Chi-Med to Discuss Select Global Clinical Trial Data Presented at ASCO20 - Seite 2

As of March 31, 2020, confirmed responses were seen in 49.2% of efficacy evaluable patients and disease control were seen in 93.4% of efficacy evaluable patients. 

Data were not mature for Duration of Response (“DoR”), Progression Free Survival (“PFS”) and Overall Survival (“OS”).  Median DoR was 9.6 months (95% confidence interval [“CI”] 5.5–not reached [“NR”]) with maturity of 40%.  Median PFS was 6.9 months (95% CI 4.2–19.3) with maturity of 50%. Median OS was 14.0 months (95% CI: 9.7–NR) with maturity of 46%.  Efficacy observations were consistent across subgroups in this analysis. 

Clinical data indicate an acceptable safety profile of savolitinib in patients with locally advanced or metastatic NSCLC who had MET exon 14 skipping mutations, with a low rate of adverse event (“AE”) related discontinuations of 14.3%.

On May 29, 2020, a new drug application (“NDA”) for savolitinib in this setting was accepted for review by the China National Medical Products Administration.

Presentation Title:	SAVOIR: A phase III study of savolitinib versus sunitinib in patients with MET-driven papillary renal cell carcinoma (“PRCC”)
Authors:	TK Choueiri, DYC Heng, JL Lee, M Cancel, RB Verheijen, A Mellemgaard, L Ottesen, MM Frigault, A L'Hernault, Z Szijgyarto, S Signoretti, L Albiges
Abstract Link:	5002

In this global study of savolitinib monotherapy compared with sunitinib in patients with MET-driven, locally advanced or metastatic PRCC, savolitinib demonstrated encouraging efficacy and an improved safety profile versus sunitinib (NCT03091192).  This Phase III study was stopped in late 2018 due to confounding results from a separate, external, retrospective observational study.  60 randomized patients (33 savolitinib, 27 sunitinib) were followed through August 19, 2019.  Although patient numbers and follow-up were limited, savolitinib demonstrated encouraging efficacy versus sunitinib, with fewer grade ≥3 AEs and fewer dose modifications.  Based on these data, AstraZeneca and Chi-Med are actively evaluating the opportunity to restart clinical work in PRCC for monotherapy savolitinib.