Lilly reports 14.5‑month response duration with olomorasib lung-cancer combination
The uncontrolled first-line analyses support continued development, with randomized SUNRAY-01 results expected in the first half of 2027.
Adrian Kessler
Tumour responses lasted a median 14.5 months with an olomorasib combination as Eli Lilly and Company NYSELLY reported updated first-line lung-cancer results on Sunday. The 77-patient analysis produced a confirmed response rate of 62 per cent, ahead of randomized results expected in the first half of 2027.
Lilly's Oct. 25 release describes findings presented at ESMO in Madrid. The data come from its Phase 1/2 trial and SUNRAY-01's safety lead-in. The analyses lack a concurrent control, so they cannot establish how much benefit olomorasib adds to existing treatment.
Lilly is a large Indianapolis-based drugmaker developing and selling medicines across metabolic disease, cancer and other specialties.
Shares closed at US$1,273.46 in New York on Oct. 23 at 4:00 p.m. EDT NYSELLY, before the Sunday announcement. The next clinical test is whether adding olomorasib improves progression-free survival against the same treatment without the investigational drug.
The chemotherapy combination paired olomorasib with pembrolizumab, pemetrexed and platinum chemotherapy. Investigators confirmed responses in 48 patients after median follow-up of 18.7 months; most participants had PD-L1 expression below 50 per cent.
Median response duration had a 95 per cent confidence interval from 8.5 months to a limit that could not yet be estimated. Median progression-free survival was 11.6 months, with a 95 per cent confidence interval of 9.5 to 21.5 months.
The separate chemotherapy-free analysis included 85 patients receiving olomorasib plus pembrolizumab. Median response duration and progression-free survival remained unreached after median follow-up of 20.7 months, meaning neither median could yet be calculated from the observed events.
Patients with PD-L1 expression of at least 50 per cent accounted for 64 per cent of that group. The different patient mixes prevent a reliable comparison between the chemotherapy and chemotherapy-free combinations.
Liver Enzyme Elevations Accompany Responses
Grade 3 or higher treatment-related events included neutropenia in 21 per cent of the chemotherapy group and increased ALT, a liver enzyme, in 15.3 per cent of the chemotherapy-free group. Neither analysis reported treatment-related deaths.
Treatment-related events led to discontinuation of the regimen in 7.8 per cent of the chemotherapy group, versus 11.8 per cent without chemotherapy. Olomorasib dose reductions occurred in 19.5 per cent and 31.8 per cent, respectively; neither protocol required preventive medication for olomorasib.
"Responses lasting a median of more than a year in patients across all PD-L1 tumor expression levels - including many with low expression - is the type of progress we want to see in the first-line setting," presenting author Dr. Marcelo V. Negrao, associate professor at MD Anderson Cancer Center, said in Lilly's release.
Randomized Trials Test The First-Line Opportunity
Amgen Inc. NASDAQAMGN already markets the KRAS G12C inhibitor Lumakras, but its U.S. lung-cancer indication requires at least one prior systemic therapy. Lilly said on Oct. 25 that no targeted therapy was approved for first-line KRAS G12C-mutant NSCLC, leaving the earlier treatment setting as its development opportunity.
The broader iShares Biotechnology ETF NASDAQIBB closed at US$207.74 on Oct. 23 at 4:00 p.m. EDT. That sector benchmark also predates the conference announcement.
Lilly's Aug. 3 regulatory update says the FDA previously granted breakthrough therapy designation to olomorasib plus pembrolizumab for first-line disease with PD-L1 expression of at least 50 per cent. The designation expedites development and review; olomorasib remains investigational.
SUNRAY-01 Part A compares olomorasib plus pembrolizumab against placebo plus pembrolizumab in that high-expression population. Part B, which has completed enrolment, adds olomorasib or placebo to chemoimmunotherapy regardless of PD-L1 expression.
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The trial registry, updated Oct. 7, identifies independently reviewed progression-free survival as the primary endpoint for both randomized parts. Lilly expects the first randomized chemotherapy-combination results in the first half of 2027, when the study will test whether olomorasib improves disease control over chemoimmunotherapy alone.
