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Showing content from https://www.esmo.org/guidelines/esmo-mcbs/esmo-magnitude-of-clinical-benefit-scale below:

ESMO-MCBS for Solid Tumours | ESMO

Trastuzumab emtansine (T-DM1) - Trastuzumab Adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease in the breast and/or lymph nodes after neoadjuvant taxane-based and HER2-targeted therapy KATHERINE

Breast Cancer

Early Breast Cancer HER2+ KATHERINE Pembrolizumab - Placebo FDA theraputic indication: adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC following complete resection. EMA therapeutic indication: adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB, IIC or III melanoma and who have undergone complete resection KEYNOTE-716

Skin Cancers

Cutaneous Melanoma - KEYNOTE-716 Nivolumab Platinum-doublet ChT Platinum-doublet ChT Treatment of adult patients with resectable non-small cell lung cancer in the neoadjuvant setting CheckMate-816

Thoracic Malignancies

Non-small-cell Lung Cancer - CheckMate-816 Selpercatinib - Single arm Treatment of adults with advanced RET fusion positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor LIBRETTO-001

Thoracic Malignancies

Non-small-cell Lung Cancer RET fusion-positive LIBRETTO-001 Trastuzumab deruxtecan - Trastuzumab emtansine (T-DM1) Treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti HER2 based regimens DESTINY-Breast03

Breast Cancer

Breast Cancer HER2+ DESTINY-Breast03 Nivolumab Fluoropyrimidine + platinum-based combination ChT ChT First-line treatment of adult patients with advance or metastatic oesophageal squamous cell carcinoma in combination with fluoropyrimidine and platinum-based combination ChT CheckMate 648

Gastrointestinal Cancers

Oesophageal squamous cell carcinoma - CheckMate 648 Nivolumab + ipilimumab - ChT First-line treatment of adult patients with advance or metastatic oesophageal squamous cell carcinoma in combination with ipilimumab CheckMate 648

Gastrointestinal Cancers

Oesophageal squamous cell carcinoma - CheckMate 648 Dab/Tram (dabrafenib and trametinib) - Single arm (Phase II) For the treatment of adult and pediatric patients ≥ 6 years of age with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options ROAR

Brain Tumours

Glioma (high grade) BRAF V600E ROAR Dab/Tram (dabrafenib and trametinib) - Single arm (Phase II) For the treatment of adult and pediatric patients ≥ 6 years of age with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options ROAR

Brain Tumours

Glioma (low grade) BRAF V600E ROAR Dab/Tram (dabrafenib and trametinib) - Single arm Patients with locally advanced or metastatic ATC with BRAF V600E mutation and with no satisfactory locoregional treatment options ROAR

Endocrine Tumours

Thyroid Cancer - anaplastic BRAF V600E ROAR Dab/Tram (dabrafenib and trametinib) - Single arm (Phase II) For the treatment of adult and pediatric patients ≥ 6 years of age with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options ROAR

Gastrointestinal Cancers

Biliary tract cancer BRAF V600E ROAR Durvalumab Gemcitabine and cisplatin Placebo + gemcitabine and cisplatin Durvalumab in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer TOPAZ-1

Gastrointestinal Cancers

Biliary tract cancer - TOPAZ-1 Trastuzumab deruxtecan - Pysician's ChT choice (eribulin, capecitabine, gemcitabine, nab-paclitaxel, or paclitaxel) Treatment of patients with unresectable or metastatic HER2‑low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy DESTINY-Breast04

Breast Cancer

Breast Cancer HER2-low DESTINY-Breast04 Darolutamide ADT ((androgen deprivation therapy) + docetaxel ADT + Docetaxel + placebo For adult patients with metastatic hormone-sensitive prostate cancer (mHSPC). ARASENS

Genitourinary Cancers

Prostate cancer - ARASENS Camrelizumab Gemcitabine + cisplatin Placebo + gemcitabine + cisplatin First-line treatment of recurrent or metastatic nasopharyngeal carcinoma CAPTAIN-1st

Head and neck cancer

Nasopharyngeal carcinoma - CAPTAIN-1st Toripalimab Gemcitabine + cisplatin Placebo + gemcitabine + cisplatin Toripalimab with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC) JUPITER-02

Head and neck cancer

Nasopharyngeal carcinoma - JUPITER-02 Atezolizumab - Single arm (Phase II) Patients with locally advanced or metastatic UC who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥5% IMvigor210 – Cohort 1

Genitourinary Cancers

Urothelial Carcinoma PD-L1 expression ≥5% IMvigor210 – Cohort 1 Pembrolizumab - Single arm Patients with locally advanced or metastatic UC who are not eligible for any platinum-containing ChT KEYNOTE-052

Genitourinary Cancers

Urothelial Carcinoma - KEYNOTE-052 Selpercatinib - Single arm (Phase I/II) EMA/FDA: Treatment for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options (other than non-small cell lung cancer and thyroid cancer). LIBRETTO-001

Tumour agnostic

- RET gene fusion LIBRETTO-001 Tremelimumab Durvalumab Sorafenib EMA: Treatment for adult patients in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma - FDA: Treatment for adult patients in combination with durvalumab with unresectable hepatocellular carcinoma HIMALAYA

Gastrointestinal Cancers

Hepatobiliary Cancers - Hepatocellular Carcinoma - HIMALAYA Pembrolizumab - Single arm (Phase II) For patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. KEYNOTE-629

Skin Cancers

Cutaneous Squamous Cell Carcinoma - KEYNOTE-629 Cemiplimab - Single arm (Phase II) For the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation R2810-ONC-1423/R2810-ONC-1540

Skin Cancers

Cutaneous Squamous Cell Carcinoma - R2810-ONC-1423/R2810-ONC-1540 Cemiplimab - Investigator's choice of ChT Indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy EMPOWER-Cervical 1

Gynaecological Malignancies

Cervical Cancer - EMPOWER-Cervical 1 Tremelimumab Durvalumab and platinum-based ChT Platinum-based ChT EMA: First-line treatment of tremelimumab in combination with durvalumab and platinum-based chemotherapy (ChT) for adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations - FDA: Tremelimumab in combination with durvalumab and platinum-based ChT for adult patients with metastatic NSCLC with no EGFR mutation or ALK genomic tumor aberrations. POSEIDON

Thoracic Malignancies

Non-small-cell Lung Cancer - POSEIDON Abemaciclib - Single arm Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer with disease progression following ET and prior ChT in the metastatic setting MONARCH 1

Breast Cancer

Breast Cancer HR+ HER2- MONARCH 1 Bevacizumab Capecitabine Placebo + capecitabine First-line treatment of patients with metastatic breast cancer in whom treatment with other ChT options, including taxanes or anthracyclines, is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with bevacizumab–capecitabine RIBBON-1

Breast Cancer

Breast Cancer - RIBBON-1 Olaparib Abiraterone + prednisone or prednisolone Placebo + abiraterone + prednisone or prednisolone EMA: Olaparib is indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated. FDA: olaparib with abiraterone and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). PROpel

Genitourinary Cancers

Prostate cancer - PROpel Relatlimab Nivolumab Nivolumab First line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell PD-L1 expression <1%. RELATIVITY-047

Skin Cancers

Cutaneous Melanoma PD-L1 expression <1% RELATIVITY-047 Adagrasib - Single arm Indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and disease progression after at least one prior systemic therapy KRYSTAL-1

Thoracic Malignancies

Non-small-cell Lung Cancer KRAS G12C KRYSTAL-1 Abemaciclib Standard endocrine therapy (aromatase inhibitors and/or antiestrogens with or without ovarian suppression) Standard endocrine therapy Adjuvant treatment of adult patients with hormone receptor-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence monarchE

Breast Cancer

Early Breast Cancer HR+ HER2- node-positive monarchE

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