Lung Cancer Drug From Merck Solidifies Lead in Crowded Field

(Bloomberg) -- In the race to dominate a crowded field of new cancer drugs, Merck & Co. is edging out rivals with data showing that its treatment Keytruda gave a group of patients with advanced lung cancer a better chance at living longer than chemotherapy did.

Keytruda helps turn the immune system on tumors, and in a trial of the drug presented at the American Society of Clinical Oncology meeting in Chicago, patients given Keytruda as a first treatment lived four to eight months longer than those on chemotherapy, the current standard of care.

The results add to a bevy of data from Kenilworth, New Jersey-based Merck showing that Keytruda is effective against the majority of advanced lung tumors -- results that helped the drug bring in $3.81 billion in sales last year. The data also create the opportunity for some patients to skip toxic chemotherapy.

A second study tested the drug in patients with the hard-to-treat squamous form of non-small cell lung cancer. It found that patients lived longer when given Keytruda as an initial treatment in combination with chemotherapy -- a first. It also reduced the risk of dying during the trial by 36 percent.

Similar drugs from Roche Holding AG, Bristol-Myers Squibb Co. and AstraZeneca Plc have yet to show such broad-based benefits.

“We have the data; we have demonstrated the efficacy of Keytruda broadly across five randomized trials, all positive,” said Roy Baynes, senior vice president of global clinical development at Merck Research Laboratories. “Oncology is a data-driven specialty and I think the data speak for themselves right now.”

Standard of Care

The studies also position immune therapy, which blocks a protein that helps tumors hide from the immune system, as the new standard of care for front-line treatment.

“Every patient like those in our study with newly diagnosed advanced lung cancer should get immunotherapy, some alone and some in combination with chemotherapy,” said Gilberto Lopes, associate director for global oncology at the Sylvester Comprehensive Cancer Center at the University of Miami, who is presenting the results of the first trial at the Chicago medical meeting. “Keytruda has been the first entrant in all these indications. It has a brand recognition that is hard to beat.”

Lung cancer is the second most common type of tumor in the U.S., following prostate in men and breast in women, with 234,000 new diagnoses expected in 2018, according to the American Cancer Society. It’s also the most deadly, killing 154,000 Americans each year.

Roche Drug

A separate study from Roche using its drug Tecentriq as a first-line treatment showed promise when it was combined with chemotherapy in the hard-to-treat patients with squamous cell cancer. The study included patients with genetic mutations that drove the disease, a group that previously didn’t respond to immunotherapy and were excluded from most other trials.

Tecentriq plus chemotherapy delayed progression of the disease to 6.3 months, from 5.6 months of those given chemotherapy alone. There was not yet any sign that the drug improved survival, though that angle is still being monitored. It did offer 22 percent greater survival when it was combined with two chemotherapy drugs and Avastin, the company’s medicine to cut off blood supply to a tumor, with even better results in patients whose cancer had spread to the liver or who had the genetic mutations.

Roche officials said it is too soon to rule out Tecentriq as the most effective first-line therapy for lung cancer, as it has several studies still underway. Of the company’s eight studies in the disease, three have results and all are positive.

“There is often a rush to oversimplification in this area,” said Dan O’Day, head of Roche’s pharmaceutical unit. “We are going to need more data to answer these questions. There will need to be a personalized approach to treating this disease -- you will not have a one-size-fits-all therapy.”

Biological Signal

Keytruda worked best in patients whose tumors had high levels of a protein, known as PD-L1, that helps the cancer hide from the immune system. Among patients who expressed 50 percent or more PD-L1, those given Keytruda lived on average for 20 months, versus 12.2 months for those on chemotherapy.

That benefit fell in patients with lower levels of PD-L1. For some of those patients, doctors may want to prescribe Keytruda in addition to chemotherapy, an already proven approach, he said.

“For the first time we can say that the majority of advanced non-small cell lung cancer patients can be treated with immunotherapy alone, instead of chemotherapy,” said John Heymach, chair of thoracic head and neck medical oncology at M.D. Anderson Cancer Center in Houston who reviewed the data on behalf of ASCO. “That’s a very strong appeal to patients. In addition to being more effective, it is significantly better tolerated.”

Drug companies are now rushing to try and to treat patients whose cancer has returned despite getting one of the new immune oncology drugs, Heymach said.

“So far there are no positive randomized studies yet for those patients, but this is where a lot of new immunotherapy drugs are banking their future,” he said.

While the treatments are getting better, most patients still don’t respond and eventually die of their disease, said Martin Edelman, chair of Hematology/Oncology at Fox Chase Cancer Center in Philadelphia.

“Despite these positive findings, it is clear that that there remains a substantial group of patients for whom therapy is primarily ineffective,” he said. “We are not curing anybody yet. Research in this space remains a huge area of potential.”

To contact the reporter on this story: Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net

To contact the editors responsible for this story: Drew Armstrong at darmstrong17@bloomberg.net, Keith Gosman

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