LONDON, UK I February 20, 2017 I Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) today announces that a Phase II study of savolitinib has been initiated in locally advanced or metastatic pulmonary sarcomatoid carcinoma (“PSC”) in China. Savolitinib is a highly selective and potent oral c-Met inhibitor with global first-in-class potential. The first drug dose was administered on February 10, 2017.
This Phase II study is a multi-center, single-arm, open-label study to evaluate the efficacy and safety of savolitinib as a monotherapy in treating locally advanced or metastatic PSC patients harboring mesenchymal epithelial transition (“Met”) gene alterations. The primary endpoint is objective response rate (ORR), with secondary endpoints including progression free survival (PFS), disease control rate (DCR), duration of response (DoR), overall survival (OS) and safety. Additional details about this study can be found at clinicaltrials.gov, using identifier NCT02897479.
About PSC and Met gene alterations
PSC is a rare subset of poorly differentiated non-small cell lung cancer (“NSCLC”). Containing a component with sarcoma-like (spindle and/or giant cell) features, PSC accounts for approximately 0.4% of all cases of lung cancer in the US, according to the Surveillance, Epidemiology and End Results database. These tumors are highly aggressive with outcomes significantly worse than other forms of NSCLC, and are more resistant to conventional chemotherapies1,2. There is no approved targeted therapy for this fatal disease.
The sarcomatoid component of some PSC tumors is believed to derive from carcinoma cells through the activation of Met. Met gene exon 14 skipping has been reported as one of the major genetic alterations in PSC, acting as a negative control in Met signaling. This genetic alteration has been found in approximately 20-30% of PSC patients3. As such, a highly selective c-Met inhibitor may provide clinically meaningful benefit to patients with PSC.
About Savolitinib
Savolitinib is a potential global first-in-class inhibitor of c-Met (also known as mesenchymal epithelial transition factor) receptor tyrosine kinase, an enzyme which has been shown to function abnormally in many types of solid tumors. It was developed as a potent and highly selective oral inhibitor specifically designed to address issues observed in the clinic with first-generation c-Met inhibitors, including renal toxicity.
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.
SOURCE: Chi-Med
Post Views: 15
LONDON, UK I February 20, 2017 I Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) today announces that a Phase II study of savolitinib has been initiated in locally advanced or metastatic pulmonary sarcomatoid carcinoma (“PSC”) in China. Savolitinib is a highly selective and potent oral c-Met inhibitor with global first-in-class potential. The first drug dose was administered on February 10, 2017.
This Phase II study is a multi-center, single-arm, open-label study to evaluate the efficacy and safety of savolitinib as a monotherapy in treating locally advanced or metastatic PSC patients harboring mesenchymal epithelial transition (“Met”) gene alterations. The primary endpoint is objective response rate (ORR), with secondary endpoints including progression free survival (PFS), disease control rate (DCR), duration of response (DoR), overall survival (OS) and safety. Additional details about this study can be found at clinicaltrials.gov, using identifier NCT02897479.
About PSC and Met gene alterations
PSC is a rare subset of poorly differentiated non-small cell lung cancer (“NSCLC”). Containing a component with sarcoma-like (spindle and/or giant cell) features, PSC accounts for approximately 0.4% of all cases of lung cancer in the US, according to the Surveillance, Epidemiology and End Results database. These tumors are highly aggressive with outcomes significantly worse than other forms of NSCLC, and are more resistant to conventional chemotherapies1,2. There is no approved targeted therapy for this fatal disease.
The sarcomatoid component of some PSC tumors is believed to derive from carcinoma cells through the activation of Met. Met gene exon 14 skipping has been reported as one of the major genetic alterations in PSC, acting as a negative control in Met signaling. This genetic alteration has been found in approximately 20-30% of PSC patients3. As such, a highly selective c-Met inhibitor may provide clinically meaningful benefit to patients with PSC.
About Savolitinib
Savolitinib is a potential global first-in-class inhibitor of c-Met (also known as mesenchymal epithelial transition factor) receptor tyrosine kinase, an enzyme which has been shown to function abnormally in many types of solid tumors. It was developed as a potent and highly selective oral inhibitor specifically designed to address issues observed in the clinic with first-generation c-Met inhibitors, including renal toxicity.
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.
SOURCE: Chi-Med
Post Views: 15
