- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
Clinical, Review, Journal, HEOR: Current Treatment Landscape for Advanced Hepatocellular Carcinoma: Patient Outcomes and the Impact on Quality of Life. (Pubmed Central) - Jun 21, 2019
Recently, the treatment landscape for advanced HCC has expanded rapidly, with the additional FDA approvals of several oral tyrosine kinase inhibitors (lenvatinib, regorafenib, and cabozantinib), as well as immunotherapies such as immune check point inhibitors (nivolumab and pembrolizumab) and the monoclonal IgG1 antibody, ramucirumab...In light of these developments, an evaluation of the impact of FDA-approved therapeutics on patient-centered outcomes such as health-related quality of life (HRQoL) is warranted. An increased understanding of HRQoL in patients included in advanced HCC clinical trials could potentially help physician decision-making for treatment sequencing in patients with advanced HCC.
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD)
Clinical, Journal: Tyrosine Kinase Inhibitor Therapy in Locally Advanced Differentiated Thyroid Cancer: A Case Report. (Pubmed Central) - Jun 14, 2019
...TKI therapy with lenvatinib was used for 14 months...In this case, TKI therapy in a locally advanced unresectable DTC reduced tumour size and infiltration to a degree that surgical resection of macroscopic disease was possible, without requiring airway resection. This raises the possibility that TKIs may have a neoadjuvant role in selected cases of locally advanced DTC to reduce tumour volume and therefore morbidity of subsequent surgical resection.
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD)
Enrollment open, Trial completion date, Trial primary completion date, Monotherapy: Study to Assess the Long-term Safety of Lenvatinib Monotherapy, a Lenvatinib Combination Regimen, or a Comparator Treatment Arm to Cancer Participants in Eisai Sponsored Lenvatinib Trials (clinicaltrials.gov) - Jun 12, 2019
P2, N=50, Enrolling by invitation,
Trial completion date: Jun 2019 --> Dec 2019 Not yet recruiting --> Enrolling by invitation | Trial completion date: Mar 2028 --> Sep 2020 | Trial primary completion date: Mar 2028 --> Sep 2020
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD)
Trial completion date, Trial primary completion date, Metastases: Testing Lenvatinib in Patients With Adenoid Cystic Carcinoma (clinicaltrials.gov) - Jun 4, 2019
P2, N=33, Active, not recruiting,
Overall, this combination therapy shows encouraging antitumor activity in Japanese patients with renal cell carcinoma. Trial completion date: May 2019 --> May 2020 | Trial primary completion date: May 2019 --> May 2020
- |||||||||| Loqtorzi (toripalimab-tpzi) / Shanghai Junshi Biosci, Coherus Biosci, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Enrollment change, Trial withdrawal, Metastases: Phase II of Lenvatinib Plus Toripalimab for Advanced HCC (clinicaltrials.gov) - Jun 2, 2019
P2, N=0, Withdrawn,
Trial completion date: May 2019 --> May 2020 | Trial primary completion date: May 2019 --> May 2020 N=25 --> 0 | Recruiting --> Withdrawn
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD), Nexavar (sorafenib) / Bayer, Amgen
Review, Journal, IO Biomarker: Novel Drug Treatments of Progressive Radioiodine-Refractory Differentiated Thyroid Cancer. (Pubmed Central) - May 31, 2019
Treatments based on targeting specific somatic genetic alterations are also available, which potentially also may prolong progression-free survival but are not yet approved for use by the Food and Drug Administration for this specific disease. More novel approaches that may benefit select patients include resensitization therapies that allow further radioiodine utilization and new immunotherapy concepts.
- |||||||||| Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
Biomarker, Review, Journal, IO Biomarker: Molecular therapies and precision medicine for hepatocellular carcinoma. (Pubmed Central) - May 24, 2019
New drugs - lenvatinib in the frontline and regorafenib, cabozantinib, and ramucirumab in the second line - have also been demonstrated to improve clinical outcomes, although the median overall survival remains ~1 year; thus, therapeutic breakthroughs are still needed...Research on biomarkers of a response or primary resistance to immunotherapies is also advancing. Herein, we summarize the molecular targets and therapies for the management of HCC and discuss the advancements expected in the near future, including biomarker-driven treatments and immunotherapies.
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD), Cabometyx (cabozantinib tablet) / Exelixis
Trial completion date, Metastases: Effect of Cabozantinib S-Malate or Lenvatinib Mesylate on Weight and Body Composition in Patients With Metastatic Endocrine Cancer (clinicaltrials.gov) - May 24, 2019
P=N/A, N=23, Active, not recruiting,
Herein, we summarize the molecular targets and therapies for the management of HCC and discuss the advancements expected in the near future, including biomarker-driven treatments and immunotherapies. Trial completion date: Nov 2019 --> Nov 2020
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD)
Journal: Different loci associated with root and foliar resistance to sudden death syndrome (Fusarium virguliforme) in soybean. (Pubmed Central) - May 17, 2019
...A mapping population consisting of 153 F-derived recombinant inbred lines from the cross U01-390489 × E07080 was genotyped by SoySNP6 K BeadChip assay...Foliar damage-related traits, especially disease index, are valuable indicators for SDS resistance breeding because of consistency of the identified loci and their stronger correlation with plot yield. The information provided by this study will facilitate marker-assisted selection to improve SDS resistance in soybean.
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD)
Journal: Targeted therapies: Lenvatinib SELECTs survival benefit. (Pubmed Central) - May 17, 2019
The information provided by this study will facilitate marker-assisted selection to improve SDS resistance in soybean. No abstract available
- |||||||||| Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
Review, Journal: Targeted and immune therapies for hepatocellular carcinoma: Predictions for 2019 and beyond. (Pubmed Central) - May 15, 2019
Furthermore, all of 5 clinical trials of combination therapy with transcatheter chemoembolization (TACE) plus a molecular targeted agent failed to date, however, the combination of TACE and sorafenib (TACTICS trials) was reported to be successful and presented at ASCO in 2018. Phase 3 clinical trials of immune checkpoint inhibitors and a combination therapy of immune checkpoint inhibitors and molecular targeted agents are also ongoing, which suggests treatment paradigm of HCC in all stages from early, intermediate and advanced stage, is expected to be changed drastically in the very near future.
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD)
Trial completion date: REFLECT: A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-line Treatment of Participants With Unresectable Hepatocellular Carcinoma (clinicaltrials.gov) - May 9, 2019
P3, N=954, Active, not recruiting,
Phase 3 clinical trials of immune checkpoint inhibitors and a combination therapy of immune checkpoint inhibitors and molecular targeted agents are also ongoing, which suggests treatment paradigm of HCC in all stages from early, intermediate and advanced stage, is expected to be changed drastically in the very near future. Trial completion date: Mar 2019 --> Sep 2019
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD)
Trial completion, Trial completion date: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC) (clinicaltrials.gov) - May 9, 2019
P3, N=392, Completed,
Trial completion date: Mar 2019 --> Sep 2019 Active, not recruiting --> Completed | Trial completion date: Dec 2019 --> Mar 2019
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD), Nexavar (sorafenib) / Bayer, Amgen
Journal: Number needed to treat in indirect treatment comparison. (Pubmed Central) - May 7, 2019
No abstract available Using NNT to summarize the results of a matching adjusted indirect comparison can help the clinicians to better understand the results in addition to OR.
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD)
Clinical, Journal: Destructive Thyroiditis Induced by Lenvatinib in Three Patients with Hepatocellular Carcinoma. (Pubmed Central) - May 7, 2019
One patient developed hyperthyroidism only one week after the initiation of lenvatinib treatment. Thus, the possibility of hyperthyroidism developing within one week after the first administration should be kept in mind, and periodic surveillance of the thyroid function should be performed during the early period of lenvatinib therapy (within the first two weeks or so after the initial administration).
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Trial completion date, Trial primary completion date, Metastases: Testing Lenvatinib and Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma and Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov) - May 6, 2019
P1, N=16, Recruiting,
Thus, the possibility of hyperthyroidism developing within one week after the first administration should be kept in mind, and periodic surveillance of the thyroid function should be performed during the early period of lenvatinib therapy (within the first two weeks or so after the initial administration). Trial completion date: Apr 2019 --> Apr 2020 | Trial primary completion date: Apr 2019 --> Apr 2020
- |||||||||| Afinitor (everolimus) / Novartis, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Review, Journal, Adverse events: Managing the adverse events associated with lenvatinib therapy in radioiodine-refractory differentiated thyroid cancer. (Pubmed Central) - May 5, 2019
We discuss the potential mechanisms underlying these AEs and present practical recommendations for managing toxicities. The development of treatment plans that include prophylactic and therapeutic strategies for the management of lenvatinib-associated AEs has the potential to improve patient quality of life, optimize adherence, minimize the need for dose reductions, treatment interruptions, or discontinuations, and maximize patient outcomes.
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD)
Trial primary completion date: Pharmacokinetic Study of E7080/Lenvatinib in Chinese Subjects With Solid Tumor (clinicaltrials.gov) - May 2, 2019
P1, N=12, Active, not recruiting,
The development of treatment plans that include prophylactic and therapeutic strategies for the management of lenvatinib-associated AEs has the potential to improve patient quality of life, optimize adherence, minimize the need for dose reductions, treatment interruptions, or discontinuations, and maximize patient outcomes. Trial primary completion date: Sep 2019 --> Dec 2018
- |||||||||| Caprelsa (vandetanib) / Sanofi, Lenvima (lenvatinib) / Eisai, Merck (MSD), Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
Preclinical, Journal: Tyrosine kinase inhibitors vandetanib, lenvatinib and cabozantinib modulate oxidation of an anticancer agent ellipticine catalyzed by cytochromes P450 in vitro. (Pubmed Central) - Apr 28, 2019
In contrast, they practically do not influence its detoxification catalyzed by CYP1A1, 1A2 and peroxidases. The present study indicates that tested TKIs seem not to have a potency to increase ellipticine anticancer efficiency.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Review, Journal: Hepatocellular Carcinoma: Etiology and Current and Future Drugs. (Pubmed Central) - Apr 27, 2019
Therefore, there is an urgent need for new systemic combination therapies that target different signaling mechanisms, thereby decreasing the prospect of cancer cells developing resistance to treatment. In this review, HCC etiology and new therapeutic strategies that include currently approved drugs and other potential candidates of HCC such as Milciclib, palbociclib, galunisertib, ipafricept, and ramucirumab are evaluated.
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD)
Clinical, Journal: Case Report: 84-Month Disease-Free Survival after Surgery for Anaplastic Thyroid Carcinoma. (Pubmed Central) - Apr 25, 2019
Bone metastasis occurred after 84 months, and he was treated with Lenvatinib, but he died from a decline in his general condition 3 months later. We suggest that surgery is effective for stage IVA ATC, but adjuvant therapy is necessary for long-term disease-free survival in this patient population.
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