2020-07-05| Trials & Approvals

Bavencio Bags FDA Approval as First-line Maintenance Treatment for Urothelial Carcinoma

by Daniel Ojeda
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By Daniel Ojeda, Ph.D.

On June 30th, EMD Serono and Pfizer announced that the FDA has approved the supplemental Biologics License Application (sBLA) of BAVENCIO® (Avelumab) as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma.

Bladder cancer is the sixth most common type of cancer in the United States, and Urothelial Carcinoma (UC) is the predominant type accounting for about 90% of bladder cancers [1]. The American Cancer Society estimates that in 2020 there will be over 81,000 new cases and almost 18,000 deaths from bladder cancer [2]. Platinum-based chemotherapy is the current standard of care for people diagnosed with advanced UC. However, this does not eliminate the disease, and in most cases, cancer continues to spread within 9 months after treatment. Estimates suggest that only 5% of patients with advanced disease live longer than five years.

BAVENCIO® is a monoclonal antibody that binds to the programmed death ligand-1 (PD-L1) protein and blocks its interaction with its receptor. This removes a stop signal and allows the T-cells to mediate an antitumor response [3]. The drug is a result of an alliance between EMD Serono and Pfizer Inc.


Success in Phase III UC Trial

BAVENCIO® demonstrated the ability to reinforce the benefits of chemotherapy and significantly extend the lives of patients in a multicenter, multinational, randomized, open-label, parallel-arm Phase III clinical trial. The JAVELIN Bladder 100 (NCT02603432) study included a total of 700 patients with locally advanced or metastatic UC that did not progress with platinum-containing chemotherapy. Treatment with BAVENCIO®, in combination with best supportive care, resulting in an increase of the median overall survival of patients from 21.4 months on average vs. 14.3 months on average for patients that received the best supportive care alone. This represented a 31% decrease in the risk of death (HR 0.69; 95% CI: 0.56-0.86; P=0.001); in other words, it extended survival by 50%, approximately 7.1-months.

“With this approval for BAVENCIO, we have the opportunity to fundamentally shift the standard of care in the first-line setting of advanced bladder cancer. Our focus now is to work closely with the GU community to ensure that this novel and potentially life-changing treatment paradigm is rapidly integrated into clinical practice,” said Rehan Verjee, President, EMD Serono and Global Head of Innovative Medicine Franchises for the Biopharma business of Merck KGaA, Darmstadt, Germany.


Safety and Tolerance

The most common side effects include fatigue, musculoskeletal pain, nausea, decreased appetite, urinary tract infection, increased blood triglycerides and cholesterol, hemoglobin decrease, decrease in white blood cells, and others.

BAVENCIO® was first approved by the FDA in 2017 under the accelerated approval program, and after showing clinical benefit, it has received full approval. With this, BAVENCIO® has become the first, and only FDA approved immunotherapy to improve survival as a first-line setting in a Phase III clinical trial. Additionally, it received accelerated approval by the FDA for Merkel cell carcinoma in 2017, which is contingent upon the verification of clinical benefits in ongoing clinical trials [4].

Related Article: ASCO 2020: Maintenance Therapy with Avelumab Post-Chemo Improves Overall Survival of Bladder Cancer Patients



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