DARMSTADT, GERMANY-- February 14, 2023 -- Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced findings of a new analysis of long-term follow-up data from the Phase III JAVELIN Bladder 100 trial. These analyses reinforce the proven survival benefits of BAVENCIO® (avelumab) in the first-line maintenance setting for patients with locally advanced or metastatic urothelial carcinoma (UC). With median follow-up of at least 38 months from randomization, patients who were progression-free following platinum-based chemotherapy who received BAVENCIO first-line maintenance plus best supportive care (BSC) had longer median overall survival (OS) than those who received BSC alone in the maintenance setting. This benefit was seen regardless of whether their initial chemotherapy regimens included cisplatin or carboplatin. This analysis, as well as multiple studies of BAVENCIO in the real-world setting, are being presented at the 2023 American Society of Clinical Oncology’s annual Genitourinary Cancers Symposium, February 16-18, 2023.

“Based on the significant improvement in overall survival demonstrated in the Phase III JAVELIN Bladder 100 study, platinum-based chemotherapy followed by avelumab maintenance treatment in patients without evidence of disease progression, has become a standard of care for advanced urothelial carcinoma. The findings presented today reinforce that all patients eligible for platinum-based chemotherapy, either cisplatin or carboplatin, can benefit from avelumab maintenance therapy. These findings reported here provide a reference point for outcomes of ongoing and future clinical trials in advanced bladder cancer,” said Srikala Sridhar, MD, MSc, FRCPC, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.

In the overall population, patients who received BAVENCIO plus BSC had a median OS of 29.7 months (95% CI, 25.2-34.0) as measured from the start of first-line chemotherapy, compared with 20.5 months (95% CI, 19.0-23.5) in patients who received BSC alone (HR, 0.77; 95% CI, 0.636-0.921). This result further supports the JAVELIN Bladder 100 regimen of BAVENCIO first-line maintenance in patients with advanced UC who are progression-free following first-line platinum-based chemotherapy as standard of care.

The analysis also confirmed that the overall survival of BAVENCIO first-line maintenance were similar regardless of whether patients received cisplatin- or carboplatin-based chemotherapy.

· In patients who received cisplatin plus gemcitabine (n=389), median OS from start of chemotherapy was 31.0 months (95% CI, 24.9-37.1) in the BAVENCIO plus BSC arm (n=183), compared with 23.0 months (95% CI, 19.2-30.9) for BSC alone (n=206) (HR, 0.79; 95% CI, 0.613-1.024).
· In patients who received carboplatin plus gemcitabine (n=269), median OS from start of chemotherapy was 25.8 months (95% CI, 22.8-33.3) for BAVENCIO plus BSC (n=147), compared with 17.6 months (95% CI, 14.8-21.3) for BSC alone (n=122) (HR, 0.69; 95% CI, 0.514-0.920).

Long-term safety was similar in both the cisplatin plus gemcitabine and carboplatin plus gemcitabine subgroups, with no new safety concerns identified. Grade 3 or greater treatment-related adverse events were 16 percent and 23 percent for cisplatin and carboplatin cohorts, respectively.

“BAVENCIO remains the only immunotherapy to show improved overall survival in advanced UC patients in the first-line maintenance setting in a Phase III trial. The large, randomized Phase III JAVELIN Bladder 100 trial established BAVENCIO first-line maintenance treatment following platinum-based chemotherapy as a standard of care, and long-term and real-world data such as these presented at ASCO GU 2023, continue adding to the evidence supporting its benefits for patients with advanced bladder cancer,” said Tamas Sütö, MD, PhD, Senior Vice President & Head of Medical Unit Oncology, Merck.

Additional data presented at the meeting include updates from real-world studies of patient populations in France, Italy, Germany, and the U.S. This includes the first full analysis from the AVENANCE real-world study investigating the efficacy and safety of BAVENCIO first-line maintenance therapy in advanced UC patients in France, and the READY study of real-world data from a compassionate use program in Italy, which supports the findings of JAVELIN Bladder 100 in real-world settings.

· In the ongoing (median follow-up 15.2 months) noninterventional AVENANCE study of 593 patients in France with advanced UC that had not progressed with first-line platinum-based chemotherapy who received BAVENCIO as a first-line maintenance treatment, median OS from start of BAVENCIO treatment was 20.7 months (95% CI, 17.1-not estimable) and the 12-month OS rate was 65.4% (95% CI, 61.0-69.4). Median progression-free survival (PFS) was 5.7 months (95% CI, 5.3-7.0).
· In the READY study of 464 patients in Italy who received BAVENCIO first-line maintenance treatment following platinum-based chemotherapy, median OS was not reached and the 12-month OS rate from the start of BAVENCIO treatment was 69.2% (95% CI, 64.8%-73.7%). The median PFS was 8.1 months (95% CI, 6.1-10.4) with a 12-month PFS rate of 44.3% (95% CI, 39.5-49.1).