Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
eftilagimod alpha · 3 trials · 3 indications
ORR was defined as the percentage of participants for each dose level whose best overall response is rated as iCR or iPR per immune Response Evaluation Criteria In Solid Tumors (iRECIST) for target lesions and assessed by CT or MRI. iCR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
ORR was defined as the percentage of participants for each dose level whose best overall response is rated as iCR or iPR per immune Response Evaluation Criteria In Solid Tumors (iRECIST) for target lesions and assessed by CT or MRI. iCR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
| Arm | Type | Description |
|---|---|---|
| open label lead-in (phase 2): eftilagimod alpha 30mg + paclitaxel | EXPERIMENTAL | eftilagimod alpha 30mg s.c. + 80mg/m\^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned. |
| open label lead-in (phase 2): eftilagimod alpha 90mg + paclitaxel | EXPERIMENTAL | eftilagimod alpha 90mg s.c. + 80mg/m\^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned. |
| Phase 3: eftilagimod alpha + paclitaxel | EXPERIMENTAL | eftilagimod alpha s.c. (OBD) + 80mg/m\^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned. |
| Phase 3: placebo + paclitaxel | PLACEBO_COMPARATOR | placebo s.c. + 80mg/m\^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned. |
| (CPS ≥1): pembrolizumab (KEYTRUDA®) + efti | EXPERIMENTAL | eftilagimod alpha: 30 mg every 2 weeks for the first 4 cycles;thereafter every 3 weeks for up to 18 cycles (1 cycle = 6 weeks). pembrolizumab (KEYTRUDA®): 400 mg every 6 weeks for up to 18 cycles (1 cycle = 6 weeks). |
| (CPS ≥1): pembrolizumab (KEYTRUDA®) | ACTIVE_COMPARATOR | pembrolizumab (KEYTRUDA®): 400 mg every 6 weeks for up to 18 cycles (1 cycle = 6 weeks). |
| (CPS <1): pembrolizumab (KEYTRUDA®) + efti | EXPERIMENTAL | eftilagimod alpha: 30 mg every 2 weeks for the first 4 cycles;thereafter every 3 weeks for up to 18 cycles (1 cycle = 6 weeks). pembrolizumab (KEYTRUDA®): 400 mg every 6 weeks for up to 18 cycles (1 cycle = 6 weeks). |
| 1st line NSCLC | EXPERIMENTAL | eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9). pembrolizumab (KEYTRUDA®): 200 mg every 3 weeks. |
| 2nd line NSCLC | EXPERIMENTAL | eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9). pembrolizumab (KEYTRUDA®): 200 mg every 3 weeks. |
| HNSCC | EXPERIMENTAL | eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9). pembrolizumab (KEYTRUDA®): 200 mg every 3 weeks. |
| Name | Type | Description |
|---|---|---|
| eftilagimod alpha | BIOLOGICAL | APC activator, MHC II agonist |
| Paclitaxel | DRUG | paclitaxel will be given as standard of care (chemotherapy) |
| placebo | OTHER | placebo matching eftilagimod alpha |
| pembrolizumab (KEYTRUDA®) | DRUG | anti-PD-1 antibody |
Inclusion Criteria: * Metastatic HR+ positive (estrogen receptor positive and/or progesterone receptor positive) or hormone receptor negative (HR˗), and HER2-neg breast adenocarcinoma, histologically proven by biopsy on the last available tumor tissue * Participants with HR+ metastatic breast cance...