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FDA approves avelumab as frontline maintenance in urothelial carcinoma


The FDA has approved the PD-L1 inhibitor avelumab for the frontline maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma.

The FDA has approved the PD-L1 inhibitor avelumab (Bavencio) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.

The approval was based on results from the phase 3 JAVELIN Bladder 100 study, in which the median overall survival (OS) was 21.4 months with avelumab plus best supportive care (BSC) compared with 14.3 months with BSC alone. This 7.1-month benefit translated to a 31% reduction in the risk of death (HR, 0.69; 95% CI, 0.56-0.86; P <.001).

"As the first immunotherapy to demonstrate a statistically significant improvement in overall survival 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, stated in a press release.

"With median overall survival of more than 21 months measured from randomization, the longest overall survival 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,” added Grivas.

The open-label, international JAVELIN Bladder 100 trial included 700 patients with locally advanced or metastatic urothelial cancer who achieved a complete response (CR), partial response (PR), or stable disease (SD) after receiving 4 to 6 cycles of standard gemcitabine combined with either cisplatin or carboplatin.

Patients were randomized in a 1:1 ratio to intravenous avelumab (10 mg/kg every 2 weeks in 4-week cycles) plus BSC or BSC alone. Specific components of BSC could be correction of metabolic disorders, antibiotics, pain management, nutritional support, and symptom control.

The primary end point was OS, with key secondary end points including progression-free survival and safety.

The investigators reported that the avelumab OS benefit was observed across patient subgroups, including those defined by best response to treatment (CR, PR, or SD), and choice of frontline platinum chemotherapy (carboplatin or cisplatin).

Biomarker testing showed that 51% (n = 358) of patients were PD-L1 positive across the overall study population. In this subgroup, avelumab plus BSC induced a 44% reduction in the risk of death compared with BSC alone (HR, 0.56; 95% CI, 0.40-0.79; P <.001). An exploratory analysis was also conducted among PD-L1–negative patients (n = 271), showing a hazard ratio for OS of 0.85 (95% CI, 0.62-1.18).

According to a press release from EMD Serono (Merck KGaA) and Pfizer, the codevelopers of the PD-L1 inhibitor, adverse events (AEs) occurring in ≥20% of patients in the avelumab cohort were fatigue, musculoskeletal pain, urinary tract infection, and rash.

In the avelumab cohort, 28% of patients experienced serious AEs (sAEs). The most common (≥1%) sAEs in the avelumab group 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%). There was 1 AE-related death (sepsis) among patients receiving avelumab plus BSC.

"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," Rehan Verjee, president, EMD Serono and Global Head of Innovative Medicine Franchises for the Biopharma business of Merck KGaA, Darmstadt, Germany, stated in the press release.


FDA Approves BAVENCIO as First-Line Maintenance Treatment for Patients with Locally Advanced or Metastatic Urothelial Carcinoma. Posted June 30, 2020. https://prn.to/2ZvnzFA. Accessed June 30, 2020.

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