Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Belantamab mafodotin frozen liquid · 1 trial · 1 indication
ORR was determined according to the 2016 international myeloma working group (IMWG) response criteria by IRC. ORR was calculated as the percentage of participants with a confirmed partial response (PR) or better (that is \[i.e.\], PR, very good partial response \[VGPR\], complete response \[CR\] and stringent complete response \[sCR\]). Confidence intervals were based on the exact method.
ORR was determined according to the 2016 IMWG response criteria by IRC. ORR was calculated as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR and sCR). Confidence intervals were based on the exact method. Efficacy Population comprised of first 130 intent-to-treat participants whether or not randomized treatment (frozen solution) was administered. Intent-to-treat Population comprised of all randomized participants whether or not randomized treatment was administered.
| Arm | Type | Description |
|---|---|---|
| Participants receiving frozen 2.5 mg/kg belantamab mafodotin | EXPERIMENTAL | Participants will receive 2.5 mg/kg frozen liquid belantamab mafodotin. Participants will be administered with frozen liquid belantamab mafodotin via infusion pump every 3 weeks. |
| Participants receiving frozen 3.4 mg/kg belantamab mafodotin | EXPERIMENTAL | Participants will receive 3.4 mg/kg frozen liquid belantamab mafodotin. Participants will be administered with frozen liquid belantamab mafodotin via infusion pump every 3 weeks. |
| Participants receiving lyophilized belantamab mafodotin | EXPERIMENTAL | Participants in lyophilized arm will receive lyophilized belantamab mafodotin once lyophilized configuration becomes available and enrollment has been completed for frozen liquid arms. |
| Name | Type | Description |
|---|---|---|
| Belantamab mafodotin frozen liquid | DRUG | Belantamab mafodotin will be available as frozen liquid. Frozen liquid will be available as 30 milligram (mg)/vial solution in a single use vial with unit dose strength of 2.5 or 3.4 mg/kg. Belantamab mafodotin will be administered as IV solution over at least 30 minutes. Frozen belantamab mafodotin will be diluted in 0.9 percent saline and administered via infusion pump. |
| Belantamab mafodotin lyophilized powder | DRUG | Belantamab mafodotin will be available as lyophilized powder. Lyophilized powder will be available as 100 mg/vial in single-use vial for reconstitution with unit dose strength of 3.4 mg/kg. Lyophilized belantamab mafodotin will be reconstituted using water for injection and diluted with saline before use. |
Inclusion Criteria: * Participants who provided signed written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. * Male or female, 18 years or older. * Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2....
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Belantamab mafodotin frozen liquid is used for the treatment of multiple myeloma. It is being investigated in patients who have failed prior treatment with an anti-CD38 antibody. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Belantamab mafodotin frozen liquid targets B-cell maturation antigen (BCMA), a protein expressed on multiple myeloma cells. By binding to BCMA, the drug delivers a cytotoxic agent to the cancer cells, leading to their destruction. This mechanism is being studied in patients with relapsed or refractory multiple myeloma.
Belantamab mafodotin frozen liquid is being developed by GSK plc, a global biopharmaceutical company. GSK is listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the safety and efficacy of this drug in multiple myeloma.
Belantamab mafodotin frozen liquid is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The Phase 2 trial has been completed, and the results will inform further development of the drug.
Belantamab mafodotin frozen liquid is associated with clinical trial NCT03525678, a Phase 2 study investigating the efficacy and safety of two doses of GSK2857916 in participants with multiple myeloma who have failed prior treatment with an anti-CD38 antibody. The trial enrolled 221 participants and has been completed.
Yes, Belantamab mafodotin frozen liquid is also known as GSK2857916. In clinical trial NCT03525678, the drug is referred to as GSK2857916. This alternative name is used in the study title and may appear in scientific literature and regulatory documents.