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  4. ESMO-MCBS for Solid Tumours

ESMO-MCBS Scorecards

ESMO MCBS 1000x150

The ESMO-MCBS Scorecards provides a centralised location of cancer medicines approved by the European Medicines Agency and the US Food and Drug Administration that have been scored and published by ESMO.

ESMO-MCBS scores are based on peer reviewed clinical trial reports. They are generated using a validated standard methodology and are reviewed by a team of clinicians and statisticians before publication. ESMO-MCBS scores should be interpreted in the context of an evolving treatment landscape, in connection with clinical practice guidelines.

ESMO-MCBS Scores
Number of studies
Non-curative setting
5 22
4 135
3 161
2 55
1 24
NEB 4
Curative setting
A 59
C 3
NEB 3
ESMO-MCBS Scores by tumour type
Non-curative setting
Brain Tumours 4
Breast Cancer 39
Endocrine Tumours 23
Gastrointestinal Cancers 76
Genitourinary Cancers 71
Gynaecological Malignancies 38
Head and neck cancer 12
Non-cancerous soft-tissue tumour 3
Sarcoma 13
Skin Cancers 29
Thoracic Malignancies 86
TMB-H solid tumours 1
Tumour agnostic 6
Curative setting
Brain Tumours 2
Breast Cancer 9
Endocrine Tumours 0
Gastrointestinal Cancers 17
Genitourinary Cancers 5
Gynaecological Malignancies 1
Head and neck cancer 1
Non-cancerous soft-tissue tumour 0
Sarcoma 3
Skin Cancers 14
Thoracic Malignancies 13
TMB-H solid tumours 0
Tumour agnostic 0

The ESMO-MCBS Scorecards

reset selection
Evaluation form 1  For new approaches to adjuvant therapy or new potentially curative therapies
Evaluation form 2a For therapies that are not likely to be curative with primary endpoint of OS with separate sheets for:
Evaluation form 2b For therapies that are not likely to be curative with primary endpoint PFS with separate sheets for:
Evaluation form 2c  For therapies that are not likely to be curative with primary endpoint other than OS or PFS or equivalent (non-inferiority) studies
Evaluation form 3  For single-arm studies in orphan diseases and for diseases with high unmet need when primary outcome is PFS or ORR.
To evaluate ESMO-MCBS score adjustments based on quality of life .

My watchlist

    Tested Agent(s) Combined Agent(s) Control Arm Therapeutic Indication Tumour Type Tumour Sub-type Tumour Sub-group Trial Name Ref. Score Scorecard Scorecard
    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

    A

    PRELIMINARY SCORE

    • DFS

    ADJUSTMENTS

    SCORE

    • F1

      A
    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

    A

    PRELIMINARY SCORE

    • RFS

    ADJUSTMENTS

    SCORE

    • F1

      A
    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

    A

    PRELIMINARY SCORE

    • EFS

    ADJUSTMENTS

    SCORE

    • F1

      A
    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

    3

    PRELIMINARY SCORE

    • ORR

    ADJUSTMENTS

    SCORE

    • F3
      3
    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

    4

    PRELIMINARY SCORE

    • PFS

    ADJUSTMENTS

    SCORE

    • F2b
      4
    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

    4

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      4
    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

    4

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      4
    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

    3

    PRELIMINARY SCORE

    • ORR

    ADJUSTMENTS

    SCORE

    • F3
      3
    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

    3

    PRELIMINARY SCORE

    • ORR

    ADJUSTMENTS

    SCORE

    • F3
      3
    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

    3

    PRELIMINARY SCORE

    • ORR

    ADJUSTMENTS

    SCORE

    • F3
      3
    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

    3

    PRELIMINARY SCORE

    • ORR

    ADJUSTMENTS

    SCORE

    • F3
      3
    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

    4

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      4
    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

    4

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      4
    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

    4

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      4
    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

    3

    PRELIMINARY SCORE

    • PFS

    ADJUSTMENTS

    SCORE

    • F2b
      3
    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

    3

    PRELIMINARY SCORE

    • PFS

    ADJUSTMENTS

    SCORE

    • F2b
      3
    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

    3

    PRELIMINARY SCORE

    • ORR

    ADJUSTMENTS

    SCORE

    • F3
      3
    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

    3

    PRELIMINARY SCORE

    • ORR

    ADJUSTMENTS

    SCORE

    • F3
      3
    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

    3

    PRELIMINARY SCORE

    • ORR

    ADJUSTMENTS

    SCORE

    • F3
      3
    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

    5

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      5
    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

    3

    PRELIMINARY SCORE

    • ORR

    ADJUSTMENTS

    SCORE

    • F3
      3
    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

    4

    PRELIMINARY SCORE

    • ORR

    ADJUSTMENTS

    SCORE

    • F3
      4
    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

    5

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      5
    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

    4

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      4
    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

    3

    PRELIMINARY SCORE

    • ORR

    ADJUSTMENTS

    SCORE

    • F3
      3
    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

    3

    PRELIMINARY SCORE

    • PFS

    ADJUSTMENTS

    SCORE

    • F2b
      3
    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

    2

    PRELIMINARY SCORE

    • PFS

    ADJUSTMENTS

    SCORE

    • F2b
      2
    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

    3

    PRELIMINARY SCORE

    • PFS

    ADJUSTMENTS

    SCORE

    • F2b
      3
    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

    2

    PRELIMINARY SCORE

    • ORR

    ADJUSTMENTS

    SCORE

    • F3
      2
    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

    A

    PRELIMINARY SCORE

    • DFS

    ADJUSTMENTS

    SCORE

    • F1

      A

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