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IMAAVY™ (nipocalimab-aahu)
Medical Information
IMAAVY - Alternative Dosing Intervals in Patients with Warm Autoimmune Hemolytic Anemia
Last Updated: 09/04/2026
SUMMARY
- The company cannot recommend any practices, procedures, or usage of IMAAVY that deviate from the approved labeling.
- Please refer to the local labeling for relevant information regarding the dosage of IMAAVY.
- ENERGY is a phase 2/3, multicenter, randomized, double-blind, placebo (PBO)-controlled study evaluating the efficacy and safety of IMMAVY vs PBO for the treatment of wAIHA.1
- Durable hemoglobin (Hgb) response was achieved by 21.1% of patients in the IMAAVY 15 mg/kg every 2 weeks (Q2W) group compared to 7.7% of patients in the PBO group.
- The most commonly reported (≥10%) adverse events (AEs) occurring in the IMAAVY 15 mg/kg Q2W group were wAIHA (27.0%), diarrhea, fatigue, dizziness, peripheral edema, and headache (10.8% each).
Clinical DATA
Phase 2/3 Study: ENERGY
Fattizzo et al (2026)1 evaluated the efficacy and safety of IMAAVY in adults with wAIHA in a phase 2/3 multicenter, randomized, double-blind, PBO-controlled study.
Study Design/Methods
- The study included adults (≥18 years of age) diagnosed with primary or secondary wAIHA for ≥3 months, defined as having all of the following1,
2 : - Hemoglobin (Hgb) <10 g/dL
- Signs of hemolysis (lactic dehydrogenase [LDH] >upper limit of normal [ULN], or indirect bilirubin >ULN, or haptoglobin [Hp] <lower limit of normal [LLN])
- Direct antiglobulin test (DAT) positive for immunoglobulin G (IgG) ± complement component 3d (C3d)
- The study consisted of a 2-week screening phase, followed by a 24-week, double-blind, PBO-controlled treatment phase, a 144-week open-label extension (OLE) phase, and safety follow-up at 8 weeks after the last infusion.1
- Eligible patients were randomized (1:1:1) to receive IV IMAAVY 30 mg/kg Q4W, IMAAVY 15 mg/kg Q2W, or matching PBO Q2W through week 24.
- Efficacy analyses were performed using the full analysis set (all randomized patients excluding 3 patients randomized to receive IMAAVY 30 mg/kg IV Q2W, a regimen which was subsequently discontinued).
- The safety analysis population included all randomized patients who received any dose of study treatment, including the 3 patients who received IMAAVY 30 mg/kg Q2W.
Results
Baseline Demographics
- For baseline demographics, see Table: Baseline Demographic Characteristics.
| Characteristics | IMAAVY 15 mg/kg Q2W (n=38) | PBO (n=39) |
|---|---|---|
| Age, years, mean (SD) | 53.1 (18.98) | 59.9 (15.73) |
| Female, n (%) | 22 (57.9) | 20 (51.3) |
| Race, n (%) | ||
| White | 17 (44.7) | 20 (51.3) |
| Black or African American | 1 (2.6) | 1 (2.6) |
| Asian | 15 (39.5) | 13 (33.3) |
| Others/not reported | 5 (13.2) | 5 (12.8) |
| wAIHA disease classification,a | ||
| Primary wAIHA | 33 (86.8) | 32 (82.1) |
| Secondary wAIHA | 5 (13.2) | 7 (17.9) |
| Time since diagnosis of disease, months, median (IQR) | 44.2 (20.8-81.2) | 23.1 (17.2-71.1) |
| Hgb >8.5 g/dL,a n (%) | 22 (57.9) | 25 (64.1) |
| Hgb, g/dL, mean (SD) | 8.6 (1.33) | 9.0 (1.42) |
| FACIT-Fatigue score, mean (SD) | 35.0 (10.54) | 31.1 (12.16) |
| Monospecific DAT performed at screening, n | 38 | 38 |
| IgG positive only, n (%) | 17 (44.7) | 24 (63.2) |
| IgG positive and C3d positive, n (%) | 21 (55.3) | 14 (36.8) |
| Concurrent treatment for wAIHA, n (%) | 34 (89.5) | 36 (92.3) |
| Any corticosteroid | 33 (86.8) | 30 (76.9) |
| Immunosuppressants or corticosteroids at >20 mg/day of prednisone or equivalenta | 15 (39.5) | 18 (46.2) |
| No treatment or ≤20 mg/day of prednisone or equivalent with no immunosuppressantsa | 23 (60.5) | 21 (53.8) |
| Prednisone equivalent corticosteroid dose, mg/day, mean (SD) | 17.9 (22.7) | 15.4 (17.8) |
| Prior treatments for wAIHA, n (%) | ||
| Rituximab | 21 (55.3) | 19 (48.7) |
| Splenectomy | 6 (15.8) | 4 (10.3) |
| Abbreviations: C3d, complement component 3d; DAT, direct antiglobulin test; FACIT, Functional Assessment of Chronic Illness Therapy; Hgb, hemoglobin; IgG, immunoglobulin G; IQR, interquartile range; PBO, placebo; Q2W, every 2 weeks; SD, standard deviation; wAIHA, warm autoimmune hemolytic anemia. aStratification factors (primary or secondary wAIHA; Hgb ≤8.5 g/dL or >8.5 g/dL; immunosuppressants or corticosteroids at >20 mg/day of prednisone or equivalent or no such treatment). | ||
Efficacy
Primary Endpoint and Primary Endpoint Related Analyses (Pre-planned)
- Durable Hgb response was achieved by 21.1% (8/38) of patients in the IMAAVY 15 mg/kg Q2W group compared to 7.7% (3/39) in the PBO group (P=0.044; not significant).1
- The mean time to first durable Hgb response was 5.0 weeks and 10.6 weeks in the IMAAVY 15 mg/kg Q2W and PBO groups, respectively.
- The median duration of durable response from the double-blind period including those continuing the same dose into the OLE was 15.1 (interquartile range [IQR], 9.6-22.9) weeks in the IMAAVY 15 mg/kg Q2W group and 4.9 (IQR, 4.1-15.9) weeks in the PBO group.
- An increase in mean Hgb change from baseline of 0.6 g/dL was observed at week 1 with IMAAVY 15 mg/kg Q2W.
- Additional prespecified Hgb response related analyses are summarized in Table: Components of Durable Hgb Response.
| n (%) | IMAAVY 15 mg/kg Q2W (n=38) | Nominal P-valuea vs PBO | PBO (n=39) |
| Hgb ≥10 g/dL and increase of ≥2 g/dL for ≥3 consecutive visits by week 24 | 9 (23.7) | 0.020 | 3 (7.7) |
| Hgb increase of ≥2 g/dL for ≥3 consecutive visits by week 16 | 9 (23.7) | 0.027 | 3 (7.7) |
| Hgb ≥10 g/dL for ≥3 consecutive visits by week 16 | 14 (36.8) | 0.498 | 14 (35.9) |
| Hgb increase of ≥2 g/dL for ≥1 visit by week 24 | 18 (47.4) | <0.001 | 6 (15.4) |
| Hgb ≥10 g/dL and increase of ≥2 g/dL for ≥1 visit by week 24 | 16 (42.1) | 0.004 | 6 (15.4) |
| Abbreviations: Hgb, hemoglobin; PBO, placebo; Q2W, every 2 weeks. aAll P-values for IMAAVY vs PBO are nominal against a 1-sided α=0.02499. These endpoints were not controlled for multiple comparisons. Therefore, the P-value is nominal, and statistical significance has not been established | |||
Key Secondary Endpoints
- The mean change from baseline at week 24 in FACIT-Fatigue score results are summarized in Table: FACIT-Fatigue Total Score Endpoint Results.1
| IMAAVY 15 mg/kg Q2W (n=37) | Nominal P-valuea vs PBO | PBO (n=37) | |
|---|---|---|---|
| Change from baseline at week 24, mean (SD) | 1.2 (6.07) | 0.267 | 0.6 (3.42) |
| Abbreviations: FACIT, Functional Assessment of Chronic Illness Therapy; PBO, placebo; Q2W, every 2 weeks; SD, standard deviation. aAll P-values for IMAAVY vs PBO are nominal against a 1-sided α=0.02499. Based on the statistical analysis plan, the statistical significance has not been established. | |||
Corticosteroid dose reduction from baseline to week 24 was observed in the IMAAVY group (see Table: Corticosteroid Dose Reduction). - The mean (SD) absolute prednisone-equivalent daily dose reduction was 2.5 (6.8) and 0.7 (2.7) mg for IMAAVY 15 mg/kg Q2W and PBO groups, respectively.
| IMAAVY 15 mg/kg Q2W (n=32) | Nominal P-valuea vs PBO | PBO (n=28) | |
|---|---|---|---|
| Mean (SD) percent reduction in daily dose of prednisone or equivalent from baseline to week 24, % | -14.0 (30.42) | 0.055 | -3.9 (16.33) |
| Abbreviations: PBO, placebo; Q2W, every 2 weeks; SD, standard deviation. aAll P-values for IMAAVY vs PBO are nominal against a 1-sided α=0.02499. Based on the statistical analysis plan, the statistical significance has not been established. | |||
Safety
- Overall, TEAEs were comparable between PBO and IMAAVY 15 mg/kg Q2W group. For a summary of adverse events, see Table: Summary of AEs
| AE, n (%) | IMAAVY 15 mg/kg Q2W (n=37) | PBO (n=39) |
|---|---|---|
| TEAEs | 30 (81.1) | 35 (89.7) |
| Related AEs | 10 (27.0) | 4 (10.3) |
| AEs leading to death | 2 (5.4) | 0 |
| Related AEs leading to death | 0 | 0 |
| SAEs | 6 (16.2) | 14 (35.9) |
| AEs leading to treatment discontinuation | 5 (13.5) | 1 (2.6) |
| AEs of interest | ||
| Grade ≥3 infections | 3 (8.1) | 5 (12.8) |
| Infusion reactions | 3 (8.1) | 2 (5.1) |
| Malignancy | 0 | 0 |
| Activation of latent virus | 1 (2.7) | 0 |
| MACE | 2 (5.4) | 0 |
| DVT and/or PE | 0 | 0 |
| Hypoalbuminemia | 0 | 0 |
| AEs reported in ≥10% of patients in any group | ||
| wAIHAa | 10 (27.0) | 20 (51.3) |
| Diarrhea | 4 (10.8) | 3 (7.7) |
| Fatigue | 4 (10.8) | 3 (7.7) |
| COVID-19 | 2 (5.4) | 4 (10.3) |
| Dizziness | 4 (10.8) | 3 (7.7) |
| Pyrexia | 3 (8.1) | 1 (2.6) |
| Peripheral edema | 4 (10.8) | 1 (2.6) |
| Nasopharyngitis | 3 (8.1) | 4 (10.3) |
| Headache | 4 (10.8) | 2 (5.1) |
| Asthenia | 0 | 3 (7.7) |
| Abbreviations: AE, adverse event; COVID-19, coronavirus disease 2019; MACE, major adverse cardiovascular event; PBO, placebo; Q2W, every 2 weeks; SAE, serious adverse event; TEAE, treatment-emergent adverse event; VTE, venous thromboembolism; wAIHA, warm autoimmune hemolytic anemia. aEvents could include disease flares, ongoing disease activities etc. | ||
Literature Search
A literature search of MEDLINE®
References
| 1 | Fattizzo B, Murakhovskaya I, Ueda Y, et al. Nipocalimab for warm autoimmune hemolytic anemia: results from the phase 2/3 randomized, double-blind ENERGY study. [published online ahead of print August 28, 2026]. Blood. doi:10.1182/blood.2026034036. |
| 2 |
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