| Yes/High (3) | Medium (2) | No/Low (1) |
---|---|---|---|
Stage I screening | |||
Clinical potential | Actively considered for clinical development with at least solid preclinical data | NA | Mainly in vitro data and < 5 studies showing preclinical evidence |
Stage II screening | |||
Relevance to immunotherapy | Directly activate immune system or known to have significant indirect effects on immune system | NA | Not known to directly or indirectly activate immune system |
Stage III screening | |||
Relevance of Indication | > 3 indications in solid tumors including NSCLC in clinical development | At least 3 indications in clinical development | < 3 indications in clinical development or heme indications only |
Knowledge of MoA | Biology is clearly established with details of interactions at cellular and molecular levels | Biology is not clearly established with only few details on molecular interactions | Biology not known |
Effects on immune response | Directly activate effector immune cells such as CD8 T-cells or NK cells | Act by stimulating the proliferation of immune cells or increasing the infiltration of immune cells into tumors | Indirectly activate immune system through antigen release |
Stage IV screening | |||
Availability of data | Efficacy and safety data validated in multiple clinical studies | NA | Limited clinical or only preclinical efficacy and safety data |
Scoring of clinical data | |||
Clinical efficacy data | Data available from combination with PD-1/PD-L1 blockers in solid tumors; Data from monotherapy in solid tumors and combination with chemotherapy in solid tumors | Only data from monotherapy; or only combination therapy in solid tumors is available | Only data from heme tumors and/or preclinical data is available |
Other information summarized (not scored) | |||
Setting | Adjuvant +/- or Adv/Metastatic 1-2Â L or Adv/Metastatic 3-4Â L+ | ||
Combination studies | Combination studies with CIT or targeted therapy or with standard of care (e.g. chemotherapy) | ||
Efficacy | Molecule/target active by itself in multiple indications or single indication or only in combination | ||
Safety | Whether AEs manageable and reversible with treatment cessation or require additional treatment for reversal or require hospitalization and aggressive treatment for reversal Grade 3 or more incidence | ||
Phase | Phase 1/2/3/4 or pre-clinical | ||
Time to read out | < 1 years or 1–3 years or > 3 years |