- |||||||||| ipatasertib (RG7440) / Roche
Enrollment closed, Combination therapy, Metastases: PATHFINDER: Ipatasertib Plus Non-Taxane Chemotherapy for Advanced or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) - Nov 29, 2022 P2a, N=54, Active, not recruiting, OurdatashowthatPD-L1testingandthenewtreatment optionforPD-L1positivetumorswerequicklyimplementedinroutine care.BRCA1/2testingisperformedlessoften,especiallyinfirst-linesit- uation.Withlongerfollow-up,OPALwillshowtheimpactofthesenew targetedtherapiesontheoutcomeinroutinecare. Recruiting --> Active, not recruiting
- |||||||||| Halaven (eribulin mesylate) / Eisai
Journal: Stathmin expression alters the antiproliferative effect of eribulin in leiomyosarcoma cells. (Pubmed Central) - Nov 15, 2022 Eribulin-resistant leiomyosarcoma cell lines had enhanced expression of the class Ⅰ β-tubulin TUBB1, multi-drug resistance 1 protein MDR1 and breast cancer-resistance protein BCRP, and decreased expression of stathmin. Taken together, these results suggest that stathmin expression modulates the pharmacological efficacy of eribulin in uterine leiomyosarcoma cells.
- |||||||||| Enrollment closed, Trial completion date, Trial primary completion date, Metastases: Morpheus-TNBC: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer (clinicaltrials.gov) - Nov 14, 2022
P1/2, N=280, Active, not recruiting, Taken together, these results suggest that stathmin expression modulates the pharmacological efficacy of eribulin in uterine leiomyosarcoma cells. Recruiting --> Active, not recruiting | Trial completion date: Sep 2023 --> May 2024 | Trial primary completion date: Sep 2023 --> May 2024
- |||||||||| Halaven (eribulin mesylate) / Eisai
Journal: The Impact of Eribulin on Stathmin Dynamics and Paclitaxel Sensitivity in Ovarian Cancer Cells. (Pubmed Central) - Nov 12, 2022 These results suggest that eribulin-induced phosphorylation of stathmin, mediated in part by PP2A downregulation, reduces stathmin activity and enhances the antiproliferative effects of paclitaxel in ovarian cancer. Collectively, the results of this study indicate that eribulin may suppress the proliferation of ovarian cancer cells partly by regulating the activity of stathmin.
- |||||||||| Halaven (eribulin mesylate) / Eisai
Observational data, Journal: Eribulin for the treatment of advanced breast cancer: A prospective observational registry study. (Pubmed Central) - Nov 8, 2022 P=N/A Collectively, the results of this study indicate that eribulin may suppress the proliferation of ovarian cancer cells partly by regulating the activity of stathmin. Eribulin was well tolerated in real-world clinical practice, comparable to safety and effectiveness reported in other clinical trials.
- |||||||||| bintrafusp alfa (M7824) / EMD Serono, Halaven (eribulin mesylate) / Eisai
Trial termination, Metastases: M7824 and Eribulin Mesylate in Treating Patients With Metastatic Triple Negative Breast Cancer (clinicaltrials.gov) - Oct 31, 2022 P1, N=38, Terminated, Given previous data, it is anticipated that the use of Y90 and chemotherapy earlier in the metastatic disease course would improve survival outcomes and reduce toxicity. Completed --> Terminated; Due to the fact that the sponsor decided not to move forward with the development of M7824
- |||||||||| Tukysa (tucatinib) / Pfizer, Halaven (eribulin mesylate) / Eisai, Herceptin (trastuzumab) / Roche
Trial initiation date, Combination therapy, Metastases: Tucatinib+Trastuzumab+Eribulin in HER2+ MBC (clinicaltrials.gov) - Oct 27, 2022 P2, N=30, Not yet recruiting, Recruiting --> Completed | N=20 --> 38 Initiation date: Aug 2022 --> Nov 2022
- |||||||||| datopotamab deruxtecan (DS-1062a) / Daiichi Sankyo, AstraZeneca
TROPION-Breast02: Phase 3, open-label, randomized study of first-line datopotamab deruxtecan versus chemotherapy in patients with locally recurrent inoperable or metastatic TNBC who are not candidates for anti-PD-(L)1 therapy (Hall 1) - Oct 10, 2022 - Abstract #SABCS2022SABCS_1640; P1, P3 Secondary endpoints include ORR, duration of response, PFS by investigator assessment, time to deterioration for patient-reported outcomes, time to first subsequent therapy, time to second subsequent therapy, time to second progression or death, pharmacokinetics and immunogenicity of Dato- DXd, and safety. Recruitment for this study is ongoing as of June 2022.
- |||||||||| Halaven (eribulin mesylate) / Eisai
Capecitabine, eribulin and paclitaxel differentially impact the metabolite pool in metastatic breast cancer patients (Hall 1) - Oct 10, 2022 - Abstract #SABCS2022SABCS_1585; Although a decrease in lipid metabolites was observed while on capecitabine (prodrug of 5-fluorouracil) treatment, an increase in both lipid metabolites and amino acids was observed at disease progression. With both paclitaxel and eribulin treatment, which are microtubule inhibitors, a decrease in lipid metabolites and amino acids was observed at disease progression.
- |||||||||| Avastin (bevacizumab) / Roche
Identifying immune-related predictive factors for paclitaxel + bevacizumab therapy in patients with HER2-negative advanced breast cancer- A multicenter retrospective study (Hall 1) - Oct 10, 2022 - Abstract #SABCS2022SABCS_1253; Recently, several reports regarding the relationship between peripheral immune-related markers; such as absolute lymphocyte count (ALC) or neutrophil-to- lymphocyte ratio (NLR), and efficacy of eribulin therapy [Miyoshi, 2020, Breast Cancer; Watanabe, 2020, Breast Cancer Res Treat] or paclitaxel plus bevacizumab (PB) therapy [Nakamoto, 2021, Sci Rep], however, the relationship between the efficacy of PB therapy and peripheral immune related markers including dynamic change during the therapy or local immune-related markers is unclear. According to our real-world study, 1) PD-L1 positive rate was lower than that of previous reports, 2) low NLR at the initiation of second cycle of PB therapy and dynamic change in albumin level were identified as predictive factors and 3) PD-L1 overexpression was not a prognostic or a predictive factor for PB therapy in patients with HER2-negative ABC.
- |||||||||| TRK inhibitor in a patient with metastatic triple negative breast cancer and NTRK fusions identified via cell-free DNA analysis (Hall 1) - Oct 10, 2022 - Abstract #SABCS2022SABCS_1218;
The FDA approvals of the PD-1 inhibitor pembrolizumab and the TRK inhibitors larotrectinib and entrectinib provide rationale for next generation sequencing (NGS) in effectively all advanced solid tumor patients, as findings may indicate targeted therapy even in disease that may seem otherwise refractory...The cancer rapidly progressed through 4 lines of therapy in the metastatic setting, including immunotherapy [atezolizumab/nab-paclitaxel (progression after 5 months)], antibody-drug conjugate-based therapy [sacituzumab govitecan (progression after 2 months)], and chemotherapy [gemcitabine/carboplatin (progression after 3 months), eribulin (progression after 2 months)]...Tissue-agnostic targeted therapies now give reason for NGS testing in most solid tumors, as reflected in updated consensus guidelines. This case demonstrates the significant potential benefits of NGS testing in advanced and refractory cancers.
- |||||||||| Halaven (eribulin mesylate) / Eisai
Eribulin enhances STING-dependent induction of type I interferons in immune and triple-negative breast cancer cells (Hall 1) - Oct 10, 2022 - Abstract #SABCS2022SABCS_1109; This activation required tumor priming but was independent of any direct effect on tumor growth inhibition, demonstrating a specific role of eribulin as a tumor immune modulator. These data contribute to accumulating evidence that there are important mechanistic differences between the microtubule targeted chemotherapeutics currently used in the treatment of TNBC and suggest that eribulin elicits a more favorable innate immunological signature than paclitaxel.
- |||||||||| Halaven (eribulin mesylate) / Eisai
The development of covalent microtubule stabilizers for drug-resistant cancers (Hall 1) - Oct 10, 2022 - Abstract #SABCS2022SABCS_727; In a complementary approach, we tested the hypothesis that non-covalent microtubule stabilizers that have increased binding affinity to tubulin share properties with the taccas, such as the ability to circumvent drug resistance and provide potent and persistent in vivo efficacy with a more tolerable therapeutic window. Our data suggest that while non-covalent microtubule stabilizers with improved binding compared to paclitaxel provide improved cellular persistence after drug washout and potent antitumor efficacy, they are not able to overcome drug resistance to some degree as covalent inhibitors, demonstrating the advantage of continuing to develop irreversible drugs such as the taccalonolides for the treatment of drug resistant disease.
|