In the JAVELIN Bladder 100 study, BAVENCIO plus best supportive care (BSC) significantly extended overall survival (OS) compared with BSC alone in the two primary populations of all randomized patients and patients whose tumors were PD-L1+, and significantly more patients who received BAVENCIO as first-line maintenance were alive at one year.1 The clinical benefits of BAVENCIO were seen across a range of patient populations.1,2
"These data, which supported the recent FDA approval and updates to NCCN and ESMO guidelines, establish that BAVENCIO first-line maintenance treatment could fundamentally change clinical practice for the treatment of patients with locally advanced or metastatic urothelial carcinoma," said Thomas Powles, MBBS, MRCP, MD, Professor of Genitourinary Oncology, Lead for Solid Tumour Research at Barts Cancer Institute, Queen Mary University of London, and Director of Barts Cancer Centre, London, UK. "It is notable that the longer overall survival with BAVENCIO maintenance therapy was observed across all pre-specified subgroups examined and that this prolonged overall survival was gained without a detrimental impact on patients' quality of life."Primary Analysis
In the JAVELIN Bladder 100 study, OS was significantly longer with BAVENCIO plus BSC compared to BSC alone in the primary population of all randomized patients (n=700) whose disease had not progressed on first-line platinum-containing chemotherapy:
- Median OS was 21.4 months (95% CI, 18.9 to 26.1) vs 14.3 months (95% CI, 12.9 to 17.9), respectively (HR 0.69; 95% CI, 0.56 to 0.86; P<0.001).1
- At one year, 71.3% of patients (95% CI, 66.0% to 76.0%) in the BAVENCIO arm were alive vs 58.4% (95% CI, 52.7% to 63.7%) of patients who received BSC alone.1
In the other primary population of patients with PD-L1+ tumors (n=358):
- OS was also significantly longer with BAVENCIO plus BSC vs BSC alone (HR 0.56; 95% CI, 0.40 to 0.79; P<0.001).1
- At one year, 79.1% (95% CI, 72.1% to 84.5%) of patients who received BAVENCIO were alive vs 60.4% (95% CI, 52.0% to 67.7%) in the BSC arm.1
All endpoints were measured from the time of randomization, after completion of four to six cycles of chemotherapy.
Results of an exploratory subgroup analysis show that consistent results were observed with the JAVELIN Bladder regimen of BAVENCIO first-line maintenance across pre-specified subgroups, including best response to first-line chemotherapy, type of chemotherapy regimen, site of baseline metastasis, and other baseline factors.1 In particular, hazard ratios for OS based on response to first-line chemotherapy were as follows:
- 0.69 for complete or partial response
- 0.70 for stable disease
With regard to first-line chemotherapy regimen, hazard ratios were as follows:
- 0.69 with gemcitabine plus cisplatin
- 0.66 with gemcitabine plus carboplatin
Further detail from the subgroup analysis were presented in an on-demand mini oral session at the meeting (Presentation #704MO). Additional data evaluating the association between clinical outcomes and exploratory biomarkers will be presented in the Proffered Paper 1 - GU, non prostate session on Saturday, September 19 (Presentation #699O), and patient-reported outcomes are featured in an on-demand e-poster display (Presentation #745P).
Source: Serono, EMD. 2020. "BAVENCIO Pivotal Phase III JAVELIN Bladder 100 Results Published In The New England Journal Of Medicine". Prnewswire.Com.
JAVELIN Bladder 100: Avelumab for Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma - Thomas Powles
Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma