Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0PFKFR
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| ADC Name |
Pinatuzumab vedotin
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| Synonyms |
ACD22-VCMMAE; Anti-CD22-ADC; Anti-CD22-MCC-DM1; DCDT 2980S ADC; DCDT-2980S; DCDT2980S; FCU-2703; RG-7593; RO-5541072; RO-5541072-000; DCDT 2980S antibody-drug conjugate
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| Organization |
Genentech, Inc.
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| Drug Status |
Terminated in phase 2
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| Indication |
In total 3 Indication(s)
Diffuse large B-cell lymphoma [ICD11:2A81]
Terminated in phase 2
Follicular lymphoma [ICD11:2A80]
Terminated in phase 2
B-cell lymphoma [ICD11:2A86]
Terminated in phase 1
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| Drug-to-Antibody Ratio |
4
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| Structure |
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| Antibody Name |
Pinatuzumab
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Antibody Info | ||||
| Antigen Name |
B-cell receptor CD22 (CD22)
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Antigen Info | ||||
| Payload Name |
Monomethyl auristatin E
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Payload Info | ||||
| Therapeutic Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Mc-Val-Cit-PABC
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Linker Info | ||||
| Conjugate Type |
Random conjugation through reduced inter-chain cysteines.
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| Combination Type |
Vedotin
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| Puchem SID | ||||||
| Drugbank ID | ||||||
| ChEBI ID | ||||||
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
36.00% (DLBCL)
50.00% (iNHL) |
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| 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.
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| Administration Dosage |
Intravenously over 30-90 minutes in 21-day cycles, starting dose of 0.10 mg/kg.
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| 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.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
54.05% (R/R DLBCL, PiV% (CD22) + RTX)
66.67% (R/R FL, PiV% (CD22) + RTX) |
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| Patients Enrolled |
R/R diffuse large B-cell lymphoma (DLBCL), R/R follicular lymphoma (FL).
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| Administration Dosage |
PiV + RTX (ADC 2.40 mg/kg + RTX 375 mg/m2) every 21 days.
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| 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 3 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
60.00% (diffuse large B-cell lymphoma)
62.00% (follicular lymphoma cohort) |
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| Patients Enrolled |
Relapsed or refractory diffuse large B-cell lymphoma or relapsed or refractory grade 13a follicular lymphoma.
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| 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.
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| 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.
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References
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