Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2026

First-line (1L) olomorasib + chemoimmunotherapy (chemo-IO) in KRAS G12C-mutant NSCLC: updated results from the LOXO-RAS-20001 and SUNRAY-01 trials (146287)

Marcelo Negrao 1 , James Uyeki 2 , Irfan Cicin 3 , Yuanbin Chen 4 , Byoung Shim 5 , Masafumi Yamaguchi 6 , Timothy Burns 7 , Garrett Sherwood 8 , Jun Sakakibara-Konishi 9 , Konstantin Dragnev 10 , Natraj R. Ammakkanavar 11 , Victor T. G. Lin 12 , So Yeon Kim 13 , Yanhong Zhou 14 , Nicolas Fasnacht 14 , Aaron A. Fink 14 , Carla Visseren-Grul 14 , Melinda D. Willard 14 , Solange Peters 15 , Aarohan Pruthi 16
  1. Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
  2. Texas Oncology - Austin Midtown, Austin, TX, USA
  3. Medical Oncology Department, Trakya University, Trakya, Türkiye
  4. Cancer and Hematology Centers of Western Michigan, Grand Rapids, MI, USA
  5. Department of Medical Oncology, St. Vincent’s Hospital, The Catholic University of Korea, Suwon, South Korea
  6. Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan
  7. Department of Medicine, Division of Hematology Oncology, University of Pittsburgh Medical Center Hillman Cancer Center , Pittsburgh, PA, USA
  8. Novant Health Cancer Institute, Salem, NC, USA
  9. Hokkaido University Hospital, Hokkaido University, Sapporo, Japan
  10. Dartmouth Hitchcock Medical Center, Lebanon, NH, USA 
  11. Community Health Network, Indianapolis, IN, USA
  12. Mary Bird Perkins Cancer Center, Baton Rouge, LA, USA
  13. Department of Internal Medicine, Yale Cancer Center, Yale School of Medicine, New Haven, CT, USA
  14. Eli Lilly and Company, Indianapolis, IN, USA
  15. Oncology Department, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland
  16. Eli Lilly, Sydney, NSW, Australia

Aims:

We report updated results, with an additional 9-months of follow-up, in 1L patients who received olomorasib (a KRAS G12C inhibitor) + chemo-IO from LOXO-RAS-20001 and the SUNRAY-01 safety lead-in.

Methods:

Patients with advanced KRAS G12C-mutant NSCLC, PD-L1 0-100%, and ECOG PS 0-1 received olomorasib 50/100mg orally BID with pembrolizumab + chemotherapy (per label). Patients who received one cycle of SOC prior to enrollment were eligible. Primary endpoint: safety. Secondary endpoints: ORR per RECIST v1.1, DOR, and PFS.

Results:

As of 5March2026, 77 patients received olomorasib + chemo-IO; 25 patients (32%) received 1 prior cycle of SOC; PD-L1 expression: 34% were <1%, 40% were 1-49%, and 23% were ≥50% (3% unknown). Median follow-up was 18.7 months (IQR:16.8-20.3). ORR was 61% (47/77), with a mDOR of 14.5 months and mPFS of 11.8 months. Efficacy by PD-L1 expression: ORR was 50% (13/26) in patients with PD-L1 <1% (mDOR:14.4 months; mPFS:9.7 months), 68% (21/31) in patients with PD-L1 1–49% (mPFS:12.1 months), and 67% (12/18) in patients with PD-L1 ≥50%. Any grade TRAEs (≥20% of patients): nausea (44%), anemia (39%), fatigue (39%), diarrhea (32%), AST/ALT increased (31%/27%). Most common grade ≥3 TRAEs: anemia (16%), neutrophil count decreased (12%), ALT/AST increased (12%/10%). TRAEs led to olomorasib dose reduction in 21% patients; and discontinuation of all study treatment in 8% patients.

Conclusions:

Olomorasib + chemo-IO continues to demonstrate durable efficacy and a manageable safety profile across PD-L1 levels, including in higher-risk patients with PD-L1 0-49%. These updated findings support the ongoing Phase 3 SUNRAY-01 trial comparing 1L chemo-IO + olomorasib or placebo in patients with KRAS G12C-mutant NSCLC and PD-L1 0-100%.