KEY TAKEAWAYS
- The JAVELIN Bladder 100 trial (phase 3, NCT02603432) established that 1L cisplatin- or carboplatin-based chemotherapy followed by avelumab is for platinum-eligible patients with advanced UC.
- Post hoc analysis of long-term outcomes from the trial indicates that avelumab maintenance provides significantly longer OS and PFS from the start of maintenance in patients treated with 1L cisplatin + gemcitabine or carboplatin + gemcitabine.
- The safety findings of avelumab 1L maintenance were similar in both subgroups, indicating a favorable safety profile in patients with advanced UC.
- The overall population analysis of the trial showed that avelumab 1L maintenance provides a median OS of 29.7 months.
- The long-term follow-up from the JAVELIN Bladder 100 trial confirms the importance of avelumab maintenance as a treatment option for platinum-eligible patients with advanced UC.
The standard of care for platinum-eligible patients (pts) with advanced UC is 1L of cisplatin- or carboplatin-based chemotherapy followed by avelumab maintenance in pts without progression. On the basis of data from the phase 3 JAVELIN Bladder 100 study (NCT02603432), which compared avelumab maintenance plus best supportive care (BSC) to BSC alone (median OS, 23.8 vs. 15.0 months; HR, 0.76 [95% CI, 0.63-0.91]; p=0.0036), this is the case. Long-term results were analyzed retrospectively by 1L chemotherapy regimen and OS from the beginning of 1L chemotherapy.
Patients (n=350) with unresectable locally advanced or metastatic UC who did not progress after 4–6 cycles of 1L cisplatin + gemcitabine or carboplatin + gemcitabine were randomly assigned to receive avelumab + BSC (n=350) or BSC alone (n=350). Overall survival time was the major metric. Survival rates and side effects were secondary measures of success.
Both groups had a median follow-up time of 38 months from the time of randomization as of the data cutoff date (June 4, 2021). The avelumab + BSC arm had significantly better OS and PFS (measured from the start of maintenance [randomization]) than the BSC alone arm in the subgroups treated with 1L cisplatin + gemcitabine or carboplatin + gemcitabine (Table). However, the results for both groups’ safety were equivalent. Median overall survival from the beginning of 1L chemotherapy was 29.7 months (95% confidence interval [CI], 25.2-34.0) in the avelumab + BSC arm, and 20.5 months (95% CI [95% CI]; 0.635-0.921) in the BSC alone arm.
Patients with advanced UC who are progression-free following standard-of-care 1L cisplatin- or carboplatin-based chemotherapy receive equivalent OS and PFS advantages with avelumab 1L maintenance, with an acceptable safety profile, as shown by long-term follow-up from the JAVELIN Bladder 100 study. In addition, the median OS calculated from the initiation of chemotherapy sets a benchmark for future clinical trials and provides additional evidence for using avelumab 1L maintenance as the standard of treatment in this situation.
Source: https://meetings.asco.org/abstracts-presentations/216726
Clinical trial: https://clinicaltrials.gov/ct2/show/NCT02603432
No results DOI.
