Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INCA034176 · 5 trials · 1 indication
Defined for each treatment group as complete response (CR) or partial response (PR) at 6 months (Cycle 7 Day 1, 28-day cycles) in the absence of new systemic therapy for cGVHD. Responses defined by the 2014 NIH consensus criteria.
Defined from the date of randomization to the date of any predefined event, whichever occurs first.
The overall response rate will be assessed by the number of participants with objective response by Cycle 7 (28-day cycles), Day 1, with responses defined by the 2014 NIH consensus criteria.
Defined as adverse events reported for the first time or worsening of a pre-existing event, occurring after the first dose.
The overall response rate will be assessed by the number of participants with objective response by Cycle 7 (28-day cycles), Day 1, with responses defined by the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD.
| Arm | Type | Description |
|---|---|---|
| Axatilimab | EXPERIMENTAL | Axatilimab at the protocol-defined dose. |
| Best available Treatment (BAT) | EXPERIMENTAL | Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements. |
| Axatilimab + Corticosteroids | EXPERIMENTAL | Axatilimab and Corticosteroids at the protocol-defined dose. |
| Placebo + Corticosteroids | EXPERIMENTAL | Matching placebo and Corticosteroids at the protocol-defined dose. |
| Axatilimab Dose | EXPERIMENTAL | Axatilimab at the protocol-defined dose. |
| Part 1 Safety Evaluation | EXPERIMENTAL | Axatilimab at the protocol-defined dose. |
| Part 2 Efficacy Evaluation | EXPERIMENTAL | Axatilimab at the protocol-defined dose. |
| Name | Type | Description |
|---|---|---|
| INCA034176 | DRUG | IV infusion |
| Best Available Therapy (BAT) | DRUG | Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements. |
| Placebo | DRUG | IV infusion |
| Corticosteroids | DRUG | Oral/IV Infusion |
| Best available Treatment (BAT) | DRUG | Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements. |
Inclusion Criteria: * Age ≥ 12 years at the time of signing the ICF. * Active, moderate to severe cGVHD, requiring systemic immune suppression. * Participants with refractory or recurrent cGVHD who have received at least 2 lines of systemic therapy, including corticosteroids and ruxolitinib. * Conc...