MRK Merck and Co Inc

By Peter Loftus 

Patients with advanced lung cancer who took Merck & Co.'s immune-boosting drug Keytruda as their first treatment lived longer on average than those who received chemotherapy in a new study that could herald a big shift in treatment of the deadliest cancer.

The finding could lead to wider use of Keytruda and help Merck gain ground on rival Bristol-Myers Squibb Co. in the multibillion-dollar market for new drugs that fight cancer by harnessing patients' immune systems.

Bristol's immunotherapy Opdivo, which has so far outsold Keytruda, failed to significantly prolong survival beyond chemotherapy in a separate study of lung-cancer patients. Opdivo had global sales of $1.54 billion for the first six months of 2016, while Keytruda had sales of $563 million.

Both companies previously revealed limited results of their respective lung-cancer studies this year; researchers presented full results Sunday at a meeting of the European Society for Medical Oncology in Copenhagen, and Merck's study was published online by the New England Journal of Medicine.

Keytruda and Opdivo are approved in the U.S. to treat lung-cancer patients whose disease has progressed after prior chemotherapy treatment and for some other tumors. The drugs each cost more than $12,500 a month per patient.

Lung cancer is one of the most common types of cancer and causes the most deaths. About 224,390 new cases are expected in the U.S. this year, while about 158,080 people are expected to die from lung cancer, according to the American Cancer Society.

The Merck study tested Keytruda in patients with what is called non-small cell lung cancer, the most common type of the disease, which had spread to other parts of the body and hadn't yet been treated. For decades, the standard first-line treatment for these patients has been chemotherapy, but patients typically live only 12 to 14 months after starting treatment, according to Hossein Borghaei, a lung-cancer specialist at Fox Chase Cancer Center in Philadelphia.

About 80% of patients who took Keytruda were alive six months after the start of treatment, compared with 72% of those on chemotherapy.

Keytruda extended the time until death or disease progression to a median of 10.3 months from the start of treatment, versus six months for chemotherapy. Median overall survival of patients -- the point at which half lived longer, half lived less -- hadn't been reached as of the data-analysis cutoff, but typically this exceeds progression-free survival.

Nearly 45% of patients receiving Keytruda experienced significant tumor shrinkage, versus nearly 28% of the chemotherapy patients.

The 305 patients in the Merck study also had a high level of a substance known as PD-L1 in their tumors, which is believed to enhance the effect of drugs like Keytruda. Patients with high levels of this marker account for about 25% to 30% of all non-small cell lung cancers, said Roger Perlmutter, head of Merck's research and development unit, in an interview.

The study started in September 2014, and in June of this year it was stopped early on the recommendation of an independent monitoring committee because interim results showed that Keytruda was superior to chemotherapy. Patients who were taking chemotherapy were allowed to switch over to Keytruda.

Treatment-related side effects such as nausea and anemia occurred in 73% of patients receiving Keytruda, versus 90% for chemotherapy, though severe side effects occurred at a higher rate among chemotherapy patients.

The Keytruda study results "may establish a new standard of care" for first-line treatment of lung cancer patients whose tumors have high levels of PD-L1, Bruce E. Johnson, a lung-cancer specialist at Dana-Farber Cancer Institute in Boston, wrote in a NEJM editorial accompanying the Keytruda results.

Merck has applied for U.S. regulatory approval to market Keytruda as a first-line lung-cancer treatment; a decision is expected by Dec. 24.

Bristol-Myers tested Opdivo as a first-line treatment in a broader patient pool than Merck's study because the study also included patients with relatively low levels of PD-L1 in their tumors. The study found no significant difference in overall survival or progression-free survival between the groups. Median overall survival for Opdivo was 14.4 months, versus 13.2 months for chemotherapy, but the difference wasn't statistically significant.

The divergent outcomes between the Merck and Bristol studies could reinforce an emerging practice in medicine to identify certain biological traits of cancer and other diseases that can help predict which patients may benefit most from a drug.

Johan Vansteenkiste, a professor of medicine at University Hospitals Leuven in Belgium, said it is likely that Keytruda prolonged survival because the study only enrolled patients with high levels of PD-L1, whereas Opdivo likely failed because it also included those with lower levels.

Bristol still hopes its immunotherapies can play a role in first-line treatment of lung cancer. It is testing a combination of its drugs Opdivo and Yervoy in those patients, with results expected by early 2018, said Fouad Namouni, Bristol's head of oncology development.

In a separate study, lung-cancer patients receiving Roche Holding AG's immunotherapy Tecentriq after prior treatments had a median survival of 13.8 months, compared with 9.6 months for patients on chemotherapy. Roche has applied for U.S. regulatory approval of Tecentriq as a second-line lung-cancer treatment, and a decision is expected by Oct. 19.

Write to Peter Loftus at peter.loftus@wsj.com

(END) Dow Jones Newswires

October 09, 2016 02:29 ET (06:29 GMT)

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