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AVT32-DRL_PB · 1 trial · 1 indication
AUC0-3w (Cycle 1)
| Arm | Type | Description |
|---|---|---|
| AVT32-DRL_PB | EXPERIMENTAL | AVT32-DRL\_PB will be administered during double blind period and open label period |
| Keytruda | ACTIVE_COMPARATOR | Keytruda will be administered during double blind period |
| Name | Type | Description |
|---|---|---|
| AVT32-DRL_PB | BIOLOGICAL | AVT32-DRL\_PB at a dose 200 mg administered intravenously every 3 weeks. |
| Keytruda | BIOLOGICAL | Keytruda at a dose 200 mg administered intravenously every 3 weeks. |
Inclusion Criteria: * Participants (male/female) ≥18 years of age at the time of signing the ICF. * Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at the time of enrollment. * Participants with Stage IIB, IIC, or III histologically confirmed cutaneous melanoma ...
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AVT32-DRL_PB is an investigational monoclonal antibody being developed for the treatment of melanoma. It is currently being studied in patients with fully resected melanoma, meaning the tumor has been surgically removed. The drug is in Phase 1 clinical development and is not yet approved by regulatory authorities.
AVT32-DRL_PB is being developed by Alvotech, a biopharmaceutical company listed on the NASDAQ under the ticker symbol ALVO. The company is conducting clinical trials to evaluate the drug's pharmacokinetic similarity to an existing treatment for melanoma.
AVT32-DRL_PB is currently in Phase 1 clinical development. The drug is being studied in an active, recruiting clinical trial for patients with fully resected melanoma. As an investigational agent, it has not yet received regulatory approval and remains in the early stages of clinical testing.
AVT32-DRL_PB is being evaluated in a Phase 1 clinical trial registered as NCT07475572. This study is titled "Pharmacokinetic Similarity Study to Compare AVT32-DRL_PB With Keytruda® in Participants With Fully Resected Melanoma." The trial is currently recruiting participants in Ukraine and aims to enroll 120 patients.
AVT32-DRL_PB is not the same as Keytruda, but it is being studied as a potential biosimilar or comparable biologic to Keytruda. The ongoing Phase 1 trial is designed to compare the pharmacokinetic similarity of AVT32-DRL_PB with Keytruda in patients with fully resected melanoma, indicating the drug is intended to be a similar version of the reference product.