Information Meeting on Polivy

Agenda

Moderator: Toshiya Sasai, Head of Corporate Communcations Dept.,

Chugai Pharmaceutical Co., Ltd.

1. Product Overview of Polivy

Dr. Takaki Koga, Polivy Lifecycle Leader, Chugai Pharmaceutical Co., Ltd.

  1. Treatment Options for Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) Koji Izutsu, M.D., Ph.D., Department of Hematology, National Cancer Center Hospital
  2. Q&A Session

1

Product Overview

Polivy® Intravenous Infusion

30 mg/140 mg

June 3, 2021

Dr. Takaki Koga

Polivy Lifecycle Leader

Chugai Pharmaceutical Co., Ltd.

Product Outline

[Brand name]

Polivy® Intravenous Infusion 30 mg Polivy® Intravenous Infusion 140 mg

[Generic name] polatuzumab vedotin (genetical recombination)

[Indications]

Relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL)

3

Development History

Mar. 2011 Global phase I study started by Roche

Jul. 2014 Phase I study started in Japan

Oct. 2014 Global phase Ib/II study started in patients with R/R FL and DLBCL (GO29365)

Jun. 2017 PRIME designation (Europe)

Sep. 2017 Breakthrough Therapy designation (US)

Oct. 2018 Phase II study (P-DRIVE) started in patients with R/R DLBCL in Japan

Jun. 2019 Accelerated approval in the US

Nov. 2019 Orphan drug designation in Japan

Jan. 2020 Approved in Europe

Jun. 2020 Application for approval in Japan (R/R DLBCL)

Mar. 2021 Approved in Japan (33rd in the world)

FL: Follicular lymphoma

DLBCL: Diffuse large B-cell lymphoma

PRIME: Priority Medicines

Cited from the interview form of Polivy intravenous infusion 30 mg/140 mg [prepared in May 2021 (Ver.3)]

4

Structure of Polivy (conceptual image)

Polivy is an antibody-drug conjugate (ADC) targeting CD79b1).

Binding site for CD79b2)

Fc domain (inactive)

Linkers cleavable by lysosomal protease3)

(Stable in circulating blood)

MMAE (monomethyl auristatin E):

Mitotic inhibitor that inhibits microtubule polymerization4)

1)Li D, et al. Br J Pharmacol. 2019; 176(19): 3805-3818. 2)Polson AG, et al. Expert Opin Investig Drugs. 2011; 20(1): 75-85.

3)Dornan D, et al. Blood. 2009; 114(13): 2721-2729. 4)Doronina SO, et al. Nat Biotechnol. 2003; 21(7): 778-784.

[COI: The literature 1, 2) includes the employees of Genentech. 5 The literature 3) includes the employees of Genentech and the authors funded by Genentech.]

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Chugai Pharmaceutical Co. Ltd. published this content on 03 June 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 03 June 2021 02:24:07 UTC.