- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD), savolitinib (HMPL-504) - AstraZeneca, Chi / Med
#ASCO20 #kidneycancer highlights: @ERPlimackMD pembro-axi update, @DrChoueiri savolitinib in pRCC & FRACTION RCC, Eric Jonasch w HIF2a inhib in VHL dz, @DrRanaMcKay w OMNIVORE, Atkins w salvage ipiHCRN trial, @ChungHanLee3 pembro-lenvatinib ph2 data! A remarkable oral session! (Twitter) - Apr 29, 2020
- |||||||||| Avastin (bevacizumab) / Roche, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Clinical, Journal: Fournier's gangrene during lenvatinib treatment: A case report. (Pubmed Central) - Apr 28, 2020 The condition was likely due to a perturbation of vascular endothelial cells of the skin due to the inhibition of VEGF/VEGFR signaling. Fournier's gangrene may be a class effect of antiangiogenic treatment that clinicians should be aware of, as early diagnosis and treatment are associated with an improved outcome.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD)
Enrollment closed, PD(L)-1 Biomarker: Lenvatinib and Pembrolizumab in Differentiated Thyroid Cancers (DTC) (clinicaltrials.gov) - Apr 24, 2020 P2, N=60, Active, not recruiting, Weekends-off administration of lenvatinib was useful to recover the therapeutic response and tolerability toward AEs. Recruiting --> Active, not recruiting
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
Review, Journal, PD(L)-1 Biomarker, IO Biomarker: Harnessing big 'omics' data and AI for drug discovery in hepatocellular carcinoma. (Pubmed Central) - Apr 17, 2020 After nearly a decade with sorafenib as the only approved treatment, multiple new agents have demonstrated efficacy in clinical trials, including the targeted therapies regorafenib, lenvatinib and cabozantinib, the anti-angiogenic antibody ramucirumab, and the immune checkpoint inhibitors nivolumab and pembrolizumab...The release of such data sets to the public enhances the ability to search for information from these legacy studies and provides the opportunity to leverage them to understand HCC mechanisms, rationally develop new therapeutics and identify candidate biomarkers of treatment response. Here, we provide a comprehensive review of public data sets related to HCC and discuss how emerging artificial intelligence methods can be applied to identify new targets and drugs as well as to guide therapeutic choices for improved HCC treatment.
- |||||||||| Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
Journal, IO Biomarker: Targeted Therapy for Advanced Thyroid Cancer: Kinase Inhibitors and Beyond. (Pubmed Central) - Apr 16, 2020 Furthermore, other mutation-specific drugs, immunotherapies, and novel strategies for advanced thyroid cancer are under investigation. Understanding the molecular basis of thyroid cancer, the drugs of interest for treatment of advanced thyroid cancer, and how these drugs can be administered safely and in the appropriate clinical scenario is the topic of this review.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Enrollment open, Metastases: LENVOS: Study of the Efficacy of Lenvatinib Combined With Denosumab in the Treatment of Patients With Predominant Bone Metastatic Radioiodine Refractory Differentiated Thyroid Carcinomas (clinicaltrials.gov) - Apr 15, 2020 P2, N=35, Recruiting, Understanding the molecular basis of thyroid cancer, the drugs of interest for treatment of advanced thyroid cancer, and how these drugs can be administered safely and in the appropriate clinical scenario is the topic of this review. Suspended --> Recruiting
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD)
Trial completion date, Trial primary completion date: A Study of Lenvatinib Plus Nivolumab in Participants With Hepatocellular Carcinoma (clinicaltrials.gov) - Apr 15, 2020 P1b, N=30, Active, not recruiting, Recruiting --> Completed | N=40 --> 5 | Trial primary completion date: Apr 2019 --> Oct 2019 Trial completion date: Jun 2020 --> Jun 2021 | Trial primary completion date: Jun 2020 --> Jun 2021
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
Review, Journal, Checkpoint inhibition: Emerging role of Immune Checkpoint Inhibitors in Hepatocellular Carcinoma. (Pubmed Central) - Apr 14, 2020 Cabozantinib, regorafenib, and ramucirumab also displayed promising results in second line settings...Moreover,nivolumab and pembrolizumab,two therapeutics against the Programmed death (PD)-ligand 1 (PD-L1)/PD1 axis have been recently approvedfor subsequent-line therapy...Therefore, a lot of combinatory approaches are under investigation, including the combination of different immune checkpoint inhibitors (ICIs), the addition of ICIs after resection or during loco-regional therapy, ICIs in addition to kinase inhibitors, anti-angiogenic therapeutics, and others. This review focuses on the use of ICIs for the hepatocellular carcinoma with a careful assessmentof new ICIs-based combinatory approaches.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD), docetaxel / Generic mfg.
[VIRTUAL] Pembrolizumab plus lenvatinib vs docetaxel in patients with previously treated metastatic non-small-cell lung cancer (NSCLC) and PD after platinum-doublet chemotherapy and immunotherapy: Phase 3, randomized, open-label LEAP-008 trial (Virtual Meeting: All Session Times Are U.S. EDT) - Apr 13, 2020 - Abstract #AACRI2020AACR-I_264; P1b/2, P3 Secondary outcomes include ORR (RECIST version 1.1 by BICR), duration of response (RECIST version 1.1 by BICR), safety (AEs graded by National Cancer Institute Common Terminology for Adverse Events version 4.0), and quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and Lung Cancer Module 13). PFS and OS will be analyzed by the Kaplan-Meier method and stratified log-rank test; differences in ORR will be analyzed by the Miettinen and Nurminen method.
- |||||||||| Caprelsa (vandetanib) / Sanofi, Lenvima (lenvatinib) / Eisai, Merck (MSD), Cabometyx (cabozantinib tablet) / Exelixis
Trial primary completion date, Metastases: Adaptive Tyrosine Kinase Inhibitor (TKI) Therapy In Patients With Thyroid Cancer (clinicaltrials.gov) - Apr 9, 2020 P2, N=6, Active, not recruiting, HCC is a potentially lethal malignant tumor and the combination of immunotherapy plus anti-angiogenic inhibitors shows promising outcome for advanced diseases. Trial primary completion date: Dec 2022 --> Dec 2020
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD)
Journal: Value of lenvatinib for the treatment of advanced hepatocellular carcinoma (Pubmed Central) - Apr 9, 2020 Lenvatinib can extend the overall survival in a percentage of medium-advanced hepatocellular carcinoma patients who were unresectable and refractory to TACE. Although the incidence of adverse events is high, most of them are mild and reversible.
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD)
Trial completion date, Trial primary completion date, Metastases: CLEAR trial: Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma (clinicaltrials.gov) - Mar 30, 2020 P3, N=1069, Active, not recruiting, AFP response, baseline ALBI score, and change in the ALBI score were early predictors of OR in patients with HCC undergoing lenvatinib treatment. Trial completion date: Feb 2021 --> Apr 2022 | Trial primary completion date: Apr 2020 --> Aug 2020
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
Review, Journal: Molecular targeted and immune checkpoint therapy for advanced hepatocellular carcinoma. (Pubmed Central) - Mar 25, 2020 Regorafenib, cabozantinib, and ramucirumab are appropriate supplements for sorafenib as second-line treatment for patients with advanced HCC who are resistant, show progression or do not tolerate sorafenib...Despite phase III trials for nivolumab and pembrolizumab, the primary endpoints of improved OS were not statistically significant, immune PD-1/PD-L1 checkpoint therapy remains to be further investigated. This review summarizes the development and progression of molecular targeted and immune-based checkpoint therapies in HCC.
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