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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
3 156
2 55
1 24
NEB 4
Curative setting
A 54
C 3
NEB 3
ESMO-MCBS Scores by tumour type
Non-curative setting
Brain Tumours 4
Breast Cancer 39
Endocrine Tumours 21
Gastrointestinal Cancers 76
Genitourinary Cancers 70
Gynaecological Malignancies 38
Head and neck cancer 12
Non-cancerous soft-tissue tumour 1
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 16
Genitourinary Cancers 3
Gynaecological Malignancies 1
Head and neck cancer 1
Non-cancerous soft-tissue tumour 0
Sarcoma 3
Skin Cancers 14
Thoracic Malignancies 11
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
    Durvalumab Platinum-based chemotherapy Placebo with platinum-based chemotherapy EMA: Durvalumab in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by durvalumab as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements.. FDA: Durvalumab with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumours ≥4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. AEGEAN
    Thoracic Malignancies
    		 Non-small-cell Lung Cancer - AEGEAN

    A

    PRELIMINARY SCORE

    • A

    ADJUSTMENTS

    SCORE

    • F1

      A
    Tislelizumab Platinum + fluoropyrimidine-based ChT Placebo + platinum + fluoropyrimidine-based ChT Tislelizumab in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adult patients with HER-2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma whose tumours express PD‑L1 with a tumour area positivity (TAP) score ≥ 5% RATIONALE 305
    Gastrointestinal Cancers
    		 Gastric or gastroesophageal junction adenocarcinoma HER2- , PD-L1 TAP ≥5% RATIONALE 305

    3

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      3
    Zolbetuximab Oxaliplatin + Leucovorin + Fluorouracil (mFOLFOX6) Placebo + mFOLFOX6 Zolbetuximab, a claudin 18.2 (CLDN18.2)-directed cytolytic antibody, with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive. SPOTLIGHT
    Gastrointestinal Cancers
    		 Gastric or gastroesophageal junction adenocarcinoma HER2-negative, CLDN18.2 positive SPOTLIGHT

    4

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      4
    Ribociclib Non-steroidal aromatase inhibitor (NSAI) Non-steroidal aromatase inhibitor (NSAI) EMA/FDA: Ribociclib with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. Additionally, FDA also approved the ribociclib and letrozole co-pack for the same indication. NATALEE
    Breast Cancer
    		 Early Breast Cancer HR-positive, HER2-negative NATALEE

    A

    PRELIMINARY SCORE

    • iDFS

    ADJUSTMENTS

    SCORE

    • F1

      A
    Selpercatinib - Cabozantinib or Vandetanib Selpercatinib for adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy. LIBRETTO-531
    Endocrine Tumours
    		 Thyroid Cancer - medullary RET-mutant (M918T or other) LIBRETTO-531

    4

    PRELIMINARY SCORE

    • PFS

    ADJUSTMENTS

    SCORE

    • F2b
      4
    Serplulimab Carboplatin + Etoposide Placebo + Carboplatin + Etoposide Serplulimab in combination with carboplatin and etoposide is indicated for the first‑line treatment of adult patients with extensive‑stage small cell lung cancer (ES‑SCLC). ASTRUM-005
    Thoracic Malignancies
    		 Small-cell lung cancer - ASTRUM-005

    4

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      4
    Osimertinib - Placebo FDA: Osimertinib for adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. EMA: Osimertinib for adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum based chemoradiation therapy. LAURA
    Thoracic Malignancies
    		 Non-small-cell Lung Cancer EGFR exon 19 deletions or exon 21 L858R mutations LAURA

    4

    PRELIMINARY SCORE

    • PFS

    ADJUSTMENTS

    SCORE

    • F2b
      4
    Pembrolizumab Pemetrexed + platinum-based Cht Pemetrexed + platinum-based Cht FDA: Pembrolizumab with pemetrexed and platinum chemotherapy as first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma (MPM). EMA: Pembrolizumab, in combination with pemetrexed and platinum chemotherapy, is indicated for the first‑line treatment of adults with unresectable non-epithelioid malignant pleural mesothelioma. KEYNOTE-483
    Thoracic Malignancies
    		 Pleural mesothelioma - KEYNOTE-483

    1

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      1
    Pembrolizumab - Placebo For the treatment of patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a PD- 1/PD-L1-containing regimen KEYNOTE-394
    Gastrointestinal Cancers
    		 Hepatobiliary Cancers - Hepatocellular Carcinoma - KEYNOTE-394

    4

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      4
    Rucaparib - Single arm Patients with platinum-sensitive, relapsed or progressive, BRCA-mut (germline and/or somatic), high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer, who have been treated with ≥2 prior lines of platinum-based ChT, and who are unable to tolerate further platinum-based ChT Study 10
    Breast Cancer
    		 Ovarian, fallopian tubes and peritoneum cancer BRCA-mut Study 10

    3

    PRELIMINARY SCORE

    • ORR

    ADJUSTMENTS

    SCORE

    • F3
      3
    Inavolisib Palbociclib + fulvestrant Placebo + palbociclib + fulvestrant Inavolisib with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or after completing adjuvant endocrine therapy. INAVO120
    Breast Cancer
    		 Breast Cancer PIK3CA-mut, HR+, HER2- INAVO120

    3

    PRELIMINARY SCORE

    • PFS

    ADJUSTMENTS

    SCORE

    • F2b
      3
    TTFields (NovoTTF-200T) Standard systemic therapy (investigator’s choice of immune checkpoint inhibitor [nivolumab, pembrolizumab, or atezolizumab] or docetaxel) Standard therapy alone Addition of tumor-treating fields (TTFields) to standard-of-care (SOC) therapies in patients with non­–small cell lung cancer (NSCLC) after disease progression on or following platinum-based treatment LUNAR
    Thoracic Malignancies
    		 Non-small-cell Lung Cancer - LUNAR

    4

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      4
    Nivolumab Platinum-doublet ChT Placebo + platinum-doublet ChT EMA: Nivolumab, in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1%. . FDA: Nivolumab with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. CheckMate-77T
    Thoracic Malignancies
    		 Non-small-cell Lung Cancer EGFR-, ALK- CheckMate-77T

    A

    PRELIMINARY SCORE

    • A

    ADJUSTMENTS

    SCORE

    • F1

      A
    Zanidatamab - Single arm Treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer HERIZON-BTC-01
    Gastrointestinal Cancers
    		 Biliary tract cancer HER2+ HERIZON-BTC-01

    3

    PRELIMINARY SCORE

    • ORR

    ADJUSTMENTS

    SCORE

    • F3
      3
    Pembrolizumab - Chemotherapy Locally advanced or metastatic oesophageal or OGJ carcinoma that is not amenable to surgical resection or definitive CRT after ≥1 prior lines of systemic therapy for patients with tumours of squamous cell histology that express PD-L1 (CPS ≥10) KEYNOTE-181
    Gastrointestinal Cancers
    		 Oesophageal or gastroesophageal junction carcinoma - KEYNOTE-181

    3

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      3
    Tislelizumab Platinum + fluoropyrimidine or paclitaxel Placebo + platinum + fluoropyrimidine or paclitaxel Tislelizumab, in combination with platinum-based chemotherapy, is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic OSCC whose tumours express PD‑L1 with a tumour area positivity (TAP) score ≥ 5% RATIONALE 306
    Gastrointestinal Cancers
    		 Oesophageal squamous cell carcinoma PD-L1 TAP ≥10% RATIONALE 306

    4

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      4
    Denosumab - Single arm Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity. Study 20040215
    Sarcoma
    		 Bone sarcoma - Study 20040215

    3

    PRELIMINARY SCORE

    • ORR

    ADJUSTMENTS

    SCORE

    • F3
      3
    Mifamurtide - Chemotherapy Treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection. Intergroup study 0133
    Sarcoma
    		 Bone sarcoma - Intergroup study 0133

    A

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F1

      A
    Durvalumab - Single arm Treatment for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. ADRIATIC
    Thoracic Malignancies
    		 Small-cell lung cancer - ADRIATIC

    4

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      4
    Ensartinib - Crizotinib Ensartinib for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK-inhibitor. eXALT3
    Thoracic Malignancies
    		 Non-small-cell lung cancer ALK+ eXALT3

    3

    PRELIMINARY SCORE

    • PFS

    ADJUSTMENTS

    SCORE

    • F2b
      3
    Nivolumab + ipilimumab - Chemotherapy Nivolumab in combination with ipilimumab is indicated for the treatment of adults patients with mismatch repair deficient or microsatellite instability-high in first-line treatment of unresectable or metastatic colorectal cancer. (Arm B + Arm C) CheckMate 8HW
    Gastrointestinal Cancers
    		 Colorectal cancer dMMR or MSI-H CheckMate 8HW

    4

    PRELIMINARY SCORE

    • PFS

    ADJUSTMENTS

    SCORE

    • F2b
      4
    Trastuzumab deruxtecan - Investigator's choice chemotherapy (Capecitabine, Paclitaxel, Nab-Paclitaxel) EMA: Trastuzumab deruxtecan as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment. FDA: Trastuzumab deruxtecan for unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, that has progressed on one or more endocrine therapies in the metastatic setting. DESTINY-Breast06
    Breast Cancer
    		 Breast cancer HER2-low, HR+, HER2-ultralow DESTINY-Breast06

    3

    PRELIMINARY SCORE

    • PFS

    ADJUSTMENTS

    SCORE

    • F2b
      3
    Sotorasib Panitumumab Investigator's Choice (Trifluridine and Tipiracil, or Regorafenib) Sotorasib with panitumumab for adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. CodeBreaK 300
    Gastrointestinal Cancers
    		 Colorectal cancer KRAS G12C-mut CodeBreaK 300

    3

    PRELIMINARY SCORE

    • PFS

    ADJUSTMENTS

    SCORE

    • F2b
      3
    Datopotamab deruxtecan - Investigator’s choice of chemotherapy (Eribulin, capecitabine, vinorelbine, or gemcitabine) EMA: Datopotamab deruxtecan as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting. FDA: Datopotamab deruxtecan for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. TROPION-Breast01
    Breast Cancer
    		 Breast cancer HR+, HER2- TROPION-Breast01

    3

    PRELIMINARY SCORE

    • PFS

    ADJUSTMENTS

    SCORE

    • F2b
      3
    Encorafenib + cetuximab + mFOLFOX6 - SOC (mFOLFOX6 + FOLFOXIRI or CAPOX) ± bevacizumab Encorafenib with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. BREAKWATER
    Gastrointestinal Cancers
    		 Colorectal cancer BRAF V600E BREAKWATER

    2

    PRELIMINARY SCORE

    • RR

    ADJUSTMENTS

    SCORE

    • F2c
      2
    Imatinib - Single arm Imatinib is indicated for the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours. STIB2222
    Sarcoma
    		 GIST - STIB2222

    3

    PRELIMINARY SCORE

    • ORR

    ADJUSTMENTS

    SCORE

    • F3
      3
    Tislelizumab Platinum + etoposide (carboplatin or cisplatin) Placebo + platinum + etoposide (carboplatin or cisplatin) Tislelizumab, in combination with etoposide and platinum chemotherapy, is indicated for the first-line treatment of adult patients with extensive-stage SCLC. RATIONALE 312
    Thoracic Malignancies
    		 Small-cell lung cancer - RATIONALE 312

    2

    PRELIMINARY SCORE

    • OS

    ADJUSTMENTS

    SCORE

    • F2a
      2
    Trastuzumab - Chemotherapy Patients with HER2-positive early breast cancer following surgery, ChT (neoadjuvant or adjuvant) and RT (if applicable) HERA
    Breast Cancer
    		 Early Breast Cancer HER2+ HERA

    A

    PRELIMINARY SCORE

    • DFS

    ADJUSTMENTS

    SCORE

    • F1

      A
    Pertuzumab Trastuzumab + docetaxel Trastuzumab + docetaxel Neo-adjuvant HER2 overexpressed invasive ductal breast NeoSphere
    Breast Cancer
    		 Early Breast Cancer HER2+ NeoSphere

    C

    PRELIMINARY SCORE

    • pCR

    ADJUSTMENTS

    SCORE

    • F1

      C
    Trastuzumab emtansine (T-DM1) - Lapatinib + capecitabine As a single agent for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either received prior therapy for locally advanced or metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy EMILIA
    Breast Cancer
    		 Breast Cancer HER2+ EMILIA

    4

    PRELIMINARY SCORE

    • PFS

    ADJUSTMENTS

    SCORE

    • F2b
      4

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