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 inhibitorEMERALD
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 chemotherapyPEARLS/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 settingTROPiCS-02
Breast Cancer
Breast Cancer
HR-positive HER2-negative
TROPiCS-02
4
PRELIMINARY SCORE
OS
ADJUSTMENTS
SCORE
F2a
4
Nivolumab
-
Single arm
Treatment of patients with MSI-H or dMMR mCRC that has progressed following treatment with a 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 therapyFEONIX-CCA2
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 diseaseStudy 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 ≥ 1KEYNOTE-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 SCCHNKEYNOTE-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 ChTKEYNOTE-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 indicatedCOU-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 cancerGETUG-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 therapyStudy 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 chemotherapyRATIONALE 302
Gastrointestinal Cancers
Oesophageal squamous cell carcinoma
-
RATIONALE 302
4
PRELIMINARY SCORE
OS
ADJUSTMENTS
SCORE
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 aberrationsEMPOWER-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 regimenDESTINY-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
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 chemotherapyATHENA-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
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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