Therapy Detail

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Therapy Name Durvalumab + Trastuzumab deruxtecan
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Durvalumab Imfinzi MEDI4736 Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 122 Imfinzi (durvalumab) is a monoclonal antibody that binds to and inhibits PD-L1 (CD274), potentially resulting in increased immune response to tumors (PMID: 25943534, PMID: 28214651). Imfinzi (durvalumab) is FDA-approved for use in patients with urothelial carcinoma, unresectable, stage III non-small cell lung cancer, and limited-stage small cell lung cancer, in combination with Imjudo (tremelimumab) and platinum-based chemotherapy in patients with metastatic non-small cell lung cancer (NSCLC) without sensitizing EGFR or ALK mutations, in combination with platinum-based chemotherapy as neoadjuvant therapy followed by surgery and adjuvant Imfinzi (durvalumab) in patients with resectable non-small cell lung cancer, in combination with etoposide and carboplatin or cisplatin in patients with extensive stage small cell lung cancer, in combination with cisplatin and gemcitabine in patients with locally advanced or metastatic biliary tract cancer, in combination with Imjudo (tremelimumab) in adult patients with unresectable hepatocellular carcinoma, and in combination with carboplatin plus paclitaxel followed by single-agent Imfinzi (durvalumab) in adult patients with mismatch repair deficient endometrial cancer (FDA.gov).
Trastuzumab deruxtecan Enhertu DS-8201|DS8201a|T-DXd|DS-8201|fam-trastuzumab deruxtecan-nxki|DS-8201a HER2 (ERBB2) Antibody 76 HER2 (ERBB2) Antibody-Drug Conjugate 33 Enhertu (trastuzumab deruxtecan) is an antibody-drug conjugate (ADC) comprising an anti-ERBB2 (HER2) antibody linked to a derivative of the topoisomerase inhibitor DX-8951, which delivers the cytotoxic agent to ERBB2 (HER2)-expressing tumor cells, potentially resulting in decreased growth of tumors, including tumors with low ERBB2 (HER2) expression (PMID: 27026201). Enhertu (fam-trastuzumab deruxtecan-nxki) is FDA approved for use in patients with ERBB2 (HER2)-positive breast cancer who have received two or more anti-HER2 therapies previously, in patients with ERBB2 (HER2)-low (IHC 1+ or IHC 2+/ISH -) breast cancer received prior chemotherapy, in patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received prior trastuzumab-based therapy, in patients with non-small cell lung cancer harboring ERBB2 (HER2) activating mutations who have received prior systemic therapy, and in patients with ERBB2 (HER2)-positive (IHC 3+) solid tumors who have received prior systemic therapy (FDA.gov).

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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
NCT04379596 Phase II Cisplatin + Fluorouracil + Trastuzumab Capecitabine + Oxaliplatin + Trastuzumab Fluorouracil + Oxaliplatin + Trastuzumab Fluorouracil + Trastuzumab deruxtecan Capecitabine + Trastuzumab deruxtecan Durvalumab + Trastuzumab deruxtecan Fluorouracil + Oxaliplatin + Trastuzumab deruxtecan Pembrolizumab + Trastuzumab deruxtecan Capecitabine + Oxaliplatin + Trastuzumab deruxtecan Fluorouracil + Pembrolizumab + Trastuzumab deruxtecan Durvalumab + Fluorouracil + Trastuzumab deruxtecan Capecitabine + Durvalumab + Trastuzumab deruxtecan Capecitabine + Fluorouracil + Pembrolizumab + Trastuzumab deruxtecan Capecitabine + Fluorouracil + MEDI5752 + Trastuzumab deruxtecan Capecitabine + Pembrolizumab + Trastuzumab + Tucatinib Capecitabine + Cisplatin + Trastuzumab Trastuzumab deruxtecan Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03) (DG-03) Recruiting USA | POL | NLD | ITA | GBR | ESP | DEU | CAN | BRA 5
NCT05795101 Phase II Durvalumab + Trastuzumab deruxtecan TRUDI: TDXD+Durva in HER2+/low IBC (TRUDI) Recruiting USA 0
NCT03742102 Phase Ib/II Durvalumab + Oleclumab + Paclitaxel Durvalumab + Trastuzumab deruxtecan Durvalumab + Paclitaxel Capivasertib + Durvalumab + Paclitaxel A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer (BEGONIA) Active, not recruiting USA | POL | GBR | CAN 2
NCT04538742 Phase Ib/II Durvalumab + Trastuzumab deruxtecan Pertuzumab + Trastuzumab deruxtecan Durvalumab + Paclitaxel + Trastuzumab deruxtecan Paclitaxel + Trastuzumab deruxtecan Trastuzumab deruxtecan A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer (DB-07) Active, not recruiting USA | TUR | POL | ITA | GBR | FRA | ESP | DEU | CAN | BRA | AUS 4
NCT03334617 Phase II Danvatirsen + Durvalumab Durvalumab + Olaparib Cediranib + Durvalumab Durvalumab + Vistusertib Durvalumab + Trastuzumab deruxtecan Ceralasertib + Durvalumab Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy (HUDSON) Active, not recruiting USA | ISR | FRA | ESP | DEU | CAN | AUT 1


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