Benmelstobart Combo: PFS Advantage for Advanced ccRCC
Summary of the ETER100 trial Findings on Benmelstobart & Anlotinib for Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
This article details the positive results of the phase 3 ETER100 trial (NCT04523272) investigating the combination of benmelstobart (TQB2450) and anlotinib (Fukewei) compared to sunitinib in Chinese patients with previously untreated advanced clear cell renal cell carcinoma (ccRCC).Key Findings:
Notable PFS Improvement: The combination of benmelstobart plus anlotinib demonstrated a statistically significant improvement in progression-free survival (PFS) compared to sunitinib. Median PFS was 19.0 months (HR 0.53, P < .0001) with the combination versus 9.8 months with sunitinib.
Higher Treatment Continuation: A greater percentage of patients in the benmelstobart arm (48%) were still receiving treatment at the interim analysis (22.8 months follow-up) compared to the sunitinib arm (21%). Favorable Subgroup Analyses: The combination showed benefits across various subgroups, including those with intermediate-poor risk according to the IMDC criteria and those with low PD-L1 expression.
Manageable Safety Profile: The combination was considered to have a manageable safety profile without new concerning signals.
Promising PFS rates: Kaplan-Meier estimates showed higher PFS rates at 12 months (65% vs 44%) and 24 months (42% vs 26%) for the combination versus sunitinib.
Study Details:
Trial Design: Open-label, phase 3, randomized 1:1 trial.
Participants: 527 Chinese patients (18-80 years old) with previously untreated advanced ccRCC.
Treatment Arms:
Combination: Benmelstobart (1200mg every 3 weeks) + Anlotinib (12mg daily for 2 weeks of each cycle)
Control: Sunitinib (50mg daily for 4 weeks of each 6-week cycle)
* Overall Survival (OS): Data was not yet mature at the time of the interim analysis.
Conclusion:
The ETER100 trial suggests that benmelstobart plus anlotinib is an effective and safe first-line treatment option for Chinese patients with advanced ccRCC, offering a significant improvement in progression-free survival compared to sunitinib.