TLDR
- Eli Lilly (LLY) reported a 62% tumor response rate for olomorasib plus Keytruda and chemotherapy in first-line KRAS G12C lung cancer.
- Responses lasted a median of 14.5 months, and median progression-free survival was 11.6 months in the 77-patient study.
- Olomorasib plus Keytruda without chemotherapy had not reached median response duration or progression-free survival after 20.7 months.
- Randomized Phase 3 SUNRAY-01 results are expected in the first half of 2027.
- The data come from single-arm studies, so they do not yet prove olomorasib beats current treatments.
Eli Lilly (LLY) shared new lung cancer data on Sunday. The company presented results for its experimental drug olomorasib at the 2026 European Society for Medical Oncology congress in Madrid. The release did not include a stock price move.
The drug targets KRAS G12C, a mutation found in about 13% of non-small cell lung cancer patients. Olomorasib is an oral pill that locks the mutated protein in an inactive state. That stops the protein from sending growth signals to cancer cells.
One study covered 77 patients who had not been treated before. They received olomorasib with Merck’s (MRK) Keytruda and chemotherapy. Confirmed tumor shrinkage showed up in 62% of them, or 48 of 77 patients.
Responses lasted a median of 14.5 months. Patients went a median of 11.6 months before their cancer worsened or they died. That second measure is called progression-free survival.
Results Without Chemotherapy
A second study looked at 85 patients on olomorasib plus Keytruda alone. After a median follow-up of 20.7 months, median response duration and progression-free survival had not been reached. In plain terms, many patients were still doing well when the data were collected.
At 18 months, 55% of those patients were alive and their cancer had not worsened. Results held across PD-L1 levels. About 64% of patients in this group had PD-L1 expression of 50% or higher.
Dr. Marcelo Negrao of MD Anderson presented the work. He said responses lasting more than a year across all PD-L1 levels are the kind of progress doctors want in the first-line setting. He noted that many of these patients had low expression.
Jacob Van Naarden, who leads Lilly Oncology, said the first line is often the only line for these patients. That is because the disease is so aggressive. He said the results deepen the company’s conviction in the drug.
Safety Data
In the Keytruda-only group, the most common serious side effects were increased ALT at 15.3%, increased AST at 12.9% and diarrhea at 8.2%. Olomorasib doses were reduced in 31.8% of patients. Treatment was stopped in 11.8%.
In the chemotherapy group, the most common serious side effects were neutropenia at 21% and anemia at 17%. Increased ALT and low platelet counts each hit 12%. Dose reductions occurred in 19.5% of patients, and 7.8% stopped treatment.
No Grade 5 treatment-related events, meaning deaths, occurred in either group. The protocol does not require preventive medications for olomorasib. Lilly sees that as a possible edge over other drugs in this class.
What Comes Next
No targeted therapy is approved for first-line KRAS G12C lung cancer. Standard care is immunotherapy with or without chemotherapy. Most patients never reach second-line treatment.
Both studies were single-arm, with no comparison group. That makes it too early to say olomorasib improves on existing options. The Phase 3 trials are built to answer that question.
SUNRAY-01 is a global program with two randomized, double-blind Phase 3 trials. Part B, which tests olomorasib plus chemoimmunotherapy against placebo plus chemoimmunotherapy, has finished enrolling. Part A covers patients with PD-L1 of 50% or higher.
Olomorasib has FDA Breakthrough Therapy designation for certain lung cancer patients. It remains unapproved. Lilly expects the first randomized Phase 3 data from SUNRAY-01 in the first half of 2027.
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