Hutchison China MediTech Ltd. stopped enrolling patient for a phase 3 study of its drug savolitinib as a treatment for papillary renal cell carcinoma, or PRCC, due to a low likelihood of success.
PRCC is a difficult-to-treat kidney cancer that forms inside the lining of the kidney's tubules. The Hong Kong-based company started the study, dubbed as Savoir, in June 2017, to compare savolitinib with Pfizer Inc.'s Sutent in treating PRCC patients whose disease was triggered by a mutation in the MET kinase domain.
The main goal of the study for savolitinib was to surpass Sutent in progression-free survival, a parameter that gauges a drug's efficacy by measuring how long a patient lives with the disease without worsening conditions.
Chi-Med said based on further study of the genetic and environmental risk factors of the disease, the study is less likely to succeed in proving savolitinib as a first-line treatment for PRCC. The company is also unable to adjust the study to second-line due to minimal use of Sutent beyond initial treatment and because the number of MET positive PRCC patients is lower than expected.
Chi-Med said it will reassess its kidney cancer strategy for savolitinib. The drug is an inhibitor of c-MET, an enzyme which has been shown to function abnormally in many types of tumors.
Separately, the company also said it plans to submit new drug application for savolitinib in China in 2020 as a treatment for non-small cell lung cancer patients with MET Exon 14 deletion who have failed prior systemic therapy and not received chemotherapy. The submission is subject to phase 2 study results. MET Exon 14 deletion is a mutation on the MET gene.
Chi-Med also said it will continue enrolling patients in its clinical study that tests the combination of savolitinib and AstraZeneca PLC's Tagrisso in treating non-small cell lung cancer. The company presented initial data of the study, dubbed as Tatton at the World Conference on Lung Cancer in 2017 and plans to present complete data from the study in 2019.
Tagrisso, also known as osimertinib, was approved by the U.S. Food and Drug Administration as a treatment for patients with EGFR T790M mutation-positive non-small cell lung cancer in 2015.