271O - Interim analysis (IA) of SPADE: A prospective, real-world study of avelumab first-line maintenance (1LM) treatment in patients (pts) with locally advanced or metastatic urothelial carcinoma (la/mUC) in the Asia-Pacific (APAC) region

Background

In the JAVELIN Bladder 100 global phase III trial, avelumab 1LM + best supportive care (BSC) significantly prolonged overall survival vs BSC alone in pts with la/mUC that had not progressed with 1L platinum-based chemotherapy (PBC), with consistent findings observed in pts enrolled in Asia. We report an IA of SPADE, a noninterventional study evaluating pt characteristics, treatment patterns and outcomes, and pt-reported outcomes with avelumab 1LM in the APAC region.

Methods

Pts have unresectable la/mUC (stage IV), no disease progression after 1L PBC, and planned avelumab 1LM treatment (800 mg intravenously every 2 weeks or per local authorization). Data sources include medical records from routine clinical care. Treatment outcomes will be analyzed after 12 months of follow-up in all pts. In this IA, baseline characteristics and treatment patterns of initial pts were analyzed descriptively.

Results

At data cutoff (4 April 2024), 91 pts (of 286 planned) had been enrolled. Avelumab 1LM treatment was ongoing in 61 (67.0%), not yet received in 1 (1.1%), and discontinued in 29 (31.9%; due to disease progression [n=22], adverse event [n=1], and other reasons [n=6]). Characteristics of treated pts are shown in the table. Median duration of avelumab 1LM was 98 days (range, 14-352). 1 pt died (due to disease progression). 27/29 pts (93.1%) who discontinued avelumab received second-line treatment, most commonly paclitaxel (n=7) and enfortumab vedotin (n=6). Table: 271O

Conclusions

SPADE is the first prospective study to assess avelumab 1LM treatment in the APAC region. Among initial pts assessed in this IA, 26% received >6 PBC cycles, contrary to guidelines. Most pts who discontinued avelumab received second-line treatment. Enrollment is ongoing in Australia, Hong Kong, India, Malaysia, Singapore, South Korea, and Taiwan.

Clinical trial identification

Editorial acknowledgement

Medical writing support was provided by Jamie Ratcliffe of Nucleus Global.

Legal entity responsible for the study

Merck Pte. Ltd., Singapore (CrossRef Funder ID: 10.13039/100009945).

Funding

This study is funded by Merck Pte. Ltd., Singapore (CrossRef Funder ID: 10.13039/100009945) and was previously conducted under an alliance between Merck and Pfizer.

Disclosure

S.H. Park: Financial Interests, Personal, Other, Honoraria: Merck, Ono Pharmaceutical, Pfizer; Financial Interests, Personal, Speaker, Consultant, Advisor: Janssen Oncology; Financial Interests, Personal, Research Funding: Ono Pharmaceutical, Sanofi. M. Kim: Financial Interests, Personal, Speaker, Consultant, Advisor: Bristol Myers Squibb/Ono Pharmaceutical, Eisai, Ipsen, MSD, Yuhan. Y. Huang: Financial Interests, Personal, Other, Honoraria: Astellas Pharma, AstraZeneca, Bayer, Bristol Myers Squibb/Ono Pharmaceutical, Ipsen, Janssen, MSD, Novartis, Pfizer, Sanofi; Financial Interests, Personal, Speaker, Consultant, Advisor: Astellas Pharma, AstraZeneca, MSD. Y. Tsai: Financial Interests, Personal, Advisory Role: Astellas Pharma, AstraZeneca, Bristol Myers Squibb, Ipsen, Merck, MSD, Ono Pharmaceutical, Pfizer; Financial Interests, Personal, Speaker, Consultant, Advisor: Astellas Pharma, AstraZeneca, Bayer, Bristol Myers Squibb, Ipsen, Janssen, Merck, MSD, Ono Pharmaceutical, Pfizer. N. Oliveira: Financial Interests, Personal, Advisory Role: Eisai, Merck, MSD, Bristol Myers Squibb, Bayer, Astellas Pharma, Ipsen, Pfizer; Financial Interests, Personal, Steering Committee Member: MSD/IQVIA, Astellas Pharma, Janssen; Financial Interests, Personal, Other, travel and accommodation expenses: MSD, Ipsen, Bayer; Financial Interests, Personal, Speaker, Consultant, Advisor: Bayer, The Limbic, Eisai, Astellas Pharma, Janssen, MSD, Pfizer; Financial Interests, Institutional, Research Funding: Brandon BioCatalyst , Lions Club Australia. Y. Wang: Financial Interests, Personal, Full or part-time Employment: Merck Serono Co., Ltd., Beijing, China, an affiliate of Merck KGaA. J. Hoffman: Financial Interests, Personal, Full or part-time Employment: EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA; Financial Interests, Personal, Stocks or ownership: Merck, MSD, Pfizer. P.J. Su: Financial Interests, Personal, Advisory Role: Bristol Myers Squibb, Merck, Ono Pharmaceutical, Pfizer, MSD; Financial Interests, Personal, Speaker, Consultant, Advisor: Bristol Myers Squibb, Merck, MSD, Ono Pharmaceutical, Pfizer, Roche. All other authors have declared no conflicts of interest.