Polatuzumab vedotin Approved ADC

Antibody Information

Entry ID	130
INN	Polatuzumab vedotin
Status	Approved
Drug code(s)	RG7596, DCDS4501A
Brand name	POLIVY
mAb sequence source	mAb humanized
General Molecular Category	ADC
Format, general category	Full length Ab conjugate
Format details	None
Isotype (Fc)	IgG1
Light chain isotype	kappa
Linker	Valine-Citrulline, mc-val-cit PABC, Cleavable linker
Ave. DAR	3 to 4 drugs per mAb
Conjugated/fused moiety	Tubulin inhibitor, Monomethyl auristatin E (MMAE)
Discovery method/technology	None

Therapeutic information

Target(s)	CD79b
Indications of clinical studies	Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Follicular Lymphoma or Diffuse Large B-Cell Lymphoma
Primary therapeutic area	Cancer

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

Most advanced stage of development (global)	Approved EU, US, Japan, Australia
Status	Active
Start of clinical phase (IND filing or first Phase 1)	January 07, 2011
Start of Phase 2	September 15, 2012
Start of Phase 3	November 15, 2017
Date BLA/NDA submitted to FDA	December 19, 2018
Year of first approval (global)	2019
Date of first US approval	June 10, 2019
INN, US product name	Polatuzumab vedotin, polatuzumab vedotin-piiq
US or EU approved indications	US: First approval for Diffuse Large B-cell Lymphoma, not otherwise specified (POLIVY is indicated in combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least two prior therapies.). US supplemental approvals for: Diffuse Large B-cell Lymphoma, not otherwise specified, or high-grade B-cell lymphoma (HGBL) (POLIVY is indicated: in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater; or, in combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory DLBCL, NOS, after at least two prior therapies.) [as of April 19, 2023 label]. EU: First approval for Diffuse Large B-cell Lymphoma (POLIVY in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL). POLIVY in combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant.) [as per EPAR - Product information last updated on March 22, 2023].

Company information

Company	Hoffmann-La Roche
Licensee/Partner	None
Comments about company or candidate	Approved in EU January 16, 2020. Feb 19, 2019: Roche today announced that the FDA has accepted the company’s Biologics License Application (BLA) and granted Priority Review for polatuzumab vedotin in combination with bendamustine plus Rituxan® (rituximab) (BR) for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The FDA is expected to make a decision on approval by 19 August 2019.Polatuzumab vedotin granted Breakthrough Therapy Designation by the FDA and PRIME (PRIority MEdicines) designation by the European Medicines Agency for the treatment of people with relapsed or refractory DLBCL; US and EU orphan drug designations for diffuse large B-cell lymphoma. NCT03274492 Phase 3 in Diffuse Large B-Cell Lymphoma recruiting as of Nov 15, 2017. NCT01691898 Phase 2 study active but not recruiting as of Aug 2017
Full address of company	Basel, Switzerland Europe Switzerland https://www.roche.com/about

Description/comment

DAR: ave 3-4; mc-val-cit PABC linker

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None