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; FR
α
-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 (0.5%) patients with fatal hemorrhagic events, including cerebral hemorrhage (n=2), tracheostomy site hemorrhage and hemoptysis (1 each). Permanently discontinue Retevmo in patients with severe or life-threatening hemorrhage.
Retevmo can cause
hypersensitivity, including severe skin reactions such as Stevens-Johnson Syndrome. All grade hypersensitivity occurred in 6% of patients receiving Retevmo, including Grade 3 in 2%. The median time to onset was 1.9 weeks (range: 5 days to 6.5 years). Signs and symptoms of hypersensitivity included fever, rash and arthralgias or myalgias with concurrent decreased platelets or transaminitis. Stevens-Johnson Syndrome has been observed in the post-marketing setting. Discontinue Retevmo in patients with Stevens-Johnson Syndrome. If hypersensitivity occurs, withhold Retevmo and begin corticosteroids at a dose of 1 mg/kg prednisone (or equivalent). Upon resolution of the event, resume Retevmo at a reduced dose and increase the dose of Retevmo by 1 dose level each week as tolerated until reaching the dose taken prior to onset of hypersensitivity. Continue steroids until patient reaches target dose and then taper. Permanently discontinue Retevmo for recurrent hypersensitivity.
Tumor lysis syndrome (TLS) occurred in 0.9% of patients with medullary thyroid carcinoma and 0.3% of patients with non-small cell lung cancer receiving Retevmo. Patients may be at risk of TLS if they have rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration. Closely monitor patients at risk, consider appropriate prophylaxis including hydration, and treat as clinically indicated.
Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway. Therefore, Retevmo has the potential to adversely affect wound healing. Withhold Retevmo for at least 7 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of Retevmo after resolution of wound healing complications has not been established.
Retevmo can cause
hypothyroidism. Hypothyroidism occurred in 15% of patients treated with Retevmo; all reactions were Grade 1 or 2. Hypothyroidism occurred in 15% of patients (59/390) with thyroid cancer and 14% of patients (65/467) with other solid tumors including NSCLC. Monitor thyroid function before treatment with Retevmo and periodically during treatment. Treat with thyroid hormone replacement as clinically indicated. Withhold Retevmo until clinically stable or permanently discontinue Retevmo based on severity.
Based on data from animal reproduction studies and its mechanism of action, Retevmo can cause
fetal harm when administered to a pregnant woman. Administration of selpercatinib to pregnant rats during organogenesis at maternal exposures that were approximately equal to those observed at the recommended human dose of 160 mg twice daily resulted in embryolethality and malformations. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with Retevmo and for 1 week after the last dose. There are no data on the presence of selpercatinib or its metabolites in human milk or on their effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with Retevmo and for 1 week after the last dose.
Slipped capital femoral epiphysis/slipped upper femoral epiphysis in pediatric patients (SCFE/SUFE) occurred in 1 adolescent (2.8% of 36 patients) receiving Retevmo in LIBRETTO-121 and 1 adolescent patient (0.5% of 193 patients) receiving Retevmo in LIBRETTO-531. Monitor patients for symptoms indicative of SCFE/SUFE and treat as medically and surgically appropriate.
Severe adverse reactions (Grade 3-4) occurring in
≥
20% of patients who received Retevmo in LIBRETTO-001 were hypertension (20%), diarrhea (6.2%), prolonged QT interval (5%), fatigue (4.7%), musculoskeletal pain (4.1%), dyspnea (4.1%), hemorrhage (3.9%), abdominal pain (3.5%), vomiting (2.9%), urinary tract infection (2.2%), nausea (1.9%), headache (1.8%), edema (1.3%), decreased appetite (0.9%), constipation (0.8%), rash (0.8%), and dizziness (0.5%).
Severe adverse reactions (Grade 3-4) occurring in
≥
15% of patients who received Retevmo in LIBRETTO-121 were increased weight (11%), vomiting (8%), constipation (6%), diarrhea (2.8%), nausea (2.8%), upper respiratory tract infection (2.8%), and urinary tract infection (2.8%).
Severe adverse reactions (Grade 3-4) occurring in
≥
15% of patients who received Retevmo or chemotherapy with or without pembrolizumab in LIBRETTO-431 were hypertension (20% vs 3.1%), electrocardiogram QT prolonged (9% vs 0%), fatigue (3.2% vs 5%), edema (2.5% vs 0%), rash (1.9% vs 1.0%), diarrhea (1.3% vs 2.0%), abdominal pain (0.6% vs 2.0%), pyrexia (0.6% vs 0%), COVID19 infection (0.6% vs 0%), constipation (0% vs 1.0%), nausea (0% vs 1.0%), vomiting (0% vs 1.0%), and decreased appetite (0% vs 2.0%).
Severe adverse reactions (Grade 3-4) occurring in
≥
10% of patients who received Retevmo in LIBRETTO-531 were (Retevmo vs cabozantinib / vandetanib) hypertension (19% vs 18%), electrocardiogram QT prolonged (4.7% vs 2.1%), fatigue (4.1% vs 9%), diarrhea (3.1% vs 8%), rash (1.6% vs 4.1%), pyrexia (1.0% vs 0%), nausea (1.0% vs 5%), dry mouth (0.5% vs 1.0%), abdominal pain (0.5% vs 2.1%), stomatitis (0.5% vs 13%), headache (0.5% vs 0%), and decreased appetite (0.5% vs 5%).
Serious adverse reactions occurred in 58% of patients who received Retevmo in LIBRETTO-001. The most frequently reported serious adverse reactions (in ≥2% of patients) were pneumonia, hemorrhage, abdominal pain, dyspnea, pleural effusion, sepsis, musculoskeletal pain, hyponatremia, vomiting, diarrhea, and increased blood creatinine.
Fatal adverse reactions occurred in 3% of patients in LIBRETTO-001; fatal adverse reactions included sepsis (n=6), respiratory failure (n=5), hemorrhage (n=4), pneumonia (n=4), cardiac arrest (n=3), pneumonitis (n=2), cardiac failure (n=2), sudden death (n=1), cerebral infarction (n=1), and dyspnea (n=1).
Serious adverse reactions occurred in 42% of patients who received Retevmo in LIBRETTO-121. Serious adverse reactions occurring in more than 1 patient were vomiting and fracture (2 patients each).
Serious adverse reactions occurred in 35% of patients who received Retevmo in LIBRETTO-431. The most frequently reported serious adverse reactions (≥2% of patients) were pleural effusion and abnormal hepatic function.
Fatal adverse reactions occurred in 4.4% of patients who received Retevmo in LIBRETTO-431; fatal adverse reactions included myocardial infarction (n=2), respiratory failure (n=2), cardiac arrest, malnutrition, and sudden death (n=1 each).
Serious adverse reactions occurred in 22% of patients who received Retevmo in LIBRETTO-531. The most frequent serious adverse reactions were pneumonia and pyrexia (n=3 each), and hypertension and urinary tract infection (n=2 each).
Fatal adverse reactions occurred in 2.1% of patients who received Retevmo in LIBRETTO-531; fatal adverse reactions included COVID19, diabetic ketoacidosis, multiple organ dysfunction syndrome, and sudden death (n=1 each).
Common adverse reactions (all grades) occurring in
≥
20% of patients who received Retevmo in LIBRETTO-001 were musculoskeletal pain (59%), edema (53%), diarrhea (52%), fatigue (49%), dry mouth (44%), hypertension (43%), abdominal pain (39%), rash (38%), nausea (36%), constipation (35%), cough (30%), headache (30%), vomiting (29%), dyspnea (28%), hemorrhage (26%), decreased appetite (23%), dizziness (22%), prolonged QT interval (21%), and urinary tract infection (20%).
Common adverse reactions (all grades) occurring in
≥
15% of patients who received Retevmo in LIBRETTO-121 were musculoskeletal pain (58%), diarrhea (47%), nausea (42%), hemorrhage (39%), pyrexia (39%), abdominal pain (36%), headache (33%), vomiting (31%), fatigue (31%), cough (31%), rash (28%), coronavirus infection (28%), upper respiratory tract infection (28%), edema (25%), constipation (22%), oropharyngeal pain (22%), hypothyroidism (22%), urinary tract infection (19%), and increased weight (19%).
Common adverse reactions (all grades) occurring in
≥
15% of patients who received Retevmo or chemotherapy with or without pembrolizumab in LIBRETTO-431 were hypertension (48% vs 7%), diarrhea (44% vs 24%), edema (41% vs 28%), dry mouth (39% vs 6%), rash (33% vs 30%), fatigue (32% vs 50%), abdominal pain (25% vs 19%), musculoskeletal pain (25% vs 28%), constipation (22% vs 40%), electrocardiogram QT prolonged (20% vs 1.0%), COVID19 infection (19% vs 18%), stomatitis (18% vs 16%), decreased appetite (17% vs 34%), nausea (13% vs 44%), vomiting (13% vs 23%), and pyrexia (13% vs 23%).
Common adverse reactions (all grades) occurring in
≥
10% of patients who received Retevmo in LIBRETTO-531 (Retevmo vs cabozantinib / vandetanib) were hypertension (43% vs 41%), edema (33% vs 5%), dry mouth (32% vs 10%), fatigue (28% vs 47%), diarrhea (26% vs 61%), headache (23% vs 21%), rash (19% vs 27%), abdominal pain (18% vs 21%), constipation (16% vs 12%), erectile dysfunction (16% vs 0%), stomatitis (14% vs 42%), electrocardiogram QT prolonged (14% vs 13%), pyrexia (12% vs 2.1%), decreased appetite (12% vs 28%), hypothyroidism (11% vs 21%)
, and nausea (10% vs 32%).
Laboratory abnormalities (all grades
≥
20%; Grade 3-4) worsening from baseline in patients who received Retevmo in LIBRETTO-001, were increased AST (62%; 11%), decreased calcium (61%; 7%), decreased albumin (61%; 3.6%), increased ALT (58%; 13%), increased glucose (56%; 4.0%), decreased lymphocytes (56%; 22%), increased creatinine (51%; 3.6%), decreased sodium (49%; 13%), increased alkaline phosphatase (43%; 4.4%), decreased platelets (41%; 4.0%), increased potassium (39%; 3.5%), decreased glucose (39%; 1.5%), increased total cholesterol (37%; 1.7%), decreased magnesium (37%; 0.7%), decreased hemoglobin (36%; 4.1%), increased bilirubin (32%; 2.9%), decreased neutrophils (27%; 3.8%), and decreased phosphate (25%; 5%).
Laboratory abnormalities (all grades
≥
15%; Grade 3-4) worsening from baseline in patients who received Retevmo in LIBRETTO-121 were decreased calcium (61%; 11%), increased ALT (58%; 8%), decreased albumin (53%; 0%), increased alkaline phosphatase (50%; 0%), increased AST (50%; 2.8%), increased bilirubin (31%; 2.8%), increased cholesterol (28%, 0%), decreased magnesium (28%; 6%), increased potassium (28%; 2.8%), increased creatinine (19%, 2.8%), decreased potassium (19%, 6%), decreased sodium (17%, 0%), decreased neutrophils (40%; 8%), decreased hemoglobin (36%; 11%), increased hemoglobin (33%, 2.8%), decreased platelets (28%; 2.8%), and decreased lymphocytes (28%; 14%).
Laboratory abnormalities (all grades
≥
20%; Grade 3-4) worsening from baseline in patients who received Retevmo or chemotherapy with or without pembrolizumab in LIBRETTO-431 were increased ALT (81%; 21% vs 63%; 4.1%), increased AST (77%; 10% vs 46%; 0%), decreased calcium (53%; 1.9% vs 24%; 1.0%), decreased platelets (53%; 3.2% vs 39%; 5%), decreased lymphocytes (53%; 8% vs 64%; 15%), decreased neutrophils (53%; 2.0% vs 58%; 11%), increased bilirubin (52%; 1.3% vs 9%; 0%), increased alkaline phosphatase (35%; 1.3% vs 22%; 0%), decreased sodium (31%; 3.2% vs 41%; 2.1%), decreased albumin (25%; 0% vs 5%; 0%), increased blood creatinine (23%; 0% vs 21%; 0%), decreased hemoglobin (21%; 0% vs 91%; 5%), decreased potassium (17%; 1.3% vs 15%; 1.0%), and decreased magnesium (16%; 0.6% vs 8%; 0%).
Laboratory abnormalities (all grades
≥
5%; Grade 3-4) worsening from baseline in patients who received Retevmo in LIBRETTO-531 (Retevmo vs cabozantinib / vandetanib) were decreased calcium (55%; 5% vs 62%; 11%), increased ALT (53%; 16% vs 72%; 7%), increased AST (47%; 5% vs 68%; 3.2%), decreased lymphocytes (41%; 18% vs 36%; 13%), increased alkaline phosphatase (37%; 6% vs 28%, 5%), increased bilirubin (32%; 1.1% vs 30%; 3.2%), decreased neutrophils (33%; 14% vs 42%; 19%), decreased platelets (28%; 1.1% vs 34%; 1.1%), increased creatinine (27%; 6% vs 16%; 8%), decreased sodium (20%; 3.2% vs 16%; 0%), decreased hemoglobin (18%; 2.1% vs 23%; 2.1%), decreased albumin (11%; 1.1% vs 7%; 0%), decreased magnesium (9%; 3.3% vs 26%; 9%), and decreased potassium (8%; 0% vs 22%; 4.4%).
Concomitant use of
acid-reducing agents decreases selpercatinib plasma concentrations which may reduce Retevmo anti-tumor activity. Avoid concomitant use of proton-pump inhibitors (PPIs), histamine-2 (H2) receptor antagonists, and locally acting antacids with Retevmo. If coadministration cannot be avoided, take Retevmo with food (with a PPI) or modify its administration time (with a H2 receptor antagonist or a locally acting antacid).
Concomitant use of
strong and moderate CYP3A inhibitors increases selpercatinib plasma concentrations which may increase the risk of Retevmo adverse reactions including QTc interval prolongation. Avoid concomitant use of strong and moderate CYP3A inhibitors with Retevmo. If concomitant use of a strong or moderate CYP3A inhibitor cannot be avoided, reduce the Retevmo dosage as recommended and monitor the QT interval with ECGs more frequently.
Concomitant use of
strong and moderate CYP3A inducers decreases selpercatinib plasma concentrations which may reduce Retevmo anti-tumor activity. Avoid coadministration of Retevmo with strong and moderate CYP3A inducers.
Concomitant use of Retevmo with
CYP2C8 and CYP3A substrates increases their plasma concentrations which may increase the risk of adverse reactions related to these substrates. Avoid coadministration of Retevmo with CYP2C8 and CYP3A substrates where minimal concentration changes may lead to increased adverse reactions. If coadministration cannot be avoided, follow recommendations for CYP2C8 and CYP3A substrates provided in their approved product labeling.
Retevmo is a P-glycoprotein (P-gp) and BCRP inhibitor. Concomitant use of Retevmo with
P-gp or BCRP substrates increases their plasma concentrations, which may increase the risk of adverse reactions related to these substrates. Avoid coadministration of Retevmo with P-gp or BCRP substrates where minimal concentration changes may lead to increased adverse reactions. If coadministration cannot be avoided, follow recommendations for P-gp and BCRP substrates provided in their approved product labeling.
The safety and effectiveness of Retevmo have
not
been established in pediatric patients less than 2 years of age. The safety and effectiveness of Retevmo have been established in pediatric patients aged 2 years and older for the treatment of advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation who require systemic therapy, advanced or metastatic thyroid cancer with a RET gene fusion who require systemic therapy and are radioactive iodine-refractory (if radioactive iodine is appropriate), and locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.
Monitor open growth plates in
pediatric patients. Consider interrupting or discontinuing Retevmo if abnormalities occur.
No dosage modification is recommended for patients with
mild to severe renal impairment (estimated Glomerular Filtration Rate [eGFR] ≥15 to 89 mL/min, estimated by Modification of Diet in Renal Disease [MDRD] equation). A recommended dosage has not been established for patients with end-stage renal disease.
Reduce the dose when administering Retevmo to patients with
severe hepatic impairment (total bilirubin greater than 3 to 10 times upper limit of normal [ULN] and any AST). No dosage modification is recommended for patients with mild or moderate hepatic impairment. Monitor for Retevmo-related adverse reactions in patients with hepatic impairment.
Retevmo (selpercatinib) is available as 40 mg and 80 mg capsules, and 40 mg, 80 mg, 120 mg, and 160 mg tablets.
SE HCP ISI All_JUL2026
Please see full
Prescribing Information
and
Instructions for Use
for Retevmo.
About Verzenio (abemaciclib)
Verzenio (abemaciclib) is approved to treat people with certain HR+, HER2– breast cancers in the adjuvant and advanced or metastatic settings. Verzenio is an oral tablet taken twice daily and available in strengths of 50 mg, 100 mg, 150 mg, and 200 mg. Discovered and developed by Lilly researchers, Verzenio was first approved in 2017 and is authorized for use in more than 90 countries around the world. For full details on indicated uses of Verzenio in HR+, HER2– breast cancer, please see full Prescribing Information, available at .
INDICATIONS FOR VERZENIO
Verzenio (abemaciclib) is a kinase inhibitor indicated8,9:
in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.
in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer.
in combination with fulvestrant for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.
in combination with Inluriyo for the treatment of adults with estrogen receptor (ER)-positive, HER2-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
as monotherapy for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
IMPORTANT SAFETY INFORMATION FOR VERZENIO (abemaciclib)
Severe
diarrhea associated with dehydration and infection occurred in patients treated with Verzenio. Across five clinical trials in 3899 patients, diarrhea occurred in 81% to 90% of patients who received Verzenio. Grade 3 diarrhea occurred in 8% to 20% of patients receiving Verzenio. Most patients experienced diarrhea during the first month of Verzenio treatment. The median time to onset of the first diarrhea event ranged from 6 to 8 days; and the median duration of Grade 2 and Grade 3 diarrhea ranged from 6 to 11 days and 5 to 8 days, respectively. Across trials, 19% to 26% of patients with diarrhea required a Verzenio dose interruption and 13% to 23% required a dose reduction.
Instruct patients to start antidiarrheal therapy such as loperamide at the first sign of loose stools, increase oral fluids, and notify their healthcare provider for further instructions and appropriate follow-up. For Grade 3 or 4 diarrhea, or diarrhea that requires hospitalization, withhold Verzenio until resolution to ≤Grade 1, and then resume Verzenio at the next lower dose.
Neutropenia, including febrile neutropenia and fatal neutropenic sepsis, occurred in patients treated with Verzenio. Across five clinical trials in 3899 patients, neutropenia occurred in 37% to 51% of patients receiving Verzenio. A Grade ≥3 decrease in neutrophil count (based on laboratory findings) occurred in 19% to 32% of patients receiving Verzenio.
Across trials, the median time to first episode of Grade ≥3 neutropenia ranged from 29 days to 34 days, and the median duration of Grade ≥3 neutropenia ranged from 10 days to 16 days.
Febrile neutropenia has been reported in <1% of patients exposed to Verzenio across trials. Two deaths due to neutropenic sepsis were observed in MONARCH 2. Inform patients to promptly report any episodes of fever to their healthcare provider.
Monitor complete blood counts prior to the start of Verzenio therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.
Severe, life-threatening, or
fatal interstitial lung disease (ILD) or pneumonitis can occur in patients treated with Verzenio and other CDK4/6 inhibitors. In Verzenio-treated patients in early breast cancer (monarchE, N=2791), 3% of patients experienced ILD or pneumonitis of any grade: 0.4% were Grade 3 or 4 and there was one fatality (0.1%). In Verzenio-treated patients in advanced or metastatic breast cancer (N=1108) (MONARCH 1, MONARCH 2, MONARCH 3, EMBER-3), 3.2% of Verzenio-treated patients had ILD or pneumonitis of any grade: 0.5% had Grade 3 or 4, and 0.5% had fatal outcomes. Additional cases of ILD or pneumonitis have been observed in the postmarketing setting, with fatalities reported.
Monitor patients for pulmonary symptoms indicative of ILD or pneumonitis. Symptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams. Infectious, neoplastic, and other causes for such symptoms should be excluded by means of appropriate investigations.
Withhold or reduce dose for patients who develop persistent or recurrent Grade 2 ILD or pneumonitis. Permanently discontinue VERZENIO in all patients with Grade 3 or 4 ILD or pneumonitis.
Grade
≥
3 increases in alanine aminotransferase (ALT) (2% to 6%) and
aspartate aminotransferase (AST) (2% to 3%) were reported in patients receiving Verzenio.
Across four clinical trials in 3767 patients (monarchE, MONARCH 2, MONARCH 3, EMBER-3), the median time to onset of Grade ≥3 ALT increases ranged from 57 to 87 days and the median time to resolution to Grade <3 was 13 to 14 days. The median time to onset of Grade ≥3 AST increases ranged from 71 to 185 days and the median time to resolution to Grade <3 ranged from 11 to 15 days.
Monitor liver function tests (LFTs) prior to the start of VERZENIO therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Dose interruption, dose reduction, dose discontinuation, or delay in starting treatment cycles is recommended for patients who develop persistent or recurrent Grade 2, or any Grade 3 or Grade 4 hepatic transaminase elevation.
Venous thromboembolic events (VTE) were reported in 2% to 5% of patients treated with Verzenio across four clinical trials in 3767 patients (monarchE, MONARCH 2, MONARCH 3, EMBER-3). VTE events included deep vein thrombosis, pulmonary embolism, pelvic venous thrombosis, cerebral venous sinus thrombosis, subclavian and axillary vein thrombosis, inferior vena cava thrombosis, jugular vein thrombosis, peripheral vein thrombosis and superficial vein thrombosis. In clinical trials, deaths due to VTE occurred in patients treated with Verzenio.
Verzenio has not been studied in patients with early breast cancer who had a history of VTE. Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism and treat as medically appropriate. Dose interruption is recommended for early breast cancer patients with any grade VTE event and for advanced or metastatic breast cancer patients with a Grade 3 or 4 VTE event.
Verzenio can cause
fetal harm when administered to a pregnant woman, based on findings from animal studies and the mechanism of action. In animal reproduction studies, administration of abemaciclib to pregnant rats during the period of organogenesis caused teratogenicity and decreased fetal weight at maternal exposures that were similar to the human clinical exposure based on area under the curve (AUC) at the maximum recommended human dose.
Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Verzenio and for 3 weeks after the last dose.
Verzenio can
increase serum creatinine without affecting renal function. These increases were not associated with changes in glomerular function. In EMBER-3, creatinine increase occurred in 36% for all grades (Grade 3 or 4: 1.1%) of patients who received Inluriyo in combination with Verzenio. During Verzenio treatment, use alternative measures that are not based on serum creatinine to assess renal function such as BUN, cystatin C, or calculated GFR.
The most
common adverse reactions (all grades,
≥
10%) observed in
monarchE for
Verzenio plus tamoxifen or an aromatase inhibitor vs tamoxifen or an aromatase inhibitor, with a difference between arms of
≥
2%, were diarrhea (84% vs 9%), infections (51% vs 39%), neutropenia (46% vs 6%), fatigue (41% vs 18%), leukopenia (38% vs 7%), nausea (30% vs 9%), anemia (24% vs 4%), headache (20% vs 15%), vomiting (18% vs 4.6%), stomatitis (14% vs 5%), lymphopenia (14% vs 3%), thrombocytopenia (13% vs 2%), decreased appetite (12% vs 2.4%), ALT increased (12% vs 6%), AST increased (12% vs 5%), dizziness (11% vs 7%), rash (11% vs 4.5%), and alopecia (11% vs 2.7%).
The
most frequently reported
≥
5% Grade 3 or 4 adverse reaction that occurred in the Verzenio arm vs the tamoxifen or an aromatase inhibitor arm of monarchE were neutropenia (19.6% vs 1%), leukopenia (11% vs <1%), diarrhea (8% vs 0.2%), and lymphopenia (5% vs <1%).
Lab abnormalities (all grades; Grade 3 or 4) for
monarchE in
≥
10% for Verzenio plus tamoxifen or an aromatase inhibitor with a difference between arms of
≥
2% were increased serum creatinine (99% vs 91%; 0.5% vs <0.1%), decreased white blood cells (89% vs 28%; 19.1% vs 1.1%), decreased neutrophil count (84% vs 23%; 18.7% vs 1.9%), anemia (68% vs 17%; 1% vs .1%), decreased lymphocyte count (59% vs 24%; 13.2% vs 2.5%), decreased platelet count (37% vs 10%; .9% vs .2%), increased ALT (37% vs 24%; 2.6% vs 1.2%), increased AST (31% vs 18%; 1.6% vs .9%), and hypokalemia (11% vs 3.8%; 1.3% vs 0.2%).
The
most common adverse reactions (all grades,
≥
10%) observed in
MONARCH 3 for Verzenio plus anastrozole or letrozole vs anastrozole or letrozole, with a difference between arms of
≥
2%, were diarrhea (81% vs 30%), fatigue (40% vs 32%), neutropenia (41% vs 2%), infections (39% vs 29%), nausea (39% vs 20%), abdominal pain (29% vs 12%), vomiting (28% vs 12%), anemia (28% vs 5%), alopecia (27% vs 11%), decreased appetite (24% vs 9%), leukopenia (21% vs 2%), creatinine increased (19% vs 4%), constipation (16% vs 12%), ALT increased (16% vs 7%), AST increased (15% vs 7%), rash (14% vs 5%), pruritus (13% vs 9%), cough (13% vs 9%), dyspnea (12% vs 6%), dizziness (11% vs 9%), weight decreased (10% vs 3.1%), influenza-like illness (10% vs 8%), and thrombocytopenia (10% vs 2%).
The
most frequently reported
≥
5% Grade 3 or 4 adverse reactions that occurred in the Verzenio arm vs the placebo arm of
MONARCH 3 were neutropenia (22% vs 1%), diarrhea (9% vs 1.2%), leukopenia (7% vs <1%)), increased ALT (6% vs 2%), and anemia (6% vs 1%).
Lab abnormalities (all grades; Grade 3 or 4) for
MONARCH 3 in
≥
10% for Verzenio plus anastrozole or letrozole with a difference between arms of
≥
2% were increased serum creatinine (98% vs 84%; 2.2% vs 0%), decreased white blood cells (82% vs 27%; 13% vs 0.6%), anemia (82% vs 28%; 1.6% vs 0%), decreased neutrophil count (80% vs 21%; 21.9% vs 2.6%), decreased lymphocyte count (53% vs 26%; 7.6% vs 1.9%), decreased platelet count (36% vs 12%; 1.9% vs 0.6%), increased ALT (48% vs 25%; 6.6% vs 1.9%), and increased AST (37% vs 23%; 3.8% vs 0.6%).
The
most common adverse reactions (all grades,
≥
10%) observed in
MONARCH 2 for Verzenio plus fulvestrant vs fulvestrant, with a difference between arms of
≥
2%, were diarrhea (86% vs 25%), neutropenia (46% vs 4%), fatigue (46% vs 32%), nausea (45% vs 23%), infections (43% vs 25%), abdominal pain (35% vs 16%), anemia (29% vs 4%), leukopenia (28% vs 2%), decreased appetite (27% vs 12%), vomiting (26% vs 10%), headache (20% vs 15%), dysgeusia (18% vs 2.7%), thrombocytopenia (16% vs 3%), alopecia (16% vs 1.8%), stomatitis (15% vs 10%), ALT increased (13% vs 5%), pruritus (13% vs 6%), cough (13% vs 11%), dizziness (12% vs 6%), AST increased (12% vs 7%), peripheral edema (12% vs 7%), creatinine increased (12% vs <1%), rash (11% vs 4.5%), pyrexia (11% vs 6%), and weight decreased (10% vs 2.2%).
The
most frequently reported
≥
5% Grade 3 or 4 adverse reactions that occurred in the Verzenio arm vs the placebo arm of
MONARCH 2 were neutropenia (25% vs 1%), diarrhea (13% vs 0.4%), leukopenia (9% vs 0%), anemia (7% vs 1%), and infections (5.7% vs 3.5%).
Lab abnormalities (all grades; Grade 3 or 4) for
MONARCH 2 in
≥
10% for Verzenio plus fulvestrant with a difference between arms of
≥
2% were increased serum creatinine (98% vs 74%; 1.2% vs 0%), decreased white blood cells (90% vs 33%; 23.7% vs .9%), decreased neutrophil count (87% vs 30%; 32.5% vs 4.2%), anemia (84% vs 34%; 2.6% vs .5%), decreased lymphocyte count (63% vs 32%; 12.2% vs 1.8%), decreased platelet count (53% vs 15%; 2.1% vs 0%), increased ALT (41% vs 32%; 4.6% vs 1.4%), and increased AST (37% vs 25%; 3.9% vs 4.2%).
The
most common adverse reactions (all grades,
≥
10%) observed in
MONARCH 1 with Verzenio were diarrhea (90%), fatigue (65%), nausea (64%), decreased appetite (45%), abdominal pain (39%), neutropenia (37%), vomiting (35%), infections (31%), anemia (25%), thrombocytopenia (20%), headache (20%), cough (19%), constipation (17%), leukopenia (17%), arthralgia (15%), dry mouth (14%), weight decreased (14%), stomatitis (14%), creatinine increased (13%), alopecia (12%), dysgeusia (12%), pyrexia (11%), dizziness (11%), and dehydration (10%).
The
most frequently reported
≥
5% Grade 3 or 4 adverse reactions from
MONARCH 1 with Verzenio were diarrhea (20%), neutropenia (24%), fatigue (13%), and leukopenia (5%).
Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 1 with Verzenio were increased serum creatinine (99%; .8%), decreased white blood cells (91%; 28%), decreased neutrophil count (88%; 26.6%), anemia (69%; 0%), decreased lymphocyte count (42%; 13.8%), decreased platelet count (41%; 2.3%), increased ALT (31%; 3.1%), and increased AST (30%; 3.8%).
Serious and Fatal Adverse Reactions for Inluriyo in combination with Verzenio: Serious adverse reactions occurred in 21% of patients who received Inluriyo in combination with Verzenio. Serious adverse reactions in >1% of patients who received Inluriyo in combination with Verzenio included pneumonia (2.4%), abdominal pain, and renal failure (each 1.4%).
Fatal adverse reactions occurred in 3.8% of patients who received Inluriyo in combination with Verzenio, including pneumonia (1.4%), myocardial infarction, interstitial lung disease, and sepsis (0.5% each).
Most Common Adverse Reactions for Inluriyo in combination with Verzenio: The most common (≥10%) adverse reactions with Inluriyo in combination with Verzenio, including laboratory abnormalities, were decreased neutrophils, diarrhea, decreased hemoglobin, decreased lymphocytes, nausea, decreased platelets, fatigue, increased triglycerides, infections, increased AST, increased creatinine, increased ALT, vomiting, musculoskeletal pain, abdominal pain, decreased appetite, increased cholesterol, rash, cough, headache, and decreased weight.
Strong and moderate CYP3A inhibitors increased the exposure of abemaciclib plus its active metabolites to a clinically meaningful extent and may lead to increased toxicity. Avoid concomitant use of ketoconazole. Ketoconazole is predicted to increase the AUC of abemaciclib by up to 16-fold. In patients with recommended starting doses of 200 mg twice daily or 150 mg twice daily, reduce the Verzenio dose to 100 mg twice daily with concomitant use of strong CYP3A inhibitors other than ketoconazole. In patients who have had a dose reduction to 100 mg twice daily due to adverse reactions, further reduce the Verzenio dose to 50 mg twice daily with concomitant use of strong CYP3A inhibitors. If a patient taking Verzenio discontinues a strong CYP3A inhibitor, increase the Verzenio dose (after 3-5 half-lives of the inhibitor) to the dose that was used before starting the inhibitor. Patients should avoid grapefruit products. With concomitant use of moderate CYP3A inhibitors, monitor for adverse reactions and consider reducing the Verzenio dose in 50 mg decrements.
Avoid concomitant use of strong or moderate CYP3A inducers and consider alternative agents. Coadministration of strong or moderate CYP3A inducers decreased the plasma concentrations of abemaciclib plus its active metabolites and may lead to reduced activity.
With severe hepatic impairment (Child-Pugh C), reduce the Verzenio dosing frequency to once daily. No dosage adjustments are necessary in patients with mild or moderate hepatic impairment (Child-Pugh A or B).
Please see full
Prescribing Information
and
Patient Information
for Verzenio.
VZ IN HCP ISI ALL APPR
About Lilly
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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 sofetabart mipitecan as a potential treatment for ovarian cancer as well as other FRα-expressing solid tumors, olomorasib as a potential treatment for certain KRAS G12C-mutant advanced solid tumors, Retevmo (selpercatinib) as a treatment for advanced RET-mutant medullary thyroid cancer (MTC), and Verzenio (abemaciclib) as a treatment for certain HR+, HER2– breast cancers in the adjuvant and advanced or metastatic setting, 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.
Endnotes & References
Bax, Heather J et al. "Folate receptor alpha in ovarian cancer tissue and patient serum is associated with disease burden and treatment outcomes." British journal of cancer vol. 128,2 (2023): 342-353. doi:10.1038/s41416-022-02031-x
Scaranti, Mariana et al. "Exploiting the folate receptor α in oncology." Nature reviews. Clinical oncology vol. 17,6 (2020): 349-359. doi:10.1038/s41571-020-0339-5.
Kalli, Kimberly R et al. "Folate receptor alpha as a tumor target in epithelial ovarian cancer." Gynecologic oncology vol. 108,3 (2008): 619-26. doi:10.1016/j.ygyno.2007.11.020.
Viricel W, et al. Cancer Res. 2023;83(suppl 7):1544.
Ji J, Wang C, Fakih M. Targeting KRAS G12C-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
Retevmo. Prescribing information. Lilly USA, LLC.
Verzenio. Prescribing information. Lilly USA, LLC.
Inluriyo. Prescribing information. Lilly USA, LLC.
Refer to: Megan Talon; [email protected] (Media)
Michael Czapar; [email protected] (Investors)
SOURCE Eli Lilly and Company
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