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Label indication Unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy [see Clinical Studies (14) ] . FDA label
Also known as Unituxin®, ch14.18
Dinutuximab · 1 trial · 1 indication
OS will be derived as: (date of death - date of randomization) + 1. Subjects who are alive or permanently lost to follow-up at the cut-off date for the analysis will be censored at the last date the subject was known to be alive.
| Arm | Type | Description |
|---|---|---|
| Part 1: Dinutuximab + Irinotecan | EXPERIMENTAL | Dinutuximab (10 mg/m\^2 IV) + Irinotecan (350 mg/m\^2 IV) on Day 1 of every 21 days (q21d). Dinutuximab dose will be escalated in 2 mg/m\^2 increments per cycle if maximal pain is \<Grade 2 (and without opioids) and otherwise tolerated, up to a maximum dose of 17.5 mg/m\^2 IV. |
| Part 2: Irinotecan | ACTIVE_COMPARATOR | Irinotecan (350 mg/m\^2 IV) on Day 1 of each q21d cycle. |
| Part 2: Dinutuximab + Irinotecan | EXPERIMENTAL | Dinutuximab (16 mg/m\^2 IV) + Irinotecan (350 mg/m\^2 IV) on Day 1 of each q21d cycle. Dinutuximab dose will be escalated in 2 mg/m\^2 increments per cycle if maximal pain is \<Grade 2 (and without opioids) and otherwise tolerated, up to a maximum dose of 17.5 mg/m\^2 IV. |
| Part 2: Topotecan | ACTIVE_COMPARATOR | Topotecan (1.5 mg/m\^2 IV) on Days 1 to 5 of each q21d cycle. |
| Name | Type | Description |
|---|---|---|
| Dinutuximab | BIOLOGICAL | Dinutuximab injection, for intravenous (IV) use |
| Irinotecan | DRUG | Irinotecan injection, IV infusion |
| Topotecan | DRUG | Topotecan for injection |
Inclusion Criteria: 1. Have histologically or cytologically confirmed SCLC (undifferentiated small-cell carcinoma arising in or consistent with lung cancer origin). 2. Documented relapse or disease progression during or after first-line platinum-based therapy (subjects refractory to initial platinu...
Top 1 of 2 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Amgen Inc. | AMGN | 1 | PHASE3 | Tarlatamab |
Dinutuximab was studied in adults with relapsed or refractory small cell lung cancer. A Phase 2 trial compared dinutuximab plus irinotecan against irinotecan alone in 483 participants. The trial has been completed. Dinutuximab is also known as ch14.18 and is approved in other settings, but its use in small cell lung cancer remains investigational.
Dinutuximab is developed by United Therapeutics Corporation, which trades on the Nasdaq under the ticker UTHR. The company sponsored the Phase 2 small cell lung cancer trial of dinutuximab plus irinotecan versus irinotecan.
Dinutuximab was evaluated in a Phase 2 clinical trial for relapsed or refractory small cell lung cancer. That trial has been completed. Dinutuximab is not approved for small cell lung cancer and remains investigational in this indication.
Dinutuximab was tested in the Phase 2 trial NCT03098030, titled Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer. The trial enrolled 483 adults, was active-controlled and randomized, and has been completed. It ran across the United States, Europe, Asia, and Australia.
Yes, dinutuximab is also known as ch14.18. It is a monoclonal antibody. The ch14.18 designation refers to the same molecule studied in the Phase 2 small cell lung cancer trial NCT03098030.