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- | Tyvyt (sintilimab) / Innovent Biologics, Eli Lilly, Halaven (eribulin mesylate) / Eisai
New P2 trial: An exploratory study of the efficacy and safety of the sintilimab in combination with eribulin plus carboplatin regimen in advanced triple-negative breast cancer treated with anthracyclines and taxanes (EUDRACT) - Jul 15, 2024
P2, N=26, Recruiting, Sponsor: Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center
- | Halaven (eribulin mesylate) / Eisai
Journal: Rectal metastasis arising from breast cancer: a case report. (Pubmed Central) - Jul 11, 2024
Eribulin was administered, but due to the patient's inability to tolerate the treatment, she passed away 3 months after rectal lesion diagnosis. Although breast cancer metastasis to the rectum is rare, clinicians should consider the possibility of rectal involvement and perform a digital rectal examination if anal symptoms are present.
- | BNT327 / BioNTech
Trial completion date: BNT327-02: Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy (clinicaltrials.gov) - Jul 10, 2024
P2, N=60, Not yet recruiting, Sponsor: BioNTech SE
Although breast cancer metastasis to the rectum is rare, clinicians should consider the possibility of rectal involvement and perform a digital rectal examination if anal symptoms are present. Trial completion date: Apr 2026 --> Jan 2027
- | Halaven (eribulin mesylate) / Eisai
Journal: Toxic Epidermal Necrolysis Caused by Eribulin. (Pubmed Central) - Jul 8, 2024
The patient responded well to steroid therapy, although skin eruptions reoccurred with further eribulin treatment. This case highlights the need for further study on the immunological effects of eribulin, especially concerning severe drug eruptions potentially related to its impact on microtubule dynamics and immune cell functions.
- | dasatinib / Generic mfg.
Enrollment open: Dasatinib Combined With Quercetin to Reverse Chemo Resistance in Triple Negative Breast Cancer (clinicaltrials.gov) - Jul 8, 2024
P2, N=10, Recruiting, Sponsor: Fudan University
This case highlights the need for further study on the immunological effects of eribulin, especially concerning severe drug eruptions potentially related to its impact on microtubule dynamics and immune cell functions. Not yet recruiting --> Recruiting
- |||||| izalontamab brengitecan (BL-B01D1) / Biokin Pharma, BMS
Enrollment open: A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) - Jul 4, 2024
P3, N=436, Recruiting, Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||||| Datroway (datopotamab deruxtecan) / Daiichi Sankyo, AstraZeneca
Enrollment closed: A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02) (clinicaltrials.gov) - Jul 4, 2024
P3, N=637, Active, not recruiting, Sponsor: AstraZeneca
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- | Imfinzi (durvalumab) / AstraZeneca, Lynparza (olaparib) / Merck (MSD), AstraZeneca
Trial primary completion date, Surgery: SOLARA: Study of Stereotactic Radiosurgery With Olaparib Followed by Durvalumab and Physician's Choice Systemic Therapy in Subjects With Breast Cancer Brain Metastases (clinicaltrials.gov) - Jul 3, 2024
P1/2, N=41, Recruiting, Sponsor: Colette Shen
Recruiting --> Active, not recruiting Trial primary completion date: May 2024 --> Aug 2024
- || Halaven (eribulin mesylate) / Eisai
Review, Journal: Eribulin in breast cancer: Current insights and therapeutic perspectives. (Pubmed Central) - Jul 1, 2024
Since approval, there has been a surge in studies investigating the application of eribulin as an earlier-line treatment and also in combination with other agents such as immunotherapy and targeted therapy across all breast cancer sub-types, including hormone receptor positive, HER2 positive and triple negative breast cancer, many demonstrating promising activity. This review will focus on the application of eribulin in the treatment of metastatic breast cancer across all subtypes including its role as an earlier-line agent, its toxicity profile, and potential future directions.
- | Jiataile (sacituzumab tirumotecan) / Merck (MSD)
Enrollment open: SKB264-?-10: Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer (clinicaltrials.gov) - Jun 28, 2024
P3, N=376, Recruiting, Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
This review will focus on the application of eribulin in the treatment of metastatic breast cancer across all subtypes including its role as an earlier-line agent, its toxicity profile, and potential future directions. Not yet recruiting --> Recruiting
- || Halaven (eribulin mesylate) / Eisai
Review, Journal: Suppressing Anaphase-Promoting Complex/Cyclosome-Cell Division Cycle 20 Activity to Enhance the Effectiveness of Anti-Cancer Drugs That Induce Multipolar Mitotic Spindles. (Pubmed Central) - Jun 27, 2024
Paclitaxel induces multipolar spindles at clinically relevant doses but does not substantially increase mitotic indices...Eribulin and vinorelbine have also been reported to cause increases in multipolar spindles in cancer cells...In genomically stable healthy human cells, delayed anaphase entry may suppress the level of multipolar spindles induced by anti-cancer drugs and lower mitotic cytotoxicity. We outline specific combinations of molecules to investigate that may achieve the goal of enhancing the effectiveness of anti-cancer agents.
- |||||| sacituzumab tirumotecan (MK-2870) / Merck (MSD)
Enrollment open, Metastases: SKB264-?-11: A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) - Jun 26, 2024
P3, N=524, Recruiting, Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
We outline specific combinations of molecules to investigate that may achieve the goal of enhancing the effectiveness of anti-cancer agents. Not yet recruiting --> Recruiting
- || Trodelvy (sacituzumab govitecan-hziy) / Gilead, Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, Halaven (eribulin mesylate) / Eisai
Trial completion date, Trial primary completion date, Metastases: Scalp Cooling in MBC (clinicaltrials.gov) - Jun 25, 2024
P2, N=120, Recruiting, Sponsor: Dana-Farber Cancer Institute
Not yet recruiting --> Recruiting Trial completion date: Jun 2026 --> Jun 2028 | Trial primary completion date: Jun 2024 --> Jun 2026
- | Ixempra (ixabepilone) - Otsuka, R / Pharm, Halaven (eribulin mesylate) / Eisai
Biomarker, Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Biopsy: Pharmacodynamic Biomarkers of Standard Anti-microtubule Drugs as Assessed by Early Tumor Biopsy (clinicaltrials.gov) - Jun 25, 2024
P=N/A, N=5, Terminated, Sponsor: University of Wisconsin, Madison
Trial completion date: Jun 2026 --> Jun 2028 | Trial primary completion date: Jun 2024 --> Jun 2026 N=35 --> 5 | Trial completion date: Aug 2024 --> Feb 2024 | Recruiting --> Terminated | Trial primary completion date: Jun 2024 --> Feb 2024; slow accrual
- |||||| cisplatin/vinblastine/SHAO-FA (INT230-6) / Intensity Therap
Enrollment open, Metastases: A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3) (clinicaltrials.gov) - Jun 21, 2024
P3, N=333, Recruiting, Sponsor: Intensity Therapeutics, Inc.
N=35 --> 5 | Trial completion date: Aug 2024 --> Feb 2024 | Recruiting --> Terminated | Trial primary completion date: Jun 2024 --> Feb 2024; slow accrual Not yet recruiting --> Recruiting
- | Halaven (eribulin mesylate) / Eisai
Journal, Circulating tumor DNA, Metastases: Circulating tumour DNA dynamics during alternating chemotherapy and hormonal therapy in metastatic breast cancer: the ALERT study. (Pubmed Central) - Jun 17, 2024
P2
Not yet recruiting --> Recruiting Changes in ctDNA can occur rapidly and reflect changes in patients' clinical tumour responses (NCT02681523).
- || Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka
Clinical data, Retrospective data, Journal, Claims database, Metastases: Treatment patterns and clinical outcomes in patients with metastatic triple-negative breast cancer: a large-scale data analysis using the Japanese claims database. (Pubmed Central) - Jun 17, 2024
This study provides insight into current treatment patterns for mTNBC in Japan. The cost-benefit balance worsens with later-line treatment and a high unmet need for mTNBC drug treatment remains.
- |||| Trodelvy (sacituzumab govitecan-hziy) / Gilead
Trial completion date, Trial primary completion date: EVER-132-002: Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC) (clinicaltrials.gov) - Jun 13, 2024
P3, N=331, Active, not recruiting, Sponsor: Gilead Sciences
The cost-benefit balance worsens with later-line treatment and a high unmet need for mTNBC drug treatment remains. Trial completion date: Mar 2024 --> Dec 2025 | Trial primary completion date: Apr 2023 --> Dec 2025
- || SHEN26 / Shenzhen Kexing Pharma, Shenzhen Antaiwei Biopharm
Clinical, P1 data, PK/PD data, Journal: Safety, tolerability, and pharmacokinetics of the novel RdRp inhibitor SHEN26 against SARS-CoV-2: a randomized, placebo-controlled, double-blind phase I study in healthy subjects. (Pubmed Central) - Jun 7, 2024
P1
The trial is registered in ClinicalTrials.gov (CT. gov identifier: NCT05504746).
- |||| BNT327 / BioNTech
New P2 trial: BNT327-02: Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy (clinicaltrials.gov) - Jun 7, 2024
P2, N=60, Not yet recruiting, Sponsor: BioNTech SE
- Halaven (eribulin mesylate) / Eisai
Observational data, Journal, Metastases: Therapeutic Efficacy, Safety and Predictive Indicators of Eribulin Plus Anti-Angiogenic Medicine for Metastatic Breast Cancer. (Pubmed Central) - Jun 6, 2024
gov identifier: NCT05504746). The eribulin plus anti-angiogenic combination may act as a potential therapy for late-line MBC patients with clinically beneficial therapeutic effects.
- | Halaven (eribulin mesylate) / Eisai, Kisqali (ribociclib) / Novartis
Trial completion, Trial completion date, Trial primary completion date: DETECT-IVa: DETECT IV - A Study in Patients With HER2-negative Metastatic Breast Cancer and Persisting HER2-negative Circulating Tumor Cells (CTCs). (clinicaltrials.gov) - Jun 3, 2024
P2, N=116, Completed, Sponsor: Prof. Wolfgang Janni
The eribulin plus anti-angiogenic combination may act as a potential therapy for late-line MBC patients with clinically beneficial therapeutic effects. Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Jan 2024 | Trial primary completion date: Dec 2024 --> Jan 2024
- ||||| Herceptin (trastuzumab) / Roche, Kisqali (ribociclib) / Novartis, Perjeta (pertuzumab) / Roche
Enrollment closed, Trial completion date, Trial primary completion date: Detect V / CHEVENDO (Chemo vs. Endo) (clinicaltrials.gov) - Jun 3, 2024
P3, N=271, Active, not recruiting, Sponsor: Prof. Wolfgang Janni
Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Jan 2024 | Trial primary completion date: Dec 2024 --> Jan 2024 Recruiting --> Active, not recruiting | Trial completion date: Nov 2024 --> Jan 2025 | Trial primary completion date: Sep 2024 --> Jan 2025
- | Halaven (eribulin mesylate) / Eisai, Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date, IO biomarker: Atezolizumab With or Without Eribulin Mesylate in Treating Patients With Recurrent Locally Advanced or Metastatic Urothelial Cancer (clinicaltrials.gov) - Jun 3, 2024
P2, N=72, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
Recruiting --> Active, not recruiting | Trial completion date: Nov 2024 --> Jan 2025 | Trial primary completion date: Sep 2024 --> Jan 2025 Trial completion date: Jan 2025 --> Jun 2025 | Trial primary completion date: Jan 2025 --> Jun 2025
- |||||||||| Ziihera (zanidatamab-hrii) / Jazz
New P3 trial: JZP598-303: A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer (clinicaltrials.gov) - May 29, 2024
P3, N=550, Not yet recruiting, Sponsor: Jazz Pharmaceuticals
- || Halaven (eribulin mesylate) / Eisai, Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Review, Journal, Metastases: A clinical systematic literature review of treatments among patients with advanced and/or metastatic human epidermal growth factor receptor 2 positive breast cancer. (Pubmed Central) - May 29, 2024
Trial completion date: Jan 2025 --> Jun 2025 | Trial primary completion date: Jan 2025 --> Jun 2025 Aim: This systematic literature review aims to summarize the efficacy/effectiveness of treatments, including eribulin (ERI)-based and anti-human epidermal growth factor receptor 2 (HER2) treatments in advanced/metastatic HER2+ breast cancer...Longer overall survival (OS) was associated with 1L and 2L treatment, and for 3L+ studies that included ERI, ERI or trastuzumab (Tmab)
- |||||| izalontamab brengitecan (BL-B01D1) / Biokin Pharma, BMS
Enrollment open: A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer (clinicaltrials.gov) - May 28, 2024
P3, N=382, Recruiting, Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Aim: This systematic literature review aims to summarize the efficacy/effectiveness of treatments, including eribulin (ERI)-based and anti-human epidermal growth factor receptor 2 (HER2) treatments in advanced/metastatic HER2+ breast cancer...Longer overall survival (OS) was associated with 1L and 2L treatment, and for 3L+ studies that included ERI, ERI or trastuzumab (Tmab) Not yet recruiting --> Recruiting
- Halaven (eribulin mesylate) / Eisai
Functional paclitaxel and eribulin assay for patient derived xenograft breast cancer tissue ex vivo correlates with in vivo sensitivity in mice (Poster and Exhibition Hall) - May 26, 2024 - Abstract #EACR2024EACR_721;
- | Halaven (eribulin mesylate) / Eisai
Journal, Metastases: Efficacy and safety of eribulin mesylate in patients with locally advanced or metastatic breast cancer previously treated with anthracycline/taxanes. (Pubmed Central) - May 24, 2024
Eribulin demonstrated effective clinical activity and a favorable tolerability profile in Chinese patients with ABC in the real-world. The efficacy and safety profile were consistent with those reported in previous randomized phase 3 trials.
- || Keytruda (pembrolizumab) / Merck (MSD), Halaven (eribulin mesylate) / Eisai
Trial completion date, Trial primary completion date: A Phase II Study of Eribulin and Pembrolizumab in Soft Tissue Sarcomas (clinicaltrials.gov) - May 16, 2024
P2, N=57, Active, not recruiting, Sponsor: Dana-Farber Cancer Institute
The efficacy and safety profile were consistent with those reported in previous randomized phase 3 trials. Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Aug 2024 --> Aug 2025
- || Halaven (eribulin mesylate) / Eisai, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Trial completion, Metastases: Eribulin and Lenvatinib in Advanced Solid Tumors (clinicaltrials.gov) - May 9, 2024
P2, N=29, Completed, Sponsor: Virginia G. Kaklamani
Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Aug 2024 --> Aug 2025 Unknown status --> Completed
- | Halaven (eribulin mesylate) / Eisai, Aliqopa (copanlisib) / Bayer
Preclinical, Journal, Combination therapy: Evaluation of copanlisib in combination with eribulin in triple negative breast cancer patient-derived xenograft models. (Pubmed Central) - May 8, 2024
These data support further clinical development for the combination of copanlisib and eribulin. These data led to a phase I/II trial of copanlisib and eribulin in patients with metastatic TNBC.
- ||| TSL1502 / Tasly
Enrollment open: TSL-CM-TSL1502-?: A Study to Evaluate the Efficacy and Safety of TSL-1502 Capsules in Breast Cancer Patients With Germline BRCA Mutations (clinicaltrials.gov) - May 8, 2024
P2, N=125, Recruiting, Sponsor: Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.
These data led to a phase I/II trial of copanlisib and eribulin in patients with metastatic TNBC. Not yet recruiting --> Recruiting
- || Halaven (eribulin mesylate) / Eisai
Clinical data, Journal, HEOR, Real-world evidence, Real-world, Metastases: Real-world treatment patterns and clinical outcomes in patients treated with eribulin after prior phosphoinositide 3-Kinase inhibitor treatment for metastatic breast cancer. (Pubmed Central) - May 1, 2024
Not yet recruiting --> Recruiting Our real-world study suggests that eribulin may be a potential treatment option for MBC patients who fail a prior PI3K inhibitor.
- | Loqtorzi (toripalimab-tpzi) / Shanghai Junshi Biosci, Coherus Biosci, Halaven (eribulin mesylate) / Eisai
New P2 trial, Combination therapy, Metastases: LM-108 in Combination With PD-1 Based Treatment for Patients With Recurrent or Metastatic Triple - Negative Breast Cancer (clinicaltrials.gov) - Apr 29, 2024
P2, N=74, Recruiting, Sponsor: Fudan University
- |||||||||| OQY-3258 / Oqory
New P3 trial: A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer (clinicaltrials.gov) - Apr 25, 2024
P3, N=378, Not yet recruiting, Sponsor: Shanghai Escugen Biotechnology Co., Ltd
- Halaven (eribulin mesylate) / Eisai
Efficacy and safety of eribulin plus gemcitabine in second-line or beyond for patients with HER2-negative metastatic breast cancer (MBC): A multicenter, open-label, single-arm, phase II study. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6787;
P2
Clinical trial information: NCT05263882. >TNBC, triple-negative breast cancer.
- Halaven (eribulin mesylate) / Eisai
Eribulin and irinotecan for refractory or recurrent Ewing sarcoma: A retrospective study. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6471;
There was no need for further prospective trials on this combination unless mechanisms of synergy and biomarkers are identified. >Data are n (%); % (95% CI) or months (95% CI).
- Halaven (eribulin mesylate) / Eisai
Feasibility and tolerability of eribulin-based chemotherapy versus other chemotherapy regimens for patients with metastatic triple-negative breast cancer: A single-centre retrospective study. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6224;
P
Therefore, further investigation of eribulin-based treatment in larger randomized trials for patients with advanced TNBC is warranted. Clinical trial information: NCT05953909.
- Halaven (eribulin mesylate) / Eisai
Clinical outcomes of patients with HR-positive advanced breast cancer treated with eribulin: A retrospective multicenter study from China. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6222;
This retrospective study suggests that eribulin was effective in HR+ Chinese patients with ABC. The front-line and combined therapy of eribulin in HR+ ABC need further exploration.
- Halaven (eribulin mesylate) / Eisai
Treatment (Tx) patterns, efficacy and safety of eribulin for advanced and heavily pretreated breast cancer (ABC): Updated results from a single-center, real-world study. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6186;
In this single-center study of pts with heavily pre-treated ABC in China, eribulin Tx resulted in favorable PFS irrespective of molecular subtype, with a manageable safety profile. In pts with a large tumor burden and a good PS, eribulin-based combinations may further improve outcomes.
- Halaven (eribulin mesylate) / Eisai
Efficacy and safety of eribulin-based chemotherapy in patients with advanced breast cancer: A single-centre retrospective study. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6168;
Significant PFS benefit was associated with Eribulin treatment in patients with HER2-0 compared with HER2-low. This study still needs longer follow-up to evaluate its efficacy more comprehensively.
- Halaven (eribulin mesylate) / Eisai
Multicentric retrospective study on the treatment characteristics, efficacy and safety of eribulin in Slovenian patients with breast cancer. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6145;
In our population, eribulin was used in the late stages of treatment and in older patients with poorer performance status. The proportion of patients with visceral and CNS tumors was higher.
- Halaven (eribulin mesylate) / Eisai
Survival and safety analysis of eribulin in Indian patients with metastatic breast cancer: A real world clinical experience. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6120;
This study confirms that Eribulin is effective and has manageable toxicity in patients with MBC. It should be considered as the strategy of several chemotherapy lines in MBC.
- sacituzumab tirumotecan (MK-2870) / Merck (MSD)
Sacituzumab tirumotecan (SKB264/MK-2870) in patients (pts) with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC): Results from the phase III OptiTROP-Breast01 study. (Hall D1) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2909;
P3
trial, SKB264 was compared with physician's choice of chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine) in pts with locally recurrent or metastatic TNBC who had received two or more prior therapies including at least one for metastatic setting... Sacituzumab tirumotecan monotherapy demonstrated statistically significant and clinically meaningful PFS and OS benefit over chemotherapy, with a manageable safety profile in pts with heavily pretreated advanced TNBC and limited treatment options.
- Xtandi (enzalutamide capsule) / Pfizer, Astellas, Mifeprex (mifepristone) / Danco Laboratories
TBCRC 058: A randomized phase II study of enzalutamide, enzalutamide with mifepristone, and treatment of physician's choice in patients with androgen receptor-positive metastatic triple-negative or estrogen receptor-low breast cancer (NCT06099769). (Hall A; Poster Bd #: 107a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2567;
P2
Tumors must have AR ?10%, normal organ function, no history of brain mets. As of 1/15/2024, 2 of 201 pts have begun protocol-specified tx.
- BB-1701 / BlissBio, Eisai
An open-label, multicenter, phase 2 study to evaluate the safety and efficacy of BB-1701, a novel antibody drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2), in previously treated patients with HER2-positive (HER2+) or HER2-low unresectable or metastatic breast cancer (BC). (Hall A; Poster Bd #: 99a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2551;
P2
BB-1701 is an ADC consisting of a monoclonal antibody targeting HER2 with eribulin (microtubule inhibitor) as a payload that is capable of exerting a bystander effect...Randomization will be stratified by HER2 status (HER2+ vs. HER2-low) documented prior to T-DXd treatment...In both study parts, exploratory objectives will include evaluation of biomarkers of response to BB-1701 and BB-1701 immunogenicity; other efficacy measures (i.e., PFS on the next line of therapy) and population pharmacokinetics will be analyzed in the dose-expansion part only. Pt enrollment is currently open.
- BB-1701 / BlissBio, Eisai
Updated safety and antitumor activity of BB-1701 from study 101 in the multiple dose level cohort of patients with locally advanced/metastatic HER2-low expressing breast cancer. (Hall A; Poster Bd #: 88) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2540;
P1
Background: BB-1701 is an antibody-drug conjugate (ADC) consisting of a humanized anti-HER2 antibody and eribulin. BB-1701 shows promising antitumor activity and a manageable safety profile in HER2 low-expressing breast cancer, including patients who received prior anti-HER2 ADCs.
- ipatasertib (RG7440) / Roche
Ipatasertib (IPA) combined with non-taxane chemotherapy (CT) for patients (pts) with previously treated advanced triple-negative breast cancer (aTNBC): The PATHFINDER phase IIa trial. (Hall A; Poster Bd #: 76) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2528;
P2
However, adding IPA to CG was not tolerable. E + IPA showed promising efficacy regardless of PI3K/AKT status that merits further evaluation.
- Halaven (eribulin mesylate) / Eisai, Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Trastuzumab and pertuzumab in combination with eribulin mesylate or a taxane as first-line chemotherapeutic treatment for HER2-positive, locally advanced or metastatic breast cancer: Results of a multicenter, randomized, non-inferiority phase 3 trial in Japan (JBCRG-M06/EMERALD). (Hall B1) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2450;
P3
This is the first study to show non-inferiority of eribulin to taxane when used in combination with dual HER2 blockade. As a less toxic but equally effective alternative to the taxane-containing regimen, eribulin combined with HP could be first-line treatment of locally advanced or metastatic HER2+ BC.