Shanghai: Tuesday, February 12, 2019: Hutchison MediPharma (“HMP”), the Innovation Platform of Hutchison China MediTech (“Chi-Med”), today announced the availability of preliminary results from the Phase II CALYPSO study of the savolitinib / Imfinzi® (durvalumab) combination in a cohort of patients with metastatic papillary renal cell carcinoma (“PRCC”), an investigator initiated study led by Professor Thomas Powles, Lead for Solid Tumour Research at Barts Cancer Institute, and sponsored by Queen Mary University of London.
Full data from the PRCC cohort of the CALYPSO study will be presented on Saturday, February 16, 2019, in oral and poster presentations at the annual American Society of Clinical Oncology Genitourinary Cancers Symposium (“ASCO GU”) in San Francisco, CA.
Further details from the presentation are as follows:
|Presentation Title:||A phase II study investigating the safety and efficacy of savolitinib and durvalumab in metastatic papillary renal cancer (CALYPSO)|
|First Author:||Thomas Powles, MD, PhD, FCRP|
|Oral Presentation:||Oral Abstract Session C: Renal Cell Cancer|
|Date & Time:||Saturday, February 16: 2:00 PM-3:30 PM PST|
|Poster Presentation:||Session C: Renal Cell Cancer|
|Date & Time:||Saturday, February 16: 7:00 AM-7:55 AM and 12:30 PM-2:00 PM PST|
About PRCC in the CALYPSO study
PRCC is a subtype of kidney cancer that is unusually difficult to treat, with low response rates from current treatment options and no treatments approved for this specific indication. The CALYPSO study is an independently sponsored open-label Phase II study of Imfinzi® in combination with several drug candidates in the treatment of renal cell carcinoma in the U.K. and Spain. Several arms of CALYPSO are evaluating the treatment of PRCC and clear cell renal carcinoma (ccRCC) with savolitinib, a highly selective inhibitor of the c-MET receptor tyrosine kinase, both as a monotherapy and in combination with Imfinzi® (durvalumab), AstraZeneca’s anti-programmed death-ligand 1 (“PD-L1”) antibody. CALYPSO enrolls an all-comer PRCC population with planned retrospective molecular profiling. For further details, please refer to clinicaltrials.gov number NCT02819596.
Savolitinib is a potential first-in-class inhibitor of c-MET, an enzyme which has been shown to function abnormally in many types of solid tumors. HMP designed savolitinib to be a potent and highly selective oral inhibitor, which, through chemical structure modification, addresses human metabolite-related renal toxicity, the primary issue that halted development of several other selective c-MET inhibitors. In clinical studies to date, involving over 700 patients, savolitinib has shown promising signs of clinical efficacy in patients with c-MET gene alterations in PRCC, NSCLC, colorectal cancer (CRC) and gastric cancer with an acceptable safety profile. HMP is currently testing savolitinib in partnership with AstraZeneca in Phase Ib/II studies, in multiple solid tumor indications, both as a monotherapy and in combinations.