Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
E7777/kg · 1 trial · 1 indication
DLTs as per NCI CTCAE v4.03 were defined as 1) serious infusion reaction (CTCAE) Grade 4 adverse event of "Infusion related reaction," or recurrent CTCAE Grade 3 despite administration of systemic steroid premedication after initial occurrence. Infusion reactions were defined as symptoms (example, fatigue, nausea, vomiting, arthralgia, myalgia, pyrexia, chills, rigors) occurring within 24 hours of E7777 infusion. 2) Capillary leak syndrome (CLS) CTCAE Grade 4 or Grade 3 (with exceptions). A CLS event was defined as the noted occurrence of at least 2 of the following: hypotension, edema, or serum albumin less than (\<) 3.0 gram per decilitre (g/dL). 3) Clinical visual impairment. 4) Any CTCAE Grade greater than or equal to (\>=) 4 adverse event (AE) that may represent an infusion reaction. 5) Any other Grade 3 or greater toxicity assessed as related to E7777 treatment and which in the opinion of a safety consultancy investigator panel, was a dose-limiting toxicity.
The MTD was defined as the safe dose level established in Lead-In Part. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the Lead-In Part.
ORR was defined as the percentage of participants whose best overall response (BOR) was complete response (CR) or partial response (PR) based on independent review committee on 2 assessments at least 3 weeks apart. The tumor response was based on global response score (GRS) Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites.
| Arm | Type | Description |
|---|---|---|
| E7777 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| E7777 9 mcg/kg | DRUG | administered by intravenous (i.v.) infusion over 60 minutes (+/-10 minutes) on 5 consecutive days during every cycle of 21 days |
Inclusion Criteria: Participants must meet all of the following criteria to be included in the study: 1. Age greater than or equal to 18 years. 2. Histopathologic diagnosis of CTCL (mycosis fungoides \[MF\] or Sezary Syndrome \[SS\]), confirmed by skin biopsy, or lymph node, or blood assessment, o...
E7777/kg is being studied for the treatment of persistent or recurrent cutaneous T-cell lymphoma, a type of skin lymphoma. It is an oncology asset in Phase 3 development. The clinical program has focused on adult patients with disease that has persisted or returned after earlier therapy.
E7777/kg is being developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is the sponsor of the clinical program evaluating the drug in persistent or recurrent cutaneous T-cell lymphoma.
E7777/kg is in Phase 3 development. It is an investigational small molecule and has not been approved by the FDA. The Phase 3 trial in persistent or recurrent cutaneous T-cell lymphoma has been completed.
E7777/kg has been evaluated in one Phase 3 trial, NCT01871727, titled A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma. The trial enrolled 112 patients across the United States, Australia, and Puerto Rico and has completed. It was an uncontrolled study in adults aged 18 years and older.