Roche Lung-Cancer Drug Doubles Survival Rate in Trial

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Roche Holding AG’s experimental immunotherapy for lung cancer doubled the likelihood of survival for some patients in a study, advancing development of a medicine that may help the Swiss drugmaker compete with Bristol-Myers Squibb Co. and Merck & Co.

In a mid-stage trial among 287 patients with non-small-cell lung cancer, those who received Roche’s MPDL3280A were as much as 53 percent less likely to die during the testing period than those who received an older chemotherapy drug, according to a summary of the results distributed Wednesday by the American Society of Clinical Oncology.

The drug harnesses the immune system to attack cancer, part of a new category of therapies that may become a $31 billion market by 2020, according to Goldman Sachs Group Inc. Roche is testing its drug in combination with other cancer therapies and plans to submit it for U.S. regulatory approval next year, said Sandra Horning, Roche’s chief medical officer.

“Roche comes out shining,” Jeffrey Holford, an analyst at Jefferies International Ltd., said in a note to investors. “We continue to expect an imminent filing” to regulators.

Roche’s medicine targets a protein called PDL1 on the surface of tumor cells that switches off the body’s immune response to cancers. The drug worked best in patients with the highest levels of the protein, while patients who didn’t have it had no benefit. Roche, based in Basel, Switzerland, is developing a PDL1 test to help determine which patients will benefit most from the drug.

Sales Forecasts

“The overall goal is to continue to raise the bar in lung cancer and get to a place where we can see high response rates,” Horning said in a telephone briefing before the results were announced. The data will be presented at the American Society of Clinical Oncology’s meeting that begins May 29 in Chicago.

The medicine may generate 1.9 billion Swiss francs ($2.1 billion) in sales by 2020, according to analyst estimates compiled by Bloomberg. The company is also developing the drug as a treatment for cancers of the breast and bladder.

Bristol-Myers’s Opdivo, which works in a similar way to treat lung cancer, won U.S. approval in March and may garner sales of $6.2 billion by 2020, according to the average analyst estimate. Merck’s Keytruda was approved in September for skin cancer and is being tested in lung cancer.

Shrinking Tumors

Another Roche drug, alectinib, shrank tumors in about half of lung cancer patients who had failed treatment with Pfizer Inc.’s Xalkori, according to data from two other studies to be presented at the meeting.

Alectinib also reduced the size of tumors in as many as 69 percent of patients whose cancer had spread to the brain or other parts of the central nervous system. Roche said it plans to submit data from both trials to the U.S. Food and Drug Administration this year.

Alectinib targets patients with a genetic mutation called ALK, which is responsible for about 5 percent of lung cancers. It will garner sales of about 183 million Swiss francs by 2020, according to analyst estimates. The drug was approved in Japan in July.

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