Belantamab Mafodotin in Patients with Relapsed/Refractory Multiple Myeloma: Results of the Compassionate Use or the Expanded Access Program in Spain
Abstract
:Simple Summary
Abstract
1. Introduction
2. Methods and Patients
Statistical Analysis
3. Results
3.1. Efficacy
3.2. PFS, DoR, OS, and TTNT
3.3. Safety
3.3.1. Ocular Toxicity
3.3.2. Non-Ocular Toxicity
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Characteristics | n = 156 | |
---|---|---|
Age at diagnosis, median (IQR) | 70 (64–76.8) | |
Sex (female), no. (%) | 84 (53.8) | |
Time from diagnosis, years, median (IQR) | 6.4 (3.7–8.3) | |
Creatinine clearance (mL/min), no./total no. (%) | ||
≥30/<30 | 130 (83.3)/19 (12.2) | |
Type of MM, no. (%) | ||
IgG/Non-IgG | 84 (53.9)/72 (46.1) | |
ECOG performance status score, no./total no. (%) | ||
0/≥1 | 34 (21.8)/104 (66.7) | |
ISS at diagnosis, no./total no. (%) | ||
I/II/III | 45 (28.8)/49 (31.4)/52 (33.3) | |
R-ISS at diagnosis, no./total no. (%) | ||
I/II/III | 33 (21.2)/53 (34.0)/32 (20.5) | |
EMD, no./total no. (%) | 49 (31.4) | |
High-risk cytogenetics, no./total no. (%) | ||
del(17p) | 17/73 (23.3) | |
t(4;14) | 15/69 (21.7) | |
t(14;20) | 1/51 (2) | |
1q21+ | 28/60 (46.7) | |
Prior treatments, median (IQR) | 5 (4–6) | |
Refractory status, no. (%) | ||
Refractory to ≥1 line of treatment, no. (%) | 146 (93.6%) | |
To IMiDs | 133 (85.3) | |
To PI | 131 (84) | |
To anti-CD38 MoAbs | 129 (82.7) | |
Triple-refractory | 125 (80.1) | |
Penta-refractory | 54 (34.6) | |
Refractory to last line of therapy | 123 (83.1) | |
Previous HSCT, no. (%) | 101 (64.7) a |
Subgroup, No. | ORR, % | PFS (95% CI), mo. | OS (95% CI), mo. | |
---|---|---|---|---|
Refractoriness | ||||
Triple-refractory, 125 | 60.8 | 2.6 (1.5–3.8) | 10.62 (7.4–13.8) | |
Non-triple refractory, 23 | 69.6 | 6.9 (1.1–12.6) | 11.4 (8.2–14.7) | |
Penta-refractory, 54 | 62.8 | 2.2 (0.5–3.8) | 9.77 (0.6–18.8) | |
Non-penta refractory, 94 | 61.1 | 4.9 (2.3–7.4) | 11.05 (9.4–12.6) | |
Age | ||||
≤70 years, 71 | 62 | 2.6 (0.7–4.5) | 10.01 (5.4–14.7) | |
>70 years, 83 | 62.7 | 3.6 (1.9–5.3) | 12.07 (9.1–14.9) | |
CrCl | ||||
<30 mL/min, 17 | 41.2 | 2.07 (1.7–2.3) | 5.09 (0–21.1) | |
≥30 mL/min, 130 | 43.8 | 4.1 (2.7–5.5) | 11.05 (8.7–13.3) | |
EMD | ||||
No, 106 | 44.3 | 4.67 (2.4–6.8) | 13.2 (10.3–16.1) | |
Yes, 49 | 37.5 | 2.1 (1.3–2.8) | 4.7 (0–10.3) |
All Grades, No. (%) | ≥Grade 3, No. (%) | ||
---|---|---|---|
Hematologic | |||
Thrombocytopenia | 24 (15.4) | 17 (10.9) | |
Neutropenia | 7 (3.8) | 5 (3.1) | |
Anemia | 6 (3.9) | 2 (1.3) | |
Non-hematologic | |||
Infections | 25 (15) | 10 (5.6) | |
Gastrointestinal | 9 (5.8) | 2 (1.2) | |
Hepatobiliary | 8 (5.1) | 3 (1.8) | |
Neurological | 6 (3.9) | 2 (1.2) | |
Fatigue | 5 (3.2) | 0 | |
Cardiac & Vascular | 5 (3.2) | 1 (0.6) | |
Respiratory | 4 (2.4) | 2 (1.2) | |
Metabolic | 3 (1.9) | 0 | |
Renal | 3 (1.9) | 2 (1.2) | |
Other | 10 (6.2) | 1 (0.6) | |
Ocular a | |||
Corneal events | 73 (87.9) | 28 (33.7) | |
Reduced visual acuity | 50 (60.2) | 7 (8.4) | |
Blurry vision | 31 (37.3) | 0 | |
Dry eye | 27 (32.5) | 0 | |
Foreign body sensation | 16 (19.2) | 0 | |
Ocular discomfort | 15 (18.1) | 0 | |
Photophobia | 10 (12) | 0 | |
Other | 7 (8.4) | 0 |
Author, Year | No. of Patients | Age, Years (Range) | No. of Lines (Range) | Triple-ref, % | Penta-refr, % | ORR, % a | ≥PR, % | PFS (95% CI), mo. | DoR (95% CI), mo. | OS (95% CI), mo. |
---|---|---|---|---|---|---|---|---|---|---|
Lonial, 2020 [3] | 97 | 65 (60–70) | 7 (3–21) | 100 | NA | 35 | 31 b | 2.8 (1.6–3.6) | 11 (4.2–NR) | 13.7 (9.9–NR) |
Vaxman, 2021 [9] | 36 | 61 (37–83) | 8 (7–11) | 100 | 100 | NA | 33 | 2 (NA) | NA | 6.5 (NA) |
Iula, 2022 [10] | 28 | 67.5 (51–83) | 6 (3–14) | 100 | NA | NA | 40 | 3 (0–23)c | NR (2–23) | 8 (0–23) |
Shragai, 2022 [11] | 106 | 69.4 (36.3–80) | 6 (2–11) | 72.6 | 32 | NA | 45.5 | 4.7 (3.5–5.9) | 8.1 (5.7–10.5) | 14.5 (9.5–19.6) |
Atieh, 2021 12] | 28 | 67 (24–85) | 5 (3–15) | 100 | 54 | 46 | 46 | 4.9 (NA) | NA | 7.4 (NA) |
Rousell, 2022 [13] | 184 | 70.3 (63.3–75.9) | 5 (2->5) | NA | NA | 36.4 | 32.7 | 2.4 (1.9–3.2) | NA | 8.8 (6.3–11.6) |
Offidani, 2022 [14] | 67 | 66 (42–82) | 5 (2–10) | NA | NA | 37 | 31 | 3.7 (NA) | 13.8 (NA) | 12.9 (NA) |
Hultcrantz, 2022 [15] | 90 | 66 (37–88) | 6 (2–14) | NA | NA | 63 d | 42 | 4 (NA) | 13.1 (NA) | 20.5 (NA) |
Talbot, 2023 [17] | 106 | 66 (37–82) | 5 (3–12) | 56.7 | 11.3 | 38.1 | NA | 3.5 (1.9–4.7) | 9 (4.65–10.4) c | 9.3 (5.9.15.3) |
This series, 2023 | 156 | 72.5 (40–89) | 5 (2–10) | 80.1 | 34.6 | 41.8 | 39.8 | 3.6 (2.1–5.1) | 13.9 (8.3–19.4) | 11.05 (8.7–13.3) |
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de la Rubia, J.; Alonso, R.; Clavero, M.E.; Askari, E.; García, A.; Antón, C.; Fernández, M.; Escalante, F.; García, A.; Rios-Tamayo, R.; et al. Belantamab Mafodotin in Patients with Relapsed/Refractory Multiple Myeloma: Results of the Compassionate Use or the Expanded Access Program in Spain. Cancers 2023, 15, 2964. https://doi.org/10.3390/cancers15112964
de la Rubia J, Alonso R, Clavero ME, Askari E, García A, Antón C, Fernández M, Escalante F, García A, Rios-Tamayo R, et al. Belantamab Mafodotin in Patients with Relapsed/Refractory Multiple Myeloma: Results of the Compassionate Use or the Expanded Access Program in Spain. Cancers. 2023; 15(11):2964. https://doi.org/10.3390/cancers15112964
Chicago/Turabian Stylede la Rubia, Javier, Rafael Alonso, María Esther Clavero, Elham Askari, Alfonso García, Cristina Antón, Margarita Fernández, Fernando Escalante, Ana García, Rafael Rios-Tamayo, and et al. 2023. "Belantamab Mafodotin in Patients with Relapsed/Refractory Multiple Myeloma: Results of the Compassionate Use or the Expanded Access Program in Spain" Cancers 15, no. 11: 2964. https://doi.org/10.3390/cancers15112964
APA Stylede la Rubia, J., Alonso, R., Clavero, M. E., Askari, E., García, A., Antón, C., Fernández, M., Escalante, F., García, A., Rios-Tamayo, R., Conesa, V., Bermúdez, M. A., Merchán, B., Velasco, A. E., Blanchard, M. J., Sampol, A., Gainza, E., Hernández, P. M., & Alegre, A. (2023). Belantamab Mafodotin in Patients with Relapsed/Refractory Multiple Myeloma: Results of the Compassionate Use or the Expanded Access Program in Spain. Cancers, 15(11), 2964. https://doi.org/10.3390/cancers15112964