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TRU-016 and bendamustine · 2 trials · 2 indications
Patients had full clinical response assessment monthly during treatment, at the end of treatment (EOT) visit, 30 and 60 days after the EOT visit, and subsequently every 3 months until the earliest of progression of CLL, death, initiation of new therapy, withdrawal from the study, or completion of 18 months of follow-up evaluations. Clinical response assessment included physical examination with measurement of spleen, liver, and lymph nodes, disease-related symptoms, and laboratory measurements, specifically complete blood count (CBC) with differential.
| Arm | Type | Description |
|---|---|---|
| Phase 1: 15 mg/kg TRU-016 + Bendamustine | EXPERIMENTAL | TRU-016 (15 mg/kg) and bendamustine (70 mg/m2), n = 6 patients |
| Phase 1: 20 mg/kg TRU-016 + Bendamustine | EXPERIMENTAL | TRU-016 (20 mg/kg) and bendamustine (70 mg/m2), n = 6 patients |
| Phase 2: TRU-016 and bendamustine | EXPERIMENTAL | TRU-016 (20 mg/kg) and bendamustine (70 mg/m2), n = 32 patients |
| Phase 2: Bendamustine | ACTIVE_COMPARATOR | Bendamustine (70 mg/m2), n = 33 patients |
| 1 | EXPERIMENTAL | Dose escalation and expansion cohorts |
| Name | Type | Description |
|---|---|---|
| TRU-016 and bendamustine | DRUG | TRU-016 at 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles |
| Bendamustine | DRUG | Bendamustine at 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles |
| 15 mg/kg TRU-016 and bendamustine | DRUG | TRU-016 at 15 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles |
| 20 mg/kg TRU-016 and bendamustine | DRUG | TRU-016 at 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles |
| TRU-016 (anti-CD37 protein therapeutic) | DRUG | TRU-016 administered via IV infusion weekly for 8 weeks and then monthly |
Inclusion Criteria: * Diagnosis of relapsed CLL with 1 to 3 prior treatments * Demonstrated active disease requiring treatment * No prior bendamustine treatment * Not refractory to fludarabine or other purines, either as a single agent or in combination * Age \>/=18 years; male or female * Eastern ...
TRU-016 is an investigational small molecule being studied for Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL), and recurrent B-cell Small Lymphocytic Lymphoma. It has been evaluated in patients with previously treated CLL and in combination with other therapies for relapsed disease.
TRU-016 is being developed by Aptevo Therapeutics Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol APVO. The company has sponsored clinical trials of TRU-016 in hematologic malignancies.
TRU-016 is in Phase 1 clinical development. All three clinical trials listed for TRU-016 are Phase 1 studies, and they have all been completed. TRU-016 is investigational and has not been approved by the FDA.
TRU-016 has been studied in three completed Phase 1 trials: NCT00614042 in previously treated CLL or NHL, NCT01188681 in relapsed CLL comparing TRU-016 plus bendamustine versus bendamustine alone, and NCT01317901 in relapsed indolent lymphoma combining TRU-016 with rituximab and bendamustine.
TRU-016 is the primary name used in clinical trials and does not have alternative names listed in the available data. It is an investigational small molecule being studied for hematologic cancers.