Lilly's olomorasib receives U.S. FDA's Breakthrough Therapy designation for the treatment of certain newly diagnosed metastatic KRAS G12C-mutant lung cancers
Eli Lilly (NYSE:LLY) announced that its drug olomorasib has received FDA Breakthrough Therapy designation for first-line treatment of certain metastatic non-small cell lung cancer (NSCLC) patients. The designation applies to olomorasib in combination with KEYTRUDA for patients with unresectable advanced or metastatic NSCLC with KRAS G12C mutation and PD-L1 expression ≥ 50%.
The designation is based on promising results from the Phase 1/2 LOXO-RAS-20001 trial and Phase 3 SUNRAY-01 trial. Olomorasib is described as a potent and selective second-generation KRAS G12C inhibitor with preliminary evidence of central nervous system activity. Updated efficacy and safety data will be presented at the upcoming IASLC 2025 World Conference on Lung Cancer in Barcelona, featuring integrated analyses from multiple clinical trials.
Eli Lilly (NYSE:LLY) ha annunciato che il suo farmaco olomorasib ha ricevuto la designazione FDA di Breakthrough Therapy per il trattamento di prima linea di alcuni pazienti con carcinoma polmonare non a piccole cellule (NSCLC) metastatico. La designazione riguarda olomorasib in combinazione con KEYTRUDA per pazienti con NSCLC avanzato non resecabile o metastatico con mutazione KRAS G12C e espressione di PD-L1 ≥ 50%.
La decisione si basa su risultati promettenti provenienti dal trial di Fase 1/2 LOXO-RAS-20001 e dal trial di Fase 3 SUNRAY-01. Olomorasib è descritto come un potente e selettivo inibitore di seconda generazione del KRAS G12C con evidenze preliminari di attività nel sistema nervoso centrale. Dati aggiornati su efficacia e sicurezza saranno presentati al prossimo IASLC 2025 World Conference on Lung Cancer a Barcellona, con analisi integrate di diversi studi clinici.
Eli Lilly (NYSE:LLY) anunció que su fármaco olomorasib ha recibido la designación de Breakthrough Therapy por la FDA para el tratamiento de primera línea de ciertos pacientes con cáncer de pulmón no microcítico (NSCLC) metastásico. La designación aplica a olomorasib en combinación con KEYTRUDA para pacientes con NSCLC avanzado no resecable o metastásico con mutación KRAS G12C y expresión de PD-L1 ≥ 50%.
La designación se basa en resultados prometedores del ensayo de Fase 1/2 LOXO-RAS-20001 y del ensayo de Fase 3 SUNRAY-01. Olomorasib se describe como un potente y selectivo inhibidor de segunda generación de KRAS G12C con evidencia preliminar de actividad en el sistema nervioso central. Se presentarán datos actualizados de eficacia y seguridad en la próxima IASLC 2025 World Conference on Lung Cancer en Barcelona, incluyendo análisis integrados de varios ensayos clínicos.
Eli Lilly (NYSE:LLY)는 자사 약물 올로모라시브(olomorasib)가 특정 전이성 비소세포폐암(NSCLC) 환자의 1차 치료제로 미 FDA의 Breakthrough Therapy 지정을 받았다고 발표했습니다. 이 지정은 절제 불가능한 진행성 또는 전이성 NSCLC로 KRAS G12C 돌연변이와 PD-L1 발현 ≥ 50%인 환자에 대해 올로모라시브를 KEYTRUDA와 병용하는 경우에 적용됩니다.
이번 지정은 1/2상 LOXO-RAS-20001 시험과 3상 SUNRAY-01 시험의 유망한 결과를 근거로 합니다. 올로모라시브는 강력하고 선택적인 2세대 KRAS G12C 억제제로 중추신경계에서의 활성을 시사하는 예비 증거가 있다고 설명됩니다. 업데이트된 유효성 및 안전성 데이터는 바르셀로나에서 열리는 IASLC 2025 World Conference on Lung Cancer에서 여러 임상시험의 통합 분석과 함께 발표될 예정입니다.
Eli Lilly (NYSE:LLY) a annoncé que son médicament olomorasib a obtenu la désignation Breakthrough Therapy de la FDA pour le traitement de première ligne de certains patients atteints de cancer du poumon non à petites cellules (NSCLC) métastatique. La désignation concerne olomorasib en association avec KEYTRUDA pour les patients atteints de NSCLC avancé non résécable ou métastatique avec mutation KRAS G12C et expression de PD-L1 ≥ 50%.
La décision repose sur des résultats prometteurs des essais de phase 1/2 LOXO-RAS-20001 et de phase 3 SUNRAY-01. Olomorasib est décrit comme un inhibiteur KRAS G12C de deuxième génération, puissant et sélectif, avec des preuves préliminaires d’activité au niveau du système nerveux central. Des données mises à jour sur l’efficacité et la sécurité seront présentées lors de la IASLC 2025 World Conference on Lung Cancer à Barcelone, comprenant des analyses intégrées de plusieurs essais cliniques.
Eli Lilly (NYSE:LLY) gab bekannt, dass sein Wirkstoff Olomorasib von der FDA die Breakthrough Therapy-Zulassung für die Erstlinienbehandlung bestimmter Patienten mit metastasiertem nicht-kleinzelligem Lungenkrebs (NSCLC) erhalten hat. Die Zulassung betrifft Olomorasib in Kombination mit KEYTRUDA für Patienten mit nicht resezierbarem fortgeschrittenem oder metastasiertem NSCLC mit KRAS G12C-Mutation und PD-L1-Expression ≥ 50%.
Die Entscheidung stützt sich auf vielversprechende Ergebnisse aus der Phase-1/2-Studie LOXO-RAS-20001 und der Phase-3-Studie SUNRAY-01. Olomorasib wird als potenter und selektiver Wirkstoff der zweiten Generation gegen KRAS G12C beschrieben, mit vorläufigen Hinweisen auf eine Aktivität im zentralen Nervensystem. Aktualisierte Wirksamkeits- und Sicherheitsdaten werden auf der kommenden IASLC 2025 World Conference on Lung Cancer in Barcelona vorgestellt und integrierte Analysen mehrerer klinischer Studien enthalten.
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Insights
FDA Breakthrough designation for Lilly's olomorasib signals accelerated development path for promising KRAS G12C lung cancer therapy.
The FDA's Breakthrough Therapy designation for Eli Lilly's olomorasib represents a significant regulatory milestone that could accelerate this drug's path to market. This designation isn't given lightly—it requires preliminary clinical evidence showing substantial improvement over existing FDA-approved therapies for serious conditions.
Olomorasib targets the KRAS G12C mutation, which has been historically difficult to drug effectively. As a second-generation inhibitor with preliminary CNS activity, it addresses a critical limitation of earlier KRAS inhibitors that struggled with brain metastases. The specific indication—first-line treatment in combination with pembrolizumab for NSCLC with KRAS G12C mutation and high PD-L1 expression—positions this therapy in a treatment landscape with substantial unmet need.
The designation is based on data from both Phase 1/2 trials and the Phase 3 SUNRAY-01 trial, suggesting robust and consistent efficacy signals across multiple studies. While specific efficacy numbers aren't disclosed in this release, the FDA's decision implies the data demonstrated meaningful clinical benefit over current standard-of-care treatments.
Lilly's strategic presentation timing at the WCLC will provide the critical efficacy and safety metrics investors need to fully evaluate this asset's potential. The June 6, 2025 data cut-off will offer more mature data than the January submission, likely with longer follow-up on progression-free survival and potentially early overall survival signals.
This regulatory validation strengthens Lilly's position in precision oncology and specifically in the competitive KRAS inhibitor landscape, potentially creating a differentiated treatment option for approximately 13
The Breakthrough Therapy designation for olomorasib is based on data from the Phase 1/2 LOXO-RAS-20001 trial and Phase 3 SUNRAY-01 trial
Updated efficacy and safety data for olomorasib will be presented at the IASLC 2025 World Conference on Lung Cancer
Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over already available therapies that have received full FDA approval.
"The Breakthrough Therapy designation recognizes the potential for olomorasib to be a meaningful treatment advance and highlights the continued unmet need for improved options for patients with KRAS G12C-mutant NSCLC, particularly in the first-line setting in combination with standard-of-care immunotherapy," said David Hyman, M.D., Lilly chief medical officer. "We look forward to presenting updated data from the olomorasib development program in significantly more patients and with longer follow-up at WCLC and continuing to investigate olomorasib in combination with immunotherapy-based regimens in a variety of treatment settings across the Phase 3 SUNRAY-01 and SUNRAY-02 studies."
The FDA Breakthrough Therapy designation is based on encouraging results from the Phase 1/2 LOXO-RAS-20001 trial and the dose optimization portion of the Phase 3 SUNRAY-01 trial. Updated results from an integrated analysis from these studies will be presented at the 2025 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer (IASLC), taking place Sept. 6 - 9 in
Details on Presentations at the IASLC 2025 World Conference on Lung Cancer
In an oral presentation (Abstract #MA02.06), Lilly will report on an integrated analysis of efficacy and safety results in patients with KRAS G12C-mutant NSCLC who received olomorasib plus pembrolizumab as first-line treatment in the dose optimization cohorts of the Phase 1/2 LOXO-RAS-20001 study and Phase 3 SUNRAY-01 study. These data will be shared in an oral presentation during the New Treatment Strategies in Other Than EGFR-Positive Tumors session on Sunday, Sept. 7, 2025, from 12-1:15 p.m. Central European Summer Time (CEST).
In a second oral presentation (Abstract #OA08.02), Lilly will report results of an integrated analysis in patients with KRAS G12C-mutant advanced or metastatic NSCLC who received olomorasib in combination with chemoimmunotherapy (pembrolizumab, pemetrexed and platinum) as a first-line treatment in the Phase 1/2 LOXO-RAS-20001 trial and safety lead-in for the Phase 3 SUNRAY-01 trial. These data will be shared in an oral presentation during the Improving Outcomes in EGFR and KRAS Mutant Tumors, More is Better session on Monday, Sept. 8, 2025, from 12-1:15 p.m. CEST.
The submitted abstracts for both presentations utilized a Jan. 15, 2025 data cut-off date, and the oral presentations will utilize a June 6, 2025 data cut-off date.
For more information on the olomorasib Phase 3 studies SUNRAY-01 (NCT06119581) and SUNRAY-02 (NCT06890598), please visit https://clinicaltrials.gov/.
About LOXO-RAS-20001
LOXO-RAS-20001 is an open-label, multicenter, Phase 1/2 study evaluating the safety, tolerability and preliminary efficacy of olomorasib in patients with KRAS G12C-mutant advanced solid tumors (NCT04956640). The study includes a Phase 1a dose escalation phase of olomorasib monotherapy in KRAS G12C-mutant solid tumors and a Phase 1b dose expansion and optimization phase which are evaluating olomorasib as a monotherapy and in combination with other treatments.
About SUNRAY-01
SUNRAY-01 is a randomized, double-blind, placebo-controlled, global Phase 3 study evaluating the efficacy and safety of olomorasib in combination with pembrolizumab with or without chemotherapy as a first-line treatment for patients with KRAS G12C-mutant metastatic non-small cell lung cancer (NSCLC). The trial is designed to compare olomorasib plus standard-of-care therapies versus placebo plus standard-of-care therapies, with the goal of determining whether the addition of olomorasib can improve clinical outcomes in this patient population. SUNRAY-01 is part of Lilly's broader clinical development program investigating olomorasib across multiple stages and settings of KRAS G12C-mutant NSCLC (NCT06890598).
About Olomorasib
Olomorasib (LY3537982) is an investigational, oral, potent, and highly selective second-generation inhibitor of the KRAS G12C protein. KRAS is the most common oncogene across all tumor types, and KRAS G12C mutations occur in
Olomorasib is currently being studied in KRAS G12C-mutated cancers in combination with pembrolizumab with or without chemotherapy for first-line treatment of advanced NSCLC, in combination with immunotherapy for the treatment of resected and unresectable NSCLC, and as monotherapy and in combinations in other advanced solid tumors, including: NCT06119581, NCT06890598, and NCT04956640.
About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY
Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about olomorasib as a potential treatment for people with certain KRAS G12C-mutant advanced solid tumors, preclinical data for an antibody-drug conjugate targeting folate receptor alpha and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that any of these therapies will prove to be a safe and effective treatment or receive regulatory approval, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
References :
- Ji, Wang C, Fakih M. Targeting KRASG12C-mutated advanced colorectal cancer: Research and clinical developments. OncoTargets and Therapy. 2022;Volume 15:747-756. doi:10.2147/ott.s340392
- Peng S-B, Si C, Zhang Y, et al. Abstract 1259: Preclinical characterization of Ly3537982, a novel, highly selective and potent KRAS-G12C inhibitor. Cancer Research. 2021;81(13_Supplement):1259-1259. doi:10.1158/1538-7445.am2021-1259
Refer to: | Kyle Owens; owens_kyle@lilly.com; 332-259-3932 (Media) |
Michael Czapar; czapar_michael_c@lilly.com; 317-617-0983 (Investors) |
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