Announcement • 4h
Eli Lilly and Company Showcases Oncology Portfolio Across Tumor Types and Treatment Modalities At the American Society of Clinical Oncology Annual Meeting
Eli Lilly and Company announced the details of presentations from across its oncology portfolio at the American Society of Clinical Oncology Annual Meeting, taking place May 29 - June 2 in Chicago, Illinois. Data at ASCO include two Plenary Session presentations, featuring primary event-free survival results from the Phase 3 LIBRETTO-432 study of adjuvant Retevmo (selpercatinib) in rearranged during transfection(RET) fusion-positive non-small cell lung cancer (NSCLC) and an investigator-initiated Phase 3 study, SARC041, evaluating Verzenio (abemaciclib) in patients with advanced dedifferentiated liposarcoma. Additional data include an oral presentation of initial results of an investigational antibody drug conjugate (ADC) targeting Nectin-4 in patients with advanced or metastatic urothelial carcinoma, and data from programs in lung, breast and blood cancers. Updated data from Kelonia Therapeutics' Phase 1 inMMyCAR study of an anti-B-cell maturation antigen (BCMA) targeted in vivo CAR-T therapy in patients with relapsed and refractory multiple myeloma will also be presented in an oral session. Lilly's proposed acquisition of Kelonia Therapeutics was previously announced and is pending transaction close. Lilly Presentation Highlights: Retevmo (selpercatinib; RET kinase inhibitor): In a late-breaking presentation in the Plenary Session, Lilly will share primary event-free survival results from the Phase 3 LIBRETTO-432 study of adjuvant selpercatinib in patients with stage IB-IIIA RET fusion-positive NSCLC. Lilly previously announced that selpercatinib met the primary endpoint, demonstrating a highly significant and clinically meaningful improvement in investigator-assessed event free survival. These results were also selected to be highlighted in the ASCO Annual Meeting press program session on May 30. Verzenio (abemaciclib; CDK4/6 Inhibitor): In a Plenary Session presentation, results will be shared from the Phase 3 investigator-initiated SARC041 study, evaluating abemaciclib in patients with advanced dedifferentiated liposarcoma. LY4052031 (investigational ADC targeting Nectin-4): In an oral presentation, initial results will be shared from the Phase 1 NEXUS-01 study evaluating LY4052031, an ADC targeting Nectin-4, in patients with advanced or metastatic urothelial carcinoma. Kelonia Therapeutics Presentation: KLN-1010 (investigational in vivo CAR-T therapy): In a rapid oral presentation, updated results will be shared from the Phase 1 inMMyCAR study of KLN-1010 in patients with relapsed and refractory multiple myeloma. Updated results from PIKALO-1. KLN-1010 (Kelonia Therapeutics' investigational in vivo CAR-T therapy) Updated results from inMMyCAR, the ongoing first-in-human Phase 1 study of KLN-1010 in patients with relapsed and refractory multiple myeloma (RRMM). 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. 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. INDICATIONS FOR RETEVMO (selpercatinib) RETEVMO is a kinase inhibitor indicated for the treatment of: Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test. IMPORTANT SAFETY INFORMATION FOR RETEVMO (selpercatinib) Hepatotoxicity: Serious hepatic adverse reactions occurred in 3% of patients treated with Retevmo. Increased aspartate aminotransferase (AST) occurred in 59% of patients, including Grade 3 or 4 events in 11% and increased alanine aminotransferase (ALT) occurred in 55% of patients, including Grade 3 or 4 events in 12%. 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 1.8% of patients who received Retevmo, including 0.3% with Grade 3 or 4 events, and 0.3% 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 41% of patients, including Grade 3 hypertension in 20% and Grade 4 in one (0.1%) patient. Overall, 6.3% had their dose interrupted and 1.3% had their dose reduced 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 7% of patients and an increase in the QTcF interval of at least 60 ms over baseline was measured in 20% 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.