Dr Gupta on First-line Avelumab Maintenance in Advanced Urothelial Carcinoma

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

JAVELIN Bladder 100 enrolled patients with unresectable, locally advanced or metastatic urothelial carcinoma who achieved a complete response (CR), partial response (PR), or stable disease (SD) with 4 to 6 cycles of standard first-line platinum-based chemotherapy who were randomized to receive either avelumab (Bavencio) plus best supportive care (BSC) or BSC alone until progressive disease, unacceptable toxicity, or withdrawal from the trial.

Preliminary findings from the study showed that, at a data cutoff date of October 21, 2019, the median overall survival (OS) was 21.4 months with avelumab vs 14.3 months with BSC alone. The median progression-free survival (PFS) was 3.7 months and 2.0 months in the avelumab and BSC arms, respectively.

At a median follow-up of 38 months, an exploratory analysis evaluating survival in subgroups stratified by response to first-line chemotherapy showed that the survival benefit with avelumab was maintained, particularly in patients who had achieved a CR with platinum-based chemotherapy. For these patients, the median OS with avelumab was 39.8 months vs 26.8 months for those who received BSC alone, Gupta says. In addition, those who had achieved best responses of PR and SD had a median OS of 19.2 months and 22.3 months with avelumab, respectively, vs 12.8 months and 14.0 months with BSC alone, respectively.

Overall, every patient who responded to platinum-based chemotherapy benefitted from avelumab maintenance, with the most pronounced benefit seen in those with CRs, Gupta emphasizes. Avelumab also provided a long-term PFS benefit in responders, Gupta notes. In patients who achieved a CR, PR, and SD, the median PFS was 9.5 months, 3.8 months, and 5.6 months with avelumab, respectively, vs 5.1 months, 1.9 months, and 2.0 months with BSC alone, respectively.

Regarding safety, avelumab maintenance in this population was not associated with any new long-term toxicities, and the safety profile aligned with prior findings with avelumab, Gupta explains. These long-term follow-up data provide level 1 evidence that avelumab maintenance is effective in patients who do not progress on platinum-based chemotherapy, Gupta concludes.

Disclosures: Dr Gupta reports consulting or advisory roles with Bayer; Bristol Myers Squibb; Gilead Sciences; Guardant Health; Merck & C in Kenilworth, NJ; Pfizer; the healthcare business of Merck KGaA in Darmstadt, Germany; and Seattle Genetics. Dr Gupta also reports speaker services from Bristol Myers Squibb, Gilead Sciences, Jannsen Oncology, and Seagen; as well as stock and other ownership interests with BioNTech, Moderna, and Nektar.