On May 15, 2019 Eli Lilly and Company (NYSE: LLY) reported that data from a number of studies across the company’s oncology product portfolio will be presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, May 31-June 4, 2019 (Press release, Eli Lilly, MAY 15, 2019, View Source [SID1234536384]). Data from 23 oral presentations and posters underscore Lilly Oncology’s focus on making a meaningful difference in the lives of people living with cancer, especially those with hard-to-treat tumor types.
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"Lilly data at this year’s ASCO (Free ASCO Whitepaper) demonstrate our commitment to offering treatment solutions for patients with the greatest need. We look forward to sharing these findings, with the hope that they will shed light on our progress and future opportunities in difficult-to-treat cancers," said Maura Dickler, M.D., vice president, late phase development, Lilly Oncology. "We are excited to present the first results from RELAY, a Phase 3 study of ramucirumab in metastatic EGFR-mutated non-small cell lung cancer. Lilly will also share early-phase data from several investigational molecules as well as results from collaborative studies. This includes updated findings from the Phase 3 KEYNOTE-189 study of the pemetrexed-pembrolizumab-platinum chemotherapy combination, which has been established as the standard of care for the treatment of first-line metastatic nonsquamous non-small cell lung cancer."
Lung Cancer Data at ASCO (Free ASCO Whitepaper)
Lilly has a decades-old heritage in developing practice-changing medicines for the treatment of lung cancer. Lilly has developed multiple thoracic oncology treatments and continues to study marketed products and investigational molecules in new combinations and settings where they could help specific patient populations.
RELAY is a global, randomized, double-blind Phase 3 trial evaluating ramucirumab in combination with erlotinib, compared to placebo in combination with erlotinib, as a first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have activating EGFR mutations.
The KEYNOTE-189 trial, a randomized, double-blind, placebo-controlled Phase 3 study, evaluated pemetrexed in combination with pembrolizumab and cisplatin or carboplatin compared with pemetrexed in combination with placebo and cisplatin or carboplatin, in untreated patients with metastatic nonsquamous NSCLC, regardless of PD-L1 expression. The KEYNOTE-189 study was conducted by Merck (known as MSD outside the U.S. and Canada) in collaboration with Lilly.
Dr. Dickler added, "In addition to our lung cancer data at ASCO (Free ASCO Whitepaper) this year, we will present results of the Phase 3 ANNOUNCE trial, which studied olaratumab in combination with doxorubicin in soft tissue sarcoma. Unfortunately, this study did not confirm a survival benefit seen in a prior Phase 2 trial. We believe it’s important to share these results to inform the scientific community and to apply these learnings to the future investigation of new therapies in this heterogeneous and difficult-to-treat cancer."
Select studies, along with the dates, times and locations of their data sessions, are highlighted below.
Ramucirumab
Abstract #9000: RELAY: A multinational, double-blind, randomized Phase 3 study of erlotinib (ERL) in combination with ramucirumab (RAM) or placebo (PL) in previously untreated patients with epidermal growth factor receptor mutation-positive (EGFRm) metastatic non-small cell lung cancer (NSCLC) (Kazuhiko Nakagawa)
Oral Abstract Session; Lung Cancer—Non-Small Cell Metastatic
Monday, June 3; 8:00 – 8:12 a.m. CDT; Hall B1
Abstract #2528: Ramucirumab (Ram) and durvalumab (Durva) treatment of metastatic non-small cell lung cancer (NSCLC), gastric/gastroesophageal junction (G/GEJ) adenocarcinoma, and hepatocellular carcinoma (HCC) following progression on systemic treatment(s) (Yung-Jue Bang)
Poster Session: Poster Board #172; Developmental Immunotherapy and Tumor Immunobiology
Saturday, June 1; 8:00 – 11:00 a.m. CDT; Hall A
Abstract #4073: Ramucirumab (RAM) for sorafenib intolerant patients with hepatocellular carcinoma (HCC) and elevated baseline alpha fetoprotein (AFP): Outcomes from two randomized phase 3 studies (REACH, REACH2) (Josep M Llovet)
Poster Session: Poster Board #178; Gastrointestinal (Noncolorectal) Cancer
Monday, June 3; 8:00 – 11:00 a.m. CDT; Hall A
Pemetrexed
Abstract #9013: KEYNOTE-189: Updated OS and progression after the next line of therapy (PFS2) with pembrolizumab (pembro) plus chemo with pemetrexed and platinum vs placebo plus chemo for metastatic nonsquamous NSCLC (Shirish M. Gadgeel)
Poster Session, Poster Board #336, Lung Cancer—Non-Small Cell Metastatic
Sunday, June 2; 8:00 – 11:00 a.m. CDT; Hall A
Poster Discussion Session on Sunday, June 2; 4:30 – 6:00 p.m. CDT; Hall D1
Olaratumab
Abstract #LBA3: ANNOUNCE: A randomized, placebo (PBO)-controlled, double-blind, phase (Ph) III trial of doxorubicin (dox) + olaratumab versus dox + PBO in patients (pts) with advanced soft tissue sarcomas (STS) (William D. Tap)
Plenary Session
Sunday, June 2; 2:45 – 3:00 p.m. CDT; Hall B1
Abemaciclib
Abstract #1017: A phase II study of abemaciclib in patients (pts) with brain metastases (BM) secondary to HR+, HER2- metastatic breast cancer (MBC) (Carey K. Anders)
Poster Session; Poster Board #98; Breast Cancer—Metastatic
Sunday, June 2; 8:00 – 11:00 a.m. CDT; Hall A
Poster Discussion Session on Sunday, June 2; 11:15 a.m. – 12:45 p.m. CDT; Hall D2
Abstract #1042: Next-generation sequencing (NGS) results among hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC) patients treated with a CDK4 & 6 inhibitor: A retrospective observational study based on real-world data (Erika Paige Hamilton)
Poster Session: Poster Board #123; Breast Cancer—Metastatic
Sunday, June 2; 8:00 – 11:00 a.m. CDT; Hall A
LOXO-292
Abstract # TPS10066: A phase I study of LOXO-292, a highly selective RET inhibitor, in pediatric patients with RET-altered cancers (Steven G. DuBois)
Poster Session: Poster Board #447b; Pediatric Oncology
Saturday, June 1; 8:00 – 11:00 a.m. CDT; Hall A
Abstract #10045: First experience of LOXO-292 in the management of pediatric patients with RET-altered cancers (Ulrike Gerdemann)
Poster Session: Poster Board #427; Pediatric Oncology
Saturday, June 1; 8:00 – 11:00 a.m. CDT; Hall A
CSF-1R
Abstract #2548: Phase 1 study of LY3022855, a colony-stimulating factor-1 receptor (CSF-1R) inhibitor, in patients with metastatic breast cancer (MBC) or metastatic castration-resistant prostate cancer (MCRPC) (Karen A. Autio)
Poster Session: Poster Board #192; Developmental Immunotherapy and Tumor Immunobiology
Saturday, June 1; 8:00 – 11:00 a.m. CDT; Hall A
ERK Inhibitor
Abstract #3001: A phase I dose escalation (DE) study of ERK inhibitor, LY3214996, in advanced (adv) cancer (CA) patients (pts) (Shubham Pant)
Oral Abstract Session; Developmental Therapeutics and Tumor Biology (Nonimmuno)
Monday, June 3; 8:12 – 8:24 a.m. CDT; S406
PI3 KINASE/mTOR
Abstract #5009: Phase 1b/2 study of enzalutamide (ENZ) with LY3023414 (LY) or placebo (PL) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) after progression on abiraterone (Christopher Sweeney)
Poster Session: Poster Board #121; Genitourinary (Prostate) Cancer
Saturday, June 1; 1:15 – 4:15 p.m. CDT; Hall A
Poster Discussion Session on Saturday, June 1; 4:30 – 6:00 p.m. CDT; Arie Crown Theater
Prexasertib
Abstract #3091: A phase Ib study of prexasertib, a checkpoint kinase (CHK1) inhibitor, and LY3023414, a dual inhibitor of class I phosphatidylinositol 3-kinase (PI3K) and the mammalian target of rapamycin (mTOR) in patients with advanced solid tumors (David S. Hong)
Poster Session: Poster Board #83; Developmental Therapeutics and Tumor Biology (Nonimmuno)
Saturday, June 1; 8:00 – 11:00 a.m. CDT; Hall A
Ralimetinib
Abstract #5537: A randomized, double-blind, placebo-controlled phase Ib/II study of ralimetinib, a p38 MAPK inhibitor, plus gemcitabine (G) and carboplatin (C) versus GC for women with recurrent platinum-sensitive ovarian cancer (Ignace Vergote)
Poster Session: Poster Board #360; Gynecologic Cancer
Saturday, June 1; 1:15 – 4:15 p.m. CDT; Hall A
TIM-3/PD-L1
Abstract #TPS2654: A phase Ia/b study of TIM-3/PD-L1 bispecific antibody in patients with advanced solid tumors (Matthew David Hellmann)
Poster Session: Poster Board #293a; Developmental Immunotherapy and Tumor Immunobiology
Saturday, June 1; 8:00 – 11:00 a.m. CDT; Hall A
Galunisertib
Abstract #4124: A phase Ib dose-escalation and cohort-expansion study of safety and activity of the transforming growth factor (TGF) β receptor I kinase inhibitor galunisertib plus the anti-PD-L1 antibody durvalumab in metastatic pancreatic cancer (Davide Melisi)
Poster Session: Poster Board #229; Gastrointestinal (Noncolorectal) Cancer
Monday, June 3; 8:00 – 11:00 a.m. CDT; Hall A
Global Patient Outcomes & Real World Evidence
Abstract #2035: Clinical characteristics, treatment (Tx) patterns, and overall survival (OS) in advanced (Adv) NSCLC patients (Pts) with and without brain metastases (BM) (Emily Nash Smyth)
Poster Session: Poster Board #224; Central Nervous System Tumors
Sunday, June 2; 8:00 – 11:00 a.m. CDT; Hall A
Abstract #2014: Genomic characterization of lung tumors and metastatic (Met) sites in advanced (Adv) NSCLC (Melinda D. Willard)
Poster Session: Poster Board #203; Central Nervous System Tumors
Sunday, June 2; 8:00 – 11:00 a.m. CDT; Hall A
Poster Discussion Session on Sunday, June 2; 4:30 – 6:00 p.m.; S404
Sintilimab
Abstract #7504: Sintilimab for relapsed/refractory (r/r) extranodal NK/T cell lymphoma (ENKTL): A multicenter, single-arm, phase 2 trial (ORIENT-4) (Rong Tao)
Oral Abstract Session; Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Tuesday, June 4; 10:57 – 11:09 a.m. CDT; E451
Abstract #4042: Efficacy and safety of sintilimab in combination with XELOX in first-line gastric or gastroesophageal junction carcinoma (GC/GEJC) (Nong Xu)
Poster Session: Poster Board #147; Gastrointestinal (Noncolorectal) Cancer
Monday, June 3; 8:00 – 11:00 a.m. CDT; Hall A
Abstract #7533: Sintilimab for relapsed/refractory classical Hodgkin’s lymphoma: Extended follow-up on the multicenter, single-arm phase II ORIENT-1 study (Hang Su)
Poster Session: Poster Board #287; Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Monday, June 3; 8:00 – 11:00 a.m. CDT; Hall A
Abstract #8531: Efficacy and safety of neoadjuvant PD-1 blockade with sintilimab in resectable squamous non-small cell lung cancer (sqNSCLC) (Ning Li)
Poster Session: Poster Board #287; Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Sunday, June 2; 8:00 – 11:00 a.m. CDT; Hall A
Abstract #7534: Circulating tumor DNA to predict response and resistance by anti-PD-1 therapy in Chinese relapsed/refractory classic Hodgkin lymphoma (Hang Su)
Poster Session: Poster Board #288; Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Monday, June 3; 8:00 – 11:00 a.m. CDT; Hall A
About Lilly Oncology
For more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. To learn more about Lilly’s commitment to people with cancer, please visit www.LillyOncology.com.
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels. P-LLY