Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC) in the JAVELIN Bladder 100 trial: Subgroup analysis by duration of treatment-free interval (TFI) from end of chemotherapy to start of maintenance.

Authors

null

Srikala S. Sridhar

Princess Margaret Cancer Center, University Health Network, Toronto, ON, Canada

Srikala S. Sridhar , Thomas Powles , Yohann Loriot , Miguel A. Climent Durán , Shilpa Gupta , Norihiko Tsuchiya , Aristotelis Bamias , Andrea Ardizzoni , Anders Ullén , Bo Huang , Nuno Matos Costa , Robert J Laliberte , Alessandra Di Pietro , Cora N. Sternberg , Petros Grivas

Organizations

Princess Margaret Cancer Center, University Health Network, Toronto, ON, Canada, Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St Bartholomew’s Hospital, London, United Kingdom, Gustave Roussy, INSERMU981, Université Paris-Saclay, Villejuif, France, Instituto Valenciano de Oncología, Valencia, Spain, Department of Hematology and Medical Oncology, Cleveland Clinic, Cleveland, OH, Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan, Alexandra General Hospital, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece, Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi, Bologna, Italy, Department of Pelvic Cancer, Genitourinary Oncology Unit, Karolinska University Hospital, Solna, Sweden, Pfizer, Groton, CT, Pfizer, Porto Salvo, Portugal, Pfizer, Cambridge, MA, Pfizer srl, Milan, Italy, Englander Institute for Precision Medicine, Weill Cornell Medicine, Hematology/Oncology, New York, NY, University of Washington, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle, WA

Research Funding

Pharmaceutical/Biotech Company
Funded by Pfizer as part of an alliance between Merck KGaA, Darmstadt, Germany and Pfizer

Background: The phase 3 JAVELIN Bladder 100 trial, which enrolled patients (pts) with advanced UC that had not progressed with 1L platinum-containing chemotherapy, showed that maintenance therapy with avelumab + best supportive care (BSC) significantly prolonged overall survival (OS) compared with BSC alone (hazard ratio [HR], 0.69 [95% CI: 0.56, 0.86; 1-sided P= 0.0005]). However, the optimal timing for starting avelumab after completing 1L chemotherapy is unknown. In this post hoc analysis, we report efficacy by duration of the TFI from completion of 1L chemotherapy. Methods: In the JAVELIN Bladder 100 trial (NCT02603432), eligible pts had unresectable locally advanced or metastatic UC without disease progression following 4 to 6 cycles of 1L platinum-containing chemotherapy. Pts were randomized to receive avelumab + BSC (n = 350) or BSC alone (n = 350) after a TFI of 4 to 10 weeks from the last dose of chemotherapy. In this exploratory analysis, subgroups with a TFI of 4 to < 6 weeks ( < 42 days), 6 to < 8 weeks (42 to < 56 days), or 8 to 10 weeks (≥56 days) were evaluated. Results: In the avelumab + BSC and BSC alone arms, the TFI was 4 to < 6 weeks in 143 and 158 pts, 6 to < 8 weeks in 109 and 80 pts, and 8 to 10 weeks in 98 and 110 pts, respectively. Baseline characteristics in these subgroups were generally well balanced between arms. For both arms combined, however, the TFI 4 to < 6 weeks subgroup vs the other 2 subgroups included more pts with visceral metastases (57.8% vs 54.0% and 50.0%), an objective response with 1L chemotherapy (76.4% vs 69.3% and 68.3%), and an ECOG performance status of 1 (44.5% vs 33.3% and 35.6%). OS was prolonged with avelumab + BSC vs BSC alone in all subgroups; the HR was 0.76 (95% CI: 0.546, 1.059) in the TFI 4 to < 6 weeks subgroup (median OS, 19.9 months [95% CI: 16.3, 25.3] vs 13.5 months [95% CI: 11.7, 17.4]), 0.64 (95% CI: 0.404, 1.021) in the TFI 6 to < 8 weeks subgroup (median OS, 26.1 months [95% CI: 19.9, not estimable] vs 21.0 months [95% CI: 10.7, not estimable]), and 0.70 (95% CI: 0.468, 1.035) in the TFI 8 to 10 weeks subgroup (median OS, 20.1 months [95% CI: 13.8, not estimable] vs 14.1 months [95% CI: 11.7, 19.6]). Conclusions: In patients with advanced UC that had not progressed with 1L platinum-containing chemotherapy, avelumab 1L maintenance prolonged OS irrespective of the TFI assessed in this study (4-10 weeks), supporting this new treatment strategy as a standard of care. Differences in duration of TFI were likely related to individual patient- and disease-specific characteristics or logistics and did not impact the OS benefit observed with avelumab 1L maintenance. Clinical trial information: NCT02603432

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Abstract Details

Meeting

2021 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Genitourinary Cancer—Kidney and Bladder

Track

Genitourinary Cancer—Kidney and Bladder

Sub Track

Bladder Cancer

Clinical Trial Registration Number

NCT02603432

Citation

J Clin Oncol 39, 2021 (suppl 15; abstr 4527)

DOI

10.1200/JCO.2021.39.15_suppl.4527

Abstract #

4527

Poster Bd #

Online Only

Abstract Disclosures