Therapy Detail

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Therapy Name Pembrolizumab + SKB264
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Pembrolizumab Keytruda MK-3475 Immune Checkpoint Inhibitor 150 PD-L1/PD-1 antibody 136 Keytruda (pembrolizumab) is an antibody against PD-1 that activates T-cell mediated anti-tumor immune response (PMID: 25977344). Keytruda (pembrolizumab) is approved in melanoma, SCLC, HNSCC, classical Hodgkin Lymphoma, PMBL, urothelial carcinoma, HCC, Merkel cell carcinoma, NMIBC, cutaneous SCC, MSI-H or dMMR or TMB high advanced solid tumors, NSCLC and CD274 (PD-L1)-positive NSCLC, esophageal SCC, cervical cancer, HNSCC, and TNBC, in combination with platnum-based chemo in NSCLC, with pemetrexed and platinum in pleural mesothelioma and non-sNSCLC with no EGFR or ALK mutations, with carboplatin and paclitaxel/nab-paclitaxel in sNSCLC, with axitinib or lenvatinib in RCC, with lenvatinib in endometrial carcinoma that is not MSI-H or dMMR, with platinum and fluoropyrimidine-based chemo for esophageal or gastroesophageal carcinoma, with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemo for CD274 (PD-L1)-positive, HER2-positive gastric or GEJ adenocarcinoma, with fluoropyrimidine- and platinum-containing chemo for HER2-negative gastric or GEJ adenocarcinoma, with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-positive cervical cancer, with gemcitabine and cisplatin for biliary tract cancer, with chemoradiation for cervical cancer, with carboplatin and paclitaxel for endometrial carcinoma, with paclitaxel with or without bevacizumab for epithelial ovarian, Fallopian tube, and peritonium cancer (FDA.gov).
SKB264 SKB 264|SKB-264|ADC SKB264|MK-2870|MK 2870|MK2870|Sacituzumab tirumotecan TROP2 Antibody 18 SKB264 is an antibody-drug conjugate (ADC) composed of a monoclonal antibody that targets trophoblast cell surface protein 2 (TROP2) linked to a topoisomerase I inhibitor, which delivers the drug to TROP2-expressing tumor cells, potentially resulting in antitumor activity (Cancer Res (2024) 84 (7_Supplement): CT038).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT06841354 Phase III Carboplatin + Gemcitabine Carboplatin + Nab-paclitaxel Pembrolizumab + SKB264 SKB264 Carboplatin + Paclitaxel A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011) Recruiting USA | TUR | ROU | POL | NZL | NLD | ITA | ISR | HUN | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BRA | BEL | AUS | ARG 11
NCT05816252 Phase II Osimertinib + SKB264 Carboplatin + SKB264 Carboplatin + Pembrolizumab + SKB264 Pembrolizumab + SKB264 SKB264 A Study of SKB264 (MK-2870; Sac-TMT) for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (SKB264-II-04) (MK-2870-003) Active, not recruiting TUR | ROU | ESP 3
NCT06952504 Phase III Pembrolizumab Carboplatin + Paclitaxel + Pembrolizumab SKB264 Carboplatin + Docetaxel + Pembrolizumab Pembrolizumab + SKB264 A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (MK-2870-033/TroFuse-033/GOG-3119/ENGOT-en29) (TroFuse-033) Recruiting USA | SWE | POL | NOR | NLD | ITA | ISR | IRL | HUN | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BRA | BEL | AUT | AUS | ARG 10
NCT06422143 Phase III Pembrolizumab + SKB264 Pembrolizumab Carboplatin + Paclitaxel + Pembrolizumab Carboplatin + Nab-paclitaxel + Pembrolizumab Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023] Recruiting USA | TUR | ROU | POL | ITA | ISR | IRL | HUN | GBR | FRA | ESP | DEU | CZE | CAN | BRA | AUT | ARG 9
NCT06170788 Phase III Pembrolizumab + SKB264 Pembrolizumab Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) >= 50% (MK-2870-007) (TroFuse-007) Recruiting USA | TUR | POL | NLD | ITA | GBR | FRA | ESP | DNK | DEU | CZE | CAN | BRA | AUS | ARG 11
NCT06393374 Phase III Pembrolizumab Pembrolizumab + SKB264 Capecitabine + Pembrolizumab Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012) Recruiting USA | TUR | SWE | POL | NOR | ITA | ISR | IRL | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CHE | CAN | BRA | BEL | AUT | AUS | ARG 8
NCT07216703 Phase III Pembrolizumab + SKB264 Cisplatin + Paclitaxel + Pembrolizumab Bevacizumab + Pembrolizumab + SKB264 Bevacizumab + Cisplatin + Paclitaxel + Pembrolizumab Bevacizumab + Carboplatin + Paclitaxel + Pembrolizumab Pembrolizumab Carboplatin + Paclitaxel + Pembrolizumab Bevacizumab + Pembrolizumab A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22) Recruiting USA | SWE | POL | ITA | ISR | HUN | ESP | CZE | CAN | BEL | ARG 3
NCT05642780 Phase II Pembrolizumab + SKB264 SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors Active, not recruiting USA | POL | CAN | BEL | AUS 1
NCT06312137 Phase III Carboplatin + Paclitaxel + Pembrolizumab Cisplatin + Pembrolizumab + Pemetrexed Disodium Cisplatin + Gemcitabine + Pembrolizumab Pembrolizumab + SKB264 A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019) (TroFuse-019) Recruiting USA | TUR | ROU | POL | NZL | NOR | NLD | ITA | ISR | GRC | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BRA | BEL | AUT | AUS | ARG 9


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