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

Integrated Penpulimab, Anlotinib and AG Chemotherapy as First-Line Regimen for Metastatic Pancreatic Cancer: A Multi-Centered, Randomized Controlled Trial (RCT-PAAG) (ESMO 2026) - No abstract available

Clinical • Metastases • Oncology • Pancreatic Cancer • Solid Tumor

Chemo-radiotherapy-free neoadjuvant penpulimab plus anlotinib in frail patients with locally advanced ESCC: updated phase II results and spatial CD4⁺IDO1⁺ immunosuppressive niches associated with resistance (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Esophageal Squamous Cell Carcinoma • Oncology • CD4 • IDO1

Survival in unresectable hepatocellular carcinoma: Comparison of four treatments based on patients reconstructed from Kaplan-Meier curves of randomized trials. (PubMed, World J Gastrointest Pharmacol Ther) - "Our study compared the efficacy of the main first-line treatments recommended for unresectable HCC. While we were able to rank the magnitude of efficacy across these treatments, the intrinsic limitations of our methods (primarily the reconstruction of IPD and the indirect nature of the treatment comparisons) should be borne in mind."

Journal • Hepatocellular Cancer • Oncology • Solid Tumor

Toward precision adjuvant immunotherapy in high-risk clear cell renal cell carcinoma: integrating plasma multiomics with PD-1 blockade. (PubMed, J Immunother Cancer) - "In this issue of the Journal for ImmunoTherapy of Cancer, Wang et al report a prospective, multicenter, non-randomized phase II trial evaluating adjuvant penpulimab in patients with very-high-risk ccRCC following nephrectomy...Although the non-randomized design, limited sample size, and exploratory biomarker analyses preclude immediate changes to clinical practice, the study highlights the promise of combining prospective immunotherapy trials with liquid biopsy-based multiomics. Such approaches may ultimately enable precision adjuvant immunotherapy by improving postoperative risk stratification, monitoring minimal residual disease, and guiding individualized treatment decisions in patients with high-risk ccRCC."

Biomarker • IO biomarker • Journal • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor

A Phase II Clinical Trial of Anti-EGFR Antibody-drug Conjugate (ADC) Combined With or Without Immune Checkpoint Inhibitors in the Neoadjuvant Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: West China Hospital | Not yet recruiting ➔ Recruiting | Trial completion date: Jun 2029 ➔ Dec 2029 | Initiation date: Feb 2026 ➔ Jul 2026 | Trial primary completion date: Oct 2028 ➔ Dec 2028

Checkpoint inhibition • Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

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 | "The integrated regimen involving Penpulimab, Anlotinib, Nab-Paclitaxel and Gemcitabine appears to be a more preferable choice than Gemcitabine-based chemotherapy alone for the first-line treatment of mPC on account of its improved efficacy and acceptable safety. Future follow-up is warranted in confirmation of its impact on OS."

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

Penpulimab versus placebo in combination with chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma: A global, multicenter, randomized, double-blind, phase 3 trial (AK105-304) (AACR 2025) - P3 | "Penpulimab combined with gemcitabine and cisplatin or carboplatin demonstrated statistically significant and clinically meaningful benefit with a manageable safety profile, and provides a new beneficial treatment option in the first-line treatment for R/M NPC patients globally."

Clinical • Combination therapy • Metastases • P3 data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Response-Adapted Surgery after Neoadjuvant Immunochemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma (REMATCH): A Single-Arm Phase II Trial. (PubMed, Clin Cancer Res) - "All received three cycles of NAICT (penpulimab, nab-paclitaxel, and cisplatin). Patients achieving ≥50% primary tumor regression derived promising survival and universal laryngeal preservation. These findings support the initiation of phase III randomized trials to validate this de-escalation strategy."

Journal • P2 data • Head and Neck Cancer • Hypopharyngeal Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A prospective phase 2 study on efficacy and safety of AK105, anlotinib combined with nab-paclitaxel (nab-P) as a first-line therapy in patients(pts) with advanced triple-negative breast cancer (TNBC). (SABCS 2024) - P2 | "The combination of AK105, anlotinib and nab-P showed better treatment response and tolerable toxicity in the treatment of first-line patients with TNBC. Further studies enrolling more patients are still needed."

Clinical • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PD-L2 • PGR

Anlotinib plus penpulimab versus sorafenib in the first-line treatment of unresectable hepatocellular carcinoma (APOLLO): a randomised, controlled, phase 3 trial. (PubMed, Lancet Oncol) - P3 | "Anlotinib plus penpulimab significantly improved progression-free survival and overall survival versus sorafenib in unresectable HCC and might be a new first-line option. These findings require verification in other regions of the world."

Journal • P3 data • Cardiovascular • Hepatocellular Cancer • Hepatology • Hypertension • Liver Failure • Oncology • Solid Tumor • AFP

Final Analysis of AK105-302: A Randomized, Double-blind, Placebo-Controlled, Phase III Trial of Penpulimab Plus Carboplatin and Paclitaxel as First-line Treatment for Advanced Squamous NSCLC (ESMO-IO 2022) - P3 | "Serious TRAEs occurred in 28.3% (P+C) vs. 26.9% (C). TRAEs led to treatment discontinuation were 5.2% in P+C and 3.4% in C. Conclusions These positive data will support penpulimab plus chemotherapy may be a promising and safe first-line treatment for locally advanced or metastatic squamous NSCLC."

Clinical • P3 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

GCN Pathomics-Clinical Model Predicts Response to First-Line Chemoimmunotherapy in Advanced LUSC: A Multicenter Study (IASLC-WCLC 2026) - "Methods : In this multicenter retrospective study, 436 patients with pathologically confirmed LUSC and available WSIs were included from three centers, comprising 343 cases from the phase III AK105-302 trial including both CIT and chemotherapy-only arms, and two external CIT cohorts (n = 63 and n = 30)...These findings were validated in both external CIT cohorts, while model performance and risk stratification were less effective in the chemotherapy-only and non-lung-origin cohorts. Conclusions : The GCN-based pathomics-clinical model achieved high discrimination and external validation for predicting objective response to CIT and enabled clinically meaningful response enrichment and risk stratification in advanced LUSC, supporting its potential utility for personalized first-line treatment selection."

Clinical • IO biomarker • Metastases • Non Small Cell Lung Cancer • Oncology

Anti-TIM-3 antibody TQB2618 in combination with penpulimab in relapsed or refractory classic Hodgkin lymphoma previously treated with PD-1/PD-L1 therapy: a multicenter, open-label, single-arm, phase Ib clinical trial. (PubMed, J Immunother Cancer) - P1/2 | "TQB2618 in combination with penpulimab was well tolerated and demonstrated promising efficacy in patients with cHL who had failed prior anti-PD-1/PD-L1 therapy, supporting its potential as a therapeutic option for this difficult-to-treat population."

Journal • P1 data • Classical Hodgkin Lymphoma • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

Primary results from the phase III ALTN-AK105-III-02 study: Anlotinib plus penpulimab versus sorafenib as first-line (1L) therapy for advanced hepatocellular carcinoma (aHCC) (ESMO 2024) - P3 | "The combination of anlotinib + penpulimab significantly prolonged PFS and OS vs sorafenib with no new safety signals observed, and presents as a new 1L treatment option for aHCC."

Clinical • Late-breaking abstract • Metastases • P3 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • AFP • FGFR • KIT

Penpulimab: A Next-Generation Fc-Engineered PD-1 Inhibitor in Cancer Immunotherapy. (PubMed, Crit Rev Oncol Hematol) - "Emerging evidence suggests that Fc engineering may contribute to reduced immune-related toxicity. Overall, penpulimab offers a promising next-generation PD-1 inhibitor with potential applications across multiple malignancies."

Journal • Review • Classical Hodgkin Lymphoma • Endocrine Disorders • Fatigue • Hematological Disorders • Hematological Malignancies • Hepatocellular Cancer • Hodgkin Lymphoma • Lung Cancer • Lymphoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • C1Q

Penpulimab combined with rituximab, high-dose methotrexate, and cytarabine (Pen-RMA) in newly diagnosed primary central nervous system lymphoma (PCNSL): a phase 2 trial. (PubMed, Blood Cancer J) - P2 | "Among them, 8 had CSF ctDNA clearance while 6 were positive. Overall, Pen-RMA regimen demonstrated encouraging antitumor activity with a manageable toxicity in PCNSL."

Journal • P2 data • CNS Lymphoma • Hematological Disorders • Hematological Malignancies • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma • Thrombocytopenia • Transplantation

Early physiological phenotypes and survival outcomes in advanced non-small cell lung cancer: a longitudinal study of dynamic muscle loss and functional decline. (PubMed, Front Oncol) - "To characterize early changes in skeletal muscle and physical function among patients with advanced non-small cell lung cancer (NSCLC) receiving penpulimab monotherapy or combination therapy, and to identify distinct treatment-associated physiological phenotypes with potential clinical relevance...Combination therapy is associated with greater early declines in muscle and physical function, while longitudinal physiological phenotyping provides complementary information for identifying patients at increased risk of adverse outcomes beyond conventional tumor response assessment. Prospective studies are warranted to validate these findings and determine whether interventions targeting physiological decline can improve clinical outcomes."

Journal • Observational data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcopenia • Solid Tumor

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

Cost-effectiveness analysis of anlotinib plus Penpulimab as first-line treatment for unresectable hepatocellular carcinoma. (PubMed, Expert Rev Pharmacoecon Outcomes Res) - "The APOLLO trial showed anlotinib combined with penpulimab (AN-PE) was effective as first-line therapy for unresectable hepatocellular carcinoma (uHCC) versus sorafenib (SOR). At a willingness to pay (WTP) threshold of $40,365/QALY, AN-PE had 0% cost-effectiveness probability. AN-PE is unlikely to be cost-effective as first-line uHCC treatment in China."

HEOR • Journal • Hepatocellular Cancer • Oncology • Solid Tumor

Metronomic Oral Paclitaxel Plus PD-1/ PD-L1 Inhibitor Maintenance in Advanced Lung Cancer (PULSE Study) (clinicaltrials.gov) - P4 | N=107 | Recruiting | Sponsor: Anhui Provincial Cancer Hospital

Checkpoint inhibition • New P4 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • PD-L1

RM-MA-PD1: R-MA-PD-1 Versus R-MA in Treatment-naive Primary CNS Lymphoma (clinicaltrials.gov) - P=N/A | N=58 | Not yet recruiting | Sponsor: WEI XU

New trial • B Cell Lymphoma • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma

Penpulimab Combined With Chemotherapy for Patients With Locally Advanced Hypopharyngeal Carcinoma (clinicaltrials.gov) - P2 | N=15 | Not yet recruiting | Sponsor: Tang-Du Hospital

New P2 trial • Head and Neck Cancer • Hypopharyngeal Cancer • Oncology • Solid Tumor

Chemotherapy With the Ralox Regimen Combined With Anlotinib and Penpulimab for Unresectable Hepatocellular Carcinoma (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Nanfang Hospital, Southern Medical University

New P1 trial • Hepatocellular Cancer • Oncology • Solid Tumor

First-line penpulimab combined with anlotinib achieves complete response in an elderly patient with occult lung squamous cell carcinoma: a case report. (PubMed, Front Oncol) - "These results suggest that penpulimab plus anlotinib may be a feasible first-line treatment option for elderly patients with advanced LUSC who cannot tolerate or choose to decline standard therapies. Notably, PD-L1 expression was not assessed because the patient refused testing, which prevents definitive conclusions regarding predictive factors associated with the observed response."

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

Efficacy and biomarker exploration of anlotinib plus penpulimab in second-line ES-SCLC: Results from the phase 2 ALTER-L041 trial. (PubMed, Cell Rep Med) - P2 | "Penpulimab plus anlotinib shows promising antitumor activity with a manageable safety profile and may represent a potential second-line treatment option for platinum-resistant ES-SCLC. This study was registered at ClinicalTrials.gov (NCT05001971)."

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