalumab-EP (SUCRA = 0.36) and socazolimab-EP (SUCRA = 0.29) showed relatively modest effects.Conclusions First-line PD-L1/PD-1 inhibition plus EP confers a clinically meaningful survival advantage in elderly patients with..."

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

Efficacy and safety of immunotherapy or antiangiogenic agent-based treatment strategies versus chemotherapy as first-line treatment for extensive-stage small cell lung cancer: a network meta-analysis. (PubMed, Front Pharmacol) - "Immune checkpoint inhibitors (ICIs) combined with etoposide-platinum are recommended as the standard first-line therapy for extensive-stage small cell lung cancer (ES-SCLC)...The drug combination patterns included ipilimumab, durvalumab, adebrelimab, atezolizumab, socazolimab, pembrolizumab, serplulimab, tislelizumab, toripalimab, durvalumab + tremelimumab, tiragolumab + atezolizumab, benmelstobart + anlotinib, bevacizumab + atezolizumab, anlotinib, bevacizumab in combination with chemotherapy...The toxicity of ICI + Antiangio + Chemo was acceptable but needed careful attention. These findings clarified the roles of ICIs and antiangiogenic agent-based treatment strategies in this population."

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

Cost-effectiveness of socazolimab plus chemotherapy vs. standard chemotherapy for first-line treatment of extensive-stage small cell lung cancer: a U.S. and China perspective. (PubMed, Clin Transl Oncol) - "The combination of socazolimab with chemotherapy is not a cost-effective first-line treatment option for ES-SCLC in either China or the United States, highlighting the need for price adjustments and alternative treatment strategies to improve economic viability."

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

A clinical study to evaluate the efficacy and safety of socazolimab combined with bevacizumab and lenvatinib in the conversion therapy of advanced liver cancer (ChiCTR) - P=N/A | N=30 | Recruiting | Sponsor: Hubei Cancer Hospital; Hubei Cancer Hospital

New trial • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

UPDATE ON AN INVESTIGATIONAL ONCOLOGY DRUG PRODUCT (HKEXnews) - "The Board of the Company is pleased to announce that, on 29 July 2025, Socazolimab, an oncology drug product of China Oncology Focus Limited ('COF'), a subsidiary of the Company, has been approved for marketing in combination with chemotherapy in the first- line treatment of extensive-stage small-cell lung cancer ('ES-SCLC') in Mainland China by National Medical Products Administration ('NMPA'). The approval is based on a Phase III, multicenter, randomised, double blinded, placebo control clinical trial of Socazolimab combined with chemotherapy."

China approval • Small Cell Lung Cancer

Socazolimab Exhibits Overall Survival Benefit Vs Placebo in ES-SCLC (Cancer Network) - P3 | N=498 | NCT04878016 | Sponsor: Lee's Pharmaceutical Limited | "Socazolimab (ZKAB001) exhibited a statistically significant overall survival (OS) benefit vs placebo when added to chemotherapy containing carboplatin and etoposide as a first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC), according to results from a phase 3 trial (NCT04878016)....Efficacy data revealed that at the time of the final analysis 73.4% (n = 182/248) and 80.6% (n = 200/248) of the socazolimab and placebo groups had died. Additionally, the median OS in the respective groups was 13.90 months (95% CI, 12.22-15.34) vs 11.58 months (95% CI, 10.64-12.81), with respective 1- and 2-year OS rates of 56.8% (95% CI, 50.4%-62.7%) vs 48.8% (95% CI, 42.4%-54.8%) and 20.7% (95% CI, 14.8%-27.3%) vs 5.9% (95% CI, 0.8%-18.9%; HR, 0.799; 95% CI, 0.652-0.979, P = .0158)."

P3 data • Small Cell Lung Cancer

Phase III Study of Socazolimab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer (clinicaltrials.gov) - P3 | N=440 | Recruiting | Sponsor: Lee's Pharmaceutical Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Cervical Cancer • Oncology • Solid Tumor • PD-L1

Promising outcomes of the PD-L1 inhibitor Socazolimab in recurrent and metastatic cervical cancer: a case report. (PubMed, Front Oncol) - "In this report, the safety profile of Socazolimab was favorable, with no severe or uncontrollable adverse events. This case provides compelling evidence of the antitumor activity and manageable toxicity of Socazolimab in metastatic cervical cancer patients, offering valuable insights for further research and clinical application of the drug."

IO biomarker • Journal • Cervical Cancer • Oncology • Solid Tumor • PD-L1

A multicenter, randomized, double-blind, placebo-controlled phase 3 study of Socazolimab or placebo combined with carboplatin and etoposide in the first-line treatment of extensive-stage small cell lung cancer. (PubMed, Signal Transduct Target Ther) - P3 | "200 (80.3%) patients in the socazolimab plus EC group experienced ≥ grade 3 treatment-related adverse events and 187 (75.7%) patients occurred in the placebo plus EC group. Socazolimab combined with standard EC regimen chemotherapy for first-line treatment of ES-SCLC significantly prolonged overall survival and did not increase the safety risk of treatment."

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

Phase Ib study of anti-PD-L1 monoclonal antibody socazolimab in combination with nab-paclitaxel as first-line therapy for advanced urothelial carcinoma. (PubMed, Oncologist) - P1 | "Socazolimab combined with nab-paclitaxel has shown good safety and promising antitumor activity as first-line therapy in patients with advanced urothelial carcinoma."

Combination therapy • Journal • Metastases • P1 data • Alopecia • Anorexia • Dermatology • Fibrosis • Hematological Disorders • Immunology • Neutropenia • Oncology • Pruritus • Respiratory Diseases • Solid Tumor • Urothelial Cancer • PD-1

Lee’s Pharmaceuticals’ PD-L1 monoclonal antibody is approved for marketing in China (bydrug.pharmcube.com) - "On December 21, the official website of the State Food and Drug Administration showed that the new drug application for Socazolimab, an anti-PD-L1 monoclonal antibody, submitted by Zhaoke Oncology Pharmaceuticals Co., Ltd., a subsidiary of Lee's Pharmaceuticals, was approved for the treatment of recurrent or metastatic cervical cancer...The results of its Phase I + extended clinical study for the treatment of patients with recurrent or metastatic cervical cancer showed that the overall safety of Socazolimab was good, with most drug-related AEs (adverse events) being grade 1 to 2, and no drug-related grade 4-5 AEs occurring. The ORR (objective response rate) for efficacy evaluation was 15.4%, the PFS (progression-free survival) was 4.4 months, and the OS (overall survival) was 14.7 months."

China approval • P1 data • Cervical Cancer

Socazolimab, an anti-PD-L1 monoclonal antibody, has been approved for the treatment of recurrent or metastatic cervical cancer in #China. This marks the 6th PD-L1 monoclonal antibody to be approved for marketing in China.

China approval • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor

Phase III Study of Socazolimab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer (clinicaltrials.gov) - P3 | N=440 | Not yet recruiting | Sponsor: Lee's Pharmaceutical Limited

Metastases • New P3 trial • Cervical Cancer • Oncology • Solid Tumor

Results of a phase III clinical trial with anti-PDL1 treatment in combination with chemotherapy for extensive stage small cell lung cancer. (ASCO 2024) - P3 | "Here we study the combination of Socazolimab, an anti-PDL1 antibody, carboplatin and etoposide to treat extensive stage small cell lung cancer. These results show that Socazolimab plus chemotherapy continued to provide clinically meaningful improvements in OS for patients with extensive stage small cell lung cancer."

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

A Study of Carboplatin Plus Etoposide With or Without ZKAB001 (Anti-PD-L1 Antibody) in Patients With ES-SCLC (clinicaltrials.gov) - P3 | N=498 | Completed | Sponsor: Lee's Pharmaceutical Limited | Recruiting ➔ Completed

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

Efficacy and Safety of Anti-Programmed Death-Ligand 1 Monoclonal Antibody Socazolimab With Carboplatin and Etoposide for Extensive-Stage SCLC: Results From the Phase 1b Clinical Trial. (PubMed, JTO Clin Res Rep) - P1, P3 | "Results revealed that the combination therapy of socazolimab, carboplatin, and etoposide had preliminarily confirmed the safety of socazolimab in the first-line treatment of SCLC combined with EC chemotherapy. Currently, a phase 3, randomized, placebo-controlled trial (ClinicalTrials.gov, NCT04878016) is being conducted with 498 patients."

Journal • P1 data • Cervical Cancer • Hematological Disorders • Lung Cancer • Neuroendocrine Tumor • Neutropenia • Oncology • Small Cell Lung Cancer • Solid Tumor

Neoadjuvant socazolimab shows promise for locally advanced oesophageal squamous cell cancer (Hospital Healthcare Europe) - P1/2 | N=70 | NCT04460066 | Sponsor: Lee's Pharmaceutical Limited | "A total of 64 patients with a median age of 62 years (79.7% male) were enrolled and equally randomised between the two groups. There were 29 patients in each arm who subsequently underwent surgery. The MPR rate was 69% in the socazolimab group and 62.1% in the placebo arm although this difference was not significant (p = 0.509). Similarly, whilst the pCR rate was higher with socazolimab (41.4%) than in the placebo group (27.6%), again this was not significant (p = 0.311). However, there was a significantly higher incidence rate of ypT0 for socazolimab (37.9%) compared to placebo (3.5%, p = 0.001) and the rate of T down-staging was also higher (65.5% vs 62.1%)."

P1/2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

Comparing a PD-L1 inhibitor plus chemotherapy to chemotherapy alone in neoadjuvant therapy for locally advanced ESCC: a randomized Phase II clinical trial : A randomized clinical trial of neoadjuvant therapy for ESCC. (PubMed, BMC Med) - P1/2 | "The neoadjuvant socazolimab combined with chemotherapy demonstrated promising MPR and pCR rates and significant T downstaging in locally advanced ESCC without increasing surgical complication rates."

Clinical • Journal • Metastases • P2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Efficacy and safety of the anti-PD-L1 monoclonal antibody Socazolimab in combination with carboplatin and etoposide for extensive-stage small cell lung cancer: Results from the phase Ib clinical trial (ELCC 2022) - P1, P3 | "Conclusions Results revealed that the combination therapy of Socazolimab, carboplatin and etoposide demonstrated good safety and anti-tumor activity for the first-line treatment of extensive-stage small cell lung cancer, with an OS higher than those of previous clinical trials, notably IMPOWER133 (12.3 months) and CASPIAN (12.9 months). A phase III, randomized, placebo-controlled clinical trial (ClinicalTrials.gov, NCT04878016) is currently being conducted with 498 patients."

Clinical • Combination therapy • P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Efficacy and Safety of Anti-PD-L1 Monoclonal Antibody Socazolimab with Carboplatin and Etoposide for Extensive-Stage Small Cell Lung Cancer: Results from the Phase Ib Clinical Trial (J Thorac Oncol) - P1 | N=20 | NCT04346914 | Sponsor: Lee's Pharmaceutical Limited | "From 15th April 2020 (enrollment date) to 30th December 2021 (data cutoff), 20 patients with ES-SCLC were administered with Socazolimab, carboplatin and etoposide. ORR was 70.0% (95% CI: 45.72%, 88.11%). Median PFS was 5.65 months (95% CI: 4.14, 6.54), and the median DOR was 4.29 months (95% CI: 2.76, 5.85). Median OS was 14.88 months (95% CI: 10.09, NE). The highest incidence of TRAEs included anemia (100%), decreased neutrophil count (95%), decreased platelet count (95%) and decreased white blood cell count (95%) which occurred during combination therapy."

P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Thoracic Cancer

First-in-maintenance therapy for localized high-grade osteosarcoma: an open-label phase I/II trial of the anti-PD-L1 antibody ZKAB001. (PubMed, Clin Cancer Res) - "Switching to maintenance using ZKAB001 showed an acceptable safety profile and provided preliminary evidence of clinical activity in localized osteosarcoma patients."

Journal • P1/2 data • Dermatitis • Dermatology • Endocrine Disorders • Immunology • Oncology • Osteosarcoma • Sarcoma • Solid Tumor • MSI

Neoadjuvant PD-L1 inhibitor (socazolimab) plus chemotherapy in patients with locally advanced esophageal squamous cell carcinoma (ESCC): A multicenter, randomized, double-blind phase II study (ESMO 2022) - P1/2 | "This phase IB/II study aimed to evaluate the safety and efficacy of neoadjuvant Socazolimab, a novel PD-L1 inhibitor, combined with nab-paclitaxel/cisplatin for locally advanced ESCC. Conclusions Neoadjuvant Socazolimab with chemotherapy demonstrated outstanding MPR and pCR rates in locally advanced ESCC without increasing perioperative complications. This strategy warrants further investigations in phase III trials."

Clinical • P2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Efficacy and safety of the anti–PD-L1 monoclonal antibody socazolimab for recurrent or metastatic cervical cancer: Results from the phase I dose-escalation and expansion study. (ASCO 2022) - P1 | "Our study demonstrates that socazolimab has remarkable safety and efficacy for the treatment of recurrent or metastatic cervical cancer and exhibits a safety profile similar to other anti–PD-1/PD-L1 monoclonal antibodies."

Clinical • P1 data • Cervical Cancer • Oncology • Solid Tumor

Phase Ib study of anti-PD-L1 monoclonal antibody socazolimab in combination with nab-paclitaxel as first-line therapy for advanced urothelial carcinoma. (ASCO 2022) - P1 | "Socazolimab combined with nab-paclitaxel as first-line treatment was effective and well-tolerated in Chinese patients with advanced urothelial carcinoma, warranting phase II trials."

Clinical • Combination therapy • P1 data • Bladder Cancer • Cardiovascular • Dermatology • Immune Modulation • Inflammation • Oncology • Pruritus • Solid Tumor • Urothelial Cancer • PD-1

Efficacy and Safety of the Anti–PD-L1 mAb Socazolimab for Recurrent or Metastatic Cervical Cancer: a Phase I Dose-Escalation and Expansion Study (Clin Cancer Res) - P1 | N=101 | NCT03676959 | Sponsor: Lee's Pharmaceutical Limited | "104 patients were successfully enrolled into the study. Twelve patients were included in the dose-escalation phase, with one complete response and two partial responses in the 5 mg/kg treatment group. Ninety-two patients (5 mg/kg) were enrolled in the dose-expansion phase....ORR was 15.4% [95% confidence interval (CI), 8.7%–24.5%]. Median PFS was 4.44 months (95% CI, 2.37–5.75 months), and the median OS was 14.72 months (95% CI, 9.59–NE months). ORR of PD-L1–positive patients was 16.7%, and the ORR of PD-L1–negative patients was 17.9%....Our study demonstrates that socazolimab has durable safety and efficacy for the treatment of recurrent or metastatic cervical cancer."

P1 data • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor