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 an investigational antibody-drug conjugate being developed by GSK plc for multiple myeloma. It is a frozen liquid formulation of belantamab mafodotin, studied in patients whose disease has progressed after prior treatment with an anti-CD38 antibody. It is in Phase 2 clinical development.
Belantamab mafodotin frozen liquid is being studied for the treatment of multiple myeloma, specifically in patients who have failed prior treatment with an anti-CD38 antibody. The Phase 2 trial enrolled 221 participants with this condition across the United States, Australia, Canada, France, Germany, Italy, Spain, and the United Kingdom.
Belantamab mafodotin frozen liquid is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the Phase 2 study evaluating two doses of GSK2857916 in participants with multiple myeloma who had failed prior treatment with an anti-CD38 antibody.
Belantamab mafodotin frozen liquid is in Phase 2 clinical development. The single registered trial, NCT03525678, is a completed Phase 2 study that enrolled 221 participants. It is an investigational agent and has not been approved by the FDA for any indication based on the available development information.
Belantamab mafodotin frozen liquid has been evaluated in one clinical trial, NCT03525678, titled a study to investigate the efficacy and safety of two doses of GSK2857916 in participants with multiple myeloma who have failed prior treatment with an anti-CD38 antibody. This Phase 2 trial is completed and enrolled 221 participants.
Belantamab mafodotin frozen liquid is an antibody-drug conjugate, or ADC, built on an antibody format. It combines a monoclonal antibody component with a cytotoxic payload to deliver treatment directly to target cells. The Phase 2 trial tested two dose levels of GSK2857916 in patients with relapsed or refractory multiple myeloma.