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Attend this session at the
2019 ASCO Annual Meeting!


Session: Genitourinary (Nonprostate) Cancer

Type: Poster Session

Time: Monday June 3, 1:15 PM to 4:15 PM

Location: Hall A


Session: Genitourinary (Nonprostate) Cancer

Type: Poster Discussion Session

Time: Monday June 3, 4:30 PM to 6:00 PM

Location: Hall D2

A phase II study of RC48-ADC in HER2-positive patients with locally advanced or metastatic urothelial carcinoma.

Sub-category:
Bladder Cancer

Category:
Genitourinary (Nonprostate) Cancer

Meeting:
2019 ASCO Annual Meeting

Abstract No:
4509

Poster Board Number:
Poster Discussion Session (Board #335)

Citation:
J Clin Oncol 37, 2019 (suppl; abstr 4509)

Author(s): Xinan Sheng, Ai-Ping Zhou, Xin Yao, Yanxia Shi, Hong Luo, Benkang Shi, Jiyan Liu, Guohua Yu, Zhisong He, Changlu Hu, Weiqing Han, Jianmin Fang, Jun Guo; Peking University Cancer Hospital, Beijing, China; National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Tianjin Cancer Hospital, Tianjin, China; Sun Yat-Sen university Cancer Center, Guangzhou, China; Chongqing Cancer Hospital, Chongqing, China; Qilu Hospital of Shandong University, Jinan, China; West China Hospital, Sichuan University, Chengdu, China; Weifang People′s Hospital, Weifang, China; Peking University First Hospital, Beijing, China; Anhui Provincial Cancer Hospital, Hefei, China; Hunan Cancer Hospital, Changsha, China; School of Life Science and Technology, Tongji University, Shanghai, China; Peking University Cancer Hospital and Institute, Beijing Shi, China

Abstract Disclosures

Abstract:

Background: Urothelial carcinoma (UC) is the third largest cancer type with HER2 positive cancer. RC48-ADC is a novel humanized anti-HER2 antibody-drug conjugate (ADC). This study was to evaluate the activity of RC48-ADC in HER2-positive patients with locally advanced or metastatic urothelial carcinoma (mUC). Methods: This study is an open-label, multicenter, single-arm, non-randomized phase II study. Eligibility criteria include: histologically confirmed UC, HER2-positive (IHC 2+ or 3+), ECOG PS 0-1, treated with ≥1 prior systemic treatment. The patients received RC48-ADC treatment alone (2 mg/kg IV infusion, q2w) until disease progression, unacceptable toxicity, withdrawal, or study termination. The primary endpoint was objective response rate (ORR). Progress-free survival (PFS), overall survival (OS), and safety was also assessed. Results: Patient enrollment for this study was completed in November 2018. A total of 43 patients were enrolled, with a median age of 64 years old. At baseline, most patients (37/43) had visceral metastasis. Fourteen (32.6%) patients had received ≥ 2 lines treatment and 8 (18.6%) patients had prior immune checkpoint inhibitor (CPI) therapy in second line treatment. The objective response rate was 60.5% (95% CI: 44.4%, 75.0%) and the DCR was 90.7% (39/43). As of Jan 23, 2019, the median PFS for the overall study population was not yet reached, and the median PFS was 7.8 months (95% CI: 4.9, 10.7) for the 9 patients who started RC48-ADC prior to Jun 30, 2018. The ORR was 70.6% (12/17) in patients with HER2 FISH+ or IHC3+. The ORR was 64.9% (24/37) in patients with visceral metastasis and was 70.0% (14/20) in liver metastasis patients especially. The ORR was 64.3% in patients post to ≥ 2 lines treatment and 75.0% in patients post to immunotherapy. Common treatment-related AEs were leukopenia (51.2%), hypoesthesia (41.9%), alopecia (41.9%), neutropenia (37.2%), fatigue (34.9%), ALT increase (32.6%), and AST increase (32.6%); Most were Grade 1 or 2. Conclusions: RC48-ADC has demonstrated a clinically meaningful ORR of 60.5% in pretreated HER-2 positive mUC patients including those who underwent failure to the immunotherapy. Clinical trial information: NCT03507166

 
Other Abstracts in this Sub-Category:

 

1. CALGB 90601 (Alliance): Randomized, double-blind, placebo-controlled phase III trial comparing gemcitabine and cisplatin with bevacizumab or placebo in patients with metastatic urothelial carcinoma.

Meeting: 2019 ASCO Annual Meeting Abstract No: 4503 First Author: Jonathan E. Rosenberg
Category: Genitourinary (Nonprostate) Cancer - Bladder Cancer

 

2. Randomized double-blind phase II study of maintenance pembrolizumab versus placebo after first-line chemotherapy in patients (pts) with metastatic urothelial cancer (mUC): HCRN GU14-182.

Meeting: 2019 ASCO Annual Meeting Abstract No: 4504 First Author: Matt D. Galsky
Category: Genitourinary (Nonprostate) Cancer - Bladder Cancer

 

3. EV-201: Results of enfortumab vedotin monotherapy for locally advanced or metastatic urothelial cancer previously treated with platinum and immune checkpoint inhibitors.

Meeting: 2019 ASCO Annual Meeting Abstract No: LBA4505 First Author: Daniel Peter Petrylak
Category: Genitourinary (Nonprostate) Cancer - Bladder Cancer

 

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