Olomorasib trial results announced by Eli Lilly on October 25, 2026, showed a 62% tumor response rate when the experimental drug was combined with immunotherapy and chemotherapy in previously untreated lung cancer patients. The Phase 2 findings support further testing in cancers carrying the KRAS G12C mutation, with Lilly expecting Phase 3 SUNRAY-01 results in early 2027.
Key Takeaways
- The Phase 2 combination study involved 77 previously untreated patients with KRAS G12C-mutated non-small cell lung cancer.
- Median progression-free survival was 11.6 months, a measure distinct from overall survival.
- The ongoing Phase 3 program will test whether adding olomorasib improves outcomes against control regimens.
Table of Contents
- Olomorasib trial findings show early treatment activity
- SUNRAY-01 tests the benefit of adding olomorasib
- Conclusion
Olomorasib trial findings show early treatment activity
Lilly presented the results at the European Society for Medical Oncology’s 2026 congress in Madrid. The study tested a combination containing olomorasib, a targeted treatment directed at KRAS G12C, rather than the experimental medicine alone.
The 62% tumor response rate indicates anticancer activity, but it does not establish how much benefit olomorasib adds to immunotherapy and chemotherapy. The available findings do not provide a control-group comparison or detailed safety results.
Median progression-free survival reached 11.6 months. This endpoint measures the time before cancer progresses or a patient dies; it should not be interpreted as evidence that the regimen extends overall survival.
For Lilly’s oncology pipeline, the central question is whether this early activity translates into a benefit in a larger controlled study. The Phase 2 results alone do not establish regulatory approval or commercial availability for the treatment under investigation.
| Item | Details |
|---|---|
| Investigational medicine | Olomorasib, a KRAS G12C inhibitor |
| Phase 2 announcement | October 25, 2026 |
| Phase 2 regimen | Olomorasib combined with immunotherapy and chemotherapy |
| Phase 3 identifier | SUNRAY-01, NCT06119581 |
SUNRAY-01 tests the benefit of adding olomorasib
Lilly’s SUNRAY-01 Phase 3 trial overview describes a global study in locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer. It compares olomorasib-containing regimens with corresponding placebo-containing regimens as first-line treatment.
One part tests olomorasib plus pembrolizumab in patients whose tumors have PD-L1 expression of at least 50%. Another tests olomorasib with pembrolizumab, pemetrexed and platinum chemotherapy regardless of PD-L1 expression.
These comparisons are designed to distinguish the contribution of olomorasib from that of the accompanying treatments. Lilly’s expectation of results in early 2027 is a development timetable, not a completed outcome or an approval date.
Conclusion
The olomorasib combination has shown Phase 2 activity, but its added benefit remains to be established. The next milestone is the SUNRAY-01 Phase 3 readout, which Lilly expects in early 2027.
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