Hutchison China MediTech Limited or Chi-Med, is an innovative biopharmaceutical company, announced that the final analysis of savolitinib in phase Ib TATTON study Parts B & D will be presented at the upcoming 2020 World Conference on Lung Cancer (WCLC 2020), taking place on January 28-31, 2021, virtually.
Savolitinib is an oral, potent, and highly selective small molecule inhibitor of MET, a receptor tyrosine kinase which has been shown to function abnormally in many types of solid tumors promoting tumor growth, angiogenesis, and metastasis. Savolitinib has been studied in over 1,000 patients to date. In clinical studies, it has shown promising clinical efficacy in patients with MET gene alterations in multiple tumor types with an acceptable safety profile.
In 2011, Chi-Med entered into a global licensing and joint development and commercialization agreement with AstraZeneca Plc for savolitinib. Savolitinib’s global development plan includes non-small cell lung cancer (NSCLC) and kidney cancer, and additional MET-driven tumors are being explored.
Savolitinib development in NSCLC: phase II in MET Exon 14 alteration NSCLC – In May 2020, data from an ongoing open-label, phase II registration study was presented as part of the American Society of Clinical Oncology 2020 Virtual Scientific Program (“ASCO 2020”). In patients with MET Exon 14 skipping alteration NSCLC in the efficacy evaluable population, savolitinib demonstrated a 49.2% objective response rate (“ORR”), a 93.4% disease control rate (DCR) and a 9.6 months interim duration of response (DoR). 36% of patients in the study have pulmonary sarcomatoid carcinoma (PSC), an aggressive subtype of NSCLC. Data were not yet mature for DoR, progression-free survival (PFS) or overall survival (OS). Clinical data indicated an acceptable safety profile, with a low adverse event (AE) related discontinuations rate of 14.3%. This data supported the China new drug application (NDA) acceptance in May 2020.
SAVANNAH phase II study of savolitinib in combination with Tagrisso in patients who have progressed following Tagrisso due to MET amplification or over expression – The SAVANNAH study is a single-arm, open-label study in epidermal growth factor receptor (EGFR) mutation positive NSCLC patients with MET amplified/overexpressed tumors following progression after treatment with Tagrisso, an EGFR-tyrosine kinase inhibitor owned by AstraZeneca.
Savolitinib development in kidney cancer:MET-driven papillary renal cell carcinoma (RCC) – In May 2020, data from 60 patients in the SAVOIR global study of savolitinib monotherapy compared with sunitinib monotherapy in MET-driven papillary RCC was presented at ASCO 2020. Savolitinib demonstrated encouraging activity, including an ORR of 27% versus 7% for sunitinib, with no savolitinib responding patients with disease progression at data cut-off, and an encouraging OS hazard ratio of 0.51 (95% CI: 0.21–1.17; p=0.110) with median not reached at data cut-off.
CALYPSO phase II of savolitinib in combination with Imfinzi PD-L1 inhibitor in RCC – The CALYPSO study is an investigator initiated open-label phase I/II study of savolitinib in combination with Imfinzi, a PD-L1 antibody owned by AstraZeneca. The study is evaluating the safety and efficacy of the savolitinib/Imfinzi combination in patients with papillary RCC and clear cell RCC.
Based on these data, AstraZeneca and Chi-Med are actively evaluating the opportunity to progress clinical work in papillary RCC for savolitinib.