JOIN US AT THE ASH ANNUAL MEETING FOR A PRESENTATION ON ENJAYMO  |  MONDAY 12/12 @ 8 am

Not an official event of the 64th ASH Annual Meeting and Exposition. This presentation is not sponsored or endorsed by ASH. Not CME-accredited. MAT-US-2208046-v1.0-11/2022

VISIT US AT ASH  |  DECEMBER 10-13  |  BOOTH #643

Not an official event of the 64th ASH Annual Meeting and Exposition. This presentation is not sponsored or endorsed by ASH. Not CME-accredited. MAT-US-2208046-v1.0-11/2022

ENJAYMO is a breakthrough in the treatment of Cold Agglutinin Disease (CAD)1

ENJAYMO is indicated to decrease the need for red blood cell transfusion due to hemolysis in adults with CAD.

The CARDINAL trial established the efficacy and safety of ENJAYMO for approval in CAD.1,2

CARDINAL was a phase 3, global, multicenter, open-label, single-arm, 6-month trial in 24 patients with CAD.1-3*

OR AND 26 WEEKS Dosing at Days 0 and 7 and biweekly to Week 25 Normalization of Hb ( 12 g/dL) at the TAT Hb level increase of 2 g/dL from baseline at the TAT Transfusion independence from Week 5 through Week 26 AND No treatment for CAD beyond what was permitted per protocol from Week 5 through Week 26 COMPOSITE PRIMARY ENDPOINT
cardinal chart

Secondary endpoints assessed: Effect on Hb and laboratory measures of hemolysis (mean change from baseline in bilirubin and LDH) at the TAT.2†

A majority of patients continued on ENJAYMO, entering an extension phase.

  • Following completion of the 6-month treatment period, patients continued to receive ENJAYMO in a long-term safety and durability of response extension phase for an additional 24 months1
  • Apart from those who discontinued, all patients, including the 3 without objective evidence of a response, continued to the extension phase2
  • *Patients with confirmed CAD and a recent blood transfusion in 6 months prior to enrollment received ENJAYMO (N=24). Patients with CAS secondary to infection, rheumatologic disease, SLE, or overt hematologic malignancy were excluded, whereas patients with a history of concomitant low-grade lymphoproliferative disease were not excluded.
  • The treatment assessment time point (TAT) was defined as the mean value from Weeks 23, 25, and 26.
PARAMETER STATISTIC ENJAYMO
N=24
Age Mean (SD) Range 71.3 (8.2)
55 to 85 years
Sex
Female
Male
n (%) 15 (63)
9 (38)
Body weight Mean (SD) Range 67.8 (15.8)
40 to 112 kg
Hemoglobin Mean (SD), g/dL 8.6 (1.16)
Bilirubin (total) Mean (SD), mg/dL 3.1 (1.41) (2.6 × ULN)
LDH Mean (SD), U/L 438 (484.60)
History of transfusion
Within last 6 months
Within last 12 months
Median Number of Transfusions (Range) 2.0 (1, 19)
2.0 (1, 23)
  • N=21 for bilirubin data excluding patients with Gilbert’s syndrome.

Stop the unpredictability of C1-activated hemolysis in CAD1-3

The majority of patients achieved an improvement in hemoglobin and transfusion independence with ENJAYMO and required no additional CAD treatment (N=24)

A MAJORITY OF
PATIENTS ACHIEVED

ALL 3 COMPOSITE ENDPOINT MEASURES

54%
(13/24)
  • Substantial hemoglobin increase§
  • Transfusion independence||
  • No additional CAD treatments used||¶#
63%
(15/24)
ACHIEVED A CLINICALLY MEANINGFUL Hb INCREASE to 12 g/dL OR of 2 g/dL from baseline (mean Hb 8.6 g/dL [SD:1.16])§
71%
(17/24)
ACHIEVED TRANSFUSION INDEPENDENCE from baseline (median 2 [range 1-19]) through Weeks 5 to 26
92%
(22/24)
RECEIVED NO ADDITIONAL TREATMENT from Weeks 5 to 26¶#

Treatment assessment time point (TAT) was defined as the mean value from Weeks 23, 25, and 26.

§Hb level 12 g/dL achieved in 38% of patients (9/24); increase in Hb level of 2 g/dL achieved in 63% of patients (15/24).

||From Weeks 5 to 26.

Prohibited therapies included rituximab alone or in combination with cytotoxic agents.

#Two patients discontinued prior to Week 23 and their status was considered unknown for the purposes of this analysis.

Controlling C1-activated hemolysis in CAD starts with the first dose of ENJAYMO1,2

Mean Hb and bilirubin levels with ENJAYMO (N=24)

Hb
Hb and bilirubin
Bilirubin
WEEKS HEMOGLOBIN (g/dL) # OF SUBJECTS 24 24 23 22 23 21 23 21 22 22 22 21 21 21 20 7 9 11 13 15 17 19 21 23 25 26 5 3 1 0 12 11 10 9 8 Mean at baseline 8.6 g/dL (SD: 1.16) RAPID improvement at Week 3 2.29 g/dL MEAN INCREASE SUSTAINED improvement at TAT 3.18 g/dL MEAN INCREASE mean Hb levels over 26 weeks
  • Hb data at each time point between baseline and Week 26 is the observed mean. Interpret these data with discretion given small sample size and descriptive statistics.
3.5 3.0 2.3 1.8 1.2 0.6 12 11 10 9 8 HEMOGLOBIN (g/dL) BILIRUBIN (mg/dL) 0 n = 21-24 1 n = 20-24 3 n = 19-23 7 n = 19-22 11 n = 20-23 15 n = 19-22 19 n = 19-22 23 n = 18-21 26 n = 17-20 WEEKS ULN mean Hb and bilirubin levels over 26 weeks
  • Hb and bilirubin data at each time point between baseline and Week 26 is the observed mean. Interpret these data with discretion given small sample size and descriptive statistics.
# OF SUBJECTS 21 20 19 19 19 17 20 19 19 19 19 18 18 18 17 WEEKS 0 1 3 5 7 9 11 13 15 17 19 21 23 25 26 3.5 3.0 2.3 1.8 1.2 0.6 BILIRUBIN (mg/dL) ULN Mean at baseline 3.1 mg/dL (SD: 1.41) RAPID NORMALIZATION by Week 3 SUSTAINED NORMALIZATION through TAT 2.2 mg/dL LS mean decrease (95% CI: –2.49 to –1.98) mean bilirubin levels over 26 weeks
  • Bilirubin data at each time point between baseline and Week 26 is the observed mean. Interpret these data with discretion given small sample size and descriptive statistics.

Patients also experienced a mean improvement from baseline (424 U/L) in LDH, achieving levels that decreased to 1.2 × ULN at TAT (301 U/L)**

#Mean Hb at baseline: 8.6 g/dL (SD: 1.16);

#Mean Hb at baseline: 8.6 g/dL (SD: 1.16); mean bilirubin at baseline: 3.1 mg/dL (SD: 1.41).

#Mean bilirubin at baseline: 3.1 mg/dL (SD: 1.41).

**Among 17 patients with baseline and follow-up LDH values.

ENJAYMO provides rapid and sustained control of anemia and C1-activated hemolysis1,2

RAPID RESULTS BY WEEK 3

Blood drop

Rapidly improved anemia

2.29 g/dL increase in mean Hb levels††

Red blood cells

Rapidly inhibited chronic hemolysis

Achieved normalization of bilirubin levels‡‡

SUSTAINED RESULTS THROUGH TAT

Blood drop

Sustained improvement in anemia

3.18 g/dL improvement in mean Hb levels††

Red blood cells

Sustained inhibition of chronic hemolysis

Maintained normalization of bilirubin levels‡‡

††Observed mean model change in Hb was 2.60 g/dL (95% CI: 0.74-4.46) at TAT from baseline (mean Hb 8.6 g/dL [SD: 1.16]).

‡‡In CARDINAL, normal range of bilirubin defined as <1.2 mg/dL. Normalization maintained with LS mean decrease of 2.2 mg/dL (95% CI: 2.0-2.5).

The safety of ENJAYMO was demonstrated in CARDINAL1

The most common adverse reactions occurring in 10% of patients were respiratory tract infection, viral infection, diarrhea, dyspepsia, cough, arthralgia, arthritis, and peripheral edema.

Adverse reactions (5%) in patients receiving ENJAYMO in CARDINAL (N=24)

ADVERSE REACTION PATIENTS n (%)
Respiratory tract infection§§ 6 (25)
Viral infection§§ 3 (13)
Urinary tract infection§§ 2 (8)
Bacterial infection§§ 2 (8)
Cyanosis 2 (8)
Systemic hypertension 2 (8)
Diarrhea 3 (13)
Dyspepsia 3 (13)
Gastroenteritis 2 (8)
Abdominal pain 2 (8)
Cough 3 (13)
Arthralgia, arthritis§§ 3 (13)
Peripheral edema 3 (13)
Fatigue§§ 2 (8)
Infusion reaction 2 (8)
Headache 2 (8)

§§Events may be counted in more than 1 grouped term (eg, viral upper respiratory tract infection is counted in viral infection and respiratory tract infection).

Only 3 patients experienced serious adverse reactions with ENJAYMO

  • Serious adverse reactions were streptococcal sepsis and staphylococcal wound infection (n=1), arthralgia (n=1), and respiratory tract infection (n=1)

No patients discontinued ENJAYMO due to an adverse reaction

  • Dosage interruptions due to an adverse reaction occurred in 17% (4/24) of patients who received ENJAYMO

No meningococcal infections were reported with ENJAYMO

  • ENJAYMO may increase susceptibility to serious infections, including infections caused by encapsulated bacteria such as Neisseria meningitides (any serogroup), Streptococcus pneumoniae, and Haemophilus influenzae

Prescribe ENJAYMO for your next appropriate patient with CAD to inhibit C1-activated hemolysis

IMPORTANT SAFETY INFORMATION AND INDICATION

CONTRAINDICATIONS

ENJAYMO is contraindicated in patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients.

WARNINGS AND PRECAUTIONS

Serious Infections

  • ENJAYMO may increase susceptibility to serious infections, including infections caused by encapsulated bacteria such as Neisseria meningitides (any serogroup), Streptococcus pneumoniae, and Haemophilus influenzae.
  • Serious infections (bacterial and viral) were reported in 17% (4/24) of patients receiving ENJAYMO in a single-arm open-label clinical trial.
  • Vaccinate patients for encapsulated bacteria according to the most current ACIP recommendations for patients with persistent complement deficiencies. Revaccinate patients in accordance with ACIP recommendations.
  • Immunize patients without a history of vaccination against encapsulated bacteria at least 2 weeks prior to receiving the first dose of ENJAYMO. If urgent ENJAYMO therapy is indicated in an unvaccinated patient, administer vaccine(s) as soon as possible.
  • If ENJAYMO treatment is administered to patients with active systemic infections, monitor closely for signs and symptoms of worsening infection. Some infections may become rapidly life-threatening or fatal if not recognized and treated promptly. Inform patients of these signs and symptoms and steps to be taken to seek immediate medical care.
    • Consider interruption of ENJAYMO treatment in patients who are undergoing treatment for serious infection.
    • Consider patients’ immune status when initiating treatment with ENJAYMO.

Infusion-Related Reactions

  • Administration of ENJAYMO may result in infusion-related reactions. In the CARDINAL study, 8% (2/24) of patients treated with ENJAYMO experienced infusion-related reactions.
  • Monitor patients for infusion-related reactions and interrupt if a reaction occurs.
  • Discontinue ENJAYMO infusion and institute appropriate supportive measures if signs of hypersensitivity reactions, such as cardiovascular instability or respiratory compromise, occur.

Risk of Autoimmune Disease

  • Based on its mechanism of action, ENJAYMO may potentially increase the risk for developing autoimmune diseases such as systemic lupus erythematosus (SLE). Development of SLE has been associated with inherited classical complement deficiency.
  • Monitor patients being treated with ENJAYMO for signs and symptoms and manage medically.

Recurrent Hemolysis After ENJAYMO Discontinuation

  • If treatment with ENJAYMO is interrupted, closely monitor patients for signs and symptoms of recurrent hemolysis, e.g., elevated levels of total bilirubin or lactate dehydrogenase (LDH) accompanied by a decrease in hemoglobin, or reappearance of symptoms such as fatigue, dyspnea, palpitations, or hemoglobinuria. Consider restarting ENJAYMO if signs and symptoms of hemolysis occur after discontinuation.

ADVERSE REACTIONS

  • The most common adverse reactions (10%) with ENJAYMO were respiratory tract infection, viral infection, diarrhea, dyspepsia, cough, arthralgia, arthritis, and peripheral edema.

INDICATION

ENJAYMO (sutimlimab-jome) is indicated to decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD).


Please see full Prescribing Information.

See the full Medication Guide.

Learn more about Sanofi’s commitment to fighting counterfeit drugs.

CAD=Cold Agglutinin Disease; CAS=cold agglutinin syndrome; Hb=hemoglobin; LDH=lactate dehydrogenase; LS=least squares; SLE=systemic lupus erythematosus; TAT=treatment assessment time point; ULN=upper limit of normal.
References:
  1. ENJAYMO. Prescribing information. Genzyme Corporation.
  2. Röth A, Barcellini W, D’Sa S, et al. Sutimlimab in Cold Agglutinin Disease. N Engl J Med. 2021;384(14):1323-1334. doi:10.1056/NEJMoa2027760
  3. Data on file. Sanofi.
expand arrow

IMPORTANT SAFETY INFORMATION AND INDICATION

CONTRAINDICATIONS

ENJAYMO is contraindicated in patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients.

WARNINGS AND PRECAUTIONS

Serious Infections

  • ENJAYMO may increase susceptibility to serious infections, including infections caused by encapsulated bacteria such as Neisseria meningitides (any serogroup), Streptococcus pneumoniae, and Haemophilus influenzae.
  • Serious infections (bacterial and viral) were reported in 17% (4/24) of patients receiving ENJAYMO in a single-arm open-label clinical trial.
  • Vaccinate patients for encapsulated bacteria according to the most current ACIP recommendations for patients with persistent complement deficiencies. Revaccinate patients in accordance with ACIP recommendations.
  • Immunize patients without a history of vaccination against encapsulated bacteria at least 2 weeks prior to receiving the first dose of ENJAYMO. If urgent ENJAYMO therapy is indicated in an unvaccinated patient, administer vaccine(s) as soon as possible.
  • If ENJAYMO treatment is administered to patients with active systemic infections, monitor closely for signs and symptoms of worsening infection. Some infections may become rapidly life-threatening or fatal if not recognized and treated promptly. Inform patients of these signs and symptoms and steps to be taken to seek immediate medical care.
    • Consider interruption of ENJAYMO treatment in patients who are undergoing treatment for serious infection.
    • Consider patients’ immune status when initiating treatment with ENJAYMO.

Infusion-Related Reactions

  • Administration of ENJAYMO may result in infusion-related reactions. In the CARDINAL study, 8% (2/24) of patients treated with ENJAYMO experienced infusion-related reactions.
  • Monitor patients for infusion-related reactions and interrupt if a reaction occurs.
  • Discontinue ENJAYMO infusion and institute appropriate supportive measures if signs of hypersensitivity reactions, such as cardiovascular instability or respiratory compromise, occur.

Risk of Autoimmune Disease

  • Based on its mechanism of action, ENJAYMO may potentially increase the risk for developing autoimmune diseases such as systemic lupus erythematosus (SLE). Development of SLE has been associated with inherited classical complement deficiency.
  • Monitor patients being treated with ENJAYMO for signs and symptoms and manage medically.

Recurrent Hemolysis After ENJAYMO Discontinuation

  • If treatment with ENJAYMO is interrupted, closely monitor patients for signs and symptoms of recurrent hemolysis, e.g., elevated levels of total bilirubin or lactate dehydrogenase (LDH) accompanied by a decrease in hemoglobin, or reappearance of symptoms such as fatigue, dyspnea, palpitations, or hemoglobinuria. Consider restarting ENJAYMO if signs and symptoms of hemolysis occur after discontinuation.

ADVERSE REACTIONS

  • The most common adverse reactions (10%) with ENJAYMO were respiratory tract infection, viral infection, diarrhea, dyspepsia, cough, arthralgia, arthritis, and peripheral edema.

INDICATION

ENJAYMO (sutimlimab-jome) is indicated to decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD).


Please see full Prescribing Information.

See the full Medication Guide.

Learn more about Sanofi’s commitment to fighting counterfeit drugs.