AVENANCE : efficacité et tolérance en vie réelle d’avelumab en traitement d’entretien de première ligne (1LM) chez les patients atteints d’un carcinome urothélial avancé (aUC) et analyse exploratoire des traitements subséquents
P. Barthélémy , Y. Loriot , C. Thibault , M. Gross-Goupil , J.C. Eymard , E. Voog , C. Abraham , S. Le Moulec , M. Chasseray , A. Gobert , B. Auberger , C. Viala , M. Cabart , E. Kazan , V. Lorgis , W. Hilgers , C. Josse , P. Lambert , M.N. Solbes , A. Fléchon
Avelumab 1LM is the standard treatment for aUC without progression on first-line platinum-based chemotherapy (PBCT) (phase 3 JAVELIN Bladder 100 trial). The AVENANCE real-life study had already confirmed the effectiveness and safety of avelumab 1LM; we report an update of the data and analyzes according to second-line treatments.
Methods
The AVENANCE study (NCT04822350), non-interventional and ambispective, included patients with aUC without progression on first-line platinum PBCT and treated with avelumab 1LM. The primary endpoint was overall survival (OS).
Results
In all, 595 patients were included. With a median follow-up of 26,3 months (0.6–43.7), 125 patients (21.0%) continued treatment with avelumab. The reasons for stopping treatment were: progression (72.5%), adverse event (11.3%), death (9.4%), others (6.8%). In all, 330 patients (55.5 %) received second-line treatment after avelumab: chemotherapy in 244 (73.9%) pts, antibody conjugates (ADC) in 62 (18.8%), and other treatment in 24 (7.3%). The characteristics of patients who received ADC or second-line chemotherapy were generally similar; most had received chemotherapy with carboplatin + gemcitabine in the first line (62.3% vs. 63.6%), presented an ECOG 0/1 (81.6% vs. 82.3%) and had metastatic disease at the beginning of PCBT (96.8% vs. 95.0%).
Median overall survival from initiation of avelumab 1LM was 21.3 months (95% CI, 17.6–24.6). It was 31.3 months (29.1–NA) in patients who received a 2nd line ADC and 14.4 months (13.2–15.9) for those who received chemotherapy.
Conclusion
The new results from AVENANCE confirm the effectiveness of avelumab 1LM in the real-world population. In patients who received second-line treatment (approximately 70 % of patients who discontinued treatment), the current sequence with an ADC after first-line PBCT followed by avelumab 1LM showed encouraging overall survival.