Roche Immune Drug Helps Patients With Aggressive Breast Cancers

(Bloomberg) -- Roche Holding AG’s Tecentriq medicine helps some people with the most aggressive form of breast cancer live longer, a study showed, the first time an immune therapy has proven effective against the most common tumor that women face.

A tissue test for a protein in the patients’ tumors, called PD-L1, showed who would probably benefit. That group in the clinical trial lived an average of 25 months when they got Tecentriq along with chemotherapy -- about 10 months longer than those who got only chemotherapy.

“I think it’s going to be very meaningful for a lot of the patients,” said Nadia Harbeck, head of the Breast Center at the University of Munich. “They will have hope now.”

The study will be a signpost for other drugmakers looking to expand use of immune therapies. For Roche, it’s a bright spot for an immune-oncology development program that has often been overshadowed by that of competitor Merck & Co. Selling Tecentriq to the patient group in the study could generate as much as 1 billion Swiss francs ($1 billion) in annual sales, said Dan O’Day, Roche’s pharmaceuticals chief.

Triple-Negative Cancer

“The data are really stunning,” O’Day said. Roche has filed the results with regulators. Next year it will take another look at the data for an update on how long patients lived, he said.

The trial included 902 people with what’s called “triple-negative” breast cancer, a rare form of the disease that often affects younger women. Chemotherapy is the main option doctors have to treat these patients once the tumors have spread, and it doesn’t work for long.

Roche was testing whether Tecentriq, a treatment designed to unleash the body’s immune system on tumors, could improve the prognosis. Such immune therapies are already used in skin, lung and other cancers but hadn’t yet been successful against breast tumors.

Adding Tecentriq to chemotherapy helped extend the time before patients’ cancer got worse by an average of 1.7 months in the study. But once doctors looked at the people whose tumors tested positive for PD-L1 -- about 40 percent of those in the trial -- they found a more dramatic difference.

Any New Option

The combination extended the time before tumors got worse by 2.5 months. Most notably, it extended survival from an average of 15.5 months in the chemotherapy-only group to an average of 25 months in the Tecentriq-plus-chemotherapy group, reducing the risk of death by 38 percent.

Right now, it makes sense to add Tecentriq to chemotherapy only for patients with the PD-L1 protein, said Peter Schmid, clinical director of London’s St. Bartholomew’s Breast Cancer Center, who led the study. “All the benefit was observed in the PD-L1 positive subgroup.”

Side effects in the study were mostly linked to chemotherapy, not the addition of immune therapy, according to the study authors.

Triple-negative breast cancer accounts for about 15 percent of all breast tumors, according to Roche. The company said it anticipates that about 40 percent of people with triple-negative breast cancer will test positive for the PD-L1 protein, making them potentially eligible to use Tecentriq if it wins regulatory approval.

“It’s really a situation where we would welcome any new option, and this is a good one,” said Solange Peters, an oncologist from the University of Lausanne and scientific chairwoman for the ESMO Congress, where the study was presented. The results were published simultaneously in the New England Journal of Medicine.

To contact the reporters on this story: Naomi Kresge in Berlin at nkresge@bloomberg.net;Tim Loh in Munich at tloh16@bloomberg.net

To contact the editors responsible for this story: Eric Pfanner at epfanner1@bloomberg.net, Marthe Fourcade, John Lauerman

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