SUMMARY

• APOLLO is a phase 3 study evaluating the safety and efficacy of DARZALEX FASPRO for subcutaneous (SC) use + pomalidomide + dexamethasone (D-Pd) vs pomalidomide + dexamethasone (Pd) in patients with relapsed or refractory multiple myeloma (RRMM) who received ≥1 prior treatment with both lenalidomide and a proteasome inhibitor (PI).¹
  • Dimopoulos et al (2021)¹ reported the primary analysis of this ongoing study with a median follow-up of 16.9 months. The primary endpoint of improved progression-free survival (PFS) yielded a 37% reduction in the risk of progression or death with D-Pd arm (hazard ratio [HR], 0.63; 95% confidence interval [CI], 0.47-0.85; P=0.0018). The most common serious treatment-emergent adverse events (TEAEs) were pneumonia (D-Pd, 15%; Pd, 8%) and lower respiratory tract infection (D-Pd, 12%; Pd, 9%).
  • Dimopoulos et al (2023)² reported the final overall survival (OS) results and updated safety analysis of the APOLLO study at a median follow-up of 39.6 months. Median OS in the intent-to-treat (ITT) population was 34.4 months (95% CI, 23.7-40.3) vs 23.7 months (95% CI, 19.6-29.4) in the D-Pd vs Pd arm, respectively (HR, 0.82; 95% CI, 0.61-1.11; P=0.20). The most common grade 3 TEAEs (>10%) in the D-Pd arm were neutropenia (25%), anemia (17%), and leukopenia (11%), while those in the Pd arm were neutropenia (32%), anemia (21%), and thrombocytopenia (13%). The most common serious TEAE was pneumonia (D-Pd, 15%; Pd, 9%).
  • Other relevant literature related to the APOLLO study has been identified in addition to the data summarized above.^3-5
• EQUULEUS is a phase 1b study evaluating the safety and tolerability of DARZALEX for intravenous (IV) use when administered in combination with various treatment regimens, including Pd, for the treatment of multiple myeloma (MM).^6,7
  • The overall response rate (ORR; stringent complete response [sCR] + complete response [CR] + very good partial response [VGPR] + partial response [PR]) for patients who received D-Pd (N=103) was 66% (n=94; 95% CI, 55.5%-75.4%). TEAEs that occurred in ≥25% of patients treated with D-Pd included neutropenia, anemia, fatigue, diarrhea, thrombocytopenia, cough, leukopenia, constipation, nausea, dyspnea, pyrexia, back pain, upper respiratory tract infection, muscle spasms, vomiting, and arthralgia.
• MM-014 is a phase 2 study evaluating the safety and efficacy of D-Pd and Pd in patients with RRMM who have received 1 or 2 prior lines of therapy (LOTs) including lenalidomide.^8,9
  • Bahlis et al (2024)^10,11 reported the final OS in the D-Pd arm and updated results with a median follow-up of 41.9 months (range, 0.4-73.1). For patients in the D-Pd arm, ORR was 78.6% (95% CI, 69.8-85.8), CR was 26.8%, VGPR was 25.9%, and PR was 25.9%. The median PFS and OS in the ITT population were 23.7 months (95% CI, 15.8-36.1) and 56.7 months (95% CI, 46.5-not reached [NR]), respectively. The most common grade 3/4 TEAEs were neutropenia (72 [64.3%]), anemia (22 [19.6%]), pneumonia (20 [17.9%]), and thrombocytopenia (16 [14.3%]). Discontinuation of pomalidomide, dexamethasone, and DARZALEX occurred in 7 (6.3%), 9 (8.0%), and 6 (5.4%) patients, respectively.
• Other relevant literature has been identified in addition to the data summarized above.^12-21

   PRODUCT LABELING

• DARZALEX (daratumumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf
• DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX+Faspro-pi.pdf

CLINICAL DATA

DARZALEX FASPRO in Combination With Pomalidomide and Dexamethasone

APOLLO (MMY3013; clinicaltrials.gov identifier: NCT03180736) is an ongoing study evaluating the safety and efficacy of D-Pd vs Pd in patients with RRMM who received ≥1 prior LOT with both lenalidomide and a PI. Dimopoulos et al (2021)¹ reported the primary analysis of this ongoing study. Sonneveld et al (2021)²² presented updated efficacy and safety results at a median follow-up of 30.7 months. Dimopoulos et al (2023)² reported the final OS and updated safety analysis of D-Pd vs Pd alone in patients with RRMM in the APOLLO study with a median follow-up of 39.6 months.

Study Design/Methods

• The study design is described in the Figure: APOLLO (MMY3013): Study Design.

Results

Patient Characteristics

• Of the 353 patients assessed for eligibility, 304 were randomized (D-Pd, n=151; Pd, n=153) and included in the ITT analysis.
• Baseline characteristics are summarized in Table: Demographics and Baseline Characteristics.
• A total of 98% of patients in the D-Pd arm received DARZALEX FASPRO.
• A total of 142 of 149 (95%) of patients in the D-Pd arm started treatment with DARZALEX FASPRO.
• Seven of 149 (5%) patients had initiated treatment with DARZALEX; of these, 4 (3%) patients switched to DARZALEX FASPRO, and 3 (2%) patients progressed on DARZALEX before switching was permitted per the protocol amendment.
• Median duration of study treatment was 11.5 months (interquartile range [IQR], 4.6-17.1) in the D-Pd arm vs 6.6 months (IQR, 3.2-14.3) in the Pd arm.
• The most common reason for treatment discontinuation was progressive disease, as presented in Table: Treatment Disposition

Efficacy

• After a median follow-up of 16.9 months, median PFS was 12.4 months with D-Pd vs 6.9 months with Pd (HR, 0.63; 95% CI, 0.47-0.85; P=0.0018).
• Disease progression or death occurred in 84 (56%) patients in the D-Pd arm vs 106 (69%) patients in the Pd arm.
• A PFS benefit of D-Pd vs Pd was generally observed in all prespecified subgroups (Table: PFS in Prespecified Subgroups).
• ORR (ITT population): 69% D-Pd vs 46% Pd (odds ratio [OR], 2.7; 95% CI, 1.7-4.4; P<0.0001).
  • sCR: 9% D-Pd vs 1% Pd
  • CR: 15% D-Pd vs 3% Pd
  • ≥CR: 25% D-Pd vs 4% Pd (P<0.0001)
  • VGPR: 26% D-Pd vs 16% Pd
  • ≥VGPR: 51% D-Pd vs 20% Pd (P<0.0001)
  • PR: 18% D-Pd vs 27% Pd
• The minimal residual disease-negativity (MRD-negativity) rate was significantly higher in the D-Pd arm vs the Pd arm (9% vs 2%, respectively; P=0.010).
• The median time to first response was 1 month (95% CI, 1.0-1.1) in the D-Pd arm and 1.9 months (95% CI, 1.0-2.0) in the Pd arm.
• The median duration of response (DOR) was NR (95% CI, 15.2-NR) in the D-Pd arm vs 15.9 months (95% CI, 8.3-24.8) in the Pd arm.
• There were 48 vs 51 deaths reported in the D-Pd vs Pd arm, respectively.

Safety

• The most common grade 3/4 adverse events (AEs) were neutropenia (68% vs 51%), anemia (17% vs 21%), and thrombocytopenia (17% vs 18%) in the D-Pd vs Pd arm, respectively.
• Serious AEs occurred in 75 (50%) patients in the D-Pd arm vs 59 (39%) patients in the Pd arm.
  • The most common serious AEs were pneumonia (15% vs 8%) and lower respiratory tract infection (12% vs 9%) in the D-Pd arm vs Pd arm, respectively.
• TEAEs leading to treatment discontinuation and TEAEs leading to death were similar in both arms (D-Pd, 2% and 7%; Pd, 3% and 7%, respectively).
• Incidence of second primary malignancy was 2% in each arm.
• Infusion-related reactions were reported in 5% of D-Pd patients; all were grade 1/2 and occurred only in those receiving DARZALEX FASPRO.
• Local injection-site reactions were reported in 2% of patients who received DARZALEX FASPRO; all were grade 1.
• Safety data from the primary analysis are presented in Table: Most Common AEs During Treatment in the Safety Population.

Updated Analysis of the APOLLO Study

Dimopoulos et al (2023)presented the final OS and updated safety analysis of D-Pd vs Pd alone in patients with RRMM in the APOLLO study with a median follow-up of 39.6 months.²

Study Design/Methods

• OS was defined as the number of months from the date of randomization to the date of death from any cause). Patients were censored at the last date of contact.²
• Patients in the safety population were included if they received ≥1 administration of any study treatment.²

Results

Patient Disposition and Treatment Characteristics

• A total of 304 patients were randomized to receive either D-Pd (n=151) or Pd (n=153) and constituted the ITT population.
• Patients included in this study were refractory to lenalidomide (D-Pd, 79% [n=120]; Pd, 80% [n=122]), a PI (D-Pd, 47% [n=71]; Pd, 49% [n=75]), or both (D-Pd, 42% [n=64]; Pd, 42% [n=65]).
• Median duration of exposure to study treatment was 11.5 (interquartile range [IQR], 4.6-36.1) months vs 6.6 (IQR, 3.2-15.0) months in the D-Pd vs Pd arm, respectively.
• The median duration of follow-up was 39.6 (IQR, 37.1-43.7) months.
• In the safety population (D-Pd, n=149; Pd, n=150), the median relative dose intensity of DARZALEX and DARZALEX FASPRO was 86% (IQR, 80-94) and 95% (IQR, 86-100), respectively. In the D-Pd vs Pd arm, the median relative dose intensity of pomalidomide and dexamethasone was 74% (IQR, 55‑94) vs 91% (IQR, 77‑98; P<0.0001) and 78% (IQR, 49-95) vs 87% (IQR, 64-97; P=0.0278), respectively.

Efficacy

• Median PFS on the next LOT (PFS2) was 24.4 months (95% CI, 17.1-35.7) vs 17.6 months (95% CI, 13.6-22.0) in the D-Pd vs Pd arm, respectively (HR, 0.73; 95% CI, 0.55-0.98; P=0.034).
  • The 3-year PFS2 rate was 41.4% (95% CI, 33.1-49.4) vs 27% (95% CI, 19.8-34.8) in the D-Pd vs Pd arm, respectively.
• Median OS was 34.4 months (95% CI, 23.7-40.3) vs 23.7 months (95% CI, 19.6-29.4) in the D-Pd vs Pd arm, respectively (HR, 0.82; 95% CI, 0.61-1.11; P=0.20).
• Median time to subsequent therapy was 20.0 months (95% CI, 13.8-27.1) vs 11.8 months (95% CI, 8.9-15.4) in the D-Pd vs Pd arm, respectively (HR, 0.61; 95% CI, 0.45-0.82; P=0.0008).
• In the safety population, a total of 48% (n=72) of patients in the D-Pd arm and 68% (n=102) of patients in the Pd arm received subsequent therapy in any line as presented in Table: Most Common (>10%) subsequent antimyeloma therapies.

Safety

• No new safety concerns were reported with longer follow-up.
• The most common any grade and grade 3/4 TEAEs are presented in Table: Summary of Most Common TEAEs in the Safety Population.
• Serious TEAEs were reported in 54% (n=80) vs 40% (n=60) of patients in the D-Pd vs Pd arm, respectively.
  • The most common serious TEAE was pneumonia (D-Pd, 15% [n=23]; Pd, 9% [n=13]).
• Treatment modification occurred in 87% (n=130) vs 75% (n=112) of patients in the D-Pd vs Pd arm, respectively.
• Treatment discontinuation due to TEAEs was low among both treatment arms (D-Pd, 2% [n=3]; Pd, 4% [n=6]).
  • Treatment discontinuation due to infection was reported in 1 (1%) patient each in both arms (D-Pd, meningoencephalitis bacterial infection; Pd, Coronavirus Disease 2019 [COVID-19]).
• A total of 55% (n=83) vs 59% (n=91) of patients in the D-Pd vs Pd arm, respectively, died primarily due to disease progression, AEs unrelated to the study treatment, or COVID-19.
• Second primary malignancies (cutaneous, invasive, and hematological) were reported in 3% (n=4) vs 4% (n=6) of patients in the D-Pd vs Pd arm, respectively.
  • In the D-Pd arm, cholangiocarcinoma, malignant melanoma, and squamous cell carcinoma were each reported in 1% (n=1) of patients.
  • In the Pd arm, malignant melanoma, acute myeloid leukemia, metastatic renal cell carcinoma, and thyroid neoplasm were each reported in 1% (n=1) of patients.
• TEAEs leading to death were reported in 9% (n=13) of patients each in both arms.
  • The most common TEAEs leading to death were pneumonia (D-Pd, 2% [n=3]; Pd, 1% [n=2]) and COVID-19 (D-Pd, 1% [n=2]; Pd, 1% [n=1]).

DARZALEX Studies

EQUULEUS-Phase 1b Study

EQUULEUS (MMY1001; clinicaltrials.gov identifier: NCT01998971)^6,7 is an ongoing study evaluating the safety and tolerability of DARZALEX when administered in combination with various treatment regimens, including Pd, for the treatment of MM. Subgroup analyses and data specific to patients who received D-Pd are summarized.

Study Design/Methods

• Phase 1b, open-label, multicenter study.
• The trial is expected to enroll approximately 250 patients from about 24 sites in 3 countries, including the United States.
• The trial includes 6 arms, one of which is D-Pd (N=103 patients).
• Patients in the D-Pd arm received 28-day cycles of DARZALEX 16 mg/kg IV in combination with pomalidomide 4 mg (Days 1-21) and dexamethasone 40 mg weekly.
• DARZALEX was administered weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter.
• Eligibility criteria for the D-Pd arm: ≥18 years of age and documented myeloma; Eastern Cooperative Oncology Group performance status (ECOG PS ≤2); ≥2 prior lines of antimyeloma therapy, including at least 2 consecutive cycles of prior treatment that included lenalidomide and bortezomib; progressed on a combination regimen of lenalidomide and bortezomib, or consecutive regimens that contained lenalidomide and bortezomib separately; lenalidomide refractory; for patients with immunoglobulin G (IgG) disease, serum M-protein level ≥1.0 g/dL or urine M-protein ≥200 mg/24h; for patients with light chain MM, serum immunoglobulin free light chain ≥10 mg/dL and an abnormal serum Ig kappa/gamma free light chain ratio; hemoglobin ≥8 g/dL; absolute neutrophil count (ANC) ≥1.0 x 10⁹/L; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x upper limit of normal (ULN); total bilirubin ≤2.0 mg/dL; calculated creatinine clearance ≥45 mL/min/1.73 m²; corrected serum calcium <14 mg/dL; free ionized calcium <6.5 mg/dL; platelet count ≥75 x 10⁹/L in patients for whom <50% of bone marrow nucleated cells were plasma cells.
• Exclusion criteria: previous treatment with DARZALEX or pomalidomide; allogeneic stem cell transplantation (SCT) at any time; autologous SCT within 12 weeks of treatment start; antimyeloma therapy within 2 weeks of treatment start; monoclonal gammopathy of undetermined significance, smoldering MM, amyloidosis, or Waldenström disease; peripheral neuropathy (grade ≥2); chronic obstructive pulmonary disease; meningeal involvement of myeloma; moderate, severe or uncontrolled asthma, or significant heart disease; known hypersensitivity to thalidomide or lenalidomide.
• Primary safety endpoint: maximum tolerated dose of DARZALEX, defined as the highest dose level at which ≤1 patient out of an initial 6 patients experienced a dose limiting toxicity.
• Secondary endpoints included: ORR, CR rate, cytogenic risk, disease progression, MRD in patients who achieved ≥CR.

Results

Baseline Characteristics

• Among patients who received the D-Pd regimen (N=103)^6,7:
  • Baseline patient demographics and disease characteristics are presented in Table: Baseline Characteristics for the D-Pd Regimen.
  • Prior therapy status of patients in the study is presented in Table: Prior Therapy Status for the D-Pd Regimen.
  • Median follow-up: 28.1 months (range, 0.2-39.8).

Disposition and Drug Exposure

• Among patients who received D-Pd regimen (N=103)⁷:
  • 85% of patients discontinued treatment with D-Pd:
    • 53% due to progressive disease
    • 17% due to AEs
    • 4% due to physician’s decision
    • 4% due to death
    • 4% due to other reasons
    • 3% due to patient withdrawal

Safety

• Among patients who received the D-Pd regimen (N=103)⁶:
  • The most common (≥25%) TEAEs are presented in Table: TEAEs Occurring in ≥25% of Patients Who Received the D-Pd Regimen.
  • The most common grade 3 or 4 AEs were neutropenia (79% [febrile neutropenia 8%]), anemia (28%), and leukopenia (24%).
  • Other than neutropenia, rates of grade ≥3 AEs were similar to those observed historically with Pd alone.
  • A total of 44% of patients had preexisting grade 1/2 neutropenia at enrollment.
  • Serious AEs occurred in 57% of patients.
    • 19%, 22%, and 19% were related to DARZALEX, pomalidomide, and dexamethasone, respectively.
  • A total of 19% of patients discontinued treatment (any components) due to a TEAE; 4% were reasonably related to DARZALEX.
  • TEAEs leading to death occurred in 9% of patients.
  • Overall, no deaths were considered related to DARZALEX.
  • One patient reported a secondary primary malignancy.

Efficacy

• Among patients who received ≥1 dose of study drug D-Pd regimen (N=103)⁶:
  • ORR was 66% (n=94; 95% CI, 55.5%-75.4%).
  • Best responses:
    • sCR: 13% (n=12)
    • CR: 10% (n=9)
    • VGPR: 26%
    • PR: 18%
  • Among responders, the median DOR was 21.5 months (95% CI, 13.6-not estimable [NE]).
  • 8%, 7%, and 2% of patients became negative for MRD at thresholds of 10^-4, 10^-5, and 10^-6, respectively.
  • ORR data from a subgroup analysis of patients who received D-Pd are presented in Table: ORR Subgroup Analysis: D-Pd.
  • PFS:
    • Median PFS: 9.9 months (95% CI, 5.4-15.4).
    • 24-month PFS rate: 30.8% (95% CI, 21.3%-40.8%).
  • At a median follow-up of 28.1 months:
    • Median OS was 25.1 months (95% CI, 15.6-NE)
    • Estimated OS rate at 24 months was 52.4% (95% CI, 41.9%-61.8%).
  • The median OS was NR (95% CI, NE-NE) in ≥PR patients, 8.0 months (95% CI, 5.2-13.5) in stable disease/minimal response patients, and 2.3 months (95% CI, 0.6-4.4) in progressive disease/NE patients.

Phase 2 Study

MM-014 (clinicaltrials.gov identifier: NCT01946477) is an ongoing study evaluating the safety and efficacy of D-Pd and Pd in RRMM patients who have received 1 or 2 prior LOTs including lenalidomide.^8,9 Siegel et al (2020)⁹ reported results of the D-Pd arm with a median follow-up of 17.2 months. Bahlis et al (2022)⁸ reported the results of the D-Pd arm with a median follow-up of 28.4 months. Bahlis et al (2024)^10,11 reported the final OS in the D-Pd arm and updated the results with a median follow-up of 41.9 months (range, 0.4-73.1). Data specific to patients who received D-Pd are summarized.

Study Design/Methods

• Phase 2, nonrandomized, open-label, multicenter study.^8,9
• The trial is expected to enroll 156 participants from about 49 sites in 3 countries, including the United States.^8,9
• Patients in the D-Pd arm will receive 28-day cycles of DARZALEX 16 mg/kg IV in combination with pomalidomide 4 mg PO daily (Days 1-21) and dexamethasone 40 mg/day (20 mg for patients > 75 years) on Days 1, 8, 15 and 22 of a 28-day cycle weekly.^8,9
• DARZALEX was administered weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter.⁸
• Thromboprophylaxis was mandatory for all patients and included low-dose aspirin, low-molecular-weight heparin, or other equivalent antithrombotic agents.⁸
• Key inclusion criteria for the D-Pd arm: ≥18 years of age with documented MM diagnosis, measurable disease (serum M-protein ≥0.5 g/dL or urine M-protein ≥200 mg/24 h), and ECOG PS ≤2, 1-2 prior lines of antimyeloma therapy, documented progressive disease during or after their last LOT, treatment with a lenalidomide-containing regimen for ≥2 consecutive cycles as their most recent regimen.⁹
• Key exclusion criteria for the D-Pd arm: prior treatment with pomalidomide or DARZALEX or hypersensitivity to thalidomide, lenalidomide, dexamethasone, or monoclonal antibodies, ANC <1 × 10⁹/L, platelet count <75 × 10⁹/L (<30 × 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 <8 g/dL, AST or ALT >3.0 × ULN, serum total bilirubin level >2.0 mg/dL, and severe renal impairment (creatinine clearance <30 mL/min or requiring dialysis).⁹
• Primary endpoint: ORR per the modified International Myeloma Working Group (IMWG) criteria modified to include minimal response (MR).⁹
• Secondary endpoints: PFS, OS, DOR, time to response, time to progression, and safety.⁹
• Key exploratory endpoints for cohort B: pharmacodynamic and mechanistic biomarkers of D-Pd; quality of life by EuroQoL 5 dimensions (EQ-5D).⁹

Results

Patient Characteristics

• The median follow-up was 41.9 months (range, 0.4-73.1).¹⁰
• Baseline demographics and disease characteristics are presented in Table: Baseline Demographics and Disease Characteristics of the D-Pd ITT Population.

Patient Disposition

• At the data cutoff of December 16, 2022, a total of 97 (86.6%) patients were discontinued from treatment at a median follow-up of 41.9 months (range, 0.4-73.1), with the most common reason for discontinuation being progressive disease, as shown in Table: Patient Disposition.
• A total of 75 (67.0%) patients were discontinued from the study, with the most common reason for discontinuation being death (n=50); 47/50 patients died off treatment during the long-term follow-up.¹⁰

Drug Exposure

• Drug exposure details are summarized in Table: Drug Exposure.

Efficacy

• In the ITT population (n=112), ORR was 78.6% (95% CI, 69.8-85.8), CR was 26.8%, VGPR was 25.9%, and PR was 25.9%.¹⁰ Best ORRs are presented in Table: Best ORRs in the ITT Population and in the LEN-Relapsed and LEN-Refractory Subgroups.
• The median PFS in the ITT population was 23.7 months (95% CI, 15.8-36.1).^10,11 
  • The median PFS in patients who had ≥1 dose modification of pomalidomide, dexamethasone, or DARZALEX was 23.7 months (95% CI, 15.9-38.2).
  • The median PFS was shorter in patients who had 1 (26.4 months [95% CI, 15.8-48.9]) vs ≥2 (40.7 months [95% CI, 18.2-NR]) dose reductions of pomalidomide or dexamethasone.
  • The median PFS was 23.5 months (95% CI, 15.6-40.7) in patients who received prior lenalidomide and a PI.
  • The median PFS in the lenalidomide-refractory and lenalidomide-relapsed groups was 23.0 months (95% CI, 14.7-34.5) and NR (95% CI, 15.6-NR), respectively.
• The median OS in the ITT population was 56.7 months (95% CI, 46.5-NR), and death occurred in 50 (44.6%) patients.^10,11 
  • The 1-year and 5-year OS rates were 91.6% (95% CI, 84.5-95.5) and 48.2% (95% CI, 37.6-58.1), respectively.
  • In patients who received 1 and 2 prior LOTs, respectively, the median OS was 56.6 months (95% CI, 41.3-NR) and NR (95% CI, 22.8-NR) and death occurred in 33 (47.8%) patients and 17 (39.5%) patients.
  • The median OS in patients with ≥1 dose modification and in those with no dose modification of pomalidomide, dexamethasone, or DARZALEX was 60.3 months (95% CI, 47.6-NR) and 16.6 months (95% CI, 6.9-NR), respectively.
  • The median OS in patients with 1 and ≥2 dose reductions of pomalidomide or dexamethasone was 56.7 months (95% CI, 24.6-NR) and NR (95% CI, 53.6-NR), respectively.
  • The median OS in the lenalidomide-relapsed and lenalidomide-refractory groups was NR (95% CI, 47.6-NR) and 53.6 months (95% CI, 28.6-NR), respectively.
  • The median OS was similar in the prespecified patient subgroups; see Table: OS by Subgroup.
• Sixty-four (57.1%) patients received subsequent therapy, and the most common subsequent therapy was bortezomib/cyclophosphamide/dexamethasone (n=7; 6.3%); see Table: Subsequent Therapy.
  • Only 1 patient each received chimeric antigen receptor T-cell therapy and T cell engager therapy (data not shown) in the regimen.

Safety

• TEAEs in patients who received the D-Pd regimen (N=112) are presented in Table: Grade 3/4 TEAEs for the D-Pd Regimen.
  • The most common grade 3/4 TEAEs were neutropenia (72 [64.3%]), anemia (22 [19.6%]), pneumonia (20 [17.9%]), and thrombocytopenia (16 [14.3%]).¹⁰
  • Discontinuation of pomalidomide, dexamethasone, or DARZALEX occurred in 7 (6.3%), 9 (8.0%), and 6 (5.4%) patients, respectively, as presented in Table: Discontinuation or Modification of Dose Due to TEAEs.
  • Most patients (105 [93.8%]) experienced TEAEs related to pomalidomide. Drug-related TEAEs are presented in Table: Drug-Related TEAEs.
  • The median time to onset for the most common TEAEs of interest was <1 month, except for infections, fatigue, and nausea, as presented in Table: Onset of TEAEs.
  • Most common TEAEs of interest persisted for a median of <1 month, except for fatigue, nausea, and constipation. For cases that resolved, the median duration was ≤1.2 months for each TEAE, except for fatigue. A summary of the duration and resolution of TEAEs is presented in Table: Duration and Resolution of TEAEs.
  • Management of the most common TEAEs based on drug-relatedness is summarized in Table: Management of the Most Common TEAEs by Drug-Relatedness.