Leukemias, lymphomas, and other hematologic cancers:
Indications for: BLENREP
In 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.
Clinical Trials:
The efficacy of Blenrep was evaluated in the open-label, multicenter DREAMM-2 study (NCT03525678) in 97 patients with relapsed or refractory multiple myeloma who had previously received 3 or more prior therapies, including an anti-CD38 monoclonal antibody, and were refractory to an immunomodulatory agent and a proteasome inhibitor.
Patients received either Blenrep 2.5mg/kg or 3.4mg/kg intravenously once every 3 weeks until disease progression or unacceptable toxicity. The major efficacy outcome measure was overall response rate as evaluated by an Independent Review Committee (IRC) based on the IMWG Uniform Response Criteria for Multiple Myeloma. Only the results of the recommended dosage of 2.5 mg/kg are described below.
Findings showed an ORR in the 2.5mg/kg cohort of 31% (n=30; 97.5% CI, 21-43); 2 patients had a stringent complete response, 1 patient had a complete response, 15 patients had very good partial response, and 12 had a partial response. The median time to first response was 1.4 months (95% CI, 1.0-1.6). The median duration of response (DoR) had not yet been reached at the 6-month analysis, but 73% of responders had a DoR ≥6 months.
Adult Dosage:
Give by IV infusion over ~30mins. 2.5mg/kg (of actual body wt.) once every 3 weeks until disease progression or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling.
Children Dosage:
Not established.
Boxed Warning:
Ocular toxicity.
BLENREP Warnings/Precautions:
Risk of ocular toxicity. Conduct ophthalmic exams at baseline (within 3 weeks prior to first dose), prior to each subsequent dose, and for worsening symptoms (perform each follow-up exam at least 1 week after the previous dose and within 2 weeks prior to the next dose). Withhold therapy until improvement; resume or permanently discontinue based on severity. Thrombocytopenia: obtain CBCs at baseline and during treatment as clinically indicated; withhold and/or reduce dose based on severity. Monitor for infusion-related reactions; interrupt therapy for Grade 2 or 3 reactions; discontinue if life-threatening reactions occur. Advise use of preservative-free lubricant eye drops at least 4 times daily. Avoid contact lenses (unless directed by an ophthalmologist). Severe renal impairment (eGFR 15–29mL/min/1.73m2) or ESRD (eGFR <15mL/min/1.73m2) not on dialysis or requiring dialysis. Moderate or severe hepatic impairment (total bilirubin >1.5×ULN and any AST). Embryo-fetal toxicity. Advise to use effective contraception during and for 4 months (females of reproductive potential) or 6 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 3 months after the last dose).
BLENREP Classification:
BCMA-directed antibody + microtubule inhibitor conjugate.
Adverse Reactions:
Keratopathy, decreased visual acuity, nausea, blurred vision, pyrexia, infusion-related reactions, fatigue; Grade 3 or 4 lab abnormalities (decreased platelets, decreased lymphocytes, decreased hemoglobin, decreased neutrophils, increased creatinine, increased gamma-glutamyl transferase).
Note:
For compassionate use only. Must transition patients currently receiving Blenrep to a compassionate use program to continue treatment.
For further information or questions, contact GSK Response Center at (877) 768-0092.
For more information related to the Blenrep REMS, please visit www.BlenrepREMS.com or call (855) 209-9188.
Drug Elimination:
Half-life: 12 days (after the first dose); 14 days (at steady state).
REMS:
Generic Drug Availability:
NO
How Supplied:
Single-dose vial—1 (for compassionate use only)
