Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Imlunestrant · 1 trial · 2 indications
ORR is defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
| Arm | Type | Description |
|---|---|---|
| 1A - Low grade serous ovarian cancer cohort | EXPERIMENTAL | Participants in Cohort 1A receive combination treatment with imlunestrant, abemaciclib, and selinexor. Treatment is outpatient, with a 14-day Cycle 0 followed by 28-day cycles. |
| 1B - Endometrioid endometrial cancer cohort | EXPERIMENTAL | Participants in Cohort 1A receive combination treatment with imlunestrant, abemaciclib, and selinexor. Treatment is outpatient, with a 14-day Cycle 0 followed by 28-day cycles. |
| Name | Type | Description |
|---|---|---|
| Imlunestrant | DRUG | Oral study drug Taken once per day |
| Abemaciclib | DRUG | Oral study drug Taken twice per day |
| Selinexor | DRUG | Oral study drug Taken once per week |
Inclusion Criteria: * For Cohort 1A: Participants must have histologically confirmed diagnosis of low-grade serous carcinoma of ovary, fallopian tube or peritoneum that is recurrent or metastatic and/or resistant to standard therapies; original diagnosis of de novo low-grade serous carcinoma or ori...