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DRUG:

sacituzumab tirumotecan (MK-2870)

i
Other names: SKB-264, MK2870, MK 2870, MK-2870, SKB 264, SKB264, sac-TMT
Company:
Merck (MSD), Sichuan Kelun Pharma
Drug class:
Topoisomerase I inhibitor, TROP-2-targeted antibody-drug conjugate
Related drugs:
6d
OptiTROP-Breast01: SKB264 Injection Vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer (clinicaltrials.gov)
P3, N=254, Active, not recruiting, Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. | Trial completion date: Dec 2024 --> Mar 2025
Trial completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
|
BRCA2 mutation • BRCA1 mutation • HER-2 negative • HER-2 expression • PGR negative • HER-2 negative + HR positive + BRCA mutation
|
gemcitabine • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • sacituzumab tirumotecan (MK-2870)
16d
New P3 trial • Combination therapy • Metastases
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • sacituzumab tirumotecan (MK-2870)
1m
A Phase 1/2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers (ChiCTR2400089007)
P2, N=130, Not yet recruiting, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Union Hospital, Tongji Medical College, Huazhong University of
New P2 trial • Combination therapy
|
MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • BRCA (Breast cancer early onset) • CD4 (CD4 Molecule)
|
MSI-H/dMMR • BRCA mutation • MSH6 expression
|
FoundationOne® CDx
|
5-fluorouracil • sacituzumab tirumotecan (MK-2870)
2ms
New P3 trial
|
Tagrisso (osimertinib) • sacituzumab tirumotecan (MK-2870)
2ms
New P1/2 trial
|
sacituzumab tirumotecan (MK-2870)
3ms
Enrollment change • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • ALK fusion
|
Keytruda (pembrolizumab) • Tagrisso (osimertinib) • carboplatin • sacituzumab tirumotecan (MK-2870)
4ms
Enrollment open • Metastases
|
Keytruda (pembrolizumab) • 5-fluorouracil • capecitabine • oxaliplatin • sacituzumab tirumotecan (MK-2870) • levoleucovorin calcium
5ms
Enrollment open • Metastases
|
gemcitabine • pemetrexed • irinotecan • vinorelbine tartrate • topotecan • sacituzumab tirumotecan (MK-2870) • Tivdak (tisotumab vedotin-tftv)
5ms
Enrollment open • Combination therapy • Metastases
|
Keytruda (pembrolizumab) • paclitaxel • Cyramza (ramucirumab) • sacituzumab tirumotecan (MK-2870)
5ms
Phase 3 Trofuse-007 Study: Sacituzumab Tirumotecan Plus Pembrolizumab vs Pembrolizumab Alone for NSCLC with PD-L1 TPS ≥50% (IASLC-WCLC 2024)
AEs will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Enrollment began in December 2023 and is currently ongoing.
PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
|
TROP2 expression • TROP2 overexpression
|
PD-L1 IHC 22C3 pharmDx
|
Keytruda (pembrolizumab) • sacituzumab tirumotecan (MK-2870)
5ms
New P3 trial
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
Keytruda (pembrolizumab) • sacituzumab tirumotecan (MK-2870)
5ms
Enrollment open • Combination therapy • Metastases
|
Keytruda (pembrolizumab) • Padcev (enfortumab vedotin-ejfv) • sacituzumab tirumotecan (MK-2870)
6ms
New P1/2 trial • Combination therapy • Metastases
|
Keytruda (pembrolizumab) • Padcev (enfortumab vedotin-ejfv) • sacituzumab tirumotecan (MK-2870)
6ms
SKB264-Ⅲ-10: Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer (clinicaltrials.gov)
P3, N=376, Recruiting, Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. | Not yet recruiting --> Recruiting
Enrollment open • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
gemcitabine • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • sacituzumab tirumotecan (MK-2870)
6ms
A Clinical Study of MK-2870 Alone or With Chemotherapy to Treat Gastrointestinal Cancers (MK-9999-02A) (clinicaltrials.gov)
P1/2, N=130, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting | Phase classification: P2 --> P1/2
Enrollment open • Phase classification • Combination therapy
|
5-fluorouracil • sacituzumab tirumotecan (MK-2870) • levoleucovorin calcium
6ms
Enrollment open • Metastases
|
carboplatin • capecitabine • albumin-bound paclitaxel • Halaven (eribulin mesylate) • sacituzumab tirumotecan (MK-2870)
6ms
Enrollment open • Combination therapy • Metastases
|
Keytruda (pembrolizumab) • carboplatin • albumin-bound paclitaxel • sacituzumab tirumotecan (MK-2870)
6ms
New P1/2 trial • Metastases
|
Keytruda (pembrolizumab) • 5-fluorouracil • capecitabine • oxaliplatin • sacituzumab tirumotecan (MK-2870) • levoleucovorin calcium
6ms
Trial completion date • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
Keytruda (pembrolizumab) • Tagrisso (osimertinib) • carboplatin • sacituzumab tirumotecan (MK-2870)
6ms
KL264-01: Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (clinicaltrials.gov)
P1/2, N=1300, Recruiting, Klus Pharma Inc. | N=430 --> 1300 | Trial completion date: Dec 2025 --> Jul 2026 | Trial primary completion date: Nov 2024 --> Aug 2025
Enrollment change • Trial completion date • Trial primary completion date • Metastases
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • MSI (Microsatellite instability) • BRCA (Breast cancer early onset) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
|
sacituzumab tirumotecan (MK-2870)
6ms
Enrollment open • Combination therapy • Surgery
|
Keytruda (pembrolizumab) • capecitabine • sacituzumab tirumotecan (MK-2870)
6ms
New P3 trial • Metastases
|
gemcitabine • pemetrexed • irinotecan • vinorelbine tartrate • topotecan • sacituzumab tirumotecan (MK-2870) • Tivdak (tisotumab vedotin-tftv)
6ms
Enrollment open • Combination therapy • Metastases
|
carboplatin • pemetrexed • dexamethasone • sacituzumab tirumotecan (MK-2870)
6ms
New P3 trial • Combination therapy • Metastases
|
Keytruda (pembrolizumab) • sacituzumab tirumotecan (MK-2870)
7ms
New P1/2 trial • Combination therapy • Metastases
|
Keytruda (pembrolizumab) • paclitaxel • Cyramza (ramucirumab) • sacituzumab tirumotecan (MK-2870)
7ms
New P2 trial
|
5-fluorouracil • sacituzumab tirumotecan (MK-2870) • levoleucovorin calcium
7ms
New P3 trial • Combination therapy • Metastases
|
Keytruda (pembrolizumab) • carboplatin • albumin-bound paclitaxel • sacituzumab tirumotecan (MK-2870)
7ms
Enrollment open • Metastases
|
paclitaxel • docetaxel • irinotecan • Lonsurf (trifluridine/tipiracil) • sacituzumab tirumotecan (MK-2870)
8ms
New P3 trial • Combination therapy • Surgery
|
Keytruda (pembrolizumab) • capecitabine • sacituzumab tirumotecan (MK-2870)
8ms
Sacituzumab tirumotecan (SKB264/MK-2870) in combination with KL-A167 (anti-PD-L1) as first-line treatment for patients with advanced NSCLC from the phase II OptiTROP-Lung01 study. (ASCO 2024)
Background: Sacituzumab Tirumotecan (SKB264/MK-2870)is a TROP2 ADC developed with novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor. SKB264 in combination with KL-A167 demonstrated promising efficacy results in treatment naive advanced NSCLC with manageable safety profile. SKB264 Q2W was recommended for further investigation. A Phase 3 study of SKB264 Q2W plus pembrolizumab vs pembrolizumab in 1L metastatic NSCLC with PD-L1 TPS ≥ 50% (NCT06170788) is ongoing.
Combination therapy • P2 data • Clinical • PD(L)-1 Biomarker • IO biomarker • Metastases
|
PD-L1 IHC 22C3 pharmDx
|
Keytruda (pembrolizumab) • sacituzumab tirumotecan (MK-2870) • Camtobell (belotecan) • tagitanlimab (HBM9167)
8ms
Enrollment open • Surgery
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • pemetrexed • sacituzumab tirumotecan (MK-2870)
8ms
New P3 trial • Metastases
|
paclitaxel • docetaxel • irinotecan • Lonsurf (trifluridine/tipiracil) • sacituzumab tirumotecan (MK-2870)
9ms
Enrollment open • Combination therapy • Metastases
|
Keytruda (pembrolizumab) • capecitabine • albumin-bound paclitaxel • pegylated liposomal doxorubicin • sacituzumab tirumotecan (MK-2870)
9ms
New P3 trial • Surgery
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • pemetrexed • sacituzumab tirumotecan (MK-2870)
9ms
New P3 trial • Combination therapy • Metastases
|
Keytruda (pembrolizumab) • capecitabine • albumin-bound paclitaxel • pegylated liposomal doxorubicin • sacituzumab tirumotecan (MK-2870)
9ms
New P3 trial • Combination therapy • Metastases
|
carboplatin • pemetrexed • dexamethasone • sacituzumab tirumotecan (MK-2870)
10ms
Phase 3 MK-2870-007 study: MK-2870 (SKB264) plus pembrolizumab vs pembrolizumab alone as first-line treatment for metastatic non-small-cell lung cancer with PD-L1 tumor proportion score (TPS) ≥50% (AACR 2024)
AEs will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0. Enrollment began in December 2023 and is currently ongoing.
Clinical • PD(L)-1 Biomarker • IO biomarker • Tumor proportion score • Metastases
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
|
TROP2 expression • TROP2 overexpression
|
PD-L1 IHC 22C3 pharmDx
|
Keytruda (pembrolizumab) • sacituzumab tirumotecan (MK-2870)
10ms
New P3 trial
|
carboplatin • capecitabine • albumin-bound paclitaxel • Halaven (eribulin mesylate) • sacituzumab tirumotecan (MK-2870)
11ms
Trial completion date • Trial primary completion date • Metastases
|
Keytruda (pembrolizumab) • paclitaxel • Lenvima (lenvatinib) • irinotecan • dexamethasone • sacituzumab tirumotecan (MK-2870) • MK-4830
12ms
Enrollment open • Combination therapy • Tumor proportion score • Metastases
|
Keytruda (pembrolizumab) • sacituzumab tirumotecan (MK-2870)
1year
MK-2870 in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005) (clinicaltrials.gov)
P3, N=710, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
Enrollment open
|
paclitaxel • doxorubicin hydrochloride • sacituzumab tirumotecan (MK-2870)