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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
    Elacestrant - Standard-of-care endocrine therapy Treatment of postmenopausal women, and men, with estrogen receptor (ER)‑positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor EMERALD
    Breast Cancer
    		 Breast Cancer ER+ HER2-negative, ESR1-mutated EMERALD

    3

    PRELIMINARY SCORE

    • PFS

    ADJUSTMENTS

    SCORE

    • F2b
      3
    Pembrolizumab - Placebo Adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum‑based chemotherapy PEARLS/KEYNOTE-091
    Thoracic Malignancies
    		 Non-small-cell Lung Cancer - PEARLS/KEYNOTE-091

    A

    PRELIMINARY SCORE

    • DFS

    ADJUSTMENTS

    SCORE

    • F1

      A
    Sacituzumab govitecan - Physician's choice chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine)  Treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting TROPiCS-02
    Breast Cancer
    		 Breast Cancer HR-positive HER2-negative TROPiCS-02

    4

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      4
    Nivolumab - Single arm Nivolumab for the treatment of adult and pediatric patients 12 years of age and older with MSI-H or dMMR metastatic CRC, that has progressed following fluoropyrimidine, oxaliplatin, and irinotecan. CheckMate 142
    Gastrointestinal Cancers
    		 Colorectal Cancer dMMR or MSI-H CheckMate 142

    3

    PRELIMINARY SCORE

    • ORR

    ADJUSTMENTS

    SCORE

    • F3
      3
    Mirvetuximab soravtansine - Single arm SORAYA
    Gynaecological Malignancies
    		 Epithelial ovarian, fallopian tube or primary peritoneal cancer FRα positive SORAYA

    2

    PRELIMINARY SCORE

    • ORR

    ADJUSTMENTS

    SCORE

    • F3
      2
    Futibatinib - Single arm Treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy FEONIX-CCA2
    Gastrointestinal Cancers
    		 Intrahepatic cholangiocarcinoma FGFR2 gene fusion or other rearrangement FEONIX-CCA2

    2

    PRELIMINARY SCORE

    • ORR

    ADJUSTMENTS

    SCORE

    • F3
      2
    Talimogene Laherparepvec -  Subcutaneous granulocyte macrophage colony-stimulating factor (GM-CSF) EMA: Indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease. FDA: Indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. OPTiM
    Skin Cancers
    		 Cutaneous Melanoma - OPTiM

    3

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      3
    Avelumab - Single arm (Phase II) Adult patients with metastatic Merkel cell carcinoma (MCC) JAVELIN Merkel 200 (Part B - treatment-naïve patients)
    Skin Cancers
    		 Merkel cell carcinoma - JAVELIN Merkel 200 (Part B - treatment-naïve patients)

    4

    PRELIMINARY SCORE

    • ORR

    ADJUSTMENTS

    SCORE

    • F3
      4
    Pembrolizumab - Single arm Patients with recurrent or metastatic cervical cancer with disease progression on or after ChT whose tumours express PD-L1 (CPS ≥1) KEYNOTE-158
    Gynaecological Malignancies
    		 Cervical Cancer PD-L1 CPS≥1 KEYNOTE-158

    1

    PRELIMINARY SCORE

    • ORR

    ADJUSTMENTS

    SCORE

    • F3
      1
    Trifluridine/Tipiracil (TAS-102) Bevacizumab Trifluridine/Tipiracil (TAS-102) Treatment of patients with mCRC who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based ChT, anti-VEGF agents and/or anti-EGFR agents SUNLIGHT
    Gastrointestinal Cancers
    		 Colorectal Cancer - SUNLIGHT

    4

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      4
    Talazoparib Enzalutamide Placebo plus enzalutamide Talazoparib is indicated in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. TALAPRO-2
    Genitourinary Cancers
    		 Prostate cancer - TALAPRO-2

    3

    PRELIMINARY SCORE

    • PFS (ITT)

    ADJUSTMENTS

    SCORE

    • F2b
      3
    Cetuximab Radiotherapy Radiotherapy Patients with SCCHN for locally advanced disease Study to compare RT alone with cetuximab–RT for locally advanced SCCHN
    Head and neck cancer
    		 Squamous cell - Study to compare RT alone with cetuximab–RT for locally advanced SCCHN

    A

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F1

      A
    Pembrolizumab Cisplatin or carboplatin/5-FU Cisplatin or carboplatin/5-FU/cetuximab In combination with platinum and 5‑fluorouracil (5‑FU) chemotherapy is indicated for the first‑line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express PD‑L1 with a CPS ≥ 1 KEYNOTE-048
    Head and neck cancer
    		 Squamous cell CPS PD-L1 expression ≥20 KEYNOTE-048

    4

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      4
    Pembrolizumab Cisplatin or carboplatin/5-FU Cisplatin or carboplatin/5-FU/cetuximab First-line treatment of patients with metastatic or unresectable, recurrent SCCHN KEYNOTE-048
    Head and neck cancer
    		 Squamous cell - KEYNOTE-048

    4

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      4
    Pembrolizumab - Single arm Recurrent or metastatic SCCHN with disease progression on or after platinum-containing ChT KEYNOTE-012
    Head and neck cancer
    		 Squamous cell - KEYNOTE-012

    1

    PRELIMINARY SCORE

    • PFS

    ADJUSTMENTS

    SCORE

    • F3
      1
    Abiraterone Prednisone Placebo–prednisone Treatment of mCRPC in adult men who are asymptomatic or mildly symptomatic after failure of ADT in whom ChT is not yet clinically indicated COU-AA-302
    Genitourinary Cancers
    		 Prostate cancer - COU-AA-302

    2

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      2
    Abiraterone ADT–docetaxel ± RT ADT–docetaxel ± RT De novo mHSPC (ADT with docetaxel population) PEACE-1
    Genitourinary Cancers
    		 Prostate cancer - PEACE-1

    4

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      4
    Abiraterone ADT ± docetaxel ± RT ADT ± docetaxel ± RT De novo mHSPC (Overall population) PEACE-1
    Genitourinary Cancers
    		 Prostate cancer - PEACE-1

    4

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      4
    Olaparib - Enzalutamide or abiraterone (crossover allowed) Treatment of adult patients with mCRPC and BRCA1/2 mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent PROfound
    Genitourinary Cancers
    		 Prostate cancer BRCA mutation Patients with ≥1 alteration in BRIP1, BARD1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D or RAD54L PROfound

    3

    PRELIMINARY SCORE

    • PFS

    ADJUSTMENTS

    SCORE

    • F2b
      3
    Docetaxel ADT (androgen deprivation therapy) ADT In combination with androgen-deprivation therapy (ADT), with or without prednisone or prednisolone, is indicated for the treatment of patients with metastatic hormone-sensitive prostate cancer GETUG-15
    Genitourinary Cancers
    		 Prostate cancer - GETUG-15

    NEB

    PRELIMINARY SCORE

    • NEB

    ADJUSTMENTS

    SCORE

    • F2a
      NEB
    Cetuximab - Single arm Recurrent or metastatic SCCHN progressing after platinum-based therapy Study of cetuximab as a single agent in patients with recurrent and/or metastatic SCCHN who failed to respond to platinum-based therapy
    Head and neck cancer
    		 Squamous cell - Study of cetuximab as a single agent in patients with recurrent and/or metastatic SCCHN who failed to respond to platinum-based therapy

    NEB

    PRELIMINARY SCORE

    • NEB

    ADJUSTMENTS

    SCORE

    • F3
      NEB
    Tislelizumab - Chemotherapy Indicated for the treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy RATIONALE 302
    Gastrointestinal Cancers
    		 Oesophageal squamous cell carcinoma - RATIONALE 302

    4

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      4
    Niraparib/abiraterone acetate Prednisolone or prednisone Placebo plus abiraterone acetate + prednisone For the treatment of adult patients with metastatic castration resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) MAGNITUDE (Cohort 1)
    Genitourinary Cancers
    		 Prostate cancer BRCA-mutated MAGNITUDE (Cohort 1)

    3

    PRELIMINARY SCORE

    • PFS

    ADJUSTMENTS

    SCORE

    • F2b
      3
    Dostarlimab Carboplatin and paclitaxel Placebo + carboplatin + paclitaxel Dostarlimab with carboplatin and paclitaxel for the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability high (MSI H) primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy. RUBY
    Gynaecological Malignancies
    		 Endometrial Cancer dMMR/MSI-H RUBY

    4

    PRELIMINARY SCORE

    • PFS

    ADJUSTMENTS

    SCORE

    • F2b
      4
    Cemiplimab Platinum-based ChT Placebo + Platinum-based ChT Cemiplimab in combination with platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations EMPOWER-Lung 3
    Thoracic Malignancies
    		 Non-small-cell Lung Cancer - EMPOWER-Lung 3

    4

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      4
    Trastuzumab deruxtecan - Single arm Monotherapy indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen DESTINY-Gastric02
    Gastrointestinal Cancers
    		 Gastric or gastroesophageal junction adenocarcinoma HER2+ DESTINY-Gastric02

    2

    PRELIMINARY SCORE

    • ORR

    ADJUSTMENTS

    SCORE

    • F3
      2
    Trastuzumab deruxtecan - Single arm For adult patients with advanced non-small cell lung cancer whose tumours have an activating human epidermal growth factor receptor 2 HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. DESTINY-Lung02
    Thoracic Malignancies
    		 Non-small-cell Lung Cancer HER2-mutant DESTINY-Lung02

    3

    PRELIMINARY SCORE

    • ORR

    ADJUSTMENTS

    SCORE

    • F3
      3
    Pembrolizumab Fluoropyrimidine + platinum-containing ChT Placebo + fluoropyrimidine + platinum-containing ChT Pembrolizumab in combination with fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1 KEYNOTE-859
    Gastrointestinal Cancers
    		 Gastric or gastroesophageal junction adenocarcinoma HER2-, PD-L1 with a CPS ≥1* KEYNOTE-859

    4

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      4
    Rucaparib - Placebo Monotherapy for the maintenance treatment of adult patients with advanced (FIGO Stages III and IV) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy ATHENA-MONO (GOG- 3020/ENGOT- ov45)
    Gynaecological Malignancies
    		 Ovarian, fallopian tubes and peritoneum cancer - ATHENA-MONO (GOG- 3020/ENGOT- ov45)

    3

    PRELIMINARY SCORE

    • PFS

    ADJUSTMENTS

    SCORE

    • F2b
      3
    Pembrolizumab Platinum-containing ChT Placebo + platinum-containing ChT Pembrolizumab with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC) KEYNOTE-671
    Thoracic Malignancies
    		 Non-small-cell Lung Cancer - KEYNOTE-671

    A

    PRELIMINARY SCORE

    • EFS

    ADJUSTMENTS

    SCORE

    • F1

      A

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