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(Alliance News) - Hutchmed (China) Ltd on Wednesday said it has started a China Phase 3 study of Orphathys in combination with AstraZeneca PLC's Tagrisso as a treatment for non-small cell lung cancer.
Hutchmed shares were up 5.6% to 504.70 pence each in London on Wednesdya morning.
The Hong-Kong based pharmaceutical company said the trial is a multi-centre, open-label, randomized, controlled study in patients with locally advanced or metastatic epidermal growth factor receptor mutation-positive non-small cell lung cancer with MET amplification after disease progression on EGFR inhibitor therapy.
MET is a tyrosine kinase receptor.
The study will evaluate the efficacy and safety of Orphathys in combination with Tagrisso compared to platinum-based doublet-chemotherapy, which is the standard-of-care treatment option currently.
Orphathys, whose generic name is savolitinib, was initially developed by Hutchmed and is now being jointly progressed by Astra and Hutchmed. It is currently being trialled singularly as a treatment for gastric cancer. Tagrisso is generically known as osimertinib and was developed by Astra to treat central nervous system growths.
The primary endpoint of the study is median progression free survival.
Other endpoints include median progression free survival, median overall survival, objective response rate, duration of response, disease control rate, time to response and safety.
Some 10% to 25% of NSCLC patients in the US and Europe and 30% to 40% of patients in Asia have EGFR-mutated NSCLC, while lung cancer in general is the leading cause of cancer death among men and women, accounting for about one-fifth of all cancer deaths.
Orphathys is a potent, oral drug that has demonstrated "clinical activity" in advanced solid tumors.
Tagrisso is a third-generation, irreversible EGFR tyrosine kinase inhibitor with clinical activity against central nervous system metastases.
Astra shares were down 0.3% to 8,451.00 pence each.
By Greg Roxburgh; gregroxburgh@alliancenews.com
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