Antibody Information
General Information of This Antibody
| Antibody ID | ANI0IESDV |
|||||
|---|---|---|---|---|---|---|
| Antibody Name | Pinatuzumab |
|||||
| Organization | Genentech, Inc. |
|||||
| Indication | Neoplasms |
|||||
| Antibody Type | Monoclonal antibody (mAb) |
|||||
| Antibody Subtype | Humanized IgG1-kappa |
|||||
| Antigen Name | B-cell receptor CD22 (CD22) |
Antigen Info | ||||
| Click to Show/Hide the Sequence Information of This Antibody | ||||||
| Heavy Chain Sequence |
EVQLVESGGGLVQPGGSLRLSCAASGYEFSRSWMNWVRQAPGKGLEWVGRIYPGDGDTNY
SGKFKGRFTISADTSKNTAYLQMNSLRAEDTAVYYCARDGSSWDWYFDVWGQGTLVTVSS ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS GLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGG PSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYN STYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREE MTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRW QQGNVFSCSVMHEALHNHYTQKSLSLSPGK Click to Show/Hide
|
|||||
| Light Chain Sequence |
DIQMTQSPSSLSASVGDRVTITCRSSQSIVHSVGNTFLEWYQQKPGKAPKLLIYKVSNRF
SGVPSRFSGSGSGTDFTLTISSLQPEDFATYYCFQGSQFPYTFGQGTKVEIKRTVAAPSV FIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSL SSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC Click to Show/Hide
|
|||||
Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
Pinatuzumab vedotin [Phase 1/2 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Eligible patients must have measurable relapsed/refractory hematologic malignancies (NHL, DLBCL, MCL, CLL) with ≥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).
|
||||
| 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 | [2] | ||||
| Patients Enrolled |
Eligible patients require ECOG 0-2, measurable r/r NHL/DLBCL (≥1 lesion >1.5cm), and archived tissue. Key exclusions: prior mAb/ADC ≤4 weeks, chemo/RT ≤2 weeks, unresolved grade >2 AEs (excluding neuropathy), allo/auto-SCT within 100 days, active CNS lymphoma, or live vaccines ≤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
Click to Show/Hide
|
||||
| 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 | [3] | ||||
| 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 | [4] | ||||
| 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.
Click to Show/Hide
|
||||
| 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.
Click to Show/Hide
|
||||
| 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.
Click to Show/Hide
|
||||
| Experiment 5 Reporting the Activity Date of This ADC | [5] | ||||
| 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.
Click to Show/Hide
|
||||
| Primary Endpoint |
Pr=60.00%, CR=26.00% for large B-cell lymphoma. PR=62.00%,CR=70.00% for follicular lymphoma.
|
||||
Anti-CD22- (LC:K149C)-SN36248 [Investigative]
Discovered Using Cell Line-derived Xenograft Model
| Experiment 1 Reporting the Activity Date of This ADC | [6] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 95.70% | Positive CD22 expression (CD22+++/++) | ||
| Method Description |
The inhibitory activity of thio-hu anti-CD22-(LC:K149C)-SN36248 against cancer cell growth was compared with a Pinatuzumab vedotin (pina) and polatuzumab vedotin (pola) against various human cancer cell lines in vitro.
|
||||
| In Vitro Model | EBV-related Burkitt lymphoma | Raji cells | CVCL_0511 | ||
| Experiment 2 Reporting the Activity Date of This ADC | [6] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 96% | Positive CD22 expression (CD22+++/++) | ||
| Method Description |
The inhibitory activity of thio-hu anti-CD22-(LC:K149C)-SN36248 against cancer cell growth was compared with a Pinatuzumab vedotin (pina) and polatuzumab vedotin (pola) against various human cancer cell lines in vitro.
|
||||
| In Vitro Model | Diffuse large B-cell lymphoma | WSU-DLCL2 cells | CVCL_1902 | ||
| Experiment 3 Reporting the Activity Date of This ADC | [6] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 96.70% | Positive CD22 expression (CD22+++/++) | ||
| Method Description |
The inhibitory activity of thio-hu anti-CD22-(LC:K149C)-SN36248 against cancer cell growth was compared with a Pinatuzumab vedotin (pina) and polatuzumab vedotin (pola) against various human cancer cell lines in vitro.
|
||||
| In Vitro Model | Burkitt lymphoma | BJAB.Luc-22R1.2 cells | CVCL_5711 | ||
| Experiment 4 Reporting the Activity Date of This ADC | [6] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 99.20% | Positive CD22 expression (CD22+++/++) | ||
| Method Description |
The inhibitory activity of thio-hu anti-CD22-(LC:K149C)-SN36248 against cancer cell growth was compared with a Pinatuzumab vedotin (pina) and polatuzumab vedotin (pola) against various human cancer cell lines in vitro.
|
||||
| In Vitro Model | Burkitt lymphoma | BJAB.Luc cells | CVCL_5711 | ||
References