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

Penpulimab combined with anlotinib as first-line chemotherapy-free regimen in elderly patients with advanced NSCLC: A phase II single-center study (ESMO Asia 2025) - P=N/A | "This chemotherapy-free combination shows promising efficacy and manageable toxicity in elderly advanced NSCLC, supporting its potential as a tailored strategy for this vulnerable population."

Clinical • IO biomarker • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Updated results of anlotinib combined with penpulimab and nab-paclitaxel as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): A single-arm, open-label phase II clinical trial. (ASCO-GI 2026) - P=N/A | "Clinical Trial Registration Number: ChiCTR2400089133 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

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

Integrated penpulimab (a PD-1 inhibitor), anlotinib (an antiangiogenic targeted drug), nab-paclitaxel and gemcitabine as first-line regimen for metastatic pancreatic cancer: A multi-centered, randomized controlled trial (RCT-PAAG). (ASCO-GI 2026) - P2 | "Clinical Trial Registration Number: NCT06051851 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Metastases • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

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

A cost-effectiveness analysis of a new and more effective treatment for unresectable hepatocellular carcinoma-from a Chinese perspective. (PubMed, Ann Med) - "In 99.9% of the simulations, the incremental cost of each QALY gained by the anlotinib plus penpulimab group was less than $37,944.50. Under the threshold of three times China's per capita GDP, anlotinib plus penpulimab is more cost-effective compared with sorafenib."

HEOR • Journal • Hepatocellular Cancer • Oncology • Solid Tumor

Penpulimab: All 4 Approved Indications Now Covered by NRDL (PRNewswire) - "Penpulimab, a differentiated PD-1 monoclonal antibody, participated in the national reimbursement negotiation for the first time in 2025....During this negotiation, penpulimab successfully secured NRDL inclusion for all four of its approved indications: first-line treatment of squamous NSCLC, first-line treatment of NPC, ≥3L treatment of NPC, and ≥3L treatment of relapsed/refractory classical Hodgkin lymphoma (R/R cHL)."

Reimbursement • Hodgkin Lymphoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer

An Exploratory Clinical Study for Neoadjuvant Treatment of HER2-low Expressing, Stage II-III Breast Cancer with Vedolizumab in Combination with Pembrolizumab (SABCS 2025) - "Background: HER2-low expressing breast cancer is a heterogenous subtype with limited targeted therapeutic options. Although the clinical benefit may be limited, the combination of Disitamab Vedotin and Penpulimab as neoadjuvant treatment for HER2-low expressing, stage II-III breast cancer shows manageable safety and potential for further refinement, warranting additional investigation to optimize treatment strategies. Pretreatment CD4+ TIL density and total immune infiltration may serve as predictive markers for neoadjuvant response."

Clinical • Combination therapy • IO biomarker • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CD4 • CD8 • HER-2 • PD-L1

Exploration of the mechanism of anlotinib in reversing PD-1 immunotherapy resistance: Insights from single-cell sequencing (ESMO-IO 2025) - "This study explores how anlotinib reverses penpulimab (PD-1 inhibitor) resistance via single-cell sequencing.Methods A penpulimab-resistant model (PD-R) was established by inoculating Lewis lung cancer cells into humanized PD-1 mice with repeated penpulimab dosing. Apoe+ M2, Srgn+ M1 macrophages, and Cxcl2+ T cells are key targets. Findings highlight anti-angiogenic-immunotherapeutic combination potential in resistant tumors.Legal entity responsible for the study The authors."

IO biomarker • Lung Cancer • Oncology • Solid Tumor • APOE • TNFA

A Prospective, Open-Label, Multicenter, Randomized Controlled Study Comparing the Efficacy and Safety of Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Combined with Orelabrutinib/Chidamide/Venetoclax/Lenalidomide/Penpulimab (Pola-RCHP-X) Versus RCHOP-X and Pola-Rchp in Previously Untreated Patients with Diffuse Large B-Cell Lymphoma (ASH 2024) - P2 | "The primary endpoint of the study is progression-free survival at 24 months (PFS24) as assessed by the investigators. Secondary endpoints include investigator-assessed complete response (CR) rate, overall response rate (ORR), event-free survival (EFS), overall survival (OS), and safety."

Clinical • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • TP53

Cost-effectiveness analysis of anlotinib plus penpulimab versus sorafenib in the treatment of unresectable hepatocellular carcinoma. (PubMed, Hum Vaccin Immunother) - "Scenario analysis results showed that the Patient Assistance Program of penpulimab could help the regimen achieve favorable cost-effectiveness. Compared with sorafenib, anlotinib plus penpulimab for unresectable HCC patients was unlikely cost-effective under the perspective of the Chinese healthcare system."

HEOR • Journal • Hepatocellular Cancer • Oncology • Solid Tumor

Toripalimab and Penpulimab: Targeting PD-1 in Recurrent or Metastatic Nasopharyngeal Carcinoma. (PubMed, Ann Pharmacother) - "Toripalimab and penpulimab significantly improve outcomes in RM-NPC. Their use is anticipated to expand into additional settings and malignancies as research matures."

Journal • Review • Endocrine Disorders • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • PD-1

TQB2223-AK105-Ib-01: Clinical Study of TQB2223 Injection Combined With AK105 Injection in the Treatment of Advanced Hepatocellular Carcinoma. (clinicaltrials.gov) - P1 | N=22 | Terminated | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=34 ➔ 22 | Recruiting ➔ Terminated | Trial primary completion date: Feb 2025 ➔ Nov 2025; This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.

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

Molecular and immune correlates of response to first-line de-escalated chemotherapy plus penpulimab and anlotinib in advanced cervical cancer. (PubMed, Cancer Discov) - "Patients with a high TLS-to-tumor area ratio exhibited better survival. Our findings lay the groundwork for the feasibility of first-line de-escalated chemotherapy plus anlotinib and penpulimab in metastatic, persistent, or recurrent cervical cancer patients."

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

TQB2223 in Combination with Penpulimab in Patients with Relapsed or Refractory Lymphoma: Primary Analysis of an Open-Label Phase I Study (ASH 2024) - P1 | "Among 14 HL patients, 12 were previously treated with anti-PD-1/L1 and 7 were previously treated with Brentuximab vedotin. Conclusions : TQB2223 in combination with penpulimab was generally safe, well-tolerated and demonstrated encouraging efficacy in patients with lymphoma, especially in patients with Hodgkin lymphoma who has received extensive prior treatments including anti-PD-1/L1. A complex of TQB2223 and penpulimab was prepared and more clinical studies were planned."

Clinical • Combination therapy • P1 data • Atopic Dermatitis • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Dermatology • Diffuse Large B Cell Lymphoma • Dyslipidemia • Endocrine Disorders • Hematological Malignancies • Hodgkin Lymphoma • Hypertriglyceridemia • Immunology • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Melanoma • Metabolic Disorders • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Primary Mediastinal Large B-Cell Lymphoma • Respiratory Diseases • Solid Tumor • T Cell Non-Hodgkin Lymphoma • LAG3

Immune checkpoint blockers plus chemotherapy as the first-line treatment for advanced or metastatic squamous non-small-cell lung carcinoma: a network meta-analysis and economic evaluation. (PubMed, Front Pharmacol) - "The camrelizumab plus chemotherapy and penpulimab plus chemotherapy regimens showed the greatest OS benefit, while camrelizumab plus chemotherapy provided the best PFS benefit. However, with a threshold of $13,445/QALY or $40,334/QALY, camrelizumab plus chemotherapy provided greater QALY benefits than tislelizumab plus chemotherapy. Thus, camrelizumab plus chemotherapy is recommended as the preferred first-line treatment for advanced squamous non-small-cell lung cancer in this context."

Checkpoint inhibition • HEOR • Journal • Retrospective data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A prospective, randomized, open-label, controlled clinical study comparing ivosimod combined with chemotherapy versus pamiparib combined with chemotherapy as neoadjuvant therapy for NSCLC (ChiCTR) - P2 | N=168 | Recruiting | Sponsor: Peking University People's Hospital; Peking University People's Hospital

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Efficacy and safety of adjuvant penpulimab in very high-risk clear cell renal cell carcinoma: A prospective, controlled, phase II study (ESMO 2025) - P2 | "Background The KEYNOTE-564 trial showed adjuvant pembrolizumab improved disease-free survival (DFS) in high-risk clear cell renal cell carcinoma (ccRCC), though subgroup heterogeneity existed. No treatment-related death was observed. Conclusions Adjuvant penpulimab demonstrated promising antitumor activity and manageable safety profile in ccRCC with a very high-risk of recurrence."

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

Immune checkpoint blockers plus chemotherapy as the first-line treatment for advanced or metastatic squamous non-small-cell lung carcinoma: a network meta-analysis and economic evaluation (Front Immunol) - "The tislelizumab plus chemotherapy regimen incurred the lowest treatment cost ($42,882.3), with an incremental cost–utility ratio (ICUR) of $ 4,062.0 per quality-adjusted life-year (QALY). The camrelizumab plus chemotherapy regimen offered the highest survival benefit (2.344 QALYs), with an ICUR of $ 6,078.4/QALY. In addition, the ICUR of the penpulimab plus chemotherapy regimen is $25,712.3/QALY."

HEOR • Non Small Cell Lung Cancer

Economic Evaluation of Anlotinib Plus Penpulimab Versus Sorafenib as First-Line Therapy for Unresectable Hepatocellular Carcinoma in China (Frontiers) - "Primary outcomes included total costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) evaluated against the willingness-to-pay (WTP) threshold of $40,334.05/QALY. Model robustness was assessed through deterministic and probabilistic sensitivity analyses (PSA). Results: The base-case analysis showed that anlotinib plus penpulimab incurred a total cost of $25,681.69 and yielded 1.42 QALYs, compared with sorafenib's total cost of $18,082.48 and 1.19 QALYs."

HEOR • Hepatocellular Cancer

Immune Checkpoint blockers plus Chemotherapy as the First-Line Treatment for advanced or metastatic Squamous Non-small cell lung carcinoma: A Network Meta-Analysis and Economic Evaluation (Front Immunol) - "The tislelizumab plus chemotherapy regimen offered the lowest treatment costs ($42,882.3) and the Incremental cost-utility ratio (ICUR) is $ 4,062.0/ per quality-adjusted life-year (QALY). The camrelizumab plus chemotherapy regimen offered the highest survival benefit (2.344 QALYs) and the ICUR is $ 6,078.4/QALY. And the ICUR of penpulimab plus chemotherapy regimen is $25,712.3/QALY."

HEOR • Non Small Cell Lung Cancer

Chemotherapy plus Nimotuzumab and Immunotherapy as Induction Regime Followed by Sequential Chemoradiotherapy and Consolidation Immunotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Prospective, Single-Arm, Open-Label, Phase II Trial (ASTRO 2025) - P2 | "The induction therapy regimen consisted of TP chemotherapy (docetaxel 75 mg/m² + cisplatin 60 mg/m²) combined with nimotuzumab (400 mg) and penpulimab (200 mg), administered every three weeks for a total of two cycles. TP chemotherapy combined with nimotuzumab and immunotherapy as induction regime followed by sequential chemoradiotherapy and consolidation immunotherapy demonstrates promising therapeutic efficacy and an acceptable toxicity profile. (Registration number: ChiCTR2200064587.)"

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

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

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