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.
- Both studies were single-arm, so they do not yet show olomorasib beats current treatments.
Eli Lilly (LLY) put fresh lung cancer data on the table Sunday at the European Society for Medical Oncology congress in Madrid. The focus was olomorasib, its experimental KRAS G12C inhibitor.
One study tested the pill with Merckās (MRK) Keytruda and chemotherapy in 77 patients who had not been treated before. Tumors shrank in 62% of them, or 48 patients.
Responses lasted a median of 14.5 months. Median progression-free survival came in at 11.6 months.
Progression-free survival tracks how long patients live without their cancer getting worse. Follow-up in this group was a median of 18.7 months.
Results Without Chemotherapy
A second study followed 85 patients on olomorasib plus Keytruda alone. After a median of 20.7 months, neither median response duration nor progression-free survival had been reached.
That is a good sign, since it means many patients were still responding. At 18 months, 55% were alive with no worsening of their cancer.
About 64% of these patients had PD-L1 expression of 50% or higher. Lilly said the activity held across PD-L1 levels.
Dr. Marcelo Negrao of MD Anderson presented the work. He said responses lasting more than a year, including in low-expression tumors, are the kind of progress doctors want in first-line care.
Jacob Van Naarden, who leads Lilly Oncology, said the first line is often the only line for these patients. He said the data deepen the companyās conviction in the drug.
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%. Doses were cut in 31.8% of patients, and 11.8% stopped treatment.
In the chemotherapy group, neutropenia hit 21% and anemia 17%. Increased ALT and low platelet counts each came in at 12%.
Dose reductions occurred in 19.5% of that group, and 7.8% stopped treatment. No Grade 5 events, meaning treatment-related deaths, occurred in either study.
What Comes Next
No targeted therapy is approved for first-line KRAS G12C lung cancer today. Standard care is immunotherapy with or without chemotherapy.
Both studies were single-arm, with no comparison group. It is too early to say olomorasib beats current options.
The Phase 3 SUNRAY-01 program is built to answer that. Part A tests olomorasib plus Keytruda against placebo plus Keytruda in patients with PD-L1 of 50% or higher.
Part B compares olomorasib plus chemoimmunotherapy with placebo plus chemoimmunotherapy, and it has finished enrolling. Olomorasib holds FDA Breakthrough Therapy designation for certain patients but remains unapproved.
Lilly expects the first randomized Phase 3 data from SUNRAY-01 in the first half of 2027.
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