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combination regimens on newly diagnosed advanced lung cancer patients. Merck’s regimen of pembrolizumab (Keytruda) and chemotherapy is in the lead as the only immunotherapy approved as a first-line treatment for all non-small cell lung cancer patients. As Xconomy reported, lung cancer experts are scrambling to understand how each regimen might be best deployed.
ASCO provided a few new tidbits. In a closely watched Merck study called Keynote-042, encouraging topline results from a few months ago yielded to a more complicated picture. Used alone, pembrolizumab is already approved for NSCLC in patients who have high levels (more than 50 percent) of the protein PD-L1 on their tumors. Merck would like to expand the label to patients with lower levels of PD-L1, but the new Keynote-042 data “show some of the inconsistencies we’ve seen” with other immunotherapies in first-line lung cancer, wrote ISI Evercore analyst Umer Raffat in a research note.
For instance: Patients on pembrolizumab whose tumors produced at least 1 percent PD-L1 lived a median of 16.7 months, compared to a median of 12.1 months for chemo patients. Among these patients, pembrolizumab reduced the risk of disease worsening or death by 19 percent, compared to chemo. But for only those whose PD-L1 levels are between 1 and 49 percent—the group pembrolizumab monotherapy isn’t approved for—the risk of disease worsening or death was cut by only 8 percent.
Merck also detailed the results from Keynote-407, which tested pembrolizumab and chemotherapy in patients with the aggressive squamous form of NSCLC. Raffat noted that the regimen worked “across PD-L1 status,” and while caveats apply, appears to compare favorably to Bristol and Roche combination regimens for squamous patients. Pembro-chemo cut the risk of death by 36 percent in all patients, and by 39 percent in patients whose tumors didn’t express even 1 percent PD-L1.
Bristol, meanwhile, added new details from the Checkmate-227 study of nivolumab and its other FDA-approved immunotherapy, ipilimumab (Yervoy). Among the new insights: How patients in the study with different TMB or PD-L1 levels fared, and more granular details about nivo-ipi’s effects versus a nivo-chemo regimen. And Roche added data from IMpower131, another immunotherapy-chemo combination, meanwhile, which cut the risk of disease worsening or death by 29 percent. Still, Jefferies analyst Ian Hilliker noted last week that Merck’s regimen, which cut the risk of death in half, has “set the efficacy bar.” For Roche to directly compete, a better comparison might be Roche’s IMpower132, which tests atezolizumab with the same chemotherapy used in Merck’s regimen.
Merck shares climbed 2.4 percent on Monday.
—Shares of Waltham, MA-based Deciphera Pharmaceuticals (NASDAQ: DCPH) climbed nearly 48 percent after releasing data from a Phase 1 study testing experimental DCC-2618 in patients with gastrointestinal stromal tumors who have failed at least one treatment. (Blueprint Medicines is also developing a drug for GIST.)
—Jounce Therapeutics shares plummeted 33 percent on early data from a study testing its experimental JTX-2011 both as a monotherapy and in combination with Bristol’s nivolumab.
Alex Lash contributed to this report.
Photo of Chicago skyline by Tony Webster via a Creative Commons 2.0 license.