JAVELIN Bladder 100: Sustained survival benefit with avelumab + BSC in Asians with advanced UC

Longer-term follow-up results of the JAVELIN Bladder 100 trial continue to show prolonged overall survival (OS) and progression-free survival (PFS) with avelumab first-line maintenance and best supportive care (BSC) among Asian patients with advanced urothelial carcinoma (UC) compared with BSC alone.

The previous analysis has already shown longer OS and PFS with avelumab + BSC compared with BSC alone among Asian patients with advanced UC. The data was consistent with that seen in the overall trial population, said lead author Dr Masatoshi Eto from the Department of Urology at Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan, at ESMO Asia 2022.

This subgroup analysis involved 147 Asian patients (enrolled from Hong Kong, India, Japan, South Korea, and Taiwan) with unresectable locally advanced or metastatic UC whose disease did not progress after 4–6 cycles of chemotherapy with gemcitabine in addition to cisplatin or carboplatin. Participants were randomized to receive first-line maintenance therapy with avelumab + BSC (n=73, mean age 69 years) or BSC alone (n=74, mean age 70 years). [ESMO Asia 2022, abstract 137MO]

After ≥2 years, OS remained longer in the avelumab + BSC arm compared with the BSC alone arm (median 28.7 vs 18.2 months; stratified hazard ratio [HR], 0.78). This OS benefit was consistent with that observed in the initial trial data on the Asian population (median 25.3 vs 18.7 months; HR, 0.74).

Moreover, the 24-month OS rate was higher among those treated with avelumab + BSC compared with BSC alone (60.7 percent vs 43.5 percent).

By ≥2 years, patients treated with avelumab + BSC continued to show prolonged PFS than those treated with BSC alone (median 5.6 vs 1.9 months; stratified HR, 0.58).

The objective response rate also remained numerically higher in the avelumab + BSC arm than in the BSC alone arm (9.6 percent vs 2.7 percent), with a disease control rate of 42.5 percent vs 25.7 percent, respectively.

In terms of safety, the most common treatment-emergent adverse events (TEAEs) of any grade in the avelumab + BSC arm were pyrexia (25.0 percent), nasopharyngitis (22.2 percent), and constipation (19.4 percent).

Anaemia (9.7 percent), increased amylase (5.6 percent), urinary tract infection (4.2 percent), and haematuria and fatigue (1.4 percent each) were the most common grade ≥3 TEAEs reported.

There were no new safety signals identified. The safety profile of avelumab + BSC in the Asian subgroup was consistent with that observed in the initial trial data, said Eto.