^
16h
Sacituzumab Govitecan and Bevacizumab for NSCLC Brain Metastases (clinicaltrials.gov)
P2, N=25, Not yet recruiting, Maastricht University Medical Center
New P2 trial
|
Avastin (bevacizumab) • Trodelvy (sacituzumab govitecan-hziy)
6d
New P3 trial • Combination therapy • Surgery
|
Keytruda (pembrolizumab) • capecitabine • sacituzumab tirumotecan (MK-2870)
7d
New P3 trial
|
paclitaxel • doxorubicin hydrochloride • topotecan • SHR-A1921
11d
Antibody-drug conjugates in urothelial carcinoma: scientometric analysis and clinical trials analysis. (PubMed, Front Oncol)
Since the FDA's approval of Enfortumab Vedotin and Sacituzumab Govitecan, the therapeutic landscape has expanded, heralding a shift towards antibody-drug conjugates as potential first-line therapies. These findings affirm the increasing significance of antibody-drug conjugates in urothelial carcinoma treatment, transitioning them from posterior-line to frontline therapies. Future research is poised to focus on new therapeutic targets, combination therapy optimization, treatment personalization, exploration of double antibody-coupled drugs, and strategies to overcome drug resistance.
Review • Journal • PD(L)-1 Biomarker • IO biomarker
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • EPCAM (Epithelial cell adhesion molecule)
|
PD-L1 expression
|
Trodelvy (sacituzumab govitecan-hziy) • Padcev (enfortumab vedotin-ejfv)
12d
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) (clinicaltrials.gov)
P2, N=531, Recruiting, AstraZeneca | Trial completion date: Mar 2025 --> Aug 2026 | Trial primary completion date: Mar 2025 --> Aug 2026
Trial completion date • Trial primary completion date • Combination therapy • Pan tumor • Metastases
|
Avastin (bevacizumab) • carboplatin • Imfinzi (durvalumab) • 5-fluorouracil • capecitabine • leucovorin calcium • datopotamab deruxtecan (DS-1062a) • saruparib (AZD5305) • rilvegostomig (AZD2936) • volrustomig (MEDI5752)
12d
A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer (clinicaltrials.gov)
P3, N=378, Not yet recruiting, Shanghai Escugen Biotechnology Co., Ltd
New P3 trial • Metastases
|
gemcitabine • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • ESG401
14d
A new TROP2-targeting antibody-drug conjugate shows potent antitumor efficacy in breast and lung cancers. (PubMed, NPJ Precis Oncol)
Moreover, compared to sacituzumab govitecan, hIMB1636-LDP-AE showed more potent antitumor activity and significantly lower myelotoxicity in tumors with moderate Trop2 expression. This study fully revealed the potent antitumor efficacy of hIMB1636-LDP-AE, and also provided a new preparation method for LDM-based ADC, as well as a promising candidate for breast cancer and lung cancer therapeutics.
Journal
|
TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
|
TROP2 expression • TROP2 positive
|
Trodelvy (sacituzumab govitecan-hziy)
14d
Datopotamab Deruxtecan in Advanced or Metastatic HR+/HER2- and Triple-Negative Breast Cancer: Results From the Phase I TROPION-PanTumor01 Study. (PubMed, J Clin Oncol)
In patients with heavily pretreated advanced HR+/HER2- BC and TNBC, Dato-DXd demonstrated promising clinical activity and a manageable safety profile. Dato-DXd is currently being evaluated in phase III studies.
P1 data • Journal • Pan tumor • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 negative • EGFR positive
|
datopotamab deruxtecan (DS-1062a)
14d
Antibody Drug Conjugates in Urological Cancers: A Review of the Current Landscape. (PubMed, Curr Oncol Rep)
ADCs have advanced from hematologic to solid tumours, notably in breast cancer, and are now pivotal in metastatic urological cancers as both monotherapies and in combination regimens, underscored by the FDA's approval of enfortumab vedotin and sacituzumab govitecan for metastatic urothelial cancer. There is a continual search for agents in the metastatic, relapsed testicular cancer landscape. ADCs have emerged as a pivotal innovation in oncology, blending targeted antibody therapy with potent cytotoxic drugs, significantly advancing treatment options for urological malignancies.
Review • Journal
|
STEAP1 (STEAP Family Member 1)
|
Trodelvy (sacituzumab govitecan-hziy) • Padcev (enfortumab vedotin-ejfv)
14d
Antibody-drug conjugates in lung and breast cancer: Current evidence and future directions - a position statement from the ETOP IBCSG Partners Foundation. (PubMed, Ann Oncol)
In lung cancer, trastuzumab deruxtecan (T-DXd) is approved in human epidermal growth factor receptor 2 (HER2)-mutated, unresectable or metastatic non-small cell lung cancer, with ADCs targeting HER3 (patritumab deruxtecan), trophoblast cell-surface antigen 2 (datopotamab deruxtecan and sacituzumab govitecan [SG]) and mesenchymal-epithelial transition factor (telisotuzumab vedotin) in late-stage clinical development. In breast cancer, several agents are already approved and widely used, including trastuzumab emtansine, T-DXd and SG, and multiple late-stage trials are ongoing...The ETOP IBCSG Partners Foundation are driving strong collaborations in this field and promoting the generation/sharing of databases, repositories and registries to enable greater access data. This will allow the most important research questions to be identified and prioritised, which will ultimately accelerate progress and help to improve patient outcomes.
Review • Journal
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HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
|
EGFR mutation • HER-2 mutation
|
Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • patritumab deruxtecan (U3-1402) • Trodelvy (sacituzumab govitecan-hziy) • datopotamab deruxtecan (DS-1062a) • telisotuzumab vedotin (ABBV-399)
18d
Trial initiation date • Combination therapy • Metastases
|
TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
|
capecitabine • Trodelvy (sacituzumab govitecan-hziy)
19d
Study Evaluating Treatment of Sacituzumab-govitecan for Patients With Metastatic Esophagogastric Adenocarcinoma (clinicaltrials.gov)
P1/2, N=56, Recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Not yet recruiting --> Recruiting
Enrollment open • Metastases
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
Trodelvy (sacituzumab govitecan-hziy)
20d
Enrollment open • Surgery
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • pemetrexed • sacituzumab tirumotecan (MK-2870)
21d
Tropion-Lung08: Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations (clinicaltrials.gov)
P3, N=740, Recruiting, Daiichi Sankyo | Trial completion date: Jun 2026 --> Apr 2028 | Trial primary completion date: Jun 2026 --> Feb 2028
Trial completion date • Trial primary completion date • Metastases
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
|
PD-L1 expression
|
PD-L1 IHC 22C3 pharmDx
|
Keytruda (pembrolizumab) • datopotamab deruxtecan (DS-1062a)
21d
Saci-IO TNBC: Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC (clinicaltrials.gov)
P2, N=110, Recruiting, Dana-Farber Cancer Institute | Trial completion date: Apr 2027 --> Apr 2029 | Trial primary completion date: Apr 2024 --> Apr 2026
Trial completion date • Trial primary completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
PD-L1 expression • HER-2 negative • PD-L1 negative • PGR expression
|
PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP142) Assay
|
Keytruda (pembrolizumab) • Trodelvy (sacituzumab govitecan-hziy)
21d
A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors (clinicaltrials.gov)
P2, N=18, Recruiting, Georgetown University | Not yet recruiting --> Recruiting
Enrollment open • Metastases
|
Trodelvy (sacituzumab govitecan-hziy)
27d
Sacituzumab govitecan in metastatic triple-negative breast cancer patients treated at Institut Curie Hospitals: efficacy, safety, and impact of brain metastases. (PubMed, Breast Cancer)
The observed response rate and safety of SG are consistent with the results of the ASCENT trial, with efficacy observed in patients with brain metastases, but observed PFS and OS are numerically shorter.
Journal • BRCA Biomarker • Metastases
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
|
BRCA2 mutation • BRCA1 mutation
|
Trodelvy (sacituzumab govitecan-hziy)
27d
Sacituzumab Govitecan for the treatment of advanced triple negative breast cancer patients: a multi-center real-world analysis. (PubMed, Front Oncol)
The results of this real-world analysis showed that both safety and efficacy of sacituzumab govitecan in mTNBC patients are consistent with that previously reported in regulatory trials. The use of premedication and supportive measures was associated with a satisfactory toxicity profile.
Journal • Real-world evidence • Real-world • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
ER expression
|
Trodelvy (sacituzumab govitecan-hziy)
27d
New P3 trial • Metastases
|
paclitaxel • docetaxel • irinotecan • Lonsurf (trifluridine/tipiracil) • sacituzumab tirumotecan (MK-2870)
28d
New P3 trial • Combination therapy • IO biomarker • Metastases
|
PD-L1 (Programmed death ligand 1) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
|
TROP2 positive
|
Keytruda (pembrolizumab) • datopotamab deruxtecan (DS-1062a) • rilvegostomig (AZD2936)
28d
New trial • Real-world evidence • Real-world effectiveness • Real-world • Metastases
|
Trodelvy (sacituzumab govitecan-hziy)
28d
Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05) (clinicaltrials.gov)
P2, N=137, Active, not recruiting, Daiichi Sankyo | Trial completion date: May 2026 --> Dec 2024
Trial completion date • Metastases
|
EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
|
KRAS mutation • EGFR mutation • EGFR overexpression • MET exon 14 mutation
|
datopotamab deruxtecan (DS-1062a)
1m
Population Pharmacokinetics of Sacituzumab Govitecan in Patients with Metastatic Triple-Negative Breast Cancer and Other Solid Tumors. (PubMed, Clin Pharmacokinet)
These analyses support the approved SG dosing regimen of 10 mg/kg as intravenous infusion on days 1 and 8 of 21-day cycles and did not identify a need for dose adjustment based on evaluated covariates or disease characteristics.
PK/PD data • Journal • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
|
HR positive • HER-2 negative • UGT1A1*1*1
|
Trodelvy (sacituzumab govitecan-hziy)
1m
New P3 trial • Metastases
|
Tagrisso (osimertinib) • datopotamab deruxtecan (DS-1062a)
1m
Enrollment open • Combination therapy • Metastases
|
Keytruda (pembrolizumab) • capecitabine • albumin-bound paclitaxel • pegylated liposomal doxorubicin • sacituzumab tirumotecan (MK-2870)
1m
Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05) (clinicaltrials.gov)
P2, N=137, Active, not recruiting, Daiichi Sankyo | Trial completion date: May 2024 --> May 2026
Trial completion date • Metastases
|
EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
|
KRAS mutation • EGFR mutation • EGFR overexpression • MET exon 14 mutation
|
datopotamab deruxtecan (DS-1062a)
1m
Study to Evaluate Sacituzumab Govitecan in Combination With Talazoparib in Patients With Metastatic Breast Cancer. (clinicaltrials.gov)
P1/2, N=75, Recruiting, Massachusetts General Hospital | Phase classification: P1b/2 --> P1/2 | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Dec 2025
Phase classification • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 positive • HER-2 negative • ER negative • PGR negative
|
Talzenna (talazoparib) • Trodelvy (sacituzumab govitecan-hziy)
1m
Charting the Course in Sequencing Antibody-Drug Conjugates in Breast Cancer. (PubMed, Biomedicines)
Historically, trastuzumab emtansine (T-DM1) has been the most commonly used ADC for both early and metastatic HER2-positive disease. Considering the recent evidence related to trastuzumab deruxtecan (T-DXd), it is expected to assume the role of the main ADC in our clinical practice. Herein, we report a retrospective analysis of the sequence of different ADCs relying on available published data from clinical trials.
Review • Journal
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive
|
Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Trodelvy (sacituzumab govitecan-hziy)
1m
ASCENT-J02: Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=143, Recruiting, Gilead Sciences | Trial primary completion date: Apr 2025 --> May 2026
Trial primary completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 negative • EGFR positive
|
Trodelvy (sacituzumab govitecan-hziy)
1m
Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy (clinicaltrials.gov)
P2, N=120, Suspended, Vanderbilt-Ingram Cancer Center | Recruiting --> Suspended
Trial suspension • Circulating tumor DNA • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative • PD-L1 negative
|
Trodelvy (sacituzumab govitecan-hziy)
1m
SG-ESCC: Sacituzumab Govitecan for Advanced Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)
P2, N=35, Not yet recruiting, National Taiwan University Hospital
New P2 trial • Metastases
|
TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
|
Trodelvy (sacituzumab govitecan-hziy)
2ms
Clinical management, monitoring, and prophylaxis of adverse events of special interest associated with datopotamab deruxtecan. (PubMed, Cancer Treat Rev)
This article summarizes the incidence of AESIs among patients with HR+/HER2- BC, TNBC, and NSCLC reported in TROPION-PanTumor01. We report our recommendations for AESI prophylaxis, early detection, and management, using experience gained from treating AESIs that occur with Dato-DXd in clinical trials.
Review • Journal • Adverse events
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 negative
|
datopotamab deruxtecan (DS-1062a)
2ms
A Study of Sacituzumab Govitecan (IMMU-132) in Endometrial Carcinoma (clinicaltrials.gov)
P2, N=50, Recruiting, Yale University | Trial primary completion date: Feb 2024 --> Dec 2024
Trial primary completion date
|
TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
|
Trodelvy (sacituzumab govitecan-hziy)
2ms
TROP-2, NECTIN-4 and predictive biomarkers in sarcomatoid and rhabdoid bladder urothelial carcinoma. (PubMed, Pathologica)
Different combinations of other positive biomarkers may help the choice of medical therapies. Overall, these findings have important clinical implications for targeted therapy for BUC.
Journal • PD(L)-1 Biomarker • IO biomarker
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • FGFR2 (Fibroblast growth factor receptor 2) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • NECTIN4 (Nectin Cell Adhesion Molecule 4) • NTRK (Neurotrophic receptor tyrosine kinase) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
|
HER-2 amplification • HER-2 expression • NECTIN4 expression
2ms
Study Evaluating Treatment of Sacituzumab-govitecan for Patients With Metastatic Esophagogastric Adenocarcinoma (clinicaltrials.gov)
P1/2, N=56, Not yet recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Initiation date: Dec 2023 --> Apr 2024
Trial initiation date • Metastases
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
Trodelvy (sacituzumab govitecan-hziy)
2ms
Enrollment change • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • AR (Androgen receptor)
|
HER-2 positive • HER-2 amplification • HER-2 mutation • AR positive
|
trastuzumab rezetecan (SHR-A1811) • leuprolide acetate for depot suspension • Airui'en (rezvilutamide) • SHR-A1921
2ms
New P3 trial • Surgery
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • pemetrexed • sacituzumab tirumotecan (MK-2870)
2ms
New P3 trial • Combination therapy • Metastases
|
Keytruda (pembrolizumab) • capecitabine • albumin-bound paclitaxel • pegylated liposomal doxorubicin • sacituzumab tirumotecan (MK-2870)
2ms
New P2 trial • Metastases
|
Enhertu (fam-trastuzumab deruxtecan-nxki) • Trodelvy (sacituzumab govitecan-hziy) • Padcev (enfortumab vedotin-ejfv)
2ms
Trial initiation date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
PGR expression
|
Herceptin (trastuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Trodelvy (sacituzumab govitecan-hziy) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
2ms
Sacituzumab Govitecan in Combination With Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer (clinicaltrials.gov)
P1/2, N=54, Not yet recruiting, Icahn School of Medicine at Mount Sinai | Initiation date: Sep 2023 --> Mar 2024
Trial initiation date • Combination therapy
|
cisplatin • Trodelvy (sacituzumab govitecan-hziy)