Dr Gupta on Anticipated Real-world Benefit of the JAVELIN Bladder 100 Trial in Urothelial Carcinoma

Shilpa Gupta, MD, director, Genitourinary Medical Oncology, Taussig Cancer Institute, co-leader, Genitourinary Oncology Program, Cleveland Clinic, discusses the real-world benefit that may be derived based on findings from the long-term analysis of the phase 3 JAVELIN Bladder 100 trial (NCT02603432) in patients with advanced urothelial carcinoma.

At the 2023 American Urological Association Annual Meeting, investigators shared long-term data gleaned from an exploratory subgroup analysis of the phase 3 trial. Investigators noted that avelumab (Bavencio) used as a first-line maintenance therapy led to improved overall survival over treatment with best supportive care (BSC) alone in patients with advanced urothelial carcinoma. Notably, these responses were obtained regardless of whether patients experienced a complete or partial response to first-line chemotherapy.

The pivotal JAVELIN Bladder 100 trial evaluated 700 patients being treated with avelumab and BSC or BSC alone until their disease progressed, unacceptable toxicity, or withdrawal from the study. Additionally, prior data derived from the study supported the FDA approval of treatment with maintenance avelumab for patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-based chemotherapy. First-line platinum-based chemotherapy consisted of gemcitabine plus cisplatin or carboplatin in the study.

Moreover, it is expected that patients who benefit from frontline treatment approaches will most likely derive more benefit from leverage with immunotherapy, Gupta says. She notes that she will approach these patients with a preconceived understanding that platinum-based chemotherapy is still a frontline therapy option within this space. Even if stable disease is the patient’s best response seen, they may likely benefit from maintenance avelumab, Gupta adds.

However, if patients have a complete response and are still unsure of the reasoning they should receive any more therapy, these data will answer that question, Gupta emphasizes. Furthermore, evidence in the real-world shows that patients will benefit more from maintenance immunotherapy, even if they have no evident disease, Gupta concludes.