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

TQB2928-ALTN-Ib-01: TQB2928 Injection Combined Anlotinib Hydrochloride Capsule in Recurrent/Metastatic Osteosarcoma and Other Solid Tumors (clinicaltrials.gov) - P1 | N=20 | Terminated | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | N=43 ➔ 20 | Trial completion date: Feb 2026 ➔ Jun 2025 | Recruiting ➔ Terminated | Trial primary completion date: Oct 2025 ➔ Jun 2025; This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

Drug combination discovery assisted by AI and untargeted metabolomics: pamiparib and anlotinib synergistic potentiation for ovarian cancer treatment. (PubMed, Front Pharmacol) - "In vivo, significant downregulation of p-PI3K, p-Akt, Bcl-2, and HIF1-α, and upregulation of BAX protein expression confirmed that the mechanism of action of combination therapy is related to PI3K/Akt pathway. The combination of PAM and ANL was more effective than monotherapy for treating ovarian cancer and holds potential to become a new therapeutic approach for ovarian cancer."

IO biomarker • Journal • Oncology • Ovarian Cancer • Solid Tumor • ANXA5 • BAX • BCL2 • HIF1A

Preoperative IMRT With Concurrent Anlotinib for Localised Extremity or Trunk Sarcoma （SPARE-01） (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Trial completion date: Dec 2023 ➔ Dec 2027 | Trial primary completion date: Apr 2023 ➔ Dec 2027

Trial completion date • Trial primary completion date • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Phase II study of anlotinib hydrochloride as adjuvant therapy for localized high-risk trunk/extremity soft tissue sarcoma (ALTER-S010) (ESMO Asia 2025) - P2 | "Secondary endpoints: 12-month DFS rate, DFS, overall survival (OS), safety. The trial is opened in December 2024 and will be conducted in 6 hospitals with the aim of recruiting 54 evaluable patients Clinical trial information: ChiCTR2400094970."

Clinical • P2 data • Angiosarcoma • Brain Cancer • Leiomyosarcoma • Neurofibrosarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma • Undifferentiated Pleomorphic Sarcoma

Real world efficacy and safety of continuing anlotinib plus standard-of-care treatment beyond disease progression in patients with advanced non–small cell lung cancer (ESMO Asia 2025) - "Background: Previous studies did not demonstrate survival benefit of continued bevacizumab treatment beyond disease progression (PD) in advanced NSCLC. Our study demonstrated that there is a favorable survival benefit of continuing anlotinib treatment beyond PD in patients with NSCLC. To our knowledge, this study is the first large-scale real-world clinical data of Anlotinib across multiple lines of treatment beyond PD in NSCLC."

Clinical • Metastases • Real-world • Real-world effectiveness • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

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

RC48 combined with anlotinib for HER2-variated advanced non-small cell lung cancer: A prospective, single-arm study (ESMO Asia 2025) - P1/2 | "The preliminary results indicate that RC48 plus Anlotinib provides potential treatment option for the previously treated NSCLC patients with HER-2 variation."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

TitAN: A prospective, single-arm, phase II study of tislelizumab combined with anlotinib and nab-paclitaxel as neoadjuvant therapy for resectable stage III non-small cell lung cancer (ESMO Asia 2025) - P2 | "Primary endpoint: pathological complete response (pCR) rate. Secondary endpoints: major pathologic response (MPR), R0 resection rate, event-free survival (EFS), overall survival (OS), and safety (CTCAE v5.0)."

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

Efficacy and Safety of Niraparib in Combination with Anlotinib Based on CA 125 Level in Newly Diagnosed Ovarian Cancer: An open-label, single arm, multicenter, prospective phase II trial (ESMO Asia 2025) - P2 | "TEAEs occurred in 19/22 (86.4%) pts including 4 (18.2%) pts with grade ≥3. The most common TEAEs include mucositis, hypertension, anemia, anorexia, diarrhea and fatigue.Conclusions Niraparib plus anlotinib shows promising efficacy and tolerable safety in newly diagnosed OC with elevated CA125 during niraparib maintenance therapy."

Clinical • Combination therapy • P2 data • Oncology • Ovarian Cancer • Solid Tumor • MUC16

Preliminary results of ALTER-PA-001 trial: A multicenter, open-label, randomized, phase II trial of anlotinib and benmelstobart in combination with AG versus AG as first-line treatment for metastatic pancreatic cancer. (ASCO-GI 2026) - P2 | "Clinical Trial Registration Number: NCT06621095 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Combination therapy • Metastases • P2 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • 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

Sacituzumab Govitecan Combined with Anti-angiogenic Therapy and Radiotherapy in a BRCA1-Mutated Triple-Negative Breast Cancer Patient with Multiple Recurrences: A Case Report (SABCS 2025) - P2 | "She underwent left modified radical mastectomy, followed by 8 cycles of adjuvant chemotherapy (epirubicin + cyclophosphamide, followed by paclitaxel)...In December 2020, right chest wall recurrence was found, treated with local extended resection in January 2021, and followed by one-year oral capecitabine.In June 2023, she developed lung metastases (germline BRCA1 mutation),then enrolled in an IIT trial (NCT05085626) where she received Fluzoparib + Chidamide, achieving partial response (PR) with a progression-free survival (PFS) of 14 months...She declined brain surgery and received Bevacizumab + Trastuzumab Deruxtecan...Treatment with SG in combination with Anlotinib was initiated, accompanied by concurrent WBRT during the first cycle... This case report highlights the potential efficacy of SG in combination with anti-angiogenic therapy and radiotherapy in treating BRCA1-mutated TNBC patients with multiple recurrences and brain metastases. However, further studies..."

Case report • Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • BRCA1 • HER-2 • HRD • PGR

Comparative efficacy and safety of targeted therapeutics or immunotherapy agents combined with chemotherapy as first-line treatment for advanced biliary tract cancer: a systematic review and network meta-analysis. (PubMed, BMC Cancer) - "Our findings directly inform clinical guidelines, address gaps in current therapeutic decision-making. Durvalumab or pembrolizumab combined with GC are optimal first-line regimens for advanced BTC, balancing survival benefits and safety. Sintilimab plus anlotinib combined with GC demonstrates superior PFS but requires further validation. While EGFR inhibitors plus chemotherapy demonstrate potential in KRAS wild-type patients, confirmation in large-scale RCTs is required. PD-L1 expression may represent a promising predictive biomarker for response to PD-1 inhibitor therapy."

IO biomarker • Journal • Retrospective data • Review • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor • KRAS • PD-L1

First line PD-L1/1 inhibition based therapies in elderly patients with ES-SCLC: a Systematic Literature Review and Network Meta-Analysis (ESMO-IO 2025) - "Currently, PD-1/PD-L1 inhibitors with platinum and etoposide (EP) have been adopted as standard first-line therapy and idemonstrated survival benefits in the overall population, while the magnitude of benefit and optimal agent in elderly patients remain unclear.Methods Following PRISMA-NMA guidelines, PubMed and ClinicalTrials.gov were searched up to 29 August 2025. Eligible RCTs compared first-line PD-L1 or PD-1 inhibitors—atezolizumab, durvalumab, serplulimab, adebrelimab, tislelizumab, pembrolizumab, socazolimab, benmelstobart(+anlotinib), nivolumab, or toripalimab with or without EP in ES-SCLC...Atezolizumab-EP ranked highest for OS (SUCRA=0.88), followed by Benmelstobart + anlotinib -EP (SUCRA = 0.86) and serplulimab-EP (SUCRA = 0.77), whereas durvalumab-EP (SUCRA = 0.36) and socazolimab-EP (SUCRA = 0.29) showed relatively modest effects.Conclusions First-line PD-L1/PD-1 inhibition plus EP confers a clinically meaningful survival advantage in elderly patients with..."

Retrospective data • Review • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

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 | Not yet recruiting ➔ Active, not recruiting | Trial completion date: May 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2025

Enrollment closed • Trial completion date • Trial primary completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Efficacy and safety comparison of small molecule anti-angiogenic drugs in the treatment of bone and soft tissue sarcomas : a network meta-analysis. (PubMed, BMC Cancer) - "Short-term efficacy of small-molecule anti-angiogenic TKIs varied across bone and soft tissue sarcomas, with trends favoring apatinib plus chemotherapy and anlotinib. However, substantial heterogeneity across studies, including sarcoma subtypes and prior therapies, limits definitive conclusions regarding comparative efficacy. A multidisciplinary team is needed to better manage the side effects."

Journal • Retrospective data • Review • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Efficacy and Safety of Different Dosages of Anlotinib Combined with PD-1 Monoclonal Antibody in the Treatment of Advanced Non-Small Cell Lung Cancer. (PubMed, Cancer Invest) - "Medium-dose anlotinib combined with PD-1 therapy delivers superior survival and QoL outcomes with manageable toxicity. These results underscore its potential as an optimal treatment strategy for advanced NSCLC."

Journal • Endocrine Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Fatal Steroid-Refractory Autoimmune Encephalitis Following Sequential Immune Checkpoint Inhibitor Therapy in Squamous Non-Small Cell Lung Cancer. (PubMed, Onco Targets Ther) - "We report a fatal case of suspected steroid-refractory autoimmune encephalitis in a 71-year-old male with squamous NSCLC, occurring 14 months after sequential ICI therapy (toripalimab, then sintilimab, followed by anlotinib-sintilimab). Despite aggressive immunosuppression with high-dose corticosteroids, mycophenolate mofetil, and intravenous immunoglobulin, his condition progressed to coma with diffuse cerebral edema and hydrocephalus, leading to death within 14 days. This case highlights the lethal potential of ICI-induced encephalitis, the diagnostic challenges of seronegative presentations, and the urgent need for more effective treatment strategies."

Checkpoint inhibition • Journal • CNS Disorders • Immunology • Infectious Disease • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Ventriculomegaly

Pulmonary metastasis from adult-type granulosa cell tumor of the testis: a rare case report and literature review. (PubMed, Curr Med Res Opin) - "Second-line treatment with tislelizumab, nab-paclitaxel, carboplatin, and anlotinib led to temporary stabilization. Salvage chemotherapy with doxorubicin, ifosfamide, and dacarbazine failed, and the patient died two months later...Patients who undergo complete resection of metastatic lesions tend to achieve better outcomes, whereas responses to systemic therapy are generally poor. Early identification of high-risk features and consideration of retroperitoneal lymph node dissection may improve prognosis in selected patients."

Journal • Lung Cancer • Oncology • Testicular Cancer • FOXL2

Adjuvant benmelstobart plus anlotinib in patients with high-risk recurrence after resection of hepatocellular carcinoma: a phase II study (ALTER-H006). (PubMed, Nat Commun) - P2 | "No treatment-related deaths occur. Here, we show that adjuvant benmelstobart plus anlotinib is a feasible treatment option for HCC patients with high-risk recurrence after HCC resection, warranting confirmation in large-scale randomized clinical trials."

Clinical • Journal • P2 data • Cardiovascular • Hepatocellular Cancer • Hypertension • Oncology • Solid Tumor • Thrombosis

Efficacy and safety of anlotinib hydrochloride combined with concurrent radiotherapy in the treatment of locally advanced cervical cancer: a single-arm, single-center, exploratory, phase II clinical study. (PubMed, Front Oncol) - "The multi-target mechanism of anlotinib may contribute to consistent efficacy across different FIGO stages, supporting its potential as a therapeutic option for LACC. Larger-scale trials are warranted to validate these findings."

Journal • P2 data • Cardiovascular • Cervical Cancer • Diabetes • Endocrine Disorders • Fatigue • Hypertension • Metabolic Disorders • Oncology • Solid Tumor

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

Development and Validation of a Nomogram for Predicting Progression-Free Survival in Advanced Non-Small Cell Lung Cancer Patients Treated with Anlotinib. (PubMed, J Coll Physicians Surg Pak) - "Six significant factors affecting PFS in patients with advanced NSCLC treated with anlotinib were identified. A reliable nomogram was successfully constructed for the prediction of PFS, offering a tool to support personalised treatment planning."

Journal • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Phase II Trial of Anlotinib-Chemotherapy Combination in HER2-Negative Metastatic Breast Cancer: Therapeutic Efficacy and Proteomic Biomarker Profiling (SABCS 2025) - "Anlotinib combined with chemotherapy demonstrated promising efficacy and an acceptable safety profile for second-line or later treatment of patients with HER2-negative MBC. Baseline serum levels of VEGFA, CSF-1, IL-6, IL-10, and IL-12 identified through proteomic analysis show potential as predictive biomarkers for therapeutic response. These findings necessitate validation in larger randomized clinical trials."

Biomarker • Clinical • IO biomarker • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CSF1 • HER-2 • IL10 • IL12A • IL6