Study design

DREAMM-2 investigated BLENREP as a single agent in patients with RRMM whose prior therapy included an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent^1,a

The primary endpoint was overall response rate^b | Select secondary endpoints were duration of response and time to first response.^1,2

Patient
Population^c

DREAMM-2 was an open-label, randomized study designed with 2 parallel dosing cohorts that included patients with RRMM who had undergone autologous stem cell transplant or were considered transplant ineligible (n = 221).

Prior
Treatments

Patients previously received 3 or more anti-myeloma treatment regimens and were refractory to an anti-CD38 monoclonal antibody, an immunomodulatory agent, and a proteasome inhibitor.

Dosing
Regimen

Patients received either BLENREP 2.5 mg/kg or 3.4 mg/kg by intravenous infusion over approximately 30 minutes every 3 weeks. Dose was modified in some cases due to adverse reactions.

Treatment
Continuation

Treatment continued until disease progression or unacceptable toxicity. Efficacy analysis was based upon results in patients who received the recommended dosage of 2.5 mg/kg (N = 97).

^aRefractory myeloma is defined as disease that is nonresponsive to primary or salvage therapy or progresses within 60 days of last therapy.³
^bAs evaluated by an Independent Review Committee based on the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma. Patients had measurable disease by IMWG criteria.¹
^cPatients with corneal epithelial disease, except mild punctate keratopathy, at baseline were excluded from the study. Patients with mild or moderate renal impairment (eGFR 30 to 89 mL/min/1.73 m²) at baseline were also eligible for the study.¹

Patient characteristics

Patient characteristics^1,2	N = 97
Median age (yr) (range)	65 (39-85)
Gender	53% Male
ISS disease Stage II or III	77%
ECOG performance status of 2	16%
Received prior ASCT	87%
Median previous lines of therapy	7 (3 to 21)
Refractory to daratumumab	100%
Refractory to lenalidomide	90%
Refractory to pomalidomide	87%
Refractory to bortezomib	76%
Refractory to carfilzomib	65%
Refractory to isatuximab	3%
Patients with high-risk cytogenetics^2*	42%
1q21+	26%
17p13del	16%
t(4;14)	11%
t(14;16)	7%
Patients with renal impairment^2†	74%
Mild impairment	49%
Moderate impairment	25%

Efficacy

Nearly a third of patients with RRMM had a clinically meaningful response with BLENREP¹

At 6 months
At 13 months

At 6 months, BLENREP demonstrated a 31% ORR with durable responses^1,2

Visual Showing Overall Response Rate to BLENREP at 6 months

Median DoR NOT REACHED at 6 months of follow-up

Overall response rate: 31% (n = 30/97; 97.5% CI: 21%, 43%).¹
Median time to first response: 1.4 months (95% CI: 1.0, 1.6).¹
Depth of response: The majority of responders, 60% (18/30), achieved very good partial response or better.¹
Duration of response: 73% of responders had a DoR ≥6 months at the time of data cutoff.¹

At the 13-month follow-up, BLENREP demonstrated a 32% ORR and an estimated median DoR of 11 months³

Visual Showing Overall Response Rate to BLENREP at 13 months

Median DoR estimate was 11 MONTHS (95% CI: 4.2, NR)

Overall response rate: 32% (n = 31/97; 97.5% CI: 22%, 44%).³
Depth of response: 58% of responders (18/31) had a very good partial response or better; 7% (7/97) of patients treated with BLENREP had a complete response or better.³
Duration of response: Estimated median DoR of 11 months (95% CI: 4.2, NR).³

The DREAMM-2 clinical trial included patients with high-risk cytogenetics²

42% of patients in the DREAMM-2 study had high-risk cytogenetics^2*

In a post hoc analysis of 41 patients with high-risk cytogenetics^2,3

At 6 months and at 13-month follow-up: an overall response rate of 29%
was observed (12/41; 95% CI: 16.1, 45.5)^2,3

These were exploratory analyses not adjusted for multiplicity and not controlled for Type 1 error. No efficacy conclusions can be drawn from these data.^2,3

Patients included those with translocations 4;14 and 14;16, 17p13 deletions, and chromosome 1q21 amplification. The two most common cytogenetic risk factors in patients were 1q21 amplification and 17p13 deletions.²

1q21+: 61% (25/41)
17p13del: 39% (16/41)
t(4;14): 26% (11/41)
t(14;16): 17% (7/41)

DREAMM-2 evaluated heavily pretreated RRMM patients, including those with mild and moderate renal impairment²

74% of patients in the DREAMM-2 study had mild or moderate renal impairment²

In a post hoc analysis at 13 months:

Overall response rate for BLENREP 2.5 mg/kg by renal function³

Normal renal function
(>90 mL/min/1.73 m²)

37%

(n=7/19; 95% Cl: 16.3, 61.6)

Mild renal impairment
(≥60–<90 mL/min/1.73 m²)

33%

(n=16/48; 95% Cl: 20.4, 48.4)

Moderate renal impairment
(≥30–<60 mL/min/1.73 m²)

33%

(n=8/24; 95% Cl: 15.6, 55.3)

Learn about the dosing schedule for BLENREP

INDICATION

IMPORTANT SAFETY INFORMATION

Indication & Important Safety Info

BLENREP is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

This indication is approved under accelerated approval based on response rate.

IMPORTANT SAFETY INFORMATION

WARNING: OCULAR TOXICITY
BLENREP caused changes in the corneal epithelium resulting in changes in vision, including severe vision

WARNING: OCULAR TOXICITY
BLENREP caused changes in the corneal epithelium resulting in changes in vision, including severe vision loss and corneal ulcer, and symptoms such as blurred vision and dry eyes.

IMPORTANT SAFETY INFORMATION

WARNING: OCULAR TOXICITY
BLENREP caused changes in the corneal epithelium resulting in changes in vision, including severe vision loss and corneal ulcer, and symptoms such as blurred vision and dry eyes.
Conduct ophthalmic exams at baseline, prior to each dose, and promptly for worsening symptoms. Withhold BLENREP until improvement and resume, or permanently discontinue, based on severity.
Because of the risk of ocular toxicity, BLENREP is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BLENREP REMS.

WARNINGS AND PRECAUTIONS

Ocular Toxicity: Ocular adverse reactions occurred in 77% of the 218 patients in the pooled safety population. Ocular adverse reactions included keratopathy (76%), changes in visual acuity (55%), blurred vision (27%), and dry eye (19%). Among patients with keratopathy (n = 165), 49% had ocular symptoms, 65% had clinically relevant visual acuity changes (decline of 2 or more lines on Snellen Visual Acuity in any eye), and 34% had both ocular symptoms and visual acuity changes.

Keratopathy: Keratopathy was reported as Grade 1 in 7% of patients, Grade 2 in 22%, Grade 3 in 45%, and Grade 4 in 0.5% per the KVA scale. Cases of corneal ulcer (ulcerative and infective keratitis) have been reported. Most keratopathy events developed within the first 2 treatment cycles (cumulative incidence of 65% by Cycle 2). Of the patients with Grade 2 to 4 keratopathy (n = 149), 39% recovered to Grade 1 or lower after median follow-up of 6.2 months. Of the 61% who had ongoing keratopathy, 28% were still on treatment, 9% were in follow-up, and in 24% the follow-up ended due to death, study withdrawal, or lost to follow-up. For patients in whom events resolved, the median time to resolution was 2 months (range: 11 days to 8.3 months).

Visual Acuity Changes: A clinically significant decrease in visual acuity of worse than 20/40 in the better-seeing eye was observed in 19% of the 218 patients and of 20/200 or worse in the better-seeing eye in 1.4%. Of the patients with decreased visual acuity of worse than 20/40, 88% resolved and the median time to resolution was 22 days (range: 7 days to 4.2 months). Of the patients with decreased visual acuity of 20/200 or worse, all resolved and the median duration was 22 days (range: 15 to 22 days).

Monitoring and Patient Instruction: Conduct ophthalmic examinations (visual acuity and slit lamp) at baseline, prior to each dose, and promptly for worsening symptoms. Perform baseline examinations within 3 weeks prior to the first dose. Perform each follow-up examination at least 1 week after the previous dose and within 2 weeks prior to the next dose. Withhold BLENREP until improvement and resume at same or reduced dose, or consider permanently discontinuing based on severity. Advise patients to use preservative-free lubricant eye drops at least 4 times a day starting with the first infusion and continuing until end of treatment. Avoid use of contact lenses unless directed by an ophthalmologist. Changes in visual acuity may be associated with difficulty for driving and reading. Advise patients to use caution when driving or operating machinery. BLENREP is only available through a restricted program under a REMS.

Thrombocytopenia: Thrombocytopenia occurred in 69% of 218 patients in the pooled safety population, including Grade 2 in 13%, Grade 3 in 10%, and Grade 4 in 17%. The median time to onset of the first thrombocytopenic event was 26.5 days. Thrombocytopenia resulted in dose reduction, dose interruption, or discontinuation in 9%, 2.8%, and 0.5% of patients, respectively. Grade 3 to 4 bleeding events occurred in 6% of patients, including Grade 4 in 1 patient. Fatal adverse reactions included cerebral hemorrhage in 2 patients. Perform complete blood cell counts at baseline and during treatment as clinically indicated. Consider withholding and/or reducing the dose based on severity.

Infusion-Related Reactions: Infusion-related reactions occurred in 18% of 218 patients in the pooled safety population, including Grade 3 in 1.8%. Monitor patients for infusion-related reactions. For Grade 2 or 3 reactions, interrupt the infusion and provide supportive treatment. Once symptoms resolve, resume at a lower infusion rate. Administer premedication for all subsequent infusions. Discontinue BLENREP for life-threatening infusion-related reactions and provide appropriate emergency care.

Embryo-Fetal Toxicity: Based on its mechanism of action, BLENREP can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with BLENREP and for 4 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with BLENREP and for 6 months after the last dose. Pregnancy testing is recommended for females of reproductive potential prior to initiating BLENREP.

ADVERSE REACTIONS

The pooled safety population described in Warnings and Precautions reflects exposure to BLENREP at a dosage of 2.5 mg/kg or 3.4 mg/kg (1.4 times the recommended dose) administered intravenously once every 3 weeks in 218 patients in DREAMM-2. Of these patients, 194 received a liquid formulation (not the approved dosage form) rather than the lyophilized powder.

Patients received BLENREP at the recommended dosage of 2.5 mg/kg administered intravenously once every 3 weeks (n = 95). Permanent discontinuation due to an adverse reaction occurred in 8% of patients who received BLENREP; keratopathy (2.1%) was the most frequent adverse reaction resulting in permanent discontinuation. Dosage interruptions due to an adverse reaction occurred in 54% of patients who received BLENREP. Adverse reactions which required a dosage interruption in >3% of patients included keratopathy (47%), blurred vision (5%), dry eye (3.2%), and pneumonia (3.2%). Dose reductions due to an adverse reaction occurred in 29% of patients. Adverse reactions which required a dose reduction in >3% of patients included keratopathy (23%) and thrombocytopenia (5%).

The most common adverse reactions (≥20%) were keratopathy (71%), decreased visual acuity (53%), nausea (24%), blurred vision (22%), pyrexia (22%), infusion-related reactions (21%), and fatigue (20%). The most common Grade 3 or 4 (≥5%) laboratory abnormalities were lymphocytes decreased (22%), platelets decreased (21%), hemoglobin decreased (18%), neutrophils decreased (9%), creatinine increased (5%), and gamma-glutamyl transferase increased (5%).

Serious adverse reactions occurred in 40% of patients who received BLENREP. Serious adverse reactions in >3% of patients included pneumonia (7%), pyrexia (6%), renal impairment (4.2%), sepsis (4.2%), hypercalcemia (4.2%), and infusion-related reactions (3.2%). Fatal adverse reactions occurred in 3.2% of patients, including sepsis (1%), cardiac arrest (1%), and lung infection (1%).

USE IN SPECIFIC POPULATIONS

Lactation: Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with BLENREP and for 3 months after the last dose.

Females and Males of Reproductive Potential: Based on findings in animal studies, BLENREP may impair fertility in females and males.

Geriatric Use: Of the 218 patients who received BLENREP in DREAMM-2, 43% were aged 65 to less than 75 years and 17% were aged 75 years and older. Keratopathy occurred in 80% of patients aged less than 65 years and 73% of patients aged 65 years and older. Among the 95 patients who received BLENREP at the 2.5-mg/kg dose, keratopathy occurred in 67% of patients aged less than 65 years and 73% of patients aged 65 years and older.

Renal or Hepatic Impairment: The recommended dosage has not been established in patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m²) or end-stage renal disease (ESRD) with eGFR <15 mL/min/1.73 m² not on dialysis or requiring dialysis. The recommended dosage has not been established in patients with moderate or severe hepatic impairment (total bilirubin >1.5 × ULN and any AST).

Please see full Prescribing Information, including BOXED WARNING.

View References.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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BLENREP provided a clinically meaningful and durable response in heavily pretreated patients with relapsed/refractory multiple myeloma^1,2,a

Study design

Patient
Population^c

Prior
Treatments

Dosing
Regimen

Treatment
Continuation

DREAMM-2 evaluated BLENREP in a broad range of patients with RRMM who were considered triple-class refractory and had a median 7 lines of prior therapy¹

Patient characteristics

Efficacy

Nearly a third of patients with RRMM had a clinically meaningful response with BLENREP¹

Subgroup analysis

The DREAMM-2 clinical trial included patients with high-risk cytogenetics²

DREAMM-2 evaluated heavily pretreated RRMM patients, including those with mild and moderate renal impairment²

Normal renal function
(>90 mL/min/1.73 m²)

37%

Mild renal impairment
(≥60–<90 mL/min/1.73 m²)

33%

Moderate renal impairment
(≥30–<60 mL/min/1.73 m²)

33%

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

USE IN SPECIFIC POPULATIONS

BLENREP provided a clinically meaningful and durable response in heavily pretreated patients with relapsed/refractory multiple myeloma1,2,a

Study design

Patient Populationc

Prior Treatments

Dosing Regimen

Treatment Continuation

DREAMM-2 evaluated BLENREP in a broad range of patients with RRMM who were considered triple-class refractory and had a median 7 lines of prior therapy1

Efficacy

Nearly a third of patients with RRMM had a clinically meaningful response with BLENREP1

Subgroup analysis

The DREAMM-2 clinical trial included patients with high-risk cytogenetics2

DREAMM-2 evaluated heavily pretreated RRMM patients, including those with mild and moderate renal impairment2

Normal renal function (>90 mL/min/1.73 m2)

37%

Mild renal impairment (≥60–<90 mL/min/1.73 m2)

33%

Moderate renal impairment (≥30–<60 mL/min/1.73 m2)

33%

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

USE IN SPECIFIC POPULATIONS

BLENREP provided a clinically meaningful and durable response in heavily pretreated patients with relapsed/refractory multiple myeloma^1,2,a

Patient
Population^c

Prior
Treatments

Dosing
Regimen

Treatment
Continuation

DREAMM-2 evaluated BLENREP in a broad range of patients with RRMM who were considered triple-class refractory and had a median 7 lines of prior therapy¹

Nearly a third of patients with RRMM had a clinically meaningful response with BLENREP¹

The DREAMM-2 clinical trial included patients with high-risk cytogenetics²

DREAMM-2 evaluated heavily pretreated RRMM patients, including those with mild and moderate renal impairment²

Normal renal function
(>90 mL/min/1.73 m²)

Mild renal impairment
(≥60–<90 mL/min/1.73 m²)

Moderate renal impairment
(≥30–<60 mL/min/1.73 m²)