抗PD-L1抗体アベルマブ(バベンチオ®)+アキシチニブ(インライタ®)併用療法が未治療進行腎細胞がんのPFSを有意に延長【米・Pfizer】

 ドイツ・Merck社と米・Pfizer社は2018年9月11日、進行腎細胞がんの一次治療における抗PD-L1抗体アベルマブ+チロシンキナーゼ阻害薬(TKI)アキシチニブ併用療法の有効性および安全性について、スニチニブ単剤治療との比較により検証した第Ⅲ相試験JAVELIN Renal 101の結果から、無増悪生存期間(PFS)の有意な延長が認められたことを発表した。同試験の詳細結果については、近く開催される学会で発表される予定。がん種にかかわらず、第Ⅲ相試験において、免疫チェックポイント阻害薬とTKIの併用効果が認められたのは初めてだという。

 

 BAVENCIO® (AVELUMAB) PLUS INLYTA® (AXITINIB) SIGNIFICANTLY IMPROVED PROGRESSION-FREE SURVIVAL IN PREVIOUSLY UNTREATED PATIENTS WITH ADVANCED RENAL CELL CARCINOMA IN PHASE III STUDY

 Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE) today announced positive top-line results from the pivotal Phase III JAVELIN Renal 101 study evaluating BAVENCIO® (avelumab) in combination with INLYTA® (axitinib), compared with SUTENT® (sunitinib) as initial therapy for patients with advanced renal cell carcinoma (RCC). As part of a planned interim analysis, an independent Data Monitoring Committee confirmed that the trial showed a statistically significant improvement in progression-free survival (PFS) by central review for patients treated with the combination whose tumors had programmed death ligand-1‒positive (PD-L1+) expression greater than 1% (primary objective), as well as in the entire study population regardless of PD-L1 tumor expression (secondary objective). According to the statistical analysis plan, if PFS was statistically significant in the PD-L1+ subgroup, then PFS in the entire study population was to be analyzed for statistical significance. JAVELIN Renal 101 will continue as planned to the final analysis for the other primary endpoint of overall survival (OS). No new safety signals were observed, and adverse events for BAVENCIO, INLYTA and SUTENT in this trial were consistent with the known safety profiles for all three medicines. The alliance intends to pursue a regulatory submission in the US based on these interim results, and these results will be discussed with global health authorities. A detailed analysis will also be submitted for presentation at an upcoming medical congress.

 

コメント

Leave a comment

Your email address will not be published.


*