October 10, 2016
By Alex Keown, BioSpace.com Breaking News Staff
KENILWORTH, N.J. – Merck ’s immuno-oncology drug Keytruda continues to show its strengths in targeting lung cancer. Trial data shows patients who took the drug as a first-line defense lived longer than those who received chemotherapy.
In data released Oct. 9 during a meeting of the European Society for Medical Oncology, Merck announced patients who took Keytruda, a PD-1 Inhibitor, lived 40 percent longer than those on chemo. In its announcement, Merck said about Keytruda extended life for about 10.3 months from the start of treatment, while patients on chemo lived for about six months. Keytruda, Merck said in a statement, “demonstrated superiority in overall survival (OS) at 18 months compared to standard of care chemotherapy (docetaxel) in patients with metastatic non-small cell lung cancer (NSCLC) previously treated with platinum-containing chemotherapy whose tumors expressed PD-L1 (tumor proportion score [TPS] of one percent or more), as well as patients with high levels of PD-L1 expression (TPS of 50 percent or more).” Overall, 66 percent of patients with metastatic NSCLC expressed any level of PD-L1, and 28 percent expressed high levels of PD-L1, Merck said. Additionally, about 45 percent of patients on Keytruda saw shrinkage in their tumors, compared to the 28 percent who were undergoing chemo, Merck said.
The success of Keytruda is good news for Merck as it looks to gain ground on Bristol-Myers Squibb and its immuno-therapy drug, Opdivo. Shares of Merck were up more than 2 percent this morning following the news, trading at $64.17 as of 11:53 a.m. Merck is looking for the U.S. Food and Drug Administration (FDA) to rule on Keytruda as a first-line treatment for lung cancer by Christmas. Keytruda has already been approved for lung cancer patients whose cancer got worse after chemotherapy.
“These findings—which show superior survival with longer follow-up across patients with PD-L1 expression (tumor proportion score of one percent or more), as well as improved quality of life—point to Keytruda as a durable treatment option for many previously treated patients with advanced non-small cell lung cancer,” Roy Herbst, professor of medicine and chief of medical oncology, Yale Cancer Center, said in a statement.
BMS’ Opdivo has had its own setbacks with lung cancer. In August, BMS announced Opdivo failed to meet its endpoints in a Phase III trial as a monotherapy for a “broad patient population” in patients with previously untreated advanced non-small cell lung cancer. The company said the drug failed to meet its endpoints of progression-free survival in patients expressing PD-L1 at 5 percent. However, in comparison, the Keytruda data was from a patient population expressing 50 percent PD-1 and not 5 percent, as the Opdivo trial.
In March 2015, Opdivo was approved for treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Opdivo is an immuno-therapy drug delivered via injection that harnesses the patient’s own immune system to fight cancerous cells. It was the first PD-1 inhibitor to receive regulatory approval.
Opdivo has an advantage over Keytruda, which requires patients pass a regulatory diagnostic before being prescribed the medication. BMS’ treatment does not have that restriction, which may make it preferable to prescribe.
