Amgen Says Imdeltra Lung Cancer Results Are 'Difficult To Overstate' As It Raises 2026 Guidance
Amgen is rushing worldwide filings for first-line Imdeltra after survival of 21.1 months versus 12.7 months, and lifted revenue guidance to $38.9 billion-$39.7 billion.
Amgen, the drugmaker behind Repatha, Otezla and Prolia, said on its third-quarter earnings call that first-line survival results for its small cell lung cancer drug Imdeltra are "difficult to overstate," and that it is working to file with regulators worldwide. Chief Financial Officer Thomas Dietrich, on his first call in the role, said the company is raising 2026 guidance to $38.9 billion to $39.7 billion in revenue.
A survival gain of more than eight months
Chairman and Chief Executive Robert Bradway said he was at the European Society for Medical Oncology Congress in Madrid when the Delphi 305 results were presented, and was moved by the audience's standing ovation. "The magnitude of these results is difficult to overstate," he said, calling more than eight additional months of median overall survival an extraordinary advance.
Jay Bradner, Executive Vice President of Research and Development and Chief Scientific Officer, said Imdeltra plus Infinzi produced median overall survival of 21.1 months, against 12.7 months for Infinzi alone, as first-line maintenance treatment. Median follow-up at the data cutoff was 15.9 months, and final survival results will be reported as the data mature.
Bradner also cited a Phase 1b first-line maintenance study with 30 months of follow-up, which showed median survival of 37 months. He called those results unprecedented in small cell lung cancer. If approved in first-line maintenance, he said, Imdeltra could address 23,000 U.S. patients, used earlier and for longer than in later-line therapy.
Safer, shorter monitoring
Imdeltra is Amgen's DLL3-targeted bispecific T-cell engager, approved for second-line or later small cell lung cancer. Murdo Gordon, Executive Vice President of Global Commercial Operations, said the FDA has already cut the monitoring period after first doses from the 22-to-24 hours in the original label to under six hours. In the Delphi 305 study, monitoring was one to two hours, he said.
Gordon said only one Delphi 305 patient had grade three cytokine release syndrome, with the rest at grades one and two. Field teams, he said, report that oncologists are "blown away" by the effect. Imdeltra sales more than doubled to $406 million in the quarter.
An Evercore ISI analyst asked whether the first-line maintenance market could reach 20,000-plus patients and $5 billion. Gordon said Amgen does not issue product-specific guidance, but put the addressable U.S. small cell population at 35,000.
Guidance raised, new CFO
Dietrich said 2026 adjusted (non-GAAP) earnings per share should land between $22.90 and $23.70. Third-quarter revenue grew 8% to $10.4 billion, Bradway said, and Amgen generated $3.7 billion in free cash flow.
Dietrich said he does not expect an operating margin step-down in 2027 from 2026 guidance, and that share repurchases should not exceed $3 billion this year.
The company is pursuing regulatory discussions and consideration by guideline groups including the NCCN. Detailed data on its Sjogren's drug dezodalibep will come at the ACR meeting on November 11.
Bradner said the Imdeltra program is also moving into earlier-stage disease, antibody-drug conjugate combinations and other DLL3-expressing cancers.
