ESMO 2021: Avelumab as the Basis of Neoadjuvant Chemotherapy Regimen in Platinum Eligible and Ineligible Patients with Non-Metastatic Muscle Invasive Bladder Cancer (NM-MIBC)

( Cisplatin-based neoadjuvant chemotherapy followed by radical cystectomy is a standard of care for non-metastatic muscle-invasive bladder cancer (MIBC). However, up to half of patients are not eligible for cisplatin-based chemotherapy. Neoadjuvant immune checkpoint inhibitors have shown anti-tumor activity in MIBC in multiple studies, both as monotherapy and in combination with chemotherapy. In this presentation, Dr. Nieves Martinez Chanza presented preliminary results from the AURA study, which studied the pathologic complete response rate with the addition of avelumab to neoadjuvant therapy in both cisplatin eligible and cisplatin-ineligible patients with MIBC.


The study schema is shown below for this non-comparative randomized phase 2 trial. Patients with confirmed pathologic MIBC were stratified by their cisplatin eligibility. This presentation specifically focused on cohort 1, with patients randomized 1:1 to avelumab plus either cisplatin/gemcitabine or dose-dense MVAC.

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A total of 56 patients were evaluable from cohort 1, with most patients identifying as male. Notably, the dose-dense MVAC cohort had numerically fewer T4 or node-positive tumors relative to the cisplatin/gemcitabine group.

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Overall, in cohort 1, 21 patient (38%) had a complete response (pCR). Though a non-comparative study, the pCR rate for dose-dense MVAC was numerically higher at 43% relative to cisplatin/gemcitabine at 32%.

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The cisplatin/gemcitabine cohort experienced higher rates of grade 3+ cytopenias relative to the dose-dense MVAC cohort. No patient failed to undergo surgery as a result of a treatment-emergent adverse event.

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Dr. Chanza concluded that the addition of avelumab immunotherapy to standard cisplatin chemotherapy was associated with pathologic complete response in most patients and did not compromise surgical resection.

Presented by: Nieves Martinez Chanza, MD, PhD, Medical Oncologist in the Oncology Medicine Department at the Jules Bordet Cancer Institute, Brussels, Belgium

Written by: Alok Tewari, MD, PhD – Genitourinary Medical Oncologist, Instructor in Medicine, Dana-Farber Cancer Institute, Harvard Medical School, Twitter: @aloktewar during the 2021 European Society for Medical Oncology (ESMO) Annual Congress 2021, Thursday, Sep 16, 2021 – Tuesday, Sep 21, 2021.