Lilly Reports Olomorasib Results, Eyes First Phase 3 Data In H1 2027

(RTTNews) - Eli Lilly and Company (LLY) recently announced updated data from studies of investigational olomorasib, a next-generation KRAS G12C inhibitor, in combination with immunotherapy, with or without chemotherapy, for first-line treatment of advanced KRAS G12C-mutant non-small cell lung cancer (NSCLC) at the ESMO Congress 2026.

In the Phase 1/2 LOXO-RAS-20001 trial and the safety lead-in portion of the Phase 3 SUNRAY-01 trial, olomorasib plus pembrolizumab without chemotherapy showed durable activity across PD-L1 expression levels.

Among 85 patients, median progression-free survival (PFS) and duration of response (DOR) had not been reached after a median follow-up of 20.7 months.

In a separate analysis of 77 patients receiving olomorasib with pembrolizumab, pemetrexed and platinum chemotherapy, the confirmed overall response rate was 62%, median DOR was 14.5 months, and median PFS was 11.6 months after a median follow-up of 18.7 months.

The safety profiles were consistent with previous reports, with no Grade 5 treatment-related adverse events in either analysis. For the combination without chemotherapy, the most common Grade 3 or higher treatment-related adverse events included increased alanine aminotransferase, increased aspartate aminotransferase and diarrhea. With chemoimmunotherapy, the most common Grade 3 or higher events included neutropenia, anemia, increased alanine aminotransferase and thrombocytopenia.

Lilly said the findings support continued evaluation of olomorasib in the Phase 3 SUNRAY-01 program. The company expects the first randomized Phase 3 data in first-line KRAS G12C-mutant NSCLC in the first half of 2027.

Olomorasib is an investigational oral KRAS G12C inhibitor and has not been approved for any use.

LLY on Friday closed at $1,273, down 2.54%. In the pre-market trading, shares are up 0.64% at $1,282.40.