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INDIANAPOLIS, Sept. 10, 2020 /PRNewswire/ -- Data from 20 studies across Eli Lilly and Company's (NYSE: LLY) oncology product portfolio will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress, September 19-21, 2020. The data include positive results from the Phase 3 monarchE study of Verzenio® (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) for the treatment of high risk HR+, HER2- early breast cancer. Together, the studies presented at ESMO demonstrate Lilly's commitment to researching and developing new treatments for people around the world who are living with cancer.
"We're thrilled to share the statistically significant and clinically meaningful results from monarchE, a Phase 3 study which demonstrated the impact of Verzenio, in combination with adjuvant endocrine therapy, to reduce the risk of cancer returning and potentially change the treatment landscape in high risk early breast cancer," said Maura Dickler, M.D., vice president, late phase development, Lilly Oncology. "We're eager to use this virtual time during ESMO to learn from and collaborate with doctors, researchers and advocates and to share data that can improve treatment outcomes for patients living with cancer."
Latest Results for Verzenio in Hard-to-Treat Breast CancerLilly continues to investigate Verzenio across the breast cancer continuum, which has now shown positive results in people with high risk HR+, HER2- early breast cancer. At ESMO, Lilly will share detailed results from the Phase 3 monarchE study, which demonstrated Verzenio plus standard adjuvant ET significantly decreased the risk of breast cancer recurrence compared to standard adjuvant ET alone in people with high risk HR+, HER2- early breast cancer. These results make Verzenio the only CDK4 & 6 inhibitor to demonstrate statistically significant improvement in invasive disease-free survival in this setting.
Lilly also will present findings on genomic testing, biomarkers and treatment patterns in early breast cancer as well as the use of Ki-67 testing and scoring in HR+, HER2- early breast cancer – a biomarker of particular interest in the study of high risk early breast cancer. Additional Verzenio data to be presented include a final overall survival analysis of Verzenio monotherapy in patients with HR+, HER2- advanced breast cancer in the nextMONARCH trial.
Retevmo™ Data Highlights In May 2020, Lilly's first-in-class oral precision medicine Retevmo™ (selpercatinib) received Accelerated Approval from the U.S. Food and Drug Administration (FDA) for the treatment of metastatic RET fusion-positive non-small cell lung cancer (NSCLC), in adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, and in adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). The approval of Retevmo – a selective RET kinase inhibitor – marked the most rapid timeline in the development of an oncology medicine with multiple indications, and was based on results from the Phase 1/2 LIBRETTO-001 trial, the largest clinical trial in patients with RET-altered cancers. During ESMO, Lilly will present patient-reported outcomes and quality of life findings from both the RET fusion-positive NSCLC and RET-mutant MTC patient cohorts.
Lilly will also present new safety data on patients with previously treated metastatic RET fusion-positive NSCLC, including safety and efficacy outcomes assessed by category of last systemic therapy received prior to LIBRETTO-001 enrollment. An additional safety analysis, focusing on hypersensitivity reactions in RET fusion-positive NSCLC patients previously treated with immune checkpoint inhibitors, will also be presented.
Details on the study design of two confirmatory Phase 3 trials, LIBRETTO-431 and LIBRETTO-531, will additionally be shared. Both Phase 3 trials are currently enrolling patients.
CYRAMZA® Lung Cancer Data Highlights Earlier this year, the FDA approved CYRAMZA® (ramucirumab) in combination with erlotinib for the first-line treatment of people with metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations, based on results from the Phase 3 RELAY study. With this approval, CYRAMZA has now received six FDA approvals to treat certain types of lung, liver, stomach and colorectal cancers. CYRAMZA was also approved in the European Union earlier this year based on the RELAY results.
During ESMO, Lilly will feature data from the RELAY trial looking at outcomes by EGFR mutation type in previously untreated EGFR-mutated metastatic NSCLC patients. Additionally, a systematic literature review will spotlight outcomes of treated patients with EGFR-mutated NSCLC harboring exon 19 deletions or exon 21 mutations.
A list of the data presentations along with the viewing details are highlighted below.
Verzenio:
Abstract LBA5_PR: Abemaciclib in high risk early breast cancer (Stephen R. Johnston) Accepted for Presidential Symposium II September 20 at 19:51-20:03 CEST
Abstract 273O: nextMONARCH: Final overall survival analysis of abemaciclib monotherapy or in combination with tamoxifen in patients with HR+, HER2- metastatic breast cancer (Erika P. Hamilton) Accepted as Oral Presentation September 19 at 17:28-17:40 CEST; Session: Breast Cancer, Metastatic 1
Abstract 174P: Genomic testing, biomarkers and treatment patterns in early breast cancer (Michael Method) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST
Abstract 181P: The use of Ki67 testing and scoring in HR+, HER2- early breast cancer (Jacqueline Brown) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST
Abstract 240P: A multinational real-world study on HR+, HER2- early stage breast cancer patients' disease awareness, satisfaction, and involvement in treatment decisions (Alex Rider) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST
Abstract 239P: Impact of clinical characteristics, patients' perception of treatment goals and endocrine therapy history on HRQOL in HR+, HER2- early stage breast cancer patients (Rhys Williams) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST
Retevmo:
Abstract 1291P: Hypersensitivity reactions (HR) to selpercatinib in RET fusion+ non-small cell lung cancer (NSCLC) patients (pts) following immune checkpoint inhibition (CPI) (Caroline E. McCoach) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST
Abstract 1290P: Efficacy and safety with selpercatinib by last prior systemic therapy received in patients (Pts) with RET fusion + non-small cell lung cancer (NSCLC) (Oliver Gautschi) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST
Abstract 1292P: Exploratory patient-reported outcomes (PROs) among patients with RET-fusion non-small cell lung cancer (NSCLC) in LIBRETTO-001: A phase I/II trial of selpercatinib (Anna R. Minchom) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST
Abstract 1922P: Exploratory patient-reported outcomes among patients with RET-mutant medullary thyroid cancer in LIBRETTO-001: A phase I/II trial of selpercatinib (LOXO-292) (Lori J. Wirth) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST
Abstract 1413TiP: LIBRETTO-431: Selpercatinib in treatment (Tx)-naïve patients with RET fusion-positive (RET+) non-small cell lung cancer (NSCLC) (Herbert H. Loong) Accepted as ePoster (trial in progress; no data will be presented) Available on-demand on September 17 at 09:00 CEST
Abstract 1927TiP: LIBRETTO-531: Selpercatinib in patients with treatment (Tx)-naïve RET-mutant medullary thyroid cancer (MTC) (Jorge Hernando) Accepted as ePoster (trial in progress; no data will be presented) Available on-demand on September 17 at 09:00 CEST
CYRAMZA:
Abstract 1294P: RELAY, erlotinib plus ramucirumab or placebo in untreated EGFR-mutated metastatic NSCLC: Outcomes by EGFR mutation type (Kazuhiko Nakagawa) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST
Abstract 1357P: Outcomes of treated patients with EGFR-mutated advanced or metastatic non-small cell lung cancer harboring exon 19 deletions or L858R substitution (Exon 21) mutations: A systematic literature review (Katherine B. Winfree) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST
Abstract 1298P: RELAY, ramucirumab plus erlotinib (RAM+ERL) versus placebo plus erlotinib (P+ERL) in untreated EGFR mutated metastatic non-small cell lung cancer (NSCLC): Exposure-response relationship (Kazuhiko Nakagawa) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST
Abstract 1015TiP: Ramucirumab in patients with advanced hepatocellular carcinoma and elevated alpha fetoprotein following a non-sorafenib based systemic therapy: An expansion cohort of the phase III REACH-2 study (Richard S. Finn) Accepted as ePoster (trial in progress; no data will be presented) Available on-demand on September 17 at 09:00 CEST
TYVYT®:
Abstract 991P: Sintilimab plus IBI305 as first-line treatment for advanced hepatocellular carcinoma (Fan Jia) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST
Abstract 1498TiP: A multi-center, randomized, open-label, phase III study of sintilimab + ramucirumab as 1st-line treatment for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (ORIENT-106) (Ruihua Xu) Accepted as ePoster (trial in progress; no data will be presented) Available on-demand on September 17 at 09:00 CEST
ALIMTA®:
Abstract 1313P: Phase III LEAP-006 safety run-in (Part 1): 1L pembrolizumab (Pembro) + chemotherapy (Chemo) with lenvatinib (Len) for metastatic NSCLC (Makoto Nishio) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST
ERBITUX®:
Abstract 455P: A meta-analysis of efficacy and safety of cetuximab with biweekly vs. weekly dosing (Aparna Parikh) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST
Notes to Editors
About Verzenio® (abemaciclib) Verzenio (abemaciclib) is an inhibitor of cyclin-dependent kinases (CDK)4 & 6, which are activated by binding to D-cyclins. In estrogen receptor-positive (ER+) breast cancer cell lines, cyclin D1 and CDK4 & 6 promote phosphorylation of the retinoblastoma protein (Rb), cell cycle progression, and cell proliferation.
In vitro, continuous exposure to Verzenio inhibited Rb phosphorylation and blocked progression from G1 to S phase of the cell cycle, resulting in senescence and apoptosis (cell death). Preclinically, Verzenio dosed daily without interruption resulted in reduction of tumor size. Inhibiting CDK4 & 6 in healthy cells can result in side effects, some of which may be serious. Clinical evidence also suggests that Verzenio crosses the blood-brain barrier. In patients with advanced cancer, including breast cancer, concentrations of Verzenio and its active metabolites (M2 and M20) in cerebrospinal fluid are comparable to unbound plasma concentrations.
Verzenio is Lilly's first solid oral dosage form to be made using a faster, more efficient process known as continuous manufacturing. Continuous manufacturing is a new and advanced type of manufacturing within the pharmaceutical industry, and Lilly is one of the first companies to use this technology.
Verzenio is indicated for the treatment of HR+, HER2- advanced or metastatic breast cancer:
About Retevmo™ (selpercatinib) Retevmo (selpercatinib, formerly known as LOXO-292) (pronounced reh-TEHV-moh) is a selective and potent RET kinase inhibitor. Retevmo may affect both tumor cells and healthy cells, which can result in side effects. Retevmo is an oral prescription medicine, taken twice daily.
Retevmo is indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), and the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, or advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). Retevmo was approved under the FDA's Accelerated Approval regulations based on the LIBRETTO-001 Phase 1/2 trial's endpoints of objective response rate (ORR) and duration of response (DoR). Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
About CYRAMZA® (ramucirumab) In the U.S., CYRAMZA (ramucirumab) has six FDA approvals to treat four different types of cancers. CYRAMZA is being investigated in a broad global development program that has enrolled more than 15,000 patients across more than 100 trials worldwide. These include several studies investigating CYRAMZA in combination with other anti-cancer therapies for the treatment of multiple tumor types. To date, more than 150,000 patients have been treated with CYRAMZA.
CYRAMZA is an antiangiogenic therapy. It is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that binds specifically to VEGFR-2, thereby blocking the binding of the receptor ligands (VEGF-A, VEGF-C, and VEGF-D) – which may slow tumor growth. CYRAMZA inhibited angiogenesis in an in vivo animal model.
U.S. INDICATIONS FOR CYRAMZA
Gastric Cancer CYRAMZA, as a single agent, or in combination with paclitaxel, is indicated for the treatment of patients with advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
Non-Small Cell Lung CancerCYRAMZA, in combination with erlotinib, for first-line treatment of metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.
CYRAMZA, in combination with docetaxel, is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA.
Colorectal Cancer CYRAMZA, in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.
Hepatocellular Carcinoma CYRAMZA, as a single agent, is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha-fetoprotein (AFP) of ≥400 ng/mL and have been treated with sorafenib.
About ALIMTA® (pemetrexed for injection) ALIMTA is indicated in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic nonsquamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations. Limitation of Use: ALIMTA is not indicated for the treatment of patients with squamous cell non-small cell lung cancer. For all FDA-approved indications for ALIMTA, please see full Prescribing Information.
Indications and Usage for ERBITUX (cetuximab) injection
Head and Neck Cancer ERBITUX (cetuximab) is approved:
Metastatic Colorectal Cancer ERBITUX is indicated for the treatment of KRAS wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) as determined by an FDA-approved test for this use:
Limitations of Use: ERBITUX is not indicated for treatment of RAS-mutant colorectal cancer or when the results of the RAS mutation tests are unknown
About TYVYT (Sintilimab Injection) TYVYT (sintilimab injection) is an innovative drug with global quality standards jointly developed by Innovent and Lilly in China. TYVYT has been granted marketing approval by the NMPA for the treatment of relapsed or refractory classic Hodgkin's lymphoma after at least two lines of systemic chemotherapy and was included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies.
In April 2020, the NMPA accepted the supplemental new drug application for TYVYT in combination with ALIMTA (pemetrexed for injection) and platinum as first-line therapy in advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT combined with gemcitabine and platinum chemotherapy met the predefined primary endpoint in the Phase 3 ORIENT-12 study as first-line therapy in patients with locally advanced or metastatic squamous NSCLC. TYVYT monotherapy met the primary endpoint in the ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma as well. In August 2020, the NMPA accepted the sNDA for TYVYT in combination with gemcitabine and platinum chemotherapy as first-line therapy in patients with locally advanced or metastatic squamous NSCLC.
TYVYT is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies with TYVYT to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.
TYVYT (sintilimab injection) is not an approved product in the United States. ALIMTA (pemetrexed for injection) is not approved for use in combination with TYVYT in the United States.
IMPORTANT SAFETY INFORMATION FOR VERZENIO® (abemaciclib)
Diarrhea occurred in 81% of patients receiving Verzenio plus an aromatase inhibitor in MONARCH 3, 86% of patients receiving Verzenio plus fulvestrant in MONARCH 2 and 90% of patients receiving Verzenio alone in MONARCH 1. Grade 3 diarrhea occurred in 9% of patients receiving Verzenio plus an aromatase inhibitor in MONARCH 3, 13% of patients receiving Verzenio plus fulvestrant in MONARCH 2 and in 20% of patients receiving Verzenio alone in MONARCH 1. Episodes of diarrhea have been associated with dehydration and infection.
Diarrhea incidence was greatest during the first month of Verzenio dosing. In MONARCH 3, the median time to onset of the first diarrhea event was 8 days, and the median duration of diarrhea for Grades 2 and 3 were 11 and 8 days, respectively. In MONARCH 2, the median time to onset of the first diarrhea event was 6 days, and the median duration of diarrhea for Grades 2 and 3 were 9 days and 6 days, respectively. In MONARCH 3, 19% of patients with diarrhea required a dose omission and 13% required a dose reduction. In MONARCH 2, 22% of patients with diarrhea required a dose omission and 22% required a dose reduction. The time to onset and resolution for diarrhea were similar across MONARCH 3, MONARCH 2, and MONARCH 1.
Instruct patients that at the first sign of loose stools, they should start antidiarrheal therapy such as loperamide, 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, discontinue Verzenio until toxicity resolves to ≤Grade 1, and then resume Verzenio at the next lower dose.
Neutropenia occurred in 41% of patients receiving Verzenio plus an aromatase inhibitor in MONARCH 3, 46% of patients receiving Verzenio plus fulvestrant in MONARCH 2 and 37% of patients receiving Verzenio alone in MONARCH 1. A Grade ≥3 decrease in neutrophil count (based on laboratory findings) occurred in 22% of patients receiving Verzenio plus an aromatase inhibitor in MONARCH 3, 32% of patients receiving Verzenio plus fulvestrant in MONARCH 2 and in 27% of patients receiving Verzenio alone in MONARCH 1. In MONARCH 3, the median time to first episode of Grade ≥3 neutropenia was 33 days, and in MONARCH 2 and MONARCH 1, was 29 days. In MONARCH 3, median duration of Grade ≥3 neutropenia was 11 days, and for MONARCH 2 and MONARCH 1 was 15 days.
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.
Febrile neutropenia has been reported in
