POMALYST^® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

MM-014 PHASE 2 TRIAL

POMALYST^® (pomalidomide) + dex +
daratumumab (DPd): Data
in first- and second-relapse MM.*

*Results are not included in the Prescribing Information for POMALYST or daratumumab.

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Click to see pivotal data for RRMM:

Doublet:

Pd (MM-003)

Triplets:

DPd (EQUULEUS)

Pd + dara SC^† (APOLLO)

^†Dara SC is daratumumab and hyaluronidase-fihj subcutaneous formulation.

Indication for POMALYST

POMALYST + dexamethasone + daratumumab Indication (DPd)
POMALYST + dexamethasone + daratumumab is indicated for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

POMALYST + dexamethasone + daratumumab and hyaluronidase-fihj injection for subcutaneous use (dara SC) Indication (Pd + dara SC)
POMALYST + dexamethasone + daratumumab and hyaluronidase-fihj is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor.

Limitations of Use:
Daratumumab and hyaluronidase-fihj is not indicated and is not recommended for the treatment of patients with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.

Information about DPd and Pd + dara SC does not appear in the POMALYST Prescribing Information (PI). Please see the daratumumab and dara SC full PIs for a complete discussion of Important Safety Information at www.darzalexhcp.com/iv and www.darzalexhcp.com/faspro, respectively.

Key study limitations

The Phase 2 trial was a single-arm study with no comparator arm
The majority of patients received 1 prior line of therapy (70 of 112 patients; 63%)
Not all patients must have received a PI, though 80% of patients did receive a PI
Differences in outcomes could be due to baseline characteristics or previous lines of therapy
PFS was a secondary endpoint of MM-014 and was not statistically tested in the setting of a single-arm trial. PFS data are not in the Prescribing Information and should be interpreted with caution in a single-arm trial. The statistical significance of PFS is not known

DPd, POMALYST + dexamethasone + daratumumab; MM, multiple myeloma; Pd, POMALYST + dexamethasone; Pd + dara SC, POMALYST + dexamethasone + daratumumab
and hyaluronidase-fihj subcutaneous; PFS, progression-free survival; PI, proteasome inhibitor; RRMM, relapsed/refractory multiple myeloma.

Trial Design

MM-014 PHASE 2: TRIAL DESIGN

About the MM-014 Phase 2 trial

DPd was studied in a Phase 2, open-label, single-arm, multicenter trial with 3 cohorts that was designed to investigate the outcomes of sequencing a regimen with POMALYST in early relapse and immediately after treatment failure with a REVLIMID^® (lenalidomide)* regimen.

DPd was studied in 112 adult patients with measurable RRMM who had received 1-2 prior lines of therapy with a REVLIMID-containing regimen in the immediate prior line and an ECOG performance status of ≤2
Patients were excluded if they had prior treatment with POMALYST or dara and abnormal laboratory values^†
ORR was the primary endpoint; secondary endpoints included PFS and safety

POMALYST® (pomalidomide) MM-014 Trial Design

Treatment was administered in 28-day cycles.

*Please see full Prescribing Information, including Boxed WARNINGS, for REVLIMID.
The following laboratory values were exclusionary: absolute neutrophil count <1 x 10⁹/L, platelet count <75 x 10⁹/L (<30 x 10⁹/L for patients in whom ≥50% of bone marrow nucleated cells were plasma cells), corrected serum calcium >2.875 mmol/L (11.5 mg/dL), hemoglobin <80 g/L, AST or ALT >3.0x ULN, serum total bilirubin >34.2 µmol/L (2.0 mg/dL) or 3.0x ULN, and severe renal impairment (CrCl < 30 mL/min or requiring dialysis).
20 mg for patients ≥75 years of age.

Study sponsored by Bristol Myers Squibb.

Information about DPd does not appear in the POMALYST Prescribing Information (PI). Please see the daratumumab full PI for a complete discussion of Important Safety Information at www.darzalexhcp.com/iv.

POMALYST + dexamethasone + daratumumab Indication
POMALYST + dexamethasone + daratumumab is indicated for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

CONTRAINDICATIONS FOR DARATUMUMAB
Daratumumab is contraindicated in patients with a history of severe hypersensitivity (e.g., anaphylactic reactions) to daratumumab or any of the components of the formulation.

WARNINGS AND PRECAUTIONS FOR DARATUMUMAB

Infusion-Related Reactions: Daratumumab can cause severe and/or serious infusion-related reactions including anaphylactic reactions. These reactions can be life-threatening and fatal outcomes have been reported. Interrupt daratumumab infusion for infusion-related reactions of any severity. Permanently discontinue the infusion in case of anaphylactic reactions or life-threatening infusion reactions and institute appropriate emergency care.
Interference With Cross-Matching and Red Blood Cell Antibody Screening: Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive Indirect Antiglobulin Test (Indirect Coombs test), which may persist for up to 6 months after the last daratumumab infusion. Type and screen patients prior to starting treatment. Inform blood banks that a patient has received daratumumab.

MM-014 PHASE 2: PATIENT CHARACTERISTICS

THE MAJORITY OF PATIENTS STUDIED HAD 1 PRIOR LINE OF THERAPY¹

Additional patient characteristics^1,2

63% of patients received 1 prior line of therapy and 37% of patients received 2 lines of prior therapy
All patients had received a prior regimen with REVLIMID
- Patients who were refractory to REVLIMID: 75% (n=84)
- Patients who relapsed after REVLIMID: 25% (n=28)
Other prior therapies included: ASCT (70%), bortezomib (78%), carfilzomib (10%), and ixazomib (4%)
Median patient age was 66.5 years (range: 39-83)
The ECOG performance status was 0 in 39%, 1 in 60%, and 2 in 1% of patients
R-ISS Stage was I in 30 patients (26.8%), II in 53 patients (47.3%), and III in 8 patients (7.1%)
Of 93 patients with available cytogenetic analysis, 21.5% were high risk (presence of del[17p], t[4;14], and/or t[14;16])

ALT, alanine aminotransferase; ASCT, autologous stem cell transplantation; AST, aspartate aminotransferase; CrCl, creatinine clearance; dara, daratumumab; dex, dexamethasone; DPd, POMALYST + dexamethasone + daratumumab; ECOG, Eastern Cooperative Oncology Group; IV, intravenous; ORR, overall response rate; PFS, progression-free survival; PI, proteasome inhibitor; R-ISS, Revised International Staging System; RRMM, relapsed/refractory multiple myeloma; ULN, upper limit of normal.

Please see Important Safety Information throughout and full Prescribing Information, including Boxed WARNINGS, for POMALYST and REVLIMID.

Efficacy

MM-014 PHASE 2: EFFICACY

Efficacy results for DPd^1,2

MM-014 Trial Overall Response Rate (ORR)

WARNINGS AND PRECAUTIONS FOR DARATUMUMAB (cont’d)

Neutropenia: Monitor complete blood cell counts periodically during treatment. Monitor patients with neutropenia for signs of infection. Consider withholding daratumumab until recovery of neutrophils.
Thrombocytopenia: Monitor complete blood cell counts periodically during treatment. Consider withholding daratumumab until recovery of platelets.
Interference With Determination of Complete Response: Daratumumab can interfere with the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise pregnant women of the potential risk to a fetus and advise females of reproductive potential to use effective contraception.

CI, confidence interval; CR, complete response; DPd, POMALYST + dexamethasone + daratumumab; IMWG, International Myeloma Working Group; ITT, intent-to-treat; ORR, overall response rate; PFS, progression-free survival; PR, partial response; SC, subcutaneous; TEAE, treatment-emergent adverse event; VGPR, very good partial response.

Please see Important Safety Information throughout and full Prescribing Information, including Boxed WARNINGS, for POMALYST and REVLIMID.

Safety

MM-014 PHASE 2: SAFETY

Safety profile of DPd^1,2

TEAE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.
Reported in ≥3% of the safety population.

The adverse event profile was consistent with the known toxicities of the individual agents.

Nearly all patients (97.3%) experienced a TEAE of any grade
The most common non-hematologic any-grade TEAE was infections and infestations (85 patients [75.9%]), including 35 (31.3%) with upper respiratory tract infection
Any-grade infusion-related reactions were reported in 34 patients (30.4%)
8.6% (7/81) of patients discontinued due to adverse events

Median DoT was 15.9 months for POMALYST, 13.9 months for dex, and 16 months for dara.

MM-014 results are not contained in the POMALYST or daratumumab Prescribing Information.

Please see Important Safety Information throughout and full Prescribing Information, including Boxed WARNINGS, for POMALYST and REVLIMID.

DPd, POMALYST + dexamethasone + daratumumab; DoT, duration of therapy; TEAE, treatment-emergent adverse event.

References: 1. Bahlis NJ, Siegel D, Schiller G, et al. Pomalidomide, dexamethasone, and daratumumab immediately after lenalidomide-based treatment in patients with multiple myeloma: updated efficacy, safety, and health-related quality of life results from the phase 2 MM-014 trial. Leuk Lymphoma. 2022 Feb 8;1-11. Online ahead of print. doi: 10.1080/10428194.2022.2030477 2. Siegel DS, Schiller GJ, Samaras C, et al. Pomalidomide, dexamethasone, and daratumumab in relapsed refractory multiple myeloma after lenalidomide treatment. Leukemia. 2020;34(12):3286-3297. 3. POMALYST [package insert]. Summit, NJ: Celgene Corp.

Learn more about POMALYST once-daily
oral dosing and dose modifications.³

See Dose Modifications

POMALYST^® (pomalidomide) + dex +
daratumumab (DPd): Data
in first- and second-relapse MM.*

*Results are not included in the Prescribing Information for POMALYST or daratumumab.

Quick Links

Key study limitations

Trial Design

About the MM-014 Phase 2 trial

THE MAJORITY OF PATIENTS STUDIED HAD 1 PRIOR LINE OF THERAPY¹

Additional patient characteristics^1,2

Efficacy

Efficacy results for DPd^1,2

Safety

Safety profile of DPd^1,2

Learn more about POMALYST once-daily
oral dosing and dose modifications.³

WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM

Embryo-Fetal Toxicity

CONTRAINDICATIONS FOR POMALYST

WARNINGS AND PRECAUTIONS FOR POMALYST AND EMPLICITI

POMALYST® (pomalidomide) + dex + daratumumab (DPd): Data in first- and second-relapse MM.*

*Results are not included in the Prescribing Information for POMALYST or daratumumab.

Quick Links

Key study limitations

Trial Design

About the MM-014 Phase 2 trial

THE MAJORITY OF PATIENTS STUDIED HAD 1 PRIOR LINE OF THERAPY1

Additional patient characteristics1,2

Efficacy

Efficacy results for DPd1,2

Safety

Safety profile of DPd1,2

Learn more about POMALYST once-daily oral dosing and dose modifications.3

WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM

Embryo-Fetal Toxicity

CONTRAINDICATIONS FOR POMALYST

WARNINGS AND PRECAUTIONS FOR POMALYST AND EMPLICITI

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POMALYST^® (pomalidomide) + dex +
daratumumab (DPd): Data
in first- and second-relapse MM.*

THE MAJORITY OF PATIENTS STUDIED HAD 1 PRIOR LINE OF THERAPY¹

Additional patient characteristics^1,2

Efficacy results for DPd^1,2

Safety profile of DPd^1,2

Learn more about POMALYST once-daily
oral dosing and dose modifications.³

Please select
who you are.