- |||||||||| Halaven (eribulin mesylate) / Eisai
Journal: A unified strategy for the total syntheses of eribulin and a macrolactam analogue of halichondrin B. (Pubmed Central) - Aug 13, 2022 These syntheses, together with our previous work on the total syntheses of halichondrin B and norhalichondrin B, demonstrate and validate the powerful reverse approach in the construction of cyclic ether structural motifs. On the other hand, the unified synthetic strategy for the synthesis of the related macrolactam analog provides inspiration and opportunities in the halichondrin field and related polycyclic ether areas.
- |||||||||| datopotamab deruxtecan (DS-1062a) / Daiichi Sankyo, AstraZeneca
Datopotamab deruxtecan (Dato-DXd), a TROP2 antibody-drug conjugate, vs investigators' choice of chemotherapy (ICC) in previously-treated, inoperable or metastatic hormone-receptor (HR) positive, HER2-negative (HR+/HER2–) breast cancer: TROPION-Breast01 (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2362; P1, P3 Pts are stratified by number of prior chemotherapy lines, prior CDK4/6 inhibitor use, and region. Enrolment is ongoing.
- |||||||||| Herceptin (trastuzumab) / Roche, Kisqali (ribociclib) / Novartis, Perjeta (pertuzumab) / Roche
Trial completion date, Trial primary completion date, Combination therapy, Metastases: Detect V / CHEVENDO (Chemo vs. Endo) (clinicaltrials.gov) - Jul 28, 2022 P3, N=270, Recruiting, Conclusions Although superiority of E+AI over E single therapy seems unlikely in this scenario, E+AI combination deserves further investigation in pts with ET-resistant, HR[+]/HER2[-] mBC, after progression to CDK4/6 inhibitors. Trial completion date: Jun 2023 --> Nov 2024 | Trial primary completion date: Sep 2021 --> Sep 2024
- |||||||||| Halaven (eribulin mesylate) / Eisai, Kisqali (ribociclib) / Novartis
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Tumor cell, Metastases: DETECT IV - A Study in Patients With HER2-negative Metastatic Breast Cancer and Persisting HER2-negative Circulating Tumor Cells (CTCs). (clinicaltrials.gov) - Jul 28, 2022 P2, N=116, Active, not recruiting, Trial completion date: Jun 2023 --> Nov 2024 | Trial primary completion date: Sep 2021 --> Sep 2024 Recruiting --> Active, not recruiting | N=300 --> 116 | Trial completion date: Dec 2022 --> Dec 2024 | Trial primary completion date: Dec 2020 --> Dec 2024
- |||||||||| Halaven (eribulin mesylate) / Eisai
Journal: The interaction of spongistatin 1 with tubulin. (Pubmed Central) - Jul 28, 2022 Little inhibition also occurred with the peptides dolastatin 15, its active pentapeptide derivative, vitilevuamide, or diazonamide A, nor with the vinca alkaloid vinblastine...Spongistatin 5 was found to be a competitive inhibitor of [H]spongistatin 1 binding, with an apparent K of 2.2 μM. We propose that the strong picomolar cytotoxicity of spongistatin 1 probably derives from its extremely tight binding to tubulin.
- |||||||||| Halaven (eribulin mesylate) / Eisai
Journal: Computational study of interactions of anti-cancer drug eribulin with human tubulin isotypes. (Pubmed Central) - Jul 17, 2022 The β-tubulin isotype, which shows low sensitivity to eribulin in experimental results, had the least binding affinity in the system αβ complex and the average binding affinity in the system αβ among all 14 systems. Additionally, we performed steered MD simulations and DynDom analysis of the systems with the lowest binding energy (αβ) and the highest binding energy (αβ) and extracted force, displacement, and H-bonding profiles during the pulling simulations to get a better insight.
- |||||||||| Trial completion date, Trial initiation date, Trial primary completion date: SMMART Adaptive Clinical Treatment (ACT) Trial (clinicaltrials.gov) - Jul 14, 2022
P2, N=131, Not yet recruiting, No abstract available Trial completion date: Mar 2025 --> Mar 2026 | Initiation date: Apr 2022 --> Dec 2022 | Trial primary completion date: Mar 2025 --> Mar 2026
- |||||||||| Tukysa (tucatinib) / Pfizer, Halaven (eribulin mesylate) / Eisai, Herceptin (trastuzumab) / Roche
New P2 trial, Combination therapy, Metastases: Tucatinib+Trastuzumab+Eribulin in HER2+ MBC (clinicaltrials.gov) - Jul 14, 2022 P2, N=30, Not yet recruiting,
- |||||||||| Halaven (eribulin mesylate) / Eisai
Biomarker, Retrospective data, Journal, PD(L)-1 Biomarker, IO biomarker: B Lymphocytes Are a Predictive Marker of Eribulin Response and Overall Survival in Locally Advanced or Metastatic Breast Cancer: A Multicenter, Two-Cohort, Non-Randomized, Open-Label, Retrospective Study. (Pubmed Central) - Jul 13, 2022 Seven-color multiplex immunofluorescence was used to phenotype lymphocytes in the primary tumor. It has been shown that the PD1-negative-to-PD1-positive B cells ratio in primary tumors more than 3 is an independent predictor of the short-term effectiveness of eribulin [OR (95%CI) 14.09 (1.29-153.35), p=0.0029] and worse overall survival [HR (95%CI) 11.25 (1.37-70.25), p=0.0009] in patients with locally advanced or metastatic triple-negative breast cancer.
- |||||||||| Halaven (eribulin mesylate) / Eisai
Trial primary completion date: A Phase 2 Study of Eribulin Followed by AC as Preoperative Therapy for HER2-negative Inflammatory Breast Cancer (clinicaltrials.gov) - Jul 12, 2022 P2, N=22, Active, not recruiting, It has been shown that the PD1-negative-to-PD1-positive B cells ratio in primary tumors more than 3 is an independent predictor of the short-term effectiveness of eribulin [OR (95%CI) 14.09 (1.29-153.35), p=0.0029] and worse overall survival [HR (95%CI) 11.25 (1.37-70.25), p=0.0009] in patients with locally advanced or metastatic triple-negative breast cancer. Trial primary completion date: May 2022 --> Dec 2022
- |||||||||| Yondelis (trabectedin) / Otsuka, PharmaMar, Valeo Pharma, Votrient (pazopanib) / Novartis, Halaven (eribulin mesylate) / Eisai
Retrospective data, Journal: Poor Treatment Outcomes with Second-Line Chemotherapy in Advanced Synovial Sarcoma. (Pubmed Central) - Jul 8, 2022 Our exploratory study revealed that the response rate of second-line chemotherapy regimens for patients with SS was 9.4%. Therefore, there is an urgent need to develop more active therapeutic regimens for SSs.
- |||||||||| Halaven (eribulin mesylate) / Eisai, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Trial completion date, Metastases: LEADER: Lenvatinib and Eribulin in Advanced Soft Tissue Sarcoma (clinicaltrials.gov) - Jul 5, 2022 P1/2, N=30, Active, not recruiting, Patients with these risk factors should be carefully monitored for assessment and prophylaxis. Trial completion date: Jun 2022 --> Dec 2022
- |||||||||| Yondelis (trabectedin) / Otsuka, PharmaMar, Valeo Pharma, Halaven (eribulin mesylate) / Eisai
Establishment and characterization of a new panel of uterine leiomyosarcoma patient-derived xenograft models (Poster Area) - Jun 28, 2022 - Abstract #EACR2022EACR_1231; Conclusion We have obtained a panel of uLMS PDXs that mimics the main pathological and molecular features of the original human tumors. The heterogeneity of drug response highlights the need to expand the uLMS PDX panel to identify possible mechanisms of drug resistance and to identify new therapeutic approaches better than the standard of care.
- |||||||||| Halaven (eribulin mesylate) / Eisai
Trial completion, Trial completion date, Trial primary completion date, Combination therapy, Metastases: A Study of Eribulin With Gemcitabine in Patients With Advanced Liposarcoma or Leiomyosarcoma (clinicaltrials.gov) - Jun 16, 2022 P2, N=37, Completed, As such, we have designed the international EPOCH trial, E ribulin and P embrolizumab in O varian C arcinosarcoma, to improve treatment of this aggressive cancer. Trial completion date: Nov 2022 --> May 2022 | Trial primary completion date: Nov 2022 --> May 2022 | Active, not recruiting --> Completed
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