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

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

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) - No abstract available

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

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

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

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