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New Roche drug shrinks lung, bladder tumours

A view of the new ‘Bau 1’ office building of Swiss drug maker Roche in Basel. A lung cancer study found Roche’s Atezolizumab shrank tumours in as many as 27% of patients, Roche said in a statement yesterday.

Bloomberg
Geneva


Roche Holding, the world’s biggest maker of cancer drugs, said its experimental medicine atezolizumab shrank lung and bladder tumours in separate studies that the company plans to use to apply for US regulatory approval.
A lung cancer study dubbed Birch found the drug shrank tumours in as many as 27% of patients, Roche said yesterday in a statement. An update from another study called Poplar in patients whose lung cancer has returned after previous treatment showed those who had received atezolizumab lived 2.9 months longer than those who got chemotherapy. Both studies will be presented at the European Cancer Congress in Vienna.
 The company has said it plans to submit the drug for US regulatory approval next year. Roche is trailing Bristol-Myers Squibb Co, whose Opdivo was approved for lung cancer in March. Both medicines are part of a new category of therapies that harness the immune system to attack cancer. They may become a $100bn market by 2020, according to UBS AG.
“It’s all about getting these things to market, getting a filing under your belt,” Michael Leuchten, an analyst at Barclays Plc in London, said in a telephone interview.
Atezolizumab worked best for patients with the highest levels of PD-L1, a protein on the surface of cancer cells that prevents the immune system from attacking tumours and that the drug is designed to block. In the Birch study, the drug shrank tumours in 27% of those with high levels of PD-L1, compared with 17% of those with medium levels. Roche, based in Basel, Switzerland, said last month that the Birch study involving 667 people met its main goal, without giving details.
In the Poplar trial, those with medium to high levels of PD-L1 who received the drug lived 7.7 months longer than those who got chemotherapy, while those who lacked the protein had no benefit.
Lung cancer kills 1.6mn people globally each year, making it the leading cause of cancer death, according to the World Health Organization.
Roche also is developing atezolizumab as a treatment for bladder and breast cancer. Sales of the drug may reach 2.1bn Swiss francs ($2.1bn) by 2020, according to analysts’ estimates compiled by Bloomberg. In a third study of atezolizumab among 311 patients with a deadly and aggressive form of bladder cancer, 15% had shrinkage of their tumours, with the benefit rising to 27% for those with the highest levels of PD-L1, Roche said. That data also will be presented at the European Cancer Congress. Roche said in July that the drug had shrunk tumours, without offering more details.
The findings in bladder cancer put Roche in the lead for that disease over Bristol-Myers, Merck & Co and AstraZeneca Plc, which are all developing drugs that attack tumours by harnessing the immune system. The company has said it plans to submit the drug in early 2016.
“One of the reasons we are so excited about this data set is this is a really tough cancer for which there really haven’t been many improvements, beyond very difficult chemotherapy for patients, for about 30 years,” Sandra Horning, Roche’s chief medical officer, said in a phone interview before the data were presented.
Bristol-Myers’s Opdivo, which works in a similar way, may garner sales of $7.5bn by 2020, according to the average analyst estimate. Merck’s Keytruda was approved last year for skin cancer and is also being tested in lung cancer.
About 74,000 cases of bladder cancer will be diagnosed in the US this year, according to the American Cancer Society. About three in four cases are in men, whites are diagnosed twice as often as blacks, and the average age at diagnosis is 73. Smoking may increase the risk of bladder cancer.

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