- |||||||||| Anniko (penpulimab) / Akesobio, Sino Biopharm, Focus V (anlotinib) / Advenchen, Sino Biopharm
Enrollment open, Trial completion date, Trial primary completion date, Metastases: Anlotinib Plus Anti-PD-1 Antibody AK105 for Advanced Pancreatic Cancer (clinicaltrials.gov) - Jun 22, 2023 P1/2, N=29, Recruiting, Not yet recruiting --> Recruiting | Trial completion date: Feb 2024 --> Jun 2024 | Trial primary completion date: Feb 2023 --> Feb 2024
- |||||||||| Tyvyt (sintilimab) / Innovent Biologics, Eli Lilly, Focus V (anlotinib) / Advenchen, Sino Biopharm, Oncaspar liquid (pegaspargase) / Servier
P2 data, Clinical Trial,Phase II, Journal: A Phase II Study of Sintilimab, Anlotinib, and Pegaspargase Sandwiched with Radiotherapy as First-line Therapy in Patients with Newly Diagnosed, Stage I-II Extranodal Natural-killer/T-cell Lymphoma. (Pubmed Central) - Jun 14, 2023 P2 No treatment-related deaths occurred. First-line sintilimab, anlotinib, and pegaspargase sandwiched with radiotherapy demonstrated promising efficacy in treatment-na
- |||||||||| Tyvyt (sintilimab) / Innovent Biologics, Eli Lilly, Focus V (anlotinib) / Advenchen, Sino Biopharm
Review, Journal: Treatment of a case of primary alveolar soft part sarcoma of the lung: Case report and literature review. (Pubmed Central) - Jun 11, 2023 Programmed cell death protein 1 monoclonal antibody (sintilimab) combined with a tyrosine kinase inhibitor (anlotinib hydrochloride) achieved a good therapeutic effect, indicating that this combination therapy is worth exploring further. Large-scale prospective studies are needed to explore and develop standardized treatments for ASPS.
- |||||||||| Tuoyi (toripalimab) / Shanghai Junshi Biosci, Coherus Biosci, Focus V (anlotinib) / Advenchen, Sino Biopharm
Biomarker, Journal, Next-generation sequencing, Tumor mutational burden, MSi-H Biomarker, PD(L)-1 Biomarker, IO biomarker: Next generation sequencing predicting clinical effect of immunotherapy on adult rhabdomyosarcoma patient: A case report. (Pubmed Central) - May 30, 2023 This is the longest progression-free survival for PD-1 inhibitors in RMS, and there is a trend of continued extension of progression-free survival in this patient. This case supports the hypothesis that positive PD-L1, TMB-H, and MSI-H could be beneficial biomarkers for immunotherapy in adult RMS.
- |||||||||| Opdivo (nivolumab) / BMS, Focus V (anlotinib) / Advenchen, Sino Biopharm
Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy: Evaluation of AL3818 in Combination With Nivolumab in Solid Tumors (clinicaltrials.gov) - May 22, 2023 P1/2, N=56, Active, not recruiting, Not yet recruiting --> Recruiting | Initiation date: Jul 2022 --> Nov 2022 Recruiting --> Active, not recruiting | Trial completion date: Mar 2023 --> Mar 2024 | Trial primary completion date: Dec 2022 --> Dec 2023
- |||||||||| AiRuiKa (camrelizumab) / Jiangsu Hengrui Pharma, Focus V (anlotinib) / Advenchen, Sino Biopharm
Retrospective data, Journal, Combination therapy, Metastases: A retrospective cohort study on the efficacy and safety for combination therapy of immunotherapy, targeted agent, and chemotherapy versus immunochemotherapy or chemotherapy alone in the first-line treatment of advanced biliary tract carcinoma. (Pubmed Central) - May 18, 2023 As combinations of targeted therapy with immunotherapy are well-established in hepatocellular carcinoma, the GEMOX chemotherapy (gemcitabine and oxaliplatin) is the standard treatment for BTC...Patients who were pathologically identified advanced BTC and had received gemcitabine-based chemotherapy alone or in combination with anlotinib, and/or anti-programmed cell death protein-1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitors such as camrelizumab as first-line treatment were retrospectively screened from The First Affiliated Hospital of Guangxi Medical University from February 2018 to August 2021...Grade 3-4 AEs in all patients included neutrophil count decrease (14.3%), aspartate aminotransferase increase (8.6%), alanine aminotransferase increase (8.6%), fatigue (5.7%), and blood bilirubin increase (5.7%). Anti-PD-1/PD-L1 immunotherapy in combination with anlotinib and gemcitabine showed promising efficacy and an acceptable safety profile for the BTC patients included in this study.
- |||||||||| Focus V (anlotinib) / Advenchen, Sino Biopharm, benmelstobart (APL-502) / Apollomics
Enrollment closed, Trial completion date, Trial primary completion date, Metastases: Anlotinib Combined With TQB2450 (PD-L1 Inhibitor) in the Treatment of Advanced Esophageal Squamous Cell Carcinoma(ESCC) (clinicaltrials.gov) - May 18, 2023 P2, N=46, Active, not recruiting, Anti-PD-1/PD-L1 immunotherapy in combination with anlotinib and gemcitabine showed promising efficacy and an acceptable safety profile for the BTC patients included in this study. Not yet recruiting --> Active, not recruiting | Trial completion date: May 2024 --> Sep 2024 | Trial primary completion date: Nov 2023 --> Mar 2024
- |||||||||| AiTan (rivoceranib) / HLB Bio Group
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Metastases: A Phase 3 Study Comparing Carelizumab Plus Nab-paclitaxel and Apatinib, Carelizumab Plus Nab-paclitaxel, and Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer. (clinicaltrials.gov) - May 6, 2023 P3, N=80, Terminated, This phase II trial showed that anlotinib plus PD-1 inhibitor exhibits favorable efficacy and tolerability in patients with refractory solid tumor. N=780 --> 80 | Trial completion date: Jan 2024 --> Apr 2023 | Recruiting --> Terminated | Trial primary completion date: Jan 2024 --> Apr 2023; Sponsor R & D Strategy Adjustment
- |||||||||| Focus V (anlotinib) / Advenchen, Sino Biopharm
Anlotinib plus chemotherapy as first-line therapy for gastrointestinal tumor patients with unresectable liver metastasis: Preliminary results from a multi-cohort, multi-center phase II trial (ALTER-G-001) (Poster HALL LEVEL 0) - May 6, 2023 - Abstract #ESMOGI2023ESMO_GI_349; P2 Cohort A received anlotinib (12mg, po, qd, d1-d14), oxaliplatin (130 mg/m2, iv, d1) and capecitabine (850 mg/m2, po, bid, d1-d14), cohort B received anlotinib, cisplatin (60-750 mg/m2, i.v., d1/d1-3) and paclitaxel (135 mg/m2, i.v., d1) or docetaxel (75 mg/m2, i.v., d1) and cohort C received anlotinib plus standard chemotherapy. Anlotinib plus chemotherapy had significant efficacy and tolerable safety as first-line treatment for advanced GI tumors with LMs, especially for pancreatic cancer, which might provide a new treatment strategy for those.
- |||||||||| Focus V (anlotinib) / Advenchen, Sino Biopharm
Journal: Effects of Decitabine Combined with Anlotinib on Proliferation and Apoptosis of Multiple Myeloma Cells (Pubmed Central) - Apr 29, 2023 In this single-arm study, the treatment of metastatic TNBC with anlotinib combined with chemotherapy showed certain efficacy, and its toxicity was acceptable. Decitabine combined with anlotinib can effectively inhibit the proliferation and induce apoptosis of MM cells, which provides a certain experimental basis for the treatment of human MM.
- |||||||||| Focus V (anlotinib) / Advenchen, Sino Biopharm
A phase ll study on the neoadjuvant treatment of resectable high-risk soft tissue sarcoma with anlotinib and doxorubicin. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6779; Decitabine combined with anlotinib can effectively inhibit the proliferation and induce apoptosis of MM cells, which provides a certain experimental basis for the treatment of human MM. This study suggested that the combination of anlotinib and doxorubicin might be a option for neoadjuvant therapy for patients with resectable high-risk STS due to the anti-tumor activity and acceptable toxicity.
- |||||||||| Halaven (eribulin mesylate) / Eisai, Focus V (anlotinib) / Advenchen, Sino Biopharm, Stivarga (regorafenib) / Bayer
Analysis of the efficacy and safety of PD-1/PD-L1 inhibitors () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6769; This is the first retrospective study revealed that the PD-1/PD-L1 inhibitors-based treatment had good efficacy and tolerable toxicity in Chinese advanced or metastatic MFS patients. Further prospective clinical trials and biomarker research on forecasting the efficacy of immune checkpoint inhibitors of MFS are warranted.
- |||||||||| Focus V (anlotinib) / Advenchen, Sino Biopharm
Update on real-world efficacy of anlotinib in non-small cell lung cancer. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6524; Further prospective clinical trials and biomarker research on forecasting the efficacy of immune checkpoint inhibitors of MFS are warranted. Anlotinib shows well efficacy in NSCLC patients, prolonging progression-free survival (PFS) and overall survival (OS), especially for front-line patients, suggesting that these patients may be a preferred population for using anlotinib, providing effective evidence for the use of anlotinib treatment for NSCLC patients.
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