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 therapyKATHERINE
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 resectionKEYNOTE-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 settingCHECKMATE-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 inhibitorLIBRETTO-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 regimensDESTINY-Breast03
Breast Cancer
Breast Cancer
HER2+
DESTINY-Breast03
4
PRELIMINARY SCORE
PFS
ADJUSTMENTS
SCORE
F2b
4
Nivolumab
Fluoropyrimidine and 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 ChTCheckMate 648
Gastrointestinal Cancers
Oesophageal squamous cell carcinoma
-
CheckMate 648
3
PRELIMINARY SCORE
OS
ADJUSTMENTS
SCORE
F2a
3
Nivo/Ipi (nivolumab and ipilimumab)
-
ChT
First-line treatment of adult patients with advance or metastatic oesophageal squamous cell carcinoma in combination with ipilimumabCheckMate 648
Gastrointestinal Cancers
Oesophageal squamous cell carcinoma
-
CheckMate 648
3
PRELIMINARY SCORE
OS
ADJUSTMENTS
SCORE
F2a
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 optionsROAR
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 optionsROAR
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 optionsROAR
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 chemotherapyDESTINY-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 carcinomaCAPTAIN-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 ChTKEYNOTE-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
Tumor 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 radiationR2810-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 chemotherapyEMPOWER-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 settingMONARCH 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–capecitabineRIBBON-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 therapyKRYSTAL-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 recurrencemonarchE
Breast Cancer
Early Breast Cancer
HR+ HER2- node-positive
monarchE
A
PRELIMINARY SCORE
DFS
ADJUSTMENTS
SCORE
F1
A
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
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