Consistent overall survival benefit with frontline maintenance avelumab in locally advanced or metastatic urothelial cancer

March 2022 Pharma News Ariez

With extended follow-up of the JAVELIN Bladder 100 trial, the frontline maintenance combination of avelumab plus best supportive care (BSC) demonstrated a maintained overall survival benefit as compared to BSC alone in patients with unresectable locally advanced or metastatic urothelial cancer that had not progressed with first-line platinum-containing chemotherapy.

Previously, the phase 3 JAVELIN Bladder 100 trial showed significantly longer overall survival (OS) with avelumab plus best supportive care (BSC) vs. BSC alone in patients with advanced or metastatic urothelial cancer that had not progressed with first-line platinum-containing chemotherapy.1 At ASCO GU 2022, Prof. Powles reported long-term follow-up results with an additional 19 months of median follow-up from the initial analysis. In JAVELIN Bladder 100, 700 patients with unresectable locally advanced or metastatic urothelial cancer without disease progression after 4-6 cycles of first-line gemcitabine plus cisplatin or carboplatin were randomised (1:1) to receive avelumab plus BSC or BSC alone. Treatment was continued until disease progression, unacceptable toxicity or withdrawal.1,2

At the data cut-off (June 4, 2021), median follow-up in all randomised patients was 38.0 months with avelumab plus BSC and 39.6 months with BSC alone. With this longer follow-up, OS remained significantly longer in the avelumab plus BSC arm vs. BSC alone arm (mOS 23.8 vs. 15.0 months, HR[95%CI]: 0.76[0.631-0.915], p= 0.0036). The 2- and 3-year OS rates with avelumab plus BSC were 49.8% and 36.0%, respectively, as compared to 38.4% and 29.8% in the BSC-alone arm. OS was also prolonged in avelumab plus BSC vs. BSC alone for patients with PD-L1+ tumours. OS favoured avelumab plus BSC vs. BSC alone across most subgroups, as for example type of first-line chemotherapy. The investigator-assessed progression-free survival (PFS) was 5.5 months in the avelumab plus BSC arm and 2.1 months in the control arm, translating into a 46% reduction in the risk of disease progression or death (HR[95%CI]: 0.54[0.457-0.645], p< 0.0001). The corresponding 2- and 3-years PFS rates were 23.4% and 15.9%, respectively for avelumab plus BSC and 7.1% and 5.3% for BSC alone. Long-term safety of avelumab first-line maintenance was demonstrated, with 19.5% of patients receiving at least two years of treatment and a low rate of discontinuation due to treatment-related adverse events. No new safety signals were identified.2

Conclusion

Updated results from the JAVELIN Bladder 100 trial further support the recommendation of avelumab first-line maintenance as standard of care for patients with advanced urothelial cancer that has not progressed with first-line platinum-containing chemotherapy.

References

  1. Powles T, et al. Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2020;383:1218-30.
  2. Powles T, et al. Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC): Long-term follow-up results from the JAVELIN Bladder 100 trial. Presented at ASCO GU 2022;Abstract 487.

SmPC Bavencio: https://www.e-compendium.be/nl/bijsluiters/wetenschappelijk/6771

BE-AVEBL-00125-03.2022

X