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Innovative Merck lung cancer therapy bests chemo in trial

Shares of Merck rose Thursday after the drugmaker said its Keytruda immuno-oncology medicine succeeded in a study of patients with advanced lung cancer and showed a survival advantage over patients given standard chemotherapy.

Shares of Merck rose Thursday after the drugmaker said its Keytruda immuno-oncology medicine succeeded in a study of patients with advanced lung cancer and showed a survival advantage over patients given standard chemotherapy.

Based on the results, an independent data monitoring board recommended that the clinical trial be stopped and that patients receiving chemotherapy be allowed to switch to the company's treatment.

Merck, based in Kenilworth, N.J., employs about 9,200 in West Point and Upper Gwynedd in Montgomery County.

Keytruda, a monoclonal antibody that works by increasing the ability of the body's immune system to help detect and fight tumor cells, is already approved for patients who have undergone previous chemotherapy for advanced non-small-cell lung cancer.

Patients in the latest study had not been treated previously for their disease.

The much-anticipated results showed "Keytruda beat chemotherapy head-to-head in first-line lung cancer," pharmaceutical analyst Timothy Anderson of Sanford C. Bernstein said in a client note. "Both the primary endpoint of progression-free survival and the secondary endpoint of overall survival were hit.

"Investors have been watching these results very closely," Anderson wrote.

Given that chemotherapy is the established treatment, he said, "beating chemotherapy head to head is no slam-dunk."

Merck's competitor in the same class of cancer medicines is Bristol-Myers Squibb's drug Opdivo.

Bristol Myers is conducting a similar patient trial using Opdivo, and results are expected in the third quarter.

"In the end, our belief is that there will not likely be just one standard of care that emerges," Anderson noted. "Rather, it will probably come down to physicians and patients having more choices, with relevant considerations including cost of therapy and safety and tolerability."

Merck said the positive Keytruda results "have the potential to change the therapeutic paradigm in first-line treatment of non-small cell lung cancer," said Roger M. Perlmutter, president of Merck Research Laboratories. "We look forward to sharing these data with the medical community and with regulatory authorities around the world."

Keytruda is currently approved to treat relapsed cases of late-stage lung cancer. The company plans to file for a label expansion, so that it could be used earlier as a treatment for the most common form of lung cancer.

Merck announced in April that the Food and Drug Administration had granted "breakthrough therapy designation" for Keytruda to treat relapsed classical Hodgkin lymphoma, a blood cancer.

The designation, intended to expedite the development and review of drugs that treat serious or life-threatening diseases or conditions, was the fourth "breakthrough therapy" status for Keytruda. The FDA earlier agreed to review the treatment for advanced melanoma, non-small cell lung cancer, and colorectal cancer.

Merck, whose shares closed up 2.51 percent, or $1.41, to $57.50, said it would release more details from the study at a future medical meeting.

lloyd@phillynews.com

215-854-2831

@LoydLinda