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

Anlotinib versus bevacizumab added to standard first-line chemotherapy among patients with RAS/BRAF wild-type, unresectable metastatic colorectal cancer: A multicenter, prospective, randomised, phase 3 clinical trial (ANCHOR trial). (ASCO 2025) - P3 | " In this Chinese multicenter, randomised, non-inferiority, phase 3 trial, treatment-naïve RAS/BRAF wild-type mCRC patients with MDT-assessed unresectable metastases were 1:1 randomised to receive anlotinib (12mg, QD, days 1-14) or bevacizumab (7.5mg/kg, IV, day 1), both combined with oxaliplatin (130mg/m², IV, day 1) and capecitabine (anlotinib group:850mg/m2, bevacizumab group 1000mg/m², BID, days 1-14) in 3-week cycles. In unresectable RAS/BRAF wild-type mCRC patients, anlotinib plus CapeOX showed comparable PFS time and safety compared with bevacizumab plus CapeOX. The results provide a new treatment option for unresectable RAS/BRAF wild-type mCRC patients."

Clinical • Late-breaking abstract • Metastases • P3 data • Colorectal Cancer • Oncology • Solid Tumor • BRAF

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

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

Prospective, Single-arm, Phase II Clinical Study of Irinotecan Hydrochloride Liposome Injection Combined With Platinum and Immune Checkpoint Inhibitors Combined With Anlotinib for the Maintenance of Extensive Small Cell Lung Cancer After First-line Induction (clinicaltrials.gov) - P2 | N=31 | Not yet recruiting | Sponsor: China Medical University, China

Checkpoint inhibition • New P2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

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) - No abstract available

Checkpoint inhibition • Clinical • Metastases • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Sequential anlotinib and camrelizumab combination therapy achieves exceptional survival in multi-driver mutated, TMB-low/PD-L1-low/MSS pulmonary sarcomatoid carcinoma: case report and literature review. (PubMed, Front Immunol) - "This approach resulted in unprecedented survival outcomes: the 72-month overall survival dramatically exceeds the median OS of less than 12 months reported for advanced PSC, and the patient maintained a progression-free survival of over 37 months on combination therapy, surpassing historical PFS benchmarks. This case provides a clinically actionable framework for managing multi-driver mutated, immunoresistant PSC."

Biomarker • IO biomarker • Journal • Review • Tumor mutational burden • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • ALK • PD-L1 • PTEN • ROS1 • STK11 • TMB • TSC2

Safety and Efficacy Analysis of Oral Etoposide Combined With Anlotinib and Envafolimab in First-line Treatment of Elderly Patients With Small Cell Lung Cancer/ Open-label, Single-arm, Exploratory Phase II Clinical Study (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital | Trial completion date: Dec 2025 ➔ May 2026

Trial completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Case report: Immune checkpoint inhibitor-induced fulminant diabetic ketoacidosis: a case-based review and considerations for immunotherapy discontinuation. (PubMed, Front Immunol) - "An elderly male diagnosed with Stage IV LUAD achieved sustained stable disease (SD) and symptomatic improvement through a sequential therapeutic strategy, including platinum-based chemotherapy followed by the PD-1 inhibitor sintilimab combined with anti-angiogenic agents (apatinib or anlotinib). This case demonstrates that while ICIs can provide exceptional long-term benefits in advanced NSCLC, particularly in patients with highly immunogenic mutation profiles, they may also trigger late-onset fatal irAEs. Our findings underscore the imperative for close, long-term metabolic surveillance throughout the course of immunotherapy, regardless of treatment duration or radiological stability."

Checkpoint inhibition • IO biomarker • Journal • Review • Diabetes • Endocrine Cancer • Lung Adenocarcinoma • Lung Cancer • Metabolic Disorders • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS • TP53

A Phase II Clinical Study of Sacituzumab tirumotecan in Combination with Anlotinib in Patients with Advanced/Metastatic Non-Small Cell Lung Cancer without Driver Alterations (ChiCTR) - P2 | N=128 | Recruiting | Sponsor: Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology; Tongji Hospital, Tongji Medical College ,Huazhong University o

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • HER-2 • KRAS • NTRK • ROS1

Efficacy and Safety of Radiotherapy Combined With Tislelizumab and Anlotinib in the Treatment of Hepatocellular Carcinoma Complicated With Portal Vein Tumor Thrombus (ChiCTR) - P=N/A | N=27 | Not yet recruiting | Sponsor: Henan Cancer Hospital; Henan Cancer Hospital

New trial • Hepatocellular Cancer • Oncology • Solid Tumor • Thrombosis

Toripalimab plus Anlotinib as second-line therapy for patients with advanced thymic carcinoma: a phase 2 trial (ChiCTR) - P2 | N=33 | Recruiting | Sponsor: Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center

New P2 trial • Oncology • Solid Tumor • Thymic Carcinoma • Thymus Cancer

SKB264-ANLO: Sacituzumab Tirumotecan Plus Anlotinib in Previously Treated ES-SCLC (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: China Medical University, China

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

ANCA trial: Anlotinib Plus Camrelizumab and Chemotherapy as Neoadjuvant Therapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: A Prospective Phase II Trial (ChiCTR) - P2 | N=56 | Not yet recruiting | Sponsor: The General Hospital of the Western Theater Command of the Chinese People's Liberation Army; the General Hospital of the Western Theater Command of th

New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Nal-IRI/5-FU/LV Chemotherapy Combined With PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT as Second-line Therapy in Metastatic Pancreatic Cancer Patients (clinicaltrials.gov) - P2 | N=56 | Recruiting | Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Pancreatic Cancer • Solid Tumor

Chidamide and Anlotinib act synergistically in Jurkat cells by inhibiting the Hippo signaling pathway. (PubMed, Biochem Biophys Rep) - "To overcome these limitations, we systematically evaluated the synergistic Combination effects of three drug candidates, OTX-015 (BET inhibitor), Metformin (metabolic regulator), and Anlotinib (multitargeted tyrosine kinase inhibitor), with Chidamide. Chidamide and Anlotinib synergistically inhibit Hippo signaling pathway, which reveals a novel "dual epigenetic kinase targeting" strategy for the treatment of T-ALL. Future studies should validate these findings in vivo and investigate the impact of the metabolic microenvironment on therapeutic efficacy."

Journal • Acute Lymphocytic Leukemia • Gene Therapies • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma • CTGF

A Single-arm, Single-center Phase II Clinical Study of Sacituzumab tirumotecan Combined with Anlotinib in the Second-line Treatment of Patients with Advanced Gastric Cancer (ChiCTR) - P4 | N=33 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University

New P4 trial • Gastric Adenocarcinoma • Gastric 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

Anlotinib Plus Sintilimab for BRAFV600E Negative Unresectable or Metastatic Anaplastic Thyroid Carcinoma: A Single-Center, Single-Arm, Phase 2 Trial. (PubMed, Thyroid) - P2 | "Anlotinib plus sintilimab showed favorable efficacy and manageable safety in BRAFV600E-negative unresectable or metastatic ATC, supporting further investigation."

Journal • P2 data • Cardiovascular • Dyslipidemia • Hypertension • Hypertriglyceridemia • Oncology • Solid Tumor • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma

ERBB2 I655V mutation correlates with efficacy of immunotherapy in gallbladder cancer. (PubMed, World J Surg Oncol) - "The ERBB2 I655V mutation may be associated with improved treatment response to immunotherapy in gallbladder cancer."

IO biomarker • Journal • Gallbladder Cancer • Oncology • Solid Tumor • HER-2 • TYK2

Tislelizumab Combined With Anlotinib and Nab-paclitaxel in III Resectable Non-small Cell Lung Cancer : A Prospective, Single-Arm, Phase II Study (ChiCTR) - P=N/A | N=34 | Not yet recruiting | Sponsor: Qilu Hospital of Shandong University; Qilu Hospital of Shandong University

New trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR

Efficacy and Safety of Sintilimab Combined with Anlotinib in Relapsed and Refractory Small-Cell Lung Cancer: A Phase II Clinical Trial (ELCC 2026) - No abstract available

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

MAGNATE-S: Paclitaxel Polymer Micelles Combo in Advanced Sarcoma (clinicaltrials.gov) - P2 | N=46 | Recruiting | Sponsor: Shanghai 6th People's Hospital

New P2 trial • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Complete response to BRICS in Locally advanced pancreatic cancer (pMMR, CPS 30): a case report. (PubMed, Front Immunol) - "In this case, the treatment comprised SBRT 24 Gy/3 fractions → q21d toripalimab 240 mg + nab-paclitaxel 200→100 mg + anlotinib 12 mg d1-14, with continuous Bifidobacterium triple viable tablets. These results challenge the prevailing assumption that pMMR status invariably predicts resistance to immunotherapy. These findings suggest that, in pMMR pancreatic cancers with high PD-L1 CPS, multimodal treatment strategies may remodel the tumor microenvironment and overcome immune resistance, highlighting a promising therapeutic direction."

IO biomarker • Journal • pMMR • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CA 19-9

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 (Front Oncol) - "Endocrine irAEs were predominantly grade 1–2 and occurred later in patients treated with anlotinib (median onset 12 vs. 9 weeks). In the 12 and 24 week landmark analyses, where irAE status was determined at the landmark, endocrine irAEs were not significantly associated with PFS in the overall cohort (12 week HR 1.23, 95% CI 0.70–2.17; 24 week HR 1.27, 95% CI 0.67–2.43). Similarly, a time-dependent Cox model treating endocrine irAEs as a time-varying covariate did not demonstrate a protective effect (HR 2.38, 95% CI 1.43–3.94)."

Retrospective data • Non Small Cell Lung Cancer

ANCHOR: A Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy as First-line Treatment in Subjects With RAS/BRAF Wild Metastatic Colorectal Cancer (clinicaltrials.gov) - P3 | N=748 | Active, not recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Trial completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Colorectal Cancer • Oncology • Solid Tumor • BRAF