Focus V (anlotinib) / Advenchen, Sino Biopharm - LARVOL DELTA

Phase II study of iza-bren (BL-B01D1) in combination with serplulimab in patients with small cell lung cancer (SCLC) (ELCC 2026) - P2 | "In stage II, treatment-naive pts were treated with iza-bren at 2.5 or 2.75 mg/kg D1D8 Q3W plus serplulimab or plus serplulimab and anlotinib. Legal entity responsible for the study Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. Funding Baili-Bio (Chengdu) Pharmaceutical Co., Ltd."

Clinical • Combination therapy • P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Efficacy and safety of first-line immunotherapy and targeted therapy in advanced HCC: a network meta-analysis with subgroup analysis based on HBV and HCV infection. (PubMed, Front Immunol) - "In the overall population, regimens with significant OS advantage over sorafenib included sintilimab plus bevacizumab biosimilar (HR = 0.57, 95% CrI 0.43-0.75), camrelizumab plus rivoceranib (HR = 0.62, 0.48-0.79), and atezolizumab plus bevacizumab (HR = 0.66, 0.51-0.84). For PFS, top-ranked combinations were camrelizumab plus rivoceranib (HR = 0.52, 0.41-0.66), anlotinib plus penpulimab (HR = 0.53, 0.41-0.68), lenvatinib plus pembrolizumab (HR = 0.55, 0.44-0.68), and sintilimab plus bevacizumab biosimilar (HR = 0.56, 0.45-0.69)...Regarding safety, tislelizumab (RR = 0.42, 0.33-0.52) and nivolumab (RR = 0.45, 0.36-0.56) were associated with the lowest incidence of AEs≥3...In non-viral HCC, the STRIDE regimen (single priming dose tremelimumab plus durvalumab) was the only regimen to significantly improve OS (HR = 0.75, 0.59-0.96)...This etiology-stratified evidence..."

Clinical • Journal • Retrospective data • Review • Hepatitis C • Hepatocellular Cancer • Infectious Disease • Oncology • Solid Tumor

MPNFS Framework for Managing Herpes Zoster and Refractory Pain in an Immunotherapy-Treated Lung Cancer Patient: A Case Report. (PubMed, Cancer Manag Res) - "We report a 63-year-old woman with stage IV lung adenocarcinoma (cT2aN2M1c, bone metastases) on sindilizumab and anlotinib, who developed severe cervical herpes zoster while carrying an implanted intrathecal drug delivery system (IDDS). This case achieved key outcomes: safe IDDS preservation, effective symptom management, and seamless care continuity. It demonstrates that the MPNFS-guided integrative nursing is a clinical framework for managing complex immunotherapy-related complications, highlighting its vital role in facilitating multidisciplinary coordination and supporting patients through high-risk care transitions."

Journal • CNS Disorders • Herpes Zoster • Lung Adenocarcinoma • Lung Cancer • Mood Disorders • Neuralgia • Non Small Cell Lung Cancer • Oncology • Pain • Psychiatry • Solid Tumor • Varicella Zoster

Outcomes and Safety of PD-1 Blockades Plus Anlotinib Regimen in Previously-Treated Metastatic Esophageal Squamous Cell Carcinoma: A Retrospective, Exploratory Study. (PubMed, Drug Des Devel Ther) - "PD-1 blockades plus anlotinib demonstrated encouraging effectiveness and manageable toxicity in metastatic ESCC, achieving notable disease control and survival benefits compared with historical standards. Future prospective study is needed to confirm the therapeutic benefits and identify the optimal patient selection criteria for this promising combination therapy."

Journal • Retrospective data • Cardiovascular • Esophageal Squamous Cell Carcinoma • Fatigue • Hypertension • Oncology • Squamous Cell Carcinoma

Association of endocrine immune-related adverse events with progression-free survival in advanced non-small cell lung cancer treated with PD-1/PD-L1 inhibitors with or without anlotinib. (PubMed, Front Oncol) - "In this single-center cohort, endocrine irAEs functioned as dynamic on-treatment indicators but did not confer a clear PFS advantage after bias-aware modeling. Given the limited sample size, these findings are exploratory and require further prospective validation."

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

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

Lipid-Engineered Small-Sized Metal-Organic Frameworks for Targeted Delivery of Anlotinib in Lung Cancer Treatment. (PubMed, Int J Nanomedicine) - "Furthermore, in the orthotopic lung cancer model, AML achieved the most pronounced therapeutic efficacy among all treatment groups. This dual mode therapeutic strategy-combining targeted chemotherapy with oxidative stress induction-highlights the potential of AML as a promising nanomaterial for improving lung cancer treatment."

Journal • Acute Myelogenous Leukemia • Lung Cancer • Oncology • Solid Tumor

R-ALPS: A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial of TQB2450 with or without anlotinib as maintenance treatment in patients with locally advanced and unresectable (stage III) NSCLC without progression following concurrent or sequential chemoradiotherapy. (ASCO 2025) - P3 | "Benmelstobart, both as monotherapy and in combination with anlotinib, significantly prolonged PFS compared to placebo. Secondary endpoints also showed superiority, and the safety profile of the treatment group remained within acceptable parameters. (Funded by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; ClinicalTrials.gov number, NCT04325763)."

Clinical • Late-breaking abstract • Metastases • P3 data • Cardiovascular • Dyslipidemia • Hypertension • Hypertriglyceridemia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Anlotinib + Toripalimab maintenance in Extensive-Stage small cell lung Cancer: Clinical efficacy and preclinical mechanism of anlotinib-induced neuroendocrine differentiation Suppression via Notch1. (PubMed, Lung Cancer) - P2 | "Toripalimab plus anlotinib is associates with promising efficacy and acceptable safety as maintenance therapy in ES-SCLC. The therapeutic effect may be mediated through coordinated immunomodulation and anlotinib-induced changes in differentiation-related pathway, providing a mechanistic rationale for the observed clinical benefits. These results warrant further validation in randomized controlled trials."

IO biomarker • Journal • Preclinical • Immunology • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • GRP-10 • NOTCH1

A phase Ib/II study of second-line cadonilimab, anlotinib and docetaxel in patients with checkpoint inhibitor (CPI)-experienced advanced non-small cell lung cancer (ELCC 2026) - P1/2 | "Background This study (AK104-IIT-018, NCT05816499) aimed to evaluate the safety and efficacy of cadonilimab (a PD-1/CTLA-4 bispecific antibody), anlotinib, and docetaxel in patients with checkpoint inhibitor (CPI)-experienced advanced non-small cell lung cancer (NSCLC) without sensitizing EGFR/ALK/ROS1 mutations.Methods It was a prospective, open-label, single-arm, multi-center, phase Ib/II trial comprising a dose exploration and an expansion phase. The objective response rate (ORR) was 26.2%, and the disease control rate (DCR) was 90.5%.The duration of response (DoR) was 5.36 months, and the overall survival has not mature. Grade 3-4 treatment-related adverse events (TRAEs) occurred in 14.0%.Conclusions Cadonilimab in combination with anlotinib and docetaxel showed promising efficacy and well-tolerated safety in advanced NSCLC patients who had failed prior CPI, as a potential strategy to overcome resistance to anti-PD-(L)1 therapy."

Checkpoint inhibition • Clinical • IO biomarker • Metastases • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • CTLA4 • EGFR • ROS1

Benmelstobart plus anlotinib versus pembrolizumab as first-line treatment for PD-L1-positive, advanced non-small-cell lung cancer (CAMPASS): a blinded, randomised, controlled, phase 3 trial. (PubMed, Lancet Oncol) - P3 | "Benmelstobart plus anlotinib showed longer progression-free survival than pembrolizumab plus placebo and no unexpected safety signals were reported, suggesting benmelstobart plus anlotinib as a potential first-line option in driver gene-negative, PD-L1-positive, advanced NSCLC. Longer term follow-up is needed to establish effects on overall survival."

Journal • P3 data • Cardiovascular • Hypertension • Infectious Disease • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • PD-L1

Autoantibody profiling delineates response to combined MEK and RTKs inhibition in KRAS-mutant non-small cell lung cancer (ELCC 2026) - "Although the combined use of the MEK inhibitor trametinib and the RTK inhibitor anlotinib has shown promising preclinical and clinical activity, reliable biomarkers to predict treatment response are still lacking.Methods We conducted longitudinal, high-density plasma proteomic profiling to characterize autoantibody dynamics during combined MEK/RTK inhibition. Autoantibodies against PLP2 and GINS1 consistently exhibited marked post-treatment increases across nearly all patients, highlighting their potential as robust biomarkers of therapeutic response.Conclusions This study demonstrates the utility of high-resolution plasma proteomics for decoding drug response and identifying minimally invasive biomarkers. Autoantibody profiling provides novel insights into monitoring combined MEK/RTK inhibition in KRAS-mutant NSCLC and may guide future biomarker-driven therapeutic strategies."

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

Sintilimab plus anlotinib in later-line treatment of advanced KRAS-mutant NSCLC: a multicenter, retrospective case series. (PubMed, Front Med (Lausanne)) - "This real-world case series suggests that sintilimab plus anlotinib offers promising efficacy and manageable toxicity as a later-line, chemotherapy-free regimen for advanced KRAS-mutant NSCLC. The absence of prior anti-angiogenic therapy emerged as a strong positive predictor for survival, underscoring the importance of strategic treatment sequencing in clinical practice."

IO biomarker • Journal • Retrospective data • Cardiovascular • Dermatology • Hypertension • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Retraction Note: Anlotinib combined with temozolomide suppresses glioblastoma growth via mediation of JAK2/STAT3 signaling pathway. (PubMed, Cancer Chemother Pharmacol) - No abstract available

Journal • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

NeoLATC: Response to Neoadjuvant Treatment in Locally Advanced Thyroid Cancer (clinicaltrials.gov) - P=N/A | N=120 | Recruiting | Sponsor: Fujian Medical University

New trial • Oncology • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Medullary Carcinoma

METTL3-Mediated m6A Modification Contributes to Anlotinib Resistance in Osteosarcoma by Regulating Ferroptosis via the circFAM120B/miR-330-3p/PRKDC Axis. (PubMed, Free Radic Biol Med) - "Notably, while ferroptosis represents a key mechanism, STAT3 may also contribute to anlotinib resistance through additional pathways including apoptosis, autophagy, and immune evasion, reflecting the multifunctional role of this central signaling hub. Our results delineate a novel mechanism wherein METTL3 governs ferroptosis and anlotinib resistance in osteosarcoma through dual m6A methylation of circFAM120B and pri-miR-330, offering potential targets for overcoming therapeutic resistance."

Journal • Oncology • Osteosarcoma • Sarcoma • Solid Tumor • GPX4 • METTL3 • MIR330 • PRKDC • YTHDF2

Chemotherapy-free regimen: Real-world efficacy and safety of anlotinib plus PD-1/PD-L1 inhibitors in advanced non-small cell lung cancer. (PubMed, Chin J Cancer Res) - "Treatment-related adverse events (AEs) occurred in 198 (81.8%) patients, with grade 3-4 AEs reported in 22 (9.1%) patients. This multicenter, real-world study demonstrates that the anlotinib-ICI combination regimen exhibits clinically meaningful efficacy and tolerability as a chemotherapy-free alternative for advanced NSCLC, offering viable evidence to guide treatment for patients who are unsuitable for conventional chemotherapy."

Journal • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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

Galaxy-L-01: A multicenter, prospective study of garsorasib combined with anlotinib as first-line therapy for KRAS G12C-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (ELCC 2026) - P4 | "A total of 82 eligible patients will be randomized 1:1 to either the experimental combination of garsorasib plus anlotinib (dose from single-arm phase) or standard pemetrexed-platinum chemotherapy plus PD-(L)1 inhibitor. Randomized phase primary endpoint is PFS, with secondary endpoints including DOR, DCR, TTR, OS and safety. The study is actively recruiting and has 3 patients enrolled as of 10-Jan-2026."

Clinical • IO biomarker • Metastases • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

A Non-canonical RNA-Binding Function of NQO1 Drives Angiogenesis in Esophageal Squamous Cell Carcinoma via Extracellular Vesicle-Mediated AGRN Transfer. (PubMed, Cancer Res) - "Importantly, combined treatment with panobinostat and the anti-angiogenic agent anlotinib resulted in superior inhibition of tumor growth and vascularization compared with either monotherapy in patient-derived organoid xenograft models. Together, these findings uncover an enzymatic activity-independent RNA regulatory function of NQO1 in ESCC and provide a mechanistic rationale for targeting the NQO1/AGRN axis."

Journal • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • AGRN • NQO1

Targeting vascular endothelial growth factor and its receptors in non-small cell lung cancer for improved treatment strategies. (PubMed, J Recept Signal Transduct Res) - "Anti-angiogenic therapy, for instance, with monoclonal antibodies like bevacizumab and ramucirumab, as well as multi-targeted tyrosine kinase inhibitors (TKIs) like nintedanib and anlotinib has been shown to improve the management of NSCLC. Angiogenesis-associated biomarkers, despite extensive research, have not been seen to have a clinical impact in the management and treatment of NSCLC because of the heterogeneous characteristics and the dynamic regulation of the cascade. This review summarizes current VEGF/VEGFR-targeted therapies in NSCLC, mechanisms of resistance, and future directions toward biomarker-guided therapeutic optimization."

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

CAMPASS: Benmelstobart in combination with anlotinib vs pembrolizumab in the first-line treatment of advanced non-small cell lung cancer (aNSCLC)—A randomized, single-blind, multicenter phase 3 study. (ASCO 2025) - P3 | "To our knowledge, this is the first phase III study to demonstrate the significant PFS benefit of a multikinase inhibitor plus an anti-PD-L1 mAb in the first-line treatment of PD-L1-positive aNSCLC compared to pembrolizumab. Tolerability is favourable with a lower incidence of treatment discontinuation due to TRAE. The data support this combination as a new option for these pts."

Clinical • Combination therapy • IO biomarker • Late-breaking abstract • Metastases • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

SBRT Plus Anlotinib and Bimepolizumab in Locally Advanced or Metastatic Renal Cell Carcinoma (clinicaltrials.gov) - P2 | N=27 | Not yet recruiting | Sponsor: Fujian Cancer Hospital

New P2 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

BACON: Benmelstobart in Combination With Anlotinib and Oral Metronomic Cyclophosphamide in the Treatment of Recurrent Epithelial OvariaN, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

New P2 trial • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Cost-Effectiveness Analysis of Anlotinib Plus Penpulimab Versus Sorafenib in the First-Line Treatment of Unresectable Hepatocellular Carcinoma in China. (PubMed, Clin Drug Investig) - "Our study suggests that anlotinib combined with penpulimab represents a cost-effective first-line treatment option for patients with uHCC from the perspective of the Chinese healthcare system. These results provide critical evidence to inform clinical practice and healthcare reimbursement policy."

HEOR • Journal • Hepatocellular Cancer • Oncology • Solid Tumor