Dr. Sridhar on the Long-Term Data from the JAVELIN Bladder 100 Trial in Advanced Urothelial Carcinoma

Srikala Sridhar, MD, MSc, FRCPC, clinician investigator, Cancer Clinical Research Unit (CCRU), Princess Margaret Cancer, discusses long-term follow-up data from the phase 3 JAVELIN Bladder 100 (NCT02603432) in patients with advanced urothelial carcinoma.

The study compared first-line avelumab (Bavencio) maintenance therapy plus best supportive care vs best supportive care alone in patients with locally advanced or metastatic urothelial carcinoma.

At a median follow-up of 38 months in the avelumab arm and 39.6 months in the control arm, avelumab maintenance sustained a benefit vs best supportive care alone, Sridhar begins, adding that this benefit occurred regardless of whether patients received gemcitabine plus cisplatin or gemcitabine plus carboplatin as first-line chemotherapy.

Among all evaluable patients, the median overall survival (OS) was 23.8 months for the avelumab arm vs 15.0 months for the control arm. In patients who received the gemcitabine plus cisplatin, the median OS for the avelumab arm was 25.1 months compared with 17.5 months in the best supportive care arm. For patients treated with gemcitabine and carboplatin, the median OS for the avelumab arm and the control arm was 20.8 months and 13.0 months, respectively.

Sridhar and colleagues concluded that the long-term follow-up data further supported the use of first-line avelumab maintenance for patients who were progression-free following first-line chemotherapy, and these data should serve as the benchmark for ongoing and future clinical trial outcomes.

Sridhar notes that in her practice, she attempts to use a chemotherapy regimen featuring cisplatin when, and she ensures that patients are well hydrated and receive proper support. Although the Galsky criteria call for a creatinine clearance of at least 60 ml/min when determining if a patient is eligible to receive cisplatin, it may be beneficial to go down on the creatine cutoff to try to ensure that patients are able access to cisplatin and subsequently receive avelumab maintenance, Sridhar concludes.