Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0PFKFR
ADC Name
Pinatuzumab vedotin
Synonyms
pinatuzumab vedotin; RG7593; DCDT2980S; anti-CD22-MC-vc-PAB-MMAE
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Organization
Genentech (Top20 MNC) (Originator);Seagen (Top20 MNC) (No Rights)
Drug Status
Phase 1/2 (discontinued)
Drug-to-Antibody Ratio
3.585~4
Structure
Antibody Name
Pinatuzumab
  Antibody Info 
Antigen Name
B-cell receptor CD22 (CD22)
  Antigen Info 
Payload Name
MMAE
  Payload Info 
Therapeutic Target
Microtubule (MT)
  Target Info 
Linker Name
Mc-Val-Cit-PABC
  Linker Info 
Conjugate Type
Random Cysteines
Combination Type
vedotin
The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
Indication Phase 1 Phase 1/2 Phase 2 Phase 2/3 Phase 3 New Drug Application Approved
Unspecific non-hodgkin lymphoma
1 Trials
Trial ID
NCT01209130
Chronic lymphocytic leukemia
1 Trials
Trial ID
NCT01209130
General Information of The ADMET Data Related to This ADC(2027 Update)
Absorption
Click To Hide/Show 16 Absorption Data Related to This Level
Standard Type Value Units Description Reference
Maximum Observed Concentration (Cmax) 134 ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after a Single IV Administration of DCDT2980S to SCID Mice, 5 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 821 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after a Single IV Administration of DCDT2980S to SCID Mice, 5 mg/kg, AUCinf.
 [1]
Maximum Observed Concentration (Cmax) 11.1 ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after a Single IV Administration of DCDT2980S to SCID Mice, 0.5 mg/kg.
 [1]
Area Under the Concentration-Time Curve (AUC) 72.1 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after a Single IV Administration of DCDT2980S to SCID Mice, 0.5 mg/kg, AUCinf.
 [1]
Maximum Observed Concentration (Cmax) 24.9±2.97 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 1 mg/kg, First dose.
 [1]
Area Under the Concentration-Time Curve (AUC) 62.9±6.06 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 1 mg/kg, AUC0-21, First dose.
 [1]
Maximum Observed Concentration (Cmax) 26.9±1.13 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 1 mg/kg, Last dose.
 [1]
Area Under the Concentration-Time Curve (AUC) 76.8±7.52 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 1 mg/kg, AUC84-105, Last dose.
 [1]
Maximum Observed Concentration (Cmax) 87.8±11 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 3 mg/kg, First dose.
 [1]
Area Under the Concentration-Time Curve (AUC) 259±24.1 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 3 mg/kg, AUC0-21, First dose.
 [1]
Maximum Observed Concentration (Cmax) 108±13.4 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 3 mg/kg, Last dose.
 [1]
Area Under the Concentration-Time Curve (AUC) 400±51.8 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 3 mg/kg, AUC84-105, Last dose.
 [1]
Maximum Observed Concentration (Cmax) 134±18.1 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 5 mg/kg, First dose.
 [1]
Area Under the Concentration-Time Curve (AUC) 388±39.6 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 5 mg/kg, AUC0-21, First dose.
 [1]
Maximum Observed Concentration (Cmax) 159±13.2 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 5 mg/kg, Last dose.
 [1]
Area Under the Concentration-Time Curve (AUC) 628±71.6 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 5 mg/kg, AUC84-105, Last dose.
 [1]
Distribution
Click To Hide/Show 8 Distribution Data Related to This Level
Standard Type Value Units Description Reference
Area Under the Concentration-Time Curve (AUC) 821 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after a Single IV Administration of DCDT2980S to SCID Mice, 5 mg/kg, AUCinf.
 [1]
Area Under the Concentration-Time Curve (AUC) 72.1 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after a Single IV Administration of DCDT2980S to SCID Mice, 0.5 mg/kg, AUCinf.
 [1]
Area Under the Concentration-Time Curve (AUC) 62.9±6.06 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 1 mg/kg, AUC0-21, First dose.
 [1]
Area Under the Concentration-Time Curve (AUC) 76.8±7.52 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 1 mg/kg, AUC84-105, Last dose.
 [1]
Area Under the Concentration-Time Curve (AUC) 259±24.1 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 3 mg/kg, AUC0-21, First dose.
 [1]
Area Under the Concentration-Time Curve (AUC) 400±51.8 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 3 mg/kg, AUC84-105, Last dose.
 [1]
Area Under the Concentration-Time Curve (AUC) 388±39.6 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 5 mg/kg, AUC0-21, First dose.
 [1]
Area Under the Concentration-Time Curve (AUC) 628±71.6 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 5 mg/kg, AUC84-105, Last dose.
 [1]
Metabolism
Click To Hide/Show 8 Metabolism Data Related to This Level
Standard Type Value Units Description Reference
Area Under the Concentration-Time Curve (AUC) 821 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after a Single IV Administration of DCDT2980S to SCID Mice, 5 mg/kg, AUCinf.
 [1]
Area Under the Concentration-Time Curve (AUC) 72.1 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after a Single IV Administration of DCDT2980S to SCID Mice, 0.5 mg/kg, AUCinf.
 [1]
Area Under the Concentration-Time Curve (AUC) 62.9±6.06 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 1 mg/kg, AUC0-21, First dose.
 [1]
Area Under the Concentration-Time Curve (AUC) 76.8±7.52 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 1 mg/kg, AUC84-105, Last dose.
 [1]
Area Under the Concentration-Time Curve (AUC) 259±24.1 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 3 mg/kg, AUC0-21, First dose.
 [1]
Area Under the Concentration-Time Curve (AUC) 400±51.8 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 3 mg/kg, AUC84-105, Last dose.
 [1]
Area Under the Concentration-Time Curve (AUC) 388±39.6 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 5 mg/kg, AUC0-21, First dose.
 [1]
Area Under the Concentration-Time Curve (AUC) 628±71.6 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 5 mg/kg, AUC84-105, Last dose.
 [1]
Excretion
Click To Hide/Show 8 Excretion Data Related to This Level
Standard Type Value Units Description Reference
Area Under the Concentration-Time Curve (AUC) 821 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after a Single IV Administration of DCDT2980S to SCID Mice, 5 mg/kg, AUCinf.
 [1]
Area Under the Concentration-Time Curve (AUC) 72.1 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after a Single IV Administration of DCDT2980S to SCID Mice, 0.5 mg/kg, AUCinf.
 [1]
Area Under the Concentration-Time Curve (AUC) 62.9±6.06 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 1 mg/kg, AUC0-21, First dose.
 [1]
Area Under the Concentration-Time Curve (AUC) 76.8±7.52 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 1 mg/kg, AUC84-105, Last dose.
 [1]
Area Under the Concentration-Time Curve (AUC) 259±24.1 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 3 mg/kg, AUC0-21, First dose.
 [1]
Area Under the Concentration-Time Curve (AUC) 400±51.8 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 3 mg/kg, AUC84-105, Last dose.
 [1]
Area Under the Concentration-Time Curve (AUC) 388±39.6 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 5 mg/kg, AUC0-21, First dose.
 [1]
Area Under the Concentration-Time Curve (AUC) 628±71.6 day*ug/mL
Group Mean (±SD) Pharmacokinetic Parameters of Total Antibody after Multiple (q3w x 5) IV Administrations of DCDT2980S to Cynomolgus Monkey, 5 mg/kg, AUC84-105, Last dose.
 [1]
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 5 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Undisclosed  NCT01209130
PHASE1
An Open-Label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics of Escalating Doses of DCDT2980S in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia And DCDT2980S in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non Hodgkin's Lymphoma

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Undisclosed  NCT01691898
PHASE1|||PHASE2
A Randomized, Open-Label, Multicenter, Phase II Trial Evaluating the Safety and Activity of Pinatuzumab Vedotin (DCDT2980S) in Combination With Rituximab or Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab and a Non-Randomized Phase Ib/II Evaluation of Polatuzumab Vedotin in Combination With Obinutuzumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

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Objective Response Rate (ORR)  NCT01209130
Phase 1
An open-label, multicenter, phase 1 trial of the safety and pharmacokinetics of escalating doses of DCDT2980S in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma and chronic lymphocytic leukemia and DCDT2980S in combination with rituximab in patients with relapsed or refractory B-cell non Hodgkin's lymphoma.

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Objective Response Rate (ORR)  NCT01691898
Phase 1
A randomized, open-label, multicenter, phase 2 trial evaluating the safety and activity of pinatuzumab vedotin (DCDT2980S) in combination with rituximab or polatuzumab vedotin (DCDS4501A) in combination with rituximab and a non-randomized phase 1b/2 evaluation of polatuzumab vedotin in combination with obinutuzumab in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.

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Objective Response Rate (ORR)  NCT01691898
Phase 1
A randomized, open-label, multicenter, phase 2 trial evaluating the safety and activity of pinatuzumab vedotin (DCDT2980S) in combination with rituximab or polatuzumab vedotin (DCDS4501A) in combination with rituximab and a non-randomized phase 1b/2 evaluation of polatuzumab vedotin in combination with obinutuzumab in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.

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Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 5 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [2]
Patients Enrolled
Eligible patients must have measurable relapsed/refractory hematologic malignancies (NHL, DLBCL, MCL, CLL) with &ge;12-week life expectancy. Key exclusions include recent antibody/ADC therapies (4-week washout), chemotherapy/radiation (2-week washout), or stem cell transplants (autologous <100 days, allogeneic prohibited).
Administration Dosage
.
Related Clinical Trial
NCT Number NCT01209130  Clinical Status PHASE1
Clinical Description An Open-Label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics of Escalating Doses of DCDT2980S in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia And DCDT2980S in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non Hodgkin's Lymphoma
Primary Endpoint
DLTs will be monitored continuously throughout the study to evaluate treatment safety and tolerability, with data collected until early discontinuation if applicable.
Other Endpoint
Objective tumor response (CR/PR) will be assessed per standard criteria as a key efficacy measure, with evaluations ongoing until study completion or patient discontinuation.
Experiment 2 Reporting the Activity Date of This ADC [3]
Patients Enrolled
Eligible patients require ECOG 0-2, measurable r/r NHL/DLBCL (&ge;1 lesion >1.5cm), and archived tissue. Key exclusions: prior mAb/ADC &le;4 weeks, chemo/RT &le;2 weeks, unresolved grade >2 AEs (excluding neuropathy), allo/auto-SCT within 100 days, active CNS lymphoma, or live vaccines &le;28 days.
Administration Dosage
Pinatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycle.
Related Clinical Trial
NCT Number NCT01691898  Clinical Status PHASE1|||PHASE2
Clinical Description A Randomized, Open-Label, Multicenter, Phase II Trial Evaluating the Safety and Activity of Pinatuzumab Vedotin (DCDT2980S) in Combination With Rituximab or Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab and a Non-Randomized Phase Ib/II Evaluation of Polatuzumab Vedotin in Combination With Obinutuzumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
Primary Endpoint
Tumor response endpoints will evaluate OR (CR/PR) per modified Cheson criteria (NHL) in rituximab/polatuzumab vedotin arms (A/B, Cohort C) and PET/CT-based CR (Lugano 2014) in obinutuzumab cohorts (E/G/H), with secondary assessments of DOR, PFS, OS, and progression rates across 3.5-5.5 years follow-up.
Other Endpoint
Immunogenicity (ADAs against pinatuzumab/polatuzumab vedotin/obinutuzumab) and pharmacokinetics (AUCinf, Cmax, CL, t½, Vss of rituximab/ADCs, plus MMAE-conjugated/unconjugated drug levels) will be serially monitored through 1.5-5.5 years to assess treatment sustainability and exposure-response relationships.
Experiment 3 Reporting the Activity Date of This ADC [4]
Efficacy Data Objective Response Rate (ORR)
36.00
50.00 %
Patients Enrolled
Relapsed/refractory (r/r) diffuse diffuse large B-cell lymphoma (DLBCL), iNHL (including follicular lymphoma, marginal zone lymphoma, and small lymphocytic lymphoma), mantle cell lymphoma (MCL), and chronic lymphocytic leukemia (CLL), and for whom no suitable therapy of curative intent or higher priority existed.
Administration Dosage
Intravenously over 30-90 minutes in 21-day cycles, starting dose of 0.10 mg/kg.
Related Clinical Trial
NCT Number NCT01209130  Clinical Status Phase 1
Clinical Description An open-label, multicenter, phase 1 trial of the safety and pharmacokinetics of escalating doses of DCDT2980S in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma and chronic lymphocytic leukemia and DCDT2980S in combination with rituximab in patients with relapsed or refractory B-cell non Hodgkin's lymphoma.
Primary Endpoint
On the basis of these observations, while 3.20 mg/kg did not exceed the protocol-defined MTD.
Experiment 4 Reporting the Activity Date of This ADC [5]
Efficacy Data Objective Response Rate (ORR)
54.05
66.67 %
Patients Enrolled
R/R diffuse large B-cell lymphoma (DLBCL), R/R follicular lymphoma (FL).
Administration Dosage
PiV + RTX (ADC 2.40 mg/kg + RTX 375 mg/m2) every 21 days.
Related Clinical Trial
NCT Number NCT01691898  Clinical Status Phase 1
Clinical Description A randomized, open-label, multicenter, phase 2 trial evaluating the safety and activity of pinatuzumab vedotin (DCDT2980S) in combination with rituximab or polatuzumab vedotin (DCDS4501A) in combination with rituximab and a non-randomized phase 1b/2 evaluation of polatuzumab vedotin in combination with obinutuzumab in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.
Primary Endpoint
For R/R DLBCL, ORR=51.35% (N=19/37, 95% Cl, 34.00-68.00), CR rate=13.51% (N=5/37, 95% Cl, 5.00-29.00) and PR rate=37.84% (N=14/37,95% Cl, 23.00-55.00) in patients treated with PoV (CD79b) + RTX. For R/R DLBCL, ORR=54.05% (N=20/37,95% Cl, 37.00-71.00),CR rate=18.92% (N=7/37,95% Cl, 8.00-35.00) and PR rate=35.14% (N=13/37,95% Cl, 20.00-53.00) in patients treated with PiV (CD22) + RTX.

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Other Endpoint
For R/R FL, ORR=60.00% (N=12/20,95% Cl 36.00-81.00), CR rate=30.00% (N=6/20, 95% Cl 12.00-54.00) and PR rate=30.00% (N=6/20,95% Cl 12.00-54.00) in patients treated with PoV (CD79b) + RTX. For R/R FL, ORR=66.67% (N=14/21,95% Cl 43.00-85.00), CR rate=4.76% (N=1/21, 95% Cl 0.10-24.00) and PR rate=61.90% (N=13/21,95% Cl 38.00-52.00) in patients treated with PiV (CD22) + RTX.

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Experiment 5 Reporting the Activity Date of This ADC [6]
Efficacy Data Objective Response Rate (ORR)
60.00
62.00 %
Patients Enrolled
Relapsed or refractory diffuse large B-cell lymphoma or relapsed or refractory grade 13a follicular lymphoma.
Administration Dosage
R-pina (375 mg/m2 rituximab plus 24 mg/kg ADCs) every 21 days until disease progression or unacceptable toxicity up to 1 year.
Related Clinical Trial
NCT Number NCT01691898  Clinical Status Phase 1
Clinical Description A randomized, open-label, multicenter, phase 2 trial evaluating the safety and activity of pinatuzumab vedotin (DCDT2980S) in combination with rituximab or polatuzumab vedotin (DCDS4501A) in combination with rituximab and a non-randomized phase 1b/2 evaluation of polatuzumab vedotin in combination with obinutuzumab in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.
Primary Endpoint
Pr=60.00%, CR=26.00% for large B-cell lymphoma. PR=62.00%,CR=70.00% for follicular lymphoma.
References
Ref 1 DCDT2980S, an anti-CD22-monomethyl auristatin E antibody-drug conjugate, is a potential treatment for non-Hodgkin lymphoma
Ref 2 A Study of the Safety and Pharmacokinetics of Escalating Doses of DCDT2980S in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia And DCDT2980S in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non Hodgkin's Lymphoma
Ref 3 A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)
Ref 4 Phase I Study of the Anti-CD22 Antibody-Drug Conjugate Pinatuzumab Vedotin with/without Rituximab in Patients with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma. Clin Cancer Res. 2017 Mar 1;23(5):1167-1176.
Ref 5 Preliminary results of a phase II randomized study (ROMULUS) of polatuzumab vedotin (PoV) or pinatuzumab vedotin (PiV) plus rituximab (RTX) in patients (Pts) with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL). Journal of Clinical Oncology 32, no. 15_suppl (May 20, 2014) 8519-8519.
Ref 6 Polatuzumab vedotin or pinatuzumab vedotin plus rituximab in patients with relapsed or refractory non-Hodgkin lymphoma: final results from a phase 2 randomised study (ROMULUS). Lancet Haematol. 2019 May;6(5):e254-e265.