ESMO-MCBS for Solid Tumours

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	54
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	85
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

ESMO-MCBS V1.1 - Evaluation Forms

Evaluation form 1 Evaluation form 2a Evaluation form 2b Evaluation form 2c Evaluation form 3 Quality of Life Checklist

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 .

Column view

Tested Agent(s)	Combined Agent(s)	Control Arm	Therapeutic Indication	Tumour Type	Tumour Sub-type	Tumour Sub-group	Trial Name	Score	Scorecard
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 Non-Curative PFS ADJUSTMENTS SCORE Non-Curative F2b 3
Palbociclib	Fulvestrant	Fulvestrant + placebo	Patients with hormone receptor-positive, HER2-negative locally advanced or MBC who have received prior endocrine therapy (ET) PALOMA-3	Breast Cancer	Breast Cancer	HR+ HER2-	PALOMA-3	4	PRELIMINARY SCORE Non-Curative PFS ADJUSTMENTS SCORE Non-Curative F2b 4
Palbociclib	Letrozole	Letrozole + placebo	EMA: Palbociclib for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor. FDA: Palbociclib in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease. PALOMA-2	Breast Cancer	Breast Cancer	HR+ HER2-	PALOMA-2	2	PRELIMINARY SCORE Non-Curative PFS ADJUSTMENTS SCORE Non-Curative F2b 2
Palbociclib	Letrozole	Letrozole	Treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor. PALOMA-1/TRIO-18	Breast Cancer	Breast Cancer	HR+ HER2-	PALOMA-1/TRIO-18	3	PRELIMINARY SCORE Non-Curative PFS ADJUSTMENTS SCORE Non-Curative F2b 3

Column view

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

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.

The ESMO-MCBS Scorecards

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 .

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