The following article features coverage from the American Society of Clinical Oncology 2020 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.

Following chemotherapy for advanced urothelial carcinoma, first-line maintenance therapy with a combination of avelumab and best supportive care (BSC) is significantly associated with a 31% decreased risk of death compared with BSC alone, findings from the JAVELIN Bladder 100 trial, presented during the ASCO20 Virtual Scientific Program, demonstrated.1

Adding the checkpoint inhibitor avelumab to best supportive care (BSC) following chemotherapy for advanced urothelial carcinoma significantly improved overall survival (OS) compared with BSC alone.

In the randomized phase 3 JAVELIN Bladder 100 trial, the median OS was 21.4 months for patients treated with avelumab plus BSC compared with 14.3 months among those who received BSC alone, a team led by Thomas Powles, MD, PhD, director of Barts Cancer Centre in London, reported. Compared with BSC alone, avelumab combined with BSC was significantly associated with a 31% decreased risk of death (hazard ratio [HR], 0.69; 95% CI, 0.56-0.86; 1-sided P =.0005).

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Avelumab plus BSC also significantly improved OS compared with BSC alone among patients with PD-L1–positive tumors, significantly decreasing the risk of death by 44% (HR, 0.56; 95% CI, 0.40-0.79; 1-sided P =.0003). Median OS was 17.1 months in the BSC-only group and was not reached in the avelumab-BSC arm.

Additionally, compared with BSC alone, avelumab plus BSC was significantly associated with a 38% (HR, 0.62; 95% CI, 0.52-0.75) decreased risk of disease progression for all patients randomly selected for treatment, and by 44% (HR, 0.56; 95% CI 0.43-0.73) among patients with PD-L1–positive tumors.

“Overall, avelumab first-line maintenance therapy in patients whose disease has not progressed with platinum-based induction chemotherapy is a new first-line standard of care for advanced urothelial carcinoma,” Dr Powles said during a virtual press briefing.

The trial included 700 patients with unresectable locally advanced or metastatic urothelial carcinoma who had no disease progression following chemotherapy (gemcitabine with either cisplatin or carboplatin). Investigators randomly assigned 350 patients to receive BSC alone and 350 to receive avelumab plus BSC. The groups had a median follow-up period of 19.2 and 19.6 months, respectively. Of the 700 patients, 358 (51%) had PD-L1–positive tumors.

Although avelumab has been shown to be effective for metastatic urothelial carcinoma, the JAVELIN 100 trial provides the first data demonstrating the efficacy of avelumab as a first-line treatment in the maintenance setting.

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Grade 3 or higher adverse events (AEs) occurred in 47.4% of patients who received avelumab plus BSC compared with 25.2% of those who had BSC alone. The most common grade 3 or higher AEs were urinary tract infection, anemia, hematuria, fatigue, and back pain.

“In patients with advanced urothelial cancer, recurrence frequently happens following initial treatment with chemotherapy,” American Society of Clinical Oncology (ASCO) President Howard A. Burris III, MD, said in a press release.2 “This study shows the largest survival benefit seen to date in advanced urothelial cancer. When used as a maintenance therapy, avelumab significantly extended the period of time until recurrence.”

Disclosure: Pfizer funded the trial in partnership with Merck KGaA. For a full list of disclosures, please refer to the study abstract.

Read more of Cancer Therapy Advisor‘s coverage of the ASCO 2021 meeting by visiting the conference page.


  1. Powles T, Park SH, Voog E, et al. Maintenance avelumab + best supportive care (BSC) versus BSC alone after platinum-based first-line (1L) chemotherapy in advanced urothelial carcinoma (UC): JAVELIN Bladder 100 phase III interim analysis. Presented at: ASCO20 Virtual Scientific Program. J Clin Oncol. 2020;38(suppl):abstr LBA1.
  2. American Society of Clinical Oncology (ASCO). Immunotherapy following chemotherapy offers extended survival to patients with advanced urothelial cancer [press release]. Published May 28, 2020. Accessed May 31, 2020.