Immuno-Oncology Resource Center
Immuno-Oncology Resource Center
July 01, 2020
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FDA approves Bavencio for first-line maintenance of advanced bladder cancer

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The FDA approved avelumab for the first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma, according to a press release from the manufacturer.

This approval of avelumab (Bavencio, Pfizer), a PD-L1 antibody, is indicated for patients who have not progressed on first-line platinum-containing chemotherapy.

The FDA based its decision, in part, on data from the phase 3 JAVELIN Bladder 100 study, presented during the ASCO 2020 Virtual Scientific Program. As Healio previously reported, results of that study showed the addition of avelumab to best supportive care as first-line maintenance yielded a 7.1-month improvement in OS (21.4 months vs. 14.3 months; HR = 0.69; 95% CI, 0.56-0.86).

Photo of Petros Grivas
Petros Grivas

“As the first immunotherapy to demonstrate a statistically significant improvement in OS in the first-line setting in locally advanced or metastatic urothelial carcinoma, the FDA approval of avelumab is one of the most significant advances in the treatment paradigm in this setting in 30 years,” Petros Grivas, MD, PhD, one of the principal investigators in the JAVELIN Bladder 100 trial, said in the release. “With median OS of more than 21 months measured from randomization, the longest OS in a phase 3 trial in advanced urothelial carcinoma, the JAVELIN Bladder 100 regimen with avelumab as a first-line switch maintenance treatment has the potential to become a new standard of care based on its proven ability to reinforce the benefit (response or stable disease) of induction chemotherapy and extend the lives of patients with this devastating disease.”

Twenty-eight percent of patients who received avelumab experienced a serious adverse event, the most common of which included urinary tract infection (6.1%), pain (3.2%), acute kidney injury (1.7%), hematuria (1.5%), sepsis (1.2%) and infusion-related reaction (1.2%).

The most common adverse events of any grade included fatigue, musculoskeletal pain, urinary tract infection and rash.

Avelumab received accelerated FDA approval in 2017 for the treatment of patients with locally advanced or metastatic urothelial carcinoma that progressed during or following platinum-containing chemotherapy, or who progressed within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Results of JAVELIN Bladder 100 verified the agent’s clinical benefit, and the FDA converted the accelerated approval to a full approval.