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  • ||||||||||  Tyvyt (sintilimab) / Innovent Biologics, Eli Lilly, Focus V (anlotinib) / Advenchen, Sino Biopharm
    Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Tumor mutational burden, IO biomarker, Metastases:  Sintilimab Combined With Anlotinib in Advanced NSCLC With EGFR Uncommon Mutations (clinicaltrials.gov) -  Apr 18, 2022   
    P2,  N=21, Active, not recruiting, 
    Pancreatic adenocarcinoma (PDAC); anlotinib; nab-paclitaxel/gemcitabine; progression-free survival (PFS); overall survival (OS). Recruiting --> Active, not recruiting | N=30 --> 21 | Trial completion date: Dec 2021 --> Jun 2022 | Trial primary completion date: Dec 2021 --> Jun 2022
  • ||||||||||  Imfinzi (durvalumab) / AstraZeneca, Focus V (anlotinib) / Advenchen, Sino Biopharm
    Enrollment open, Trial completion date, Trial primary completion date:  Alotinib Plus Durvalumab-Platinum-Etoposide in First-line Treatment Extensive Small-cell Lung Cancer (clinicaltrials.gov) -  Apr 12, 2022   
    P2,  N=120, Recruiting, 
    Therefore, PNI and its variations, particularly post-PNI, are affordable and accessible predictors of NSCLC patients treated with anlotinib in clinical work. Not yet recruiting --> Recruiting | Trial completion date: Nov 2022 --> Nov 2023 | Trial primary completion date: Dec 2021 --> May 2023
  • ||||||||||  Focus V (anlotinib) / Advenchen, Sino Biopharm
    Biomarker, Preclinical, Journal:  Serum Eicosanoids Metabolomics Profile in a Mouse Model of Renal Cell Carcinoma: Predicting the Antitumor Efficacy of Anlotinib. (Pubmed Central) -  Apr 9, 2022   
    A total of eight potential metabolites from the refined partial least squares (PLS) model were considered as potential predictive biomarkers for the efficacy of ANL, and the DHA held the most outstanding sensitivity and specificity with an area under the receiver operating characteristic curve of 0.88. Collectively, the results of this exploratory study not only provide a powerful reference for understanding eicosanoid metabolic reprogramming of ANL but also offer an innovative perspective for the development of therapeutic targets and strategies, the discovery of predictive biomarkers, and the determination of effective tumor monitoring approaches.
  • ||||||||||  Focus V (anlotinib) / Advenchen, Sino Biopharm
    Journal:  Prognosis Model of Advanced Non-Small-Cell Lung Cancer Based on Max-Min Hill-Climbing Algorithm. (Pubmed Central) -  Apr 5, 2022   
    Under the guidance of the model, the research group has a smaller diameter of primary foci and metastatic foci, a higher ORR, DCR, and a longer PFS than the control group (P < 0.05). We can conclude that the MMHC algorithm can guide the maintenance treatment of advanced NSCLC, which is conducive to the prognosis judgment and treatment cost control.
  • ||||||||||  Focus V (anlotinib) / Advenchen, Sino Biopharm, Zejula (niraparib) / GSK, J&J
    New P2 trial, Combination therapy:  Niraparib Plus Anlotinib for Recurrent Ovarian Cancer (clinicaltrials.gov) -  Apr 4, 2022   
    P2,  N=36, Recruiting, 
  • ||||||||||  Focus V (anlotinib) / Advenchen, Sino Biopharm
    Journal:  Anlotinib-Induced Hypertension: Current Concepts and Future Prospects. (Pubmed Central) -  Apr 1, 2022   
    To effectively manage anlotinib-induced hypertension, early prevention, a reasonable dosage regimen, and appropriate treatment are critical to effectively manage anlotinib-induced hypertension. Additionally, anlotinib-induced hypertension may be considered a marker for predicting efficacy.
  • ||||||||||  Trial completion date, Trial primary completion date:  FUSCC Refractory TNBC Umbrella (FUTURE) (clinicaltrials.gov) -  Mar 31, 2022   
    P1/2,  N=140, Recruiting, 
    Additionally, anlotinib-induced hypertension may be considered a marker for predicting efficacy. Trial completion date: Jun 2022 --> Dec 2022 | Trial primary completion date: Jan 2022 --> Jun 2022
  • ||||||||||  Focus V (anlotinib) / Advenchen, Sino Biopharm
    New trial, Real-world evidence, Real-world, Metastases:  Anlotinib Retrospective Study for Esophageal Cancer (clinicaltrials.gov) -  Mar 31, 2022   
    P=N/A,  N=300, Completed, 
  • ||||||||||  Focus V (anlotinib) / Advenchen, Sino Biopharm
    Journal:  Gross perianal embryonal rhabdomyosarcoma with severe multiple bone metastases throughout the body: a case report. (Pubmed Central) -  Mar 30, 2022   
    A multi-target tyrosine kinase inhibitor, anlotinib, was selected to control the tumours combined with local radiotherapy to relieve pain...At 7 months after the diagnosis, the patient died of thrombocytopenia. This current case may provide supportive evidence for a potential treatment for patients with advanced ERMS, especially those not suitable for chemotherapy or surgery.
  • ||||||||||  Focus V (anlotinib) / Advenchen, Sino Biopharm
    Journal, PD(L)-1 Biomarker, IO biomarker:  Anti-tumour effect of in situ vaccines combined with VEGFR inhibitors in the treatment of metastatic cervical cancer. (Pubmed Central) -  Mar 25, 2022   
    In addition, in terms of metabolism, the anti-vascular effect of anlotinib can significantly reduce the blood supply and metabolic level of tumor, the expression of Ki67 and CD31 in the control group was significantly higher than that in each administration group. In conclusion, our preclinical research results showed that the combination of in situ vaccine and anti-angiogenic therapy has a good anti-tumor effect, and may potentially offer an effective treatment option for patients with advanced cervical cancer.
  • ||||||||||  Focus V (anlotinib) / Advenchen, Sino Biopharm
    Biomarker, Clinical, Journal:  Levels of pretreatment blood lipids are prognostic factors in advanced NSCLC patients treated with anlotinib. (Pubmed Central) -  Mar 18, 2022   
    Prior to anlotinib therapy, TC and LDL levels, are independent prognostic indicators for patients with advanced NSCLC treated with this drug as a third or further-line treatment option. In addition, a risk score of 0 was attributed to a combination of low TC and low LDL, and these patients were exhibited excellent efficacies and survival rates.
  • ||||||||||  Focus V (anlotinib) / Advenchen, Sino Biopharm
    Biomarker, Retrospective data, Journal:  Primary undifferentiated pleomorphic sarcoma in oral-maxillary area: retrospective study and molecular analysis. (Pubmed Central) -  Mar 9, 2022   
    Comparatively, 3 cases had improved OS (median survival: 17 months, range: 17-18 months) and experienced PR/SD with neoadjuvant chemotherapy (anlotinib)...Additionally, a missense mutation in gene PIK3CA (p.E545K) was also identified. Our findings could greatly expand the knowledge about primary oral-maxillary UPS, and provide molecular evidences to improve the therapeutic options for primary oral-maxillary UPS.
  • ||||||||||  Tagrisso (osimertinib) / AstraZeneca, Focus V (anlotinib) / Advenchen, Sino Biopharm
    Journal, Real-world evidence:  Performance of different methods for detecting T790M mutation in the plasma of patients with advanced NSCLC after developing resistance to first-generation EGFR-TKIs in a real-world clinical setting. (Pubmed Central) -  Mar 8, 2022   
    Only 32 patients with T790M mutations (44.4%, 32/72) were treated with third-generation epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), while 19 continued treatment with first-generation TKIs, 13 underwent chemotherapy, 1 switched to treatment with anlotinib, 4 succumbed to pericardial or brain metastases, and 3 were lost to follow-up...Of these, 8 patients had been treated with osimertinib...Of the tools available for the analysis of plasma samples, NGS exhibited the highest sensitivity and concordance with the results of tissue-based T790M detection strategies. It was additionally found that only a subset of patients harboring the T790M mutation were ultimately treated using third-generation EGFR-TKIs.
  • ||||||||||  Focus V (anlotinib) / Advenchen, Sino Biopharm
    Retrospective data, Journal:  Anlotinib treatment in elderly patients with unresectable or metastatic soft tissue sarcoma: a retrospective study. (Pubmed Central) -  Mar 5, 2022   
    Our findings suggest that anlotinib treatment has promising efficacy and an acceptable toxicity profile in elderly patients with unresectable or metastatic STS. Prospective controlled trials are needed to compare the safety and efficacy of anlotinib and chemotherapy as first-line treatment in elderly patients with advanced STS.
  • ||||||||||  Halaven (eribulin mesylate) / Eisai, Focus V (anlotinib) / Advenchen, Sino Biopharm
    Clinical, Journal:  Treatment response to eribulin and anlotinib in lung metastases from rare perianal adenoid cystic carcinoma: a case report. (Pubmed Central) -  Mar 5, 2022   
    At recent follow-ups, MRI and CT examinations revealed the diminishing perianal and pulmonary lesions. This study presented the first case of perianal ACC with multiple pulmonary metastases and particular BCOR mutations, who presented a durable response to eribulin and anlotinib, providing a potential therapeutic option for advanced refractory ACC.