- |||||||||| ladiratuzumab vedotin (SGN-LIV1A) / Merck (MSD), Pfizer
Journal: Expression of cell surface zinc transporter LIV1 in triple negative breast cancer is an indicator of poor prognosis and therapy failure. (Pubmed Central) - Feb 12, 2024 The promising preclinical data support advancing SDP03923-000-9106 into clinical testing, and Investigational New Drug (IND) application to NMPA has been submitted. Recently, in the United States of America, FDA approved the use of a new drug targeting LIV1, antibody drug conjugate SGN-LIV1A for treatment of TNBC patients...Finally, TNBC patients with 3+ staining intensity showed poor survival (4.44 year) as compared to patients with 2+
- |||||||||| ladiratuzumab vedotin (SGN-LIV1A) / Merck (MSD), Pfizer
Trial completion date, Trial termination, Trial primary completion date, Metastases: SGNLVA-005: A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors (clinicaltrials.gov) - Dec 27, 2023 P2, N=205, Terminated, Recently, in the United States of America, FDA approved the use of a new drug targeting LIV1, antibody drug conjugate SGN-LIV1A for treatment of TNBC patients...Finally, TNBC patients with 3+ staining intensity showed poor survival (4.44 year) as compared to patients with 2+ Trial completion date: Jul 2025 --> Nov 2023 | Active, not recruiting --> Terminated | Trial primary completion date: May 2024 --> Nov 2023; Study closed due to portfolio prioritization
- |||||||||| LIV-1 CAR-T / CRISPR Therap, ladiratuzumab vedotin (SGN-LIV1A) / Seagen, Merck (MSD)
Allogeneic CAR T cells targeting Liv-1 for breast cancer (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_688; Its specific expression in breast cancer, as opposed to other tissues, reduces the risk of off-target toxicity. We have demonstrated that anti-Liv1 CAR T cells can be produced with potent in vitro and in vivo CAR T cell activity against multiple breast cancer cell lines.
- |||||||||| ladiratuzumab vedotin (SGN-LIV1A) / Merck (MSD), Pfizer
Enrollment closed, Enrollment change, Metastases: SGNLVA-005: A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors (clinicaltrials.gov) - Jul 14, 2023 P2, N=205, Active, not recruiting, Active, not recruiting --> Recruiting Recruiting --> Active, not recruiting | N=414 --> 205
- |||||||||| ladiratuzumab vedotin (SGN-LIV1A) / Merck (MSD), Pfizer
Trial completion, Trial completion date: SGNLVA-001: A Safety Study of SGN-LIV1A in Breast Cancer Patients (clinicaltrials.gov) - Mar 7, 2023 P1, N=290, Completed, Trial primary completion date: Apr 2023 --> Mar 2024 Active, not recruiting --> Completed | Trial completion date: Jun 2023 --> Feb 2023
- |||||||||| ladiratuzumab vedotin (SGN-LIV1A) / Merck (MSD), Pfizer
Enrollment closed, Enrollment change, Trial primary completion date: SGNLVA-001: A Safety Study of SGN-LIV1A in Breast Cancer Patients (clinicaltrials.gov) - Dec 21, 2022 P1, N=290, Active, not recruiting, N=264 --> 414 Recruiting --> Active, not recruiting | N=448 --> 290 | Trial primary completion date: Dec 2022 --> Mar 2023
- |||||||||| ladiratuzumab vedotin (SGN-LIV1A) / Seagen, Merck (MSD)
Review, Journal, IO biomarker: Zinc transporter LIV1: A promising cell surface target for triple negative breast cancer. (Pubmed Central) - Oct 2, 2022 Early clinical trial results reveal that this novel agent reduces tumor burden by inducing mitotic arrest, immunomodulation, and immunogenic cell death, warranting further investigation of SGN-LIV1A in combination with immuno-oncology agents. Priming the patient's immune response in combination with SGN-LIV1A could eventually change the landscape for the TNBC patient population.
- |||||||||| Review, Journal, BRCA Biomarker: From seaside to bedside: Current evidence and future perspectives in the treatment of breast cancer using marine compounds. (Pubmed Central) - Sep 29, 2022
A deeper knowledge of the mechanism of action and of the potential predictive factors for response to marine-derived drugs is important for their rational and effective use, alone or in combination. In this narrative review, we discuss the role of marine-derived drugs for the treatment of BC, although most of them are not approved, and the opportunities that could arise from the potential treasure trove of the sea for novel BC therapeutics.
- |||||||||| ladiratuzumab vedotin (SGN-LIV1A) / Merck (MSD), Pfizer
Trial primary completion date: SGNLVA-001: A Safety Study of SGN-LIV1A in Breast Cancer Patients (clinicaltrials.gov) - Aug 3, 2022 P1, N=448, Recruiting, In this narrative review, we discuss the role of marine-derived drugs for the treatment of BC, although most of them are not approved, and the opportunities that could arise from the potential treasure trove of the sea for novel BC therapeutics. Trial primary completion date: Jul 2022 --> Dec 2022
- |||||||||| ladiratuzumab vedotin (SGN-LIV1A) / Merck (MSD), Pfizer
Trial completion date, Trial primary completion date, Metastases: SGNLVA-005: A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors (clinicaltrials.gov) - Aug 3, 2022 P2, N=264, Recruiting, Trial primary completion date: Jul 2022 --> Dec 2022 Trial completion date: Jul 2023 --> Jul 2025 | Trial primary completion date: Aug 2022 --> May 2024
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Review, Journal: Actively Targeted Nanomedicines in Breast Cancer: From Pre-Clinal Investigation to Clinic. (Pubmed Central) - Mar 11, 2022 In this work, all these active targeted nanomedicines are discussed, analyzing their advantages and disadvantages over conventional chemotherapy as well as the challenges involved in their lab to clinical translation. In addition, examples of formulations developed and evaluated at the preclinical level are also discussed.
- |||||||||| Trodelvy (sacituzumab govitecan-hziy) / Everest Medicines, Gilead, Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, ladiratuzumab vedotin (SGN-LIV1A) / Seagen, Merck (MSD)
Journal: Antibody-Drug Conjugates in Metastatic Triple Negative Breast Cancer: A Spotlight on Sacituzumab govitecan, Ladiratuzumab vedotin, and Trastuzumab deruxtecan. (Pubmed Central) - Feb 1, 2022 Investigation of their use in combination with other agents, including PARP inhibitors and checkpoint inhibitors, is ongoing in the metastatic setting, and their application in early-stage TNBCs are under investigation. ADCs are therefore expected to redefine treatment paradigms in TNBC.
- |||||||||| ladiratuzumab vedotin (SGN-LIV1A) / Seagen, Merck (MSD)
[VIRTUAL] Open-label, phase II study of ladiratuzumab vedotin (LV) for unresectable locally advanced or metastatic solid tumors () - Jul 22, 2021 - Abstract #ESMO2021ESMO_1992; P2 Key secondary objectives include safety, progression free survival, and overall survival. Study accrual is ongoing in the USA, Italy, South Korea, Taiwan, Australia, and the UK.
- |||||||||| [VIRTUAL] Module 3: Immune Checkpoint Inhibitors and Other Novel Strategies for the Treatment of Triple-Negative Breast Cancer (TNBC) () - Jun 5, 2021 - Abstract #ASCO2021ASCO_5853;
Further studies of LV q1w in patients with breast cancer and other tumors are underway., and provided by Sandra Hackelberg of MMS Holdings, Inc. Available results from the Phase III KEYNOTE-522 and IMpassion031 trials documenting the benefit of neoadjuvant pembrolizumab or atezolizumab, respectively, with chemotherapy versus chemotherapy alone for TNBC Current nonresearch role, if any, of neoadjuvant immune checkpoint inhibition for patients with TNBC Long-term efficacy and safety findings from the Phase III IMpassion130 trial evaluating atezolizumab/nab paclitaxel as first-line therapy for metastatic TNBC (mTNBC) Primary results from the Phase III IMpassion131 study of first-line paclitaxel with or without atezolizumab for mTNBC; recent FDA alert regarding efficacy and safety concerns with this combination Key efficacy and safety findings supporting the recent FDA approval of pembrolizumab in combination with chemotherapy for patients with previously untreated PD-L1-positive mTNBC (KEYNOTE-355 trial); effect of chemotherapy partner and previous chemotherapy exposure on outcomes FDA approvals of atezolizumab/nab paclitaxel and pembrolizumab/chemotherapy for PD-L1-positive mTNBC; optimal integration into practice Mechanism of action, available data and recent FDA approval of sacituzumab govitecan; biomarker findings from the confirmatory Phase III ASCENT study and optimal integration into mTNBC management algorithms Other promising novel agents and strategies under investigation for TNBC (eg, ladiratuzumab vedotin, datopotamab deruxtecan)
- |||||||||| ladiratuzumab vedotin (SGN-LIV1A) / Merck (MSD), Pfizer
Trial completion date, Trial primary completion date: SGNLVA-001: A Safety Study of SGN-LIV1A in Breast Cancer Patients (clinicaltrials.gov) - Apr 22, 2021 P1, N=508, Recruiting, Available results from the Phase III KEYNOTE-522 and IMpassion031 trials documenting the benefit of neoadjuvant pembrolizumab or atezolizumab, respectively, with chemotherapy versus chemotherapy alone for TNBC Current nonresearch role, if any, of neoadjuvant immune checkpoint inhibition for patients with TNBC Long-term efficacy and safety findings from the Phase III IMpassion130 trial evaluating atezolizumab/nab paclitaxel as first-line therapy for metastatic TNBC (mTNBC) Primary results from the Phase III IMpassion131 study of first-line paclitaxel with or without atezolizumab for mTNBC; recent FDA alert regarding efficacy and safety concerns with this combination Key efficacy and safety findings supporting the recent FDA approval of pembrolizumab in combination with chemotherapy for patients with previously untreated PD-L1-positive mTNBC (KEYNOTE-355 trial); effect of chemotherapy partner and previous chemotherapy exposure on outcomes FDA approvals of atezolizumab/nab paclitaxel and pembrolizumab/chemotherapy for PD-L1-positive mTNBC; optimal integration into practice Mechanism of action, available data and recent FDA approval of sacituzumab govitecan; biomarker findings from the confirmatory Phase III ASCENT study and optimal integration into mTNBC management algorithms Other promising novel agents and strategies under investigation for TNBC (eg, ladiratuzumab vedotin, datopotamab deruxtecan) Trial completion date: Mar 2022 --> Jun 2023 | Trial primary completion date: Apr 2021 --> Jul 2022
- |||||||||| ladiratuzumab vedotin (SGN-LIV1A) / Seagen, Merck (MSD)
[VIRTUAL] Open-label, phase II study of ladiratuzumab vedotin (LV) for castration-resistant prostate cancer (SGNLVA-005, trial-in-progress). () - Jan 8, 2021 - Abstract #ASCOGU2021ASCO_GU_703; P2 Study objectives include objective tumor response rate per RECIST 1.1 and prostate-specific antigen (PSA) response rate per Prostate Cancer Clinical Trials Working Group 3 (both primary); safety and tolerability, disease control rate, duration of response, progression-free and overall survival, and pharmacokinetics and immunogenicity (all secondary); and pharmacodynamics. Study accrual is ongoing in the USA, Italy, South Korea, Taiwan, Australia, and the UK.
- |||||||||| ladiratuzumab vedotin (SGN-LIV1A) / Seagen, Merck (MSD)
[VIRTUAL] Open-label, phase II study of ladiratuzumab vedotin (LV) for advanced gastric and gastroesophageal junction adenocarcinoma (SGNLVA-005, Trial-in-Progress). () - Dec 9, 2020 - Abstract #ASCOGI2021ASCO_GI_416; P2 Study objectives include objective response rate (primary); safety and tolerability, disease control rate, duration of response, progression-free and overall survival, and pharmacokinetics and immunogenicity (all secondary); and pharmacodynamics. Study accrual is ongoing in the USA, Italy, South Korea, Taiwan, Australia, and the UK.
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