Eli Lilly's olomorasib could win first-line KRAS lung cancer, and no one is trading the option
The ESMO data put Lilly's olomorasib on track to be the first targeted therapy sold into newly diagnosed KRAS G12C lung cancer, with Keytruda riding along in both combinations. The randomized proof lands next year, and nobody is trading the option yet.
Richard Tang · 3 min read
Eli Lilly−2.12% — Eli Lilly, down 2.12 percent today just showed the first KRAS G12C lung cancer data that could reach the first line of treatment, and it landed four days before the company reports earnings 13. If the Phase 3 reads out on schedule in the first half of 2027, Lilly gets a targeted therapy sold to newly diagnosed patients, Merck keeps collecting Keytruda revenue in both winning combinations, and Amgen−1.79% — Amgen, down 1.79 percent today and Bristol Myers Squibb−1.57% — Bristol Myers Squibb, down 1.57 percent today see the second-line niche their approved KRAS drugs are confined to undercut from above 13.
The unmet need is brutal, and Lilly's design claims to fix the old failure mode
KRAS G12C mutations occur in about 13% of non-small cell lung cancer patients, there is no approved targeted therapy for the first line, and most patients never make it to a second one because the disease moves so fast 1. Previous KRAS inhibitor combinations with immunotherapy failed on liver toxicity. Lilly's answer is olomorasib, a next-generation inhibitor that binds the mutated protein and locks it in its inactive state with high target occupancy, avoiding the prophylactic medications some rivals' regimens require 1.
What ESMO actually showed, and its one big caveat
The data are single-arm, not randomized, so they prove activity, not superiority. In the chemo-free arm of 85 patients, neither median progression-free survival nor duration of response had been reached at a median of about 21 months of follow-up 1. The chemoimmunotherapy arm of 77 patients posted a 62% response rate with responses lasting a median of 14.5 months 1. Across both arms, no patient died of a treatment-related side effect and no prophylactic medications are required 1.
The single number that will decide the trade is the 18-month progression-free survival rate: 55% overall, 65% in the high PD-L1 patients Part A of SUNRAY-01 enrolls 1.
Response and survival rates across olomorasib's two first-line regimens
Data
| Value | |
|---|---|
| ORR, olomorasib + chemoimmunotherapy (n=77) | 62% |
| 18-mo PFS rate, olomorasib + pembrolizumab, overall (n=85) | 55% |
| 18-mo PFS rate, PD-L1 ≥50% patients | 65% |
The problem for Lilly is that it is not first anymore
Roche's divarasib beat both Lumakras and Krazati head-to-head in a Phase 3 second-line trial in July, and Roche plans an FDA filing in 2027 3. Lilly's Phase 3 Part B has finished enrollment and reads out first, so the second line is Roche's race to win while Lilly goes where no KRAS drug has been: the first line, with a drug that could make the second line nearly irrelevant 13.
Why this matters four days before the print
The market is pricing Lilly as a GLP-1 story into the October 29 earnings report, with retatrutide and Zepbound dominating the discussion 4. Nobody is trading olomorasib. The Phase 3 readout in the first half of 2027 is the catalyst to mark, and this ESMO poster is the last cheap look at the single-arm numbers before the print 1.
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