Table 3.
Toxicity Profile of Belantamab
| Author, Year | Title | Subgroups | Hematological AE | Non Hematological AE | ||
|---|---|---|---|---|---|---|
| Grade 1–2 | Grade =/> 3 | Grade 1–2 | Grade =/> 3 | |||
| Trudel, 201917 | Antibody–drug conjugate, GSK2857916, in RRMM: an update on safety and efficacy from dose expansion phase I study |
Part 2 (n=35) | Tcp: 10/35 (29%) Anemia: 4/35 (11%) |
Tcp: 12/35 (34%) Anemia: 6/35 (17%) |
Blurred vision: 17/35 (49%) Cough: 14/35 (40%) Dry eye: 12/35 (34%) Inc AST: 11/35 (31%) Nausea: 11/35 (31%) Photophobia: 10/35 (29%) Pyrexia: 10/35 (29%) Chills: 9/35 (26%) Diarrhea: 8/35 (23%) Fatigue: 8/23 (23%) URTI: 8/35 (23%) Inc ALT: 7/35 (20%) Constipation: 6/35 (17%) Inc ALP: 6/35 (17%) Back pain: 5/35 (14%) Inc GGT: 5/35 (14%) Arthralgia: 5/35 (14%) Dyspnea: 5/35 (14%) Contusion: 5/35 (14%) Decreased appetite: 5/35 (14%) Headache: 5/35 (14%) Sinusitis: 5/35 (14%) |
Diarrhea: 4/35 (11%) |
| Lonial, 202015 | Belantamab mafodotin for RRMM (DREAMM-2): a two-arm, randomised, open-label, phase 2 study |
Belantamab mafodotin 2.5 mg/kg group (n=95) | Infusion related reactionsa: 17/95 (18%) Tcp: 14/95 (15%) |
Tcp: 19/95 (20%) Anemia: 19/95 (20%) Lymphopenia: 12/95 (13%) |
Keratopathy or changes to corneal epithelium: 41/95 (43%). Nausea: 23/95 (24%) Fever: 18/95 (19%) Blurred vision: 17/95 (18%) Inc AST: 17/95 (18%) Fatigue: 13/95 (14%) Dry Eye: 12/95 (13%) Constipation: 12/95 (13%) Diarrhea: 11/95 (12%) Dec Appetite: 11/95 (12%) Arthralgia: 10/95 (11%) |
Keratopathy or changes to corneal epithelium: 26/95 (27%). |
| Belantamab mafodotin 3.4 mg/kg group (n=99) | Tcp: 24/99 (24%) Infusion related reactionsa: 15/99 (15%) Hypercalcemia: 13/99 (13%) Anemia: 12/99 (12%) Neutropenia: 12/99 (12%) |
Tcp: 34/99 (34%) Anemia: 25/99 (25%) Neutropenia: 15/99 (15%) |
Keratopathy or changes to corneal epithelium: 53/99 (54%) Nausea: 31/99 (31%) Blurred vision: 28/99 (28%) Dry eye: 23/99 (23%) Fever: 21/99 (21%) Fatigue: 21/99 (21%) Vomiting: 20/99 (20%) Cough: 19/99 (19%) Inc AST: 18/99 (18%) Epistaxis: 17/99 (17%) Dec Appetite: 16/99 (16%) URTI: 16/99 (16%) Diarrhea: 14/99 (14%) Headache: 13/99 (13%) Inc ALP: 12/99 (12%) Hypokalemia: 11/99 (11%) Pain in extremity: 11/99 (11%) Inc blood creatinine: 10/99 (10%) |
Keratopathy or changes to corneal epithelium: 21/99 (21%) Pneumonia: 11/99 (11%) |
||
Notes: aInfusion-related reactions (considered an adverse event of special interest) includes preferred terms infusion-related reaction, pyrexia, chills, diarrhea, nausea, asthenia, hypertension, lethargy, tachycardia, vomiting, cough, and hypotension occurring within 24 hours of infusion.
Abbreviations: AE, adverse events; Tcp, Thrombocytopenia; AST, Aspartate aminotransferase; ALT, Alanine transaminase; GGT, Gamma-glutamyl transferase; URTI, Upper respiratory tract infection; Inc, increased.