First Phase 1 data for sofetabart mipitecan, Lilly's investigational FRα-targeting ADC, in platinum-sensitive ovarian cancer to be featured in a rapid oral presentation

Updated first-line data for olomorasib, an investigational therapy targeting KRAS G12C-mutant NSCLC, to be featured in a rapid oral presentation

Updated Phase 3 data for selpercatinib versus cabozantinib or vandetanib in advanced, kinase inhibitor-naïve, RET-mutant MTC to be shared in a proffered paper

INDIANAPOLIS, Oct. 18, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that new data from across its oncology portfolio will be presented at the European Society for Medical Oncology (ESMO) Congress, taking place October 23–27 in Madrid, Spain. Highlights include new Phase 1 data in platinum-sensitive ovarian cancer (PSOC) for sofetabart mipitecan (Sofe-M), Lilly's investigational FRα-targeting antibody-drug conjugate (ADC), in combination with bevacizumab, along with updated findings for olomorasib, Retevmo (selpercatinib), and Verzenio (abemaciclib) in lung, thyroid, and breast cancers, respectively.

Key Presentation Highlights:

Sofetabart mipitecan (Sofe-M; FRα-targeting ADC): A rapid oral presentation on first Phase 1 data for sofetabart mipitecan plus bevacizumab in patients with PSOC. These data support the ongoing Phase 3 clinical trial of Sofe-M in PSOC.

Olomorasib (investigational KRAS G12C inhibitor):

A rapid oral presentation on an updated integrated analysis from the Phase 1/2 LOXO-RAS-20001 trial and the safety lead-in portion of the Phase 3 SUNRAY-01 trial, assessing olomorasib in combination with chemoimmunotherapy (pembrolizumab, pemetrexed, and platinum) as potential first-line treatments for patients with advanced/metastatic KRAS G12C-mutant non-small cell lung cancer (NSCLC). These data support the ongoing Phase 3 clinical trial of olomorasib in first-line KRAS G12C-mutant lung cancer.

Retevmo (selpercatinib; RET kinase inhibitor): A proffered paper presentation on updated results from the Phase 3 LIBRETTO-531 study of selpercatinib versus cabozantinib or vandetanib (C/V) in advanced, kinase inhibitor-naïve, RET-mutant medullary thyroid cancer (MTC). These data have supported global approvals of Retevmo in this treatment setting.

Verzenio (abemaciclib; CDK4/6 inhibitor): A rapid oral presentation on overall survival data from the Phase 3 postMONARCH trial of abemaciclib plus fulvestrant in HR-positive, HER2-negative advanced breast cancer following progression on a prior CDK4/6 inhibitor and endocrine therapy. These data support the abemaciclib plus imlunestrant results in the EMBER-3 trial and add to the evidence-based practice of switching endocrine therapy and CDK4/6 inhibitor at progression in metastatic breast cancer.

"Lilly's presentations at ESMO reflect both the breadth of our oncology portfolio and the focus behind it: following compelling science wherever it has the potential to change care," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. "We're especially encouraged by the data we're sharing for sofetabart mipitecan in platinum-sensitive ovarian cancer, which build on what we've seen with this medicine in platinum-resistant disease and mark a critical step forward as we advance the ongoing Phase 3 FRAmework-01 study across both settings. Our updated first-line data for olomorasib in KRAS G12C-mutant lung cancer are very promising, with clinical activity and a safety profile consistent with earlier findings, which reinforce the importance of targeted therapy for patients from the outset of their treatment journey. Alongside new data in thyroid and breast cancers, these presentations represent meaningful momentum toward improving care for people with cancer."

A full list of abstract titles and viewing details are listed below:

For more information on Lilly's oncology pipeline, click here.

About Sofetabart Mipitecan

Sofetabart mipitecan (Sofe-M; LY4170156) is composed of an Fc-silent, folate receptor alpha (FRα) specific humanized monoclonal antibody linked to exatecan, a topoisomerase I inhibitor, via a proprietary cleavable polysarcosine linker (PSARlink). Sofe-M was designed to target FRα across all expression levels with an improved therapeutic index. FRα is a cell-surface glycoprotein encoded by the gene FOLR1 that binds to the essential nutrients folic acid and reduced folates, bringing them into cells to facilitate cell division and growth.1,2 FRα is overexpressed in many solid tumors such as ovarian and endometrial cancers.1,3,4 Sofe-M has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for platinum-resistant ovarian cancer (PROC) and is currently being evaluated in the Phase 3 FRAmework-01 trial. The study is being conducted in partnership with the European Network for Gynaecological Oncological Trial groups (ENGOT – lead groups GINECO/NOGGO e.V.), the GOG Foundation (GOG), and the Asia-Pacific Gynecologic Oncology Trials Group (APGOT).

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 13% of patients with non-small cell lung cancer (NSCLC), and 1–3% of patients with other solid tumors.5 Olomorasib is a highly potent covalent inhibitor with potential for greater than 90% target occupancy, which may allow for safer combinations with less toxicity.6

Olomorasib is currently being studied in KRAS G12C-mutant 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 (NCT06119581, NCT06890598, and NCT04956640).

About Retevmo

Retevmo (selpercatinib, formerly known as LOXO-292) (pronounced reh-TEHV-moh) is a highly selective and potent RET kinase inhibitor with central nervous system (CNS) activity. Retevmo may affect both tumor cells and healthy cells, which can result in side effects. RET-driver alterations are predominantly mutually exclusive from other oncogenic drivers. Retevmo is a U.S. FDA-approved oral prescription medicine, 120 mg or 160 mg dependent on weight (50 kg or ≥50 kg, respectively), taken twice daily until disease progression or unacceptable toxicity.7

INDICATIONS FOR RETEVMO (selpercatinib)

RETEVMO is a kinase inhibitor indicated for the treatment of:

- Adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy

IMPORTANT SAFETY INFORMATION FOR RETEVMO (selpercatinib)

Hepatotoxicity: Serious hepatic adverse reactions occurred in 4.6% of patients treated with Retevmo. Increased aspartate aminotransferase (AST) occurred in 62% of patients, including Grade 3 or 4 events in 11% and increased alanine aminotransferase (ALT) occurred in 58% of patients, including Grade 3 or 4 events in 13%. Monitor ALT and AST prior to initiating Retevmo, every 2 weeks during the first 3 months, then monthly thereafter and as clinically indicated. Withhold, reduce dose, or permanently discontinue Retevmo based on severity.

Severe, life-threatening, and fatal interstitial lung disease (ILD)/pneumonitis can occur in patients treated with Retevmo. ILD/pneumonitis occurred in 3% of patients who received Retevmo, including 0.3% with Grade 3 or 4 events, and 0.2% with fatal reactions. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Withhold Retevmo and promptly investigate for ILD in any patient who presents with acute or worsening of respiratory symptoms which may be indicative of ILD (e.g., dyspnea, cough, and fever). Withhold, reduce dose, or permanently discontinue Retevmo based on severity of confirmed ILD.

Hypertension occurred in 43% of patients, including Grade 3 hypertension in 20% and Grade 4 in one (0.1%) patient. Overall, 6.4% had their dose interrupted, 1.5% had their dose reduced, and 0.2% discontinued Retevmo for hypertension. Treatment-emergent hypertension was most commonly managed with anti-hypertension medications. Do not initiate Retevmo in patients with uncontrolled hypertension. Optimize blood pressure prior to initiating Retevmo. Monitor blood pressure after 1 week, at least monthly thereafter, and as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. Withhold, reduce dose, or permanently discontinue Retevmo based on severity.

Retevmo can cause concentration-dependent QT interval prolongation. An increase in QTcF interval to >500 ms was measured in 8% of patients and an increase in the QTcF interval of at least 60 ms over baseline was measured in 22% of patients. Retevmo has not been studied in patients with clinically significant active cardiovascular disease or recent myocardial infarction. Monitor patients who are at significant risk of developing QTc prolongation, including patients with known long QT syndromes, clinically significant bradyarrhythmias, and severe or uncontrolled heart failure. Assess QT interval, electrolytes, and thyroid-stimulating hormone (TSH) at baseline and periodically during treatment, adjusting frequency based upon risk factors including diarrhea.

Correct hypokalemia, hypomagnesemia, and hypocalcemia prior to initiating Retevmo and during treatment. Monitor the QT interval more frequently when Retevmo is concomitantly administered with strong and moderate CYP3A inhibitors or drugs known to prolong QTc interval. Withhold and dose reduce or permanently discontinue Retevmo based on the severity.

Serious, including fatal, hemorrhagic events can occur with Retevmo. Grade ≥3 hemorrhagic events occurred in 4.3% of patients treated with Retevmo including 4 (0.