Dr Gupta on the Background 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 background of the phase 3 JAVELIN Bladder 100 trial (NCT02603432) in patients with advanced urothelial carcinoma.

Long-term outcomes from the study presented in an exploratory subgroup analysis at the 2023 American Urological Association Annual Meeting showed that first-line maintenance therapy with avelumab (Bavencio) led to improved overall survival vs best supportive care (BSC) alone in patients with advanced urothelial carcinoma, regardless of whether patients experienced a complete or partial response to first-line chemotherapy.

The JAVELIN Bladder 100 trial was a pivotal study, which evaluated 700 patients who received avelumab plus BSC or BSC alone until progressive disease, unacceptable toxicity, or withdrawal from the trial. Prior data from the study supported the FDA approval of avelumab as maintenance treatment 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.

Prior to the approval of avelumab maintenance, the standard of care for patients who achieved a response was observation following 4 to 6 cycles of chemotherapy. Patients who progressed would then receive immunotherapy in the second line setting, which improved survival, Gupta explains. However, avelumab given prior to disease progression amplifies the survival benefit, Gupta notes. Notably, the use of up-front immunotherapy in combination with chemotherapy has not shown to improve outcomes vs chemotherapy alone, she says.

Since patients being treated in the second line and beyond do not always continue treatment, maximizing frontline treatment is vital to improve outcomes, Gupta concludes.