Anniko (penpulimab) / Akesobio, Sino Biopharm, Specialised Therap - LARVOL DELTA

Anlotinib combined with penpulimab in the treatment of advanced adult thoracic spinal osteosarcoma: a case report. (PubMed, Front Pharmacol) - "A 53-year-old female with stage IV thoracic spinal osteosarcoma initially received intensity-modulated radiotherapy (total dose of 45 Gy in 15 fractions) and AP chemotherapy (doxorubicin 60 mg/m2 + cisplatin 100 mg/m2). This case demonstrates that sequential molecular targeted therapy and immunotherapy following chemoradiation can yield remarkable clinical outcomes, offering a novel therapeutic option for advanced spinal osteosarcoma. However, interindividual variations in treatment response underscore the need for future research to identify predictive biomarkers for patient stratification."

IO biomarker • Journal • Dermatology • Infectious Disease • Oncology • Osteosarcoma • Pain • Sarcoma • Septic Shock • Solid Tumor

TQB2618-AK105-Ib-04: A Clinical Study of TQB2618 Injection Combined With Penpulimab Injection and Anlotinib Hydrochloride Capsules for First-line Treatment of Advanced Hepatocellular Carcinoma (HCC). (clinicaltrials.gov) - P1 | N=29 | Terminated | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting ➔ Terminated | Trial primary completion date: Dec 2024 ➔ Jun 2025; This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns

Trial primary completion date • Trial termination • Hepatocellular Cancer • Oncology • Solid Tumor

Phase II Study: Efficacy and Biomarker Exploration of Anlotinib Plus Penpulimab in ES-SCLC After Failure of Platinum-Based Chemotherapy (IASLC-WCLC 2025) - "Primary endpoint was objective response rate (ORR) per RECIST v1.1. Secondary endpoints included disease control rate (DCR), PFS, OS, and safety."

Biomarker • Clinical • IO biomarker • P2 data • Lung Cancer • Small Cell Lung Cancer • Solid Tumor

Anlotinib Combined With PD-1 Blockade and Platinum Doublet Chemotherapy for PSC as First Line Treatment (IASLC-WCLC 2025) - "The treatment regimen included albumin-bound paclitaxel (100 mg/m2, d1, d8, d15/q3w or 260mg/m 2 d1/q3w), carboplatin (AUC=5, d1/q3w), anlotinib (12 mg, po, qd, d1-14/q3w), and penpulimab (200 mg, d1/q3w) for 4 cycles, following penpulimab and anlotinib for maintenance therapy until progression of disease(PD) or intolerable toxicity. The primary endpoint is PFS, and secondary endpoint included ORR, OS, DCR and safety."

Clinical • Lung Cancer • Sarcoma • Solid Tumor

SPARC: SCRT Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of MSS Locally Advanced Rectal Cancer (clinicaltrials.gov) - P2 | N=55 | Recruiting | Sponsor: Ruijin Hospital | Not yet recruiting ➔ Recruiting | Trial primary completion date: Oct 2023 ➔ Oct 2025

Enrollment open • Trial primary completion date • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor • MSI

Efficacy and safety of adjuvant penpulimab in very high-risk clear cell renal cell carcinoma: a prospective, controlled, phase II study (ESMO 2025) - No abstract available

Clinical • P2 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor

A Phase II clinical study of penpulimab (AK105) in combination with chemotherapy +/- anlotinib hydrochloride in the treatment of advanced nasopharyngeal carcinoma (ChiCTR) - P2 | N=90 | Completed | Sponsor: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital

New P2 trial • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • PD-L1

Comment on "Efficiency and safety of Neoadjuvant PD-1 inhibitor (penpulimab) combined with chemotherapy in Resectable N1/N2 non-small cell lung cancer: a prospective Cohort Study". (PubMed, Int J Surg) - No abstract available

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

TQB2102-II-04: A Clinical Trial Evaluating TQB2102 for Injection in Combination With Behmosubaisumab/Payamprolizumab With or Without Chemotherapy in Unresectable Locally Advanced, Recurrent, or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Gastroesophageal Adenocarcinoma (clinicaltrials.gov) - P2 | N=204 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Oncology • Solid Tumor

Jimin Park. (PubMed, Angew Chem Int Ed Engl) - ""The one research question I would most like to answer is: Can we seamlessly connect living and non-living systems from the atomic level to the systemic level by leveraging the tools of chemistry?… A turning point in my career was joining Professor Anikeeva's group during my Ph.D., where I had the opportunity to design bioelectronic devices for neuroscience research…" Find out more about Jimin Park in his Introducing… Profile."

Journal

NEOINSPIRE: A Phase II Randomized Trial of Neoadjuvant Ivonescimab or Penpulimab Plus Chemotherapy in Resectable NSCLC (clinicaltrials.gov) - P2 | N=164 | Not yet recruiting | Sponsor: Yang Fan, MD

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

JDB153 Combined With Penpulimab for Hepatocellular Carcinoma After Standard Treatment Failure (clinicaltrials.gov) - P1/2 | N=10 | Not yet recruiting | Sponsor: West China Hospital

New P1/2 trial • Hepatocellular Cancer • Oncology • Solid Tumor

TQB2618-AK105-Ib-03: Clinical Trial to Evaluate the Safety and Effectiveness of TQB2618 Injection Combined Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - P1/2 | N=34 | Terminated | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=75 ➔ 34 | Trial completion date: Dec 2024 ➔ Mar 2025 | Recruiting ➔ Terminated; This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.

Enrollment change • Trial completion date • Trial termination • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • PD-L1

Penpulimab (Anniko) for nasopharyngeal carcinoma. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Cost-effectiveness analysis of penpulimab plus carboplatin-paclitaxel as first-line treatment for metastatic squamous non-small-cell lung cancer in China. (PubMed, Health Econ Rev) - "From the perspective of the Chinese healthcare system, penpulimab combined with first-line chemotherapy demonstrates is cost-effective at a willingness-to-pay threshold of $38,060.00 per QALY for patients with metastatic sqNSCLC and represents a promising first-line treatment option."

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

Penpulimab in an adolescent patient with pancreatic neuroendocrine carcinoma with liver metastasis: A case report and literature review. (PubMed, Medicine (Baltimore)) - "Pancreatic neuroendocrine cancer is rare. There are various treatment options available. However, the best treatment plan still needs further exploration. This case underscores that programmed death-1 ligand + PNEC may respond to immunotherapy/antiangiogenic combinations, offering alternatives for chemotherapy-ineligible patients. In addition, young patients with aggressive PNEC represent an understudied population, necessitating tailored strategies."

Journal • Review • Anorexia • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor

Efficiency and safety of neoadjuvant PD-1 inhibitor (penpulimab) combined with chemotherapy in resectable N1/N2 non-small cell lung cancer: a prospective cohort study. (PubMed, Int J Surg) - "This is the first report of neoadjuvant penpulimab in N1/N2 NSCLC, demonstrating efficacy, feasibility, and survival benefits, especially in patients with high tumor mutational burden."

IO biomarker • Journal • Tumor mutational burden • Fatigue • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • TMB

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) and the NCCN Drugs & Biologics Compendium (NCCN Compendium) for Head and Neck Cancers, Version 3.2025. (NCCN)

NCCN guideline • Head and Neck Cancer • Squamous Cell Carcinoma of Head and Neck

Severe immunotherapy-related thrombocytopenia in metastatic bone cancer: a multicenter retrospective case series highlighting early recognition and management. (PubMed, Front Oncol) - "We retrospectively reviewed the clinical records of patients with metastatic bone cancer who received single-agent ICI therapy-specifically, PD-1 inhibitors such as pembrolizumab, penpulimab, and sintilimab-between May 2020 and December 2024 at three tertiary hospitals...All seven patients were undergoing combination therapy with the bone anti-resorptive agent denosumab...Timely diagnosis and comprehensive treatment-supported by interdisciplinary collaboration among oncologists, hematologists, and nursing staff-are essential for achieving full recovery. Furthermore, our findings emphasize the need for future research into predictive biomarkers and risk factors for irTP."

IO biomarker • Journal • Retrospective data • Clear Cell Carcinoma • Clear Cell Renal Cell Carcinoma • Hematological Disorders • Melanoma • Oncology • Osteosarcoma • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Thrombocytopenia • Undifferentiated Pleomorphic Sarcoma

An exploratory clinical study investigating the neoadjuvant treatment of HER2-low expressing, stage II-III breast cancer with disitamab vedotin combined with penpulimab (RCVDBCIIR005). (ASCO 2025) - P2 | "While the clinical benefit may be somewhat limited, the combination of Disitamab Vedotin and Penpulimab as neoadjuvant treatment for HER2-low early or locally advanced breast cancer demonstrates manageable safety and potential for furtheroptimization. This warrants additional investigation to refine and optimize treatment strategies."

Clinical • Breast Cancer • Constipation • Gastroenterology • Gastrointestinal Disorder • HER2 Breast Cancer • HER2 Positive Breast Cancer • Herpes Zoster • Oncology • Pruritus • Solid Tumor • Varicella Zoster • HER-2 • PD-L1

Neoadjuvant immunotherapy in combination with chemotherapy in resectable locally advanced head and neck squamous cell carcinoma: A randomized, open label, phase II clinical trial. (ASCO 2025) - P2 | "Patients will be randomized into three cohorts: Cohort 1 will receive ivonescimab (PD-1/VEGF antibody, 10 mg/kg), Cohort 2 will receive cadonilimab (PD-1/CTLA-4antibody, 6 mg/kg), and Cohort 3 will receive penpulimab (PD-1 antibody, 200 mg), all in combination with cisplatin and nab-paclitaxel... Neoadjuvant single- or dual-target immunotherapy combined with chemotherapy showed promising pathological responses in resectable LAHNSCC. While dual-target therapy showed potential benefits, the small sample size limits definitive conclusions. The treatment was well-tolerated, with no serious TRAEs."

Clinical • Combination therapy • Metastases • P2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Chemotherapy plus anti-PD-1 or anti-PD-L1 in advanced PD-L1–negative squamous cell lung carcinoma: A systematic review and meta-analysis. (ASCO 2025) - " A total of 1,548 patients with advanced PD-L1–negative sqNSCLC from 11 studies were included: IMpower131, RATIONALE 307, ORIENT-12, CameL-Sq, GEMSTONE-302, CheckMate 227 Part 1, KEYNOTE-407, Empower-Lung 3, ASTRUM-004, AK105-302, and POSEIDON... Our findings support the use of combination anti-PD-(L)1 plus chemotherapy as first-line therapy for patients with advanced PD-L1–negative sqNSCLC. Prospective studies are warranted to determine whether dual checkpoint inhibition, with or without chemotherapy, is superior to anti-PD-(L)1 plus chemotherapy in this population."

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

Anlotinib in combination with penpulimab and chemotherapy as first-line treatment for extensive-stage small cell lung cancer: A single-arm, prospective clinical study. (ASCO 2025) - P2 | "This regimen comprised Anlotinib Hydrochloride (10mg,QD, from day 1 to 14 of each 21-day cycle), Penpulimab (200md, on day 1 of each 21-day cycle), Etoposide (100 mg/m² on days 1-3 of each 21-day cycle), and either CBP (AUC=4-5 on day 1 every 3 weeks) or DDP (70-75 mg/m² on day 1 every 3 weeks). The combination of Anlotinib with Penpulimab and EP/EC regimens, has demonstrated superior PFS, OS, ORR, and DCR in initial ES-SCLC treatments, with manageable adverse events. A randomized, controlled phase III clinical study will be conducted to further validate these promising results."

Clinical • Combination therapy • Anemia • Fatigue • Hypertension • Lung Cancer • Nephrology • Neutropenia • Oncology • Otorhinolaryngology • Renal Disease • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia

A phase II clinical study of neoadjuvant penpulimab combined with chemotherapy for patients with locoregionally advanced, resectable squamous cell carcinoma of the head and neck. (ASCO 2025) - P2 | "Patients received three cycles of NICT consisting of penpulimab (200 mg), nab-paclitaxel (260 mg/m²), and cisplatin (75 mg/m²) on day 1 of each 21-day cycle, followed by surgery. Neoadjuvant penpulimab combined with chemotherapy demonstrated high ORR and MPR rates, with an acceptable safety profile in resectable HNSCC. These results support further investigation of this regimen in larger, randomized trials. Clinical trial information: NCT06081673."

Clinical • Metastases • P2 data • Head and Neck Cancer • Leukopenia • Oncology • Oral Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Preliminary results of anlotinib and penpulimab (anti-PD1) combined with GEMOX in first-line treatment of advanced biliary tract cancer: A single-center, single-arm exploratory study. (ASCO 2025) - "Participants received with anlotinib (10 mg, p.o., qd, d1-14, q3w), penpulimab (200 mg, iv, d1, q3W), gemcitabine (850mg/m2,iv,d1/8,q3w), and Oxaliplatin (85mg/m2,iv,d1,q3w). Anlotinib and Penpulimab combined with GEMOX as first-line therapy demonstrated promising efficacy and a manageable safety profile in patients with advanced BTC, though further data are needed to confirm these preliminary findings."

Clinical • Metastases • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Hypertension • Leukopenia • Neutropenia • Oncology • Solid Tumor • KIT