On May 17, 2017 Juno Therapeutics, Inc. (NASDAQ: JUNO), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, reported that it will present key clinical updates in partnership with its collaborators on its investigational products JCAR017 and JCAR014 at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2017 in Chicago, Illinois, June 2-6 (Press release, Juno, MAY 17, 2017, View Source [SID1234519190]).

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JCAR017 and JCAR014 are chimeric antigen receptor (CAR) T cell product candidates that target CD19, a protein expressed on the surface of almost all B cell malignancies, including non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), and acute lymphoblastic leukemia (ALL). While the manufacturing process and final cell product differ, both product candidates utilize the 4-1BB co-stimulatory domain and use a defined cell manufacturing process, controlling the type of cells a patients receives with the goal of delivering an improved therapeutic benefit.
Insights from studies of the translational product JCAR014 are being applied to the development of JCAR017.

New data from the ongoing Phase I TRANSCEND NHL 001 trial (NCT02631044) evaluating JCAR017 in adult patients with relapsed or refractory aggressive NHL [diffuse large B cell lymphoma (DLBCL), primary mediastinal B cell lymphoma (PMBCL), follicular lymphoma Grade 3B, and mantle cell lymphoma (MCL)] will be presented, with increased patient numbers and longer duration of follow-up reported at two dose levels as compared to previous presentations. Updated safety data will also be presented from the ongoing Phase I trial (NCT01865617) evaluating JCAR014 in adult patients with relapsed or refractory ALL, NHL, or CLL. The JCAR014 presentation will also include data on clinical and laboratory biomarkers that may allow early identification of cytokine release syndrome (CRS) and neurotoxicity (NT).

Key data presentations at ASCO (Free ASCO Whitepaper) include:

JCAR017
CR Rates in Relapsed/Refractory (R/R) Aggressive B-NHL Treated with the CD19-Directed CAR T Cell Product JCAR017 (TRANSCEND NHL 001) (Abstract #7513)
Presenter: Jeremy Abramson, M.D., Massachusetts General Hospital
Poster Display & Location: Monday, June 5, 2017: 8:00 – 11:30 a.m. Central Time; Hall A, Poster Board #275
Poster Discussion & Location: Monday, June 5, 2017: 1:15 – 2:30 p.m. Central Time; Room E354b

JCAR014
Cytokine Release Syndrome (CRS) and Neurotoxicity (NT) after CD19-Specific Chimeric Antigen Receptor-Modified T cells (Abstract #3020)
Presenter: Kevin Hay, M.D., MSc, Fred Hutchinson Cancer Research Center
Poster Display & Location: Monday, June 5, 2017: 8:00 – 11:30 a.m. Central Time; Hall A, Poster Board #115
Poster Discussion & Location: Monday, June 5, 2017: 4:45 – 6:00 p.m. Central Time; Hall D1

About Juno’s Chimeric Antigen Receptor and T Cell Receptor Technologies
Juno’s CAR and TCR technologies genetically engineer T cells to recognize and kill cancer cells. Juno’s CAR T cell technology inserts a gene for a particular CAR into the T cell, enabling it to recognize cancer cells based on the expression of a specific protein located on the cell surface. Juno’s TCR technology provides the T cells with a specific T cell receptor to recognize protein fragments derived from either the surface or inside the cell. When either type of engineered T cell engages the target protein on the cancer cell, it initiates a cell-killing response against the cancer cell. JCAR014 and JCAR017 are investigational product candidates and their safety and efficacy have not been established. They are not approved by any regulatory authority.

On May 17, 2017 Kite Pharma, Inc. (Nasdaq:KITE) reported new data presentations from multiple studies related to its lead investigational candidate, axicabtagene ciloleucel (also known as KTE-C19), at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL, June 2-6, 2017 (Press release, Kite Pharma, MAY 17, 2017, View Source [SID1234519191]). The full text for abstracts is available online through the ASCO (Free ASCO Whitepaper) website at View Source

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“The presentations at ASCO (Free ASCO Whitepaper) continue to enhance our growing knowledge on the potential for cell therapy,” said David Chang, M.D., Ph.D., Executive Vice President of Research and Development and Chief Medical Officer of Kite. “The translational insights from these data presentations are invaluable as we advance axicabtagene ciloleucel/KTE-C19 and seek to optimize treatment, not only in NHL, but also across a broad range of hematologic malignancies.”

Poster Discussion:

Clinical and biologic covariates of outcomes in ZUMA-1: a pivotal trial of axicabtagene ciloleucel (axi-cel; KTE-C19) in patients with refractory aggressive non-Hodgkin lymphoma (r-NHL)

Abstract #7512
Session: Poster Session: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Poster Board #274
Session Time/Location: Monday, June 5, 2017: 8:00-11:30 AM CDT, Hall A
Poster Discussion Session Time/Location: Monday, June 5, 2017: 1:15-2:30 PM CDT, E354b
Presenter: Frederick L. Locke, M.D., Moffitt Cancer Center, Tampa, FL
Poster Presentations

Updated results from ZUMA-3, a phase 1/2 study of KTE-C19 chimeric antigen receptor (CAR) T cell therapy, in adults with high-burden relapsed/refractory acute lymphoblastic leukemia (R/R ALL)

Abstract #3024
Session: Poster Session: Developmental Therapeutics – Immunotherapy
Poster Board #119
Session Time/Location: Monday, June 5, 2017: 8:00-11:30 AM CDT, Hall A
Presenter: Bijal D. Shah, M.D., Moffitt Cancer Center, Tampa, FL
Product characteristics associated with in vivo expansion of anti-CD19 CAR T cells in patients treated with axicabtagene ciloleucel (axi-cel)

Abstract #3023
Session: Poster Session: Developmental Therapeutics – Immunotherapy
Poster Board #118
Session Time/Location: Monday, June 5, 2017: 8:00-11:30 AM CDT, Hall A
Presenter: Frederick L. Locke, M.D., Moffitt Cancer Center, Tampa, FL
Characterization of anti-CD19 chimeric antigen receptor (CAR) T cell-mediated tumor microenvironment immune gene profile in a multicenter trial (ZUMA-1) with axicabtagene ciloleucel (axi-cel, KTE-C19)

Abstract #3025
Session: Poster Session: Developmental Therapeutics – Immunotherapy
Poster Board #120
Session Time/Location: Monday, June 5, 2017: 8:00-11:30 AM CDT, Hall A
Presenter: Jerome Galon, Ph.D., Laboratory of Integrative Cancer Immunology, INSERM
ZUMA-6: Phase 1-2 multicenter study evaluating safety and efficacy of axicabtagene ciloleucel (axi-cel; KTE-C19) in combination with atezolizumab in patients with refractory diffuse large B-cell lymphoma (DLBCL)

Abstract #TPS7572
Session: Trials in Progress Poster Session: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Poster Board #331a
Session Time/Location: Monday, June 5, 2017: 8:00-11:30 AM CDT, Hall A
Presenter: Frederick L. Locke, M.D., Moffitt Cancer Center, Tampa, FL
Online Publication

Total 1-year cost of diffuse large B-cell lymphoma (DLBCL) beyond first-line (1L) therapy: A retrospective cohort analysis

Abstract # e18333
Senior Author: Anna Purdum, PharmD, M.S., Kite Pharma
About axicabtagene ciloleucel

Kite’s lead product candidate, axicabtagene ciloleucel, previously known as KTE-C19, is an investigational therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells. Axicabtagene ciloleucel has been granted Breakthrough Therapy Designation status for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) regulatory support for DLBCL in the EU.

On May 17, 2017 Incyte Corporation (Nasdaq:INCY) reported the publication of new data from the ongoing ECHO-202 trial, evaluating epacadostat, Incyte’s selective IDO1 enzyme inhibitor, in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy (Press release, Incyte, MAY 17, 2017, View Source [SID1234519189]).

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Abstracts published online by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in advance of its annual meeting in Chicago, Illinois, June 2-6, 2017 include ECHO-202 Phase 1/2 efficacy and safety data from the following cohorts: non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), bladder cancer, squamous cell carcinoma of the head and neck (SCCHN), triple-negative breast cancer (TNBC), and ovarian cancer (OVC). Pooled Phase 2 safety data across cohorts were also released today.

"We are very pleased to share these new data for epacadostat in combination with pembrolizumab. The combination is well-tolerated and preliminary efficacy outcomes for these cohorts demonstrate encouraging clinical activity, both within and across tumor types, which compares favorably to contemporary data in the second-line setting. These data, including updated data which will be presented at ASCO (Free ASCO Whitepaper) next month, supported the recently-announced progression of the epacadostat and pembrolizumab combination into pivotal trials in NSCLC, RCC, bladder cancer and SCCHN," said Steven Stein, M.D., Chief Medical Officer, Incyte.

ECHO-202 abstract data for the tumor types entering Phase 3 (data cut as of October 29, 2016) include:

n/N
(%)
NSCLC UC SCCHN RCC
All pts
0-2 prior lines of
therapy for advanced
disease
All pts
Prior Lines of
Treatment
All pts
Prior Lines of
Treatment
All pts
Prior Lines of
Treatment
Total TPS ≥50% TPS <50% Total 0-1 Total 1-2 ≥3 Total 0-1 ≥2
ORR 14/40
(35) 3/7
(43) 6/17
(35) 13/37
(35) 10/27
(37)
11/36
(31)

10/29
(34)

1/7
(14)

9/30
(30)

9/19
(47)
0/11
(0)
all PR all PR all PR all PR all PR 2 CR,
9 PR 2 CR,
8 PR 1 PR 1 CR,
8 PR 1 CR,
8 PR -
DCR 24/40
(60) 4/7
(57) 9/17
(53) 21/37
(57) 17/27
(63) 21/36
(58)
18/29
(62)
3/7
(43) 15/30
(50) 11/19
(58) 4/11
(36)

DoR
12/14 responses ongoing
range 1+ – 519 days

12/13 responses ongoing
range 1+ – 652+ days

9/11 responses ongoing
range 1+ – 563+ days

9/9 responses ongoing
range 1+ – 372+ days

In a pooled analysis evaluating 244 patients in the ECHO-202 Phase 2 safety population (abstract #3012), treatment-related adverse events (TRAEs) that occurred in ≥5 percent of patients, included fatigue (23 percent); rash (16 percent); diarrhea and nausea (7 percent each); increased alanine aminotransferase, increased aspartate aminotransferase, and pruritus (6 percent each); and pyrexia (5 percent). A total of 37 patients (15 percent) experienced Grade ≥3 TRAEs; the most common of which were increased lipase (asymptomatic) and rash (3 percent each). TRAEs led to discontinuation of treatment in 3 percent of study patients.
These abstracts, including data for TNBC and OVC (abstract #1103), were made available today on the ASCO (Free ASCO Whitepaper) website at www.asco.org.

About ECHO-202 (KEYNOTE-037)
The ECHO-202 study (NCT02178722) is evaluating the safety and efficacy of epacadostat, Incyte’s selective IDO1 inhibitor, in combination with pembrolizumab. Patients previously treated with anti-PD-1 or anti-CTLA-4 therapies were excluded from this trial. Enrollment is complete for the Phase 1 dose escalation (epacadostat 25, 50, 100 mg BID + pembrolizumab 2 mg/kg IV Q3W and epacadostat 300 mg BID + pembrolizumab 200 mg IV Q3W) and Phase 1 dose expansion (epacadostat 50, 100, and 300 mg BID + pembrolizumab 200 mg IV Q3W) portions of the trial. For more information about ECHO-202, visit View Source

About ECHO
The ECHO clinical trial program was established to investigate the efficacy and safety of epacadostat as a core component of combination therapy in oncology. Ongoing Phase 1 and Phase 2 studies evaluating epacadostat in combination with PD-1 and PD-L1 inhibitors collectively plan to enroll over 900 patients in a broad range of solid tumor types as well as hematological malignancies. ECHO-301 (NCT02752074), a Phase 3 randomized, double-blind, placebo-controlled study investigating KEYTRUDA in combination with epacadostat or placebo for the treatment of patients with unresectable or metastatic melanoma, is also underway. For more information about the ECHO clinical trial program, visit www.ECHOClinicalTrials.com.

About Epacadostat (INCB024360)
Indoleamine 2,3-dioxygenase 1 (IDO1) is a key immunosuppressive enzyme that modulates the anti-tumor immune response by promoting regulatory T cell generation and blocking effector T cell activation, thereby facilitating tumor growth by allowing cancer cells to avoid immune surveillance. Epacadostat is a first-in-class, highly potent and selective oral inhibitor of the IDO1 enzyme that regulates the tumor immune microenvironment, thereby restoring effective anti-tumor immune responses. In single-arm studies, the combination of epacadostat and immune checkpoint inhibitors has shown proof-of-concept in patients with unresectable or metastatic melanoma. In these studies, epacadostat combined with the CTLA-4 inhibitor ipilimumab or the PD-1 inhibitor pembrolizumab improved response rates compared with studies of the immune checkpoint inhibitors alone.

On May 17, 2017 Incyte Corporation (Nasdaq:INCY) reported that the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) has published Phase 1/2 data from the ongoing ECHO-204 trial evaluating the safety and efficacy of epacadostat, Incyte’s selective IDO1 enzyme inhibitor, in combination with Opdivo (nivolumab), Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor. Efficacy data in patients with squamous cell carcinoma of the head and neck (SCCHN), melanoma (MEL), ovarian cancer (OVC), and colorectal cancer (CRC), as well as overall safety data will be highlighted in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, Illinois from June 2-6, 2017.

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"These first Phase 1/2 data from our ECHO-204 trial evaluating epacadostat plus nivolumab in multiple solid tumors add to our knowledge of the therapeutic potential of IDO1 enzyme inhibition when combined with PD-1 blockade," said Steven Stein, M.D., Chief Medical Officer, Incyte. "These results show that the combination was well-tolerated across patients studied and demonstrates promising clinical responses, particularly in melanoma and SCCHN. We look forward to sharing updated data from these cohorts at ASCO (Free ASCO Whitepaper) next month, and to progressing our clinical development program for this combination into pivotal studies."

ECHO-204 Abstract Highlights

ECHO-204 evaluated the safety and efficacy of the epacadostat and nivolumab combination in 241 patients (data cut-off as of October 29, 2016). In 30 patients with MEL treated with nivolumab plus epacadostat at 100 mg or 300 mg, the combined disease control rate (DCR; defined as complete response + partial response + stable disease) was 73 percent (22/30). In patients with SCCHN treated with nivolumab plus epacadostat 300 mg, the preliminary DCR was 70 percent (16/23). Response rates based on updated data will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting.

In Phase 1 (dose escalation), 36 patients were enrolled and no dose-limiting toxicities were observed. Among the 205 patients enrolled in Phase 2, the most frequent treatment-related adverse events (TRAEs) (≥15 percent) in patients receiving epacadostat 100 mg BID (70/205) and 300 mg BID (135/205) were rash (33 percent and 22 percent, receptively), fatigue (26 percent and 31 percent), and nausea (24 percent and 19 percent). Rash was the most common ≥3 TRAE (10 percent and 12 percent). TRAEs led to discontinuation in 7 percent (100 mg) and 13 percent (300 mg) of patients. There were no treatment-related deaths.

This ECHO-204 abstract (#3003) was made available today on the ASCO (Free ASCO Whitepaper) website at www.asco.org.

About ECHO-204

The ECHO-204 study (NCT02327078) is a Phase 1/2 study evaluating the safety and efficacy of epacadostat, Incyte’s selective IDO1 inhibitor, in combination with nivolumab in subjects with select advanced solid tumors and lymphomas, including melanoma (MEL), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), head and neck squamous cell carcinoma (SCCHN), ovarian cancer, and B cell non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL). Patients previously treated with anti-PD-1 or anti-CTLA-4 therapies were excluded from this trial. Enrollment for the Phase 2 (epacadostat 100 or 300 mg BID + nivolumab 240 Q2W) tumor-specific cohorts is ongoing. For more information about ECHO-204, visit View Source

About ECHO

The ECHO clinical trial program was established to investigate the efficacy and safety of epacadostat as a core component of combination therapy in oncology. Ongoing Phase 1 and Phase 2 studies evaluating epacadostat in combination with PD-1 and PD-L1 inhibitors collectively plan to enroll over 900 patients in a broad range of solid tumor types as well as hematological malignancies. For more information about the ECHO clinical trial program, visit www.ECHOClinicalTrials.com.

About Epacadostat (INCB024360)

Indoleamine 2,3-dioxygenase 1 (IDO1) is a key immunosuppressive enzyme that modulates the anti-tumor immune response by promoting regulatory T cell generation and blocking effector T cell activation, thereby facilitating tumor growth by allowing cancer cells to avoid immune surveillance. Epacadostat is a first-in-class, highly potent and selective oral inhibitor of the IDO1 enzyme that regulates the tumor immune microenvironment, thereby restoring effective anti-tumor immune responses. In single-arm studies, the combination of epacadostat and immune checkpoint inhibitors has shown proof-of-concept in patients with unresectable or metastatic melanoma. In these studies, epacadostat combined with the CTLA-4 inhibitor ipilimumab or the PD-1 inhibitor pembrolizumab improved response rates compared with studies of the immune checkpoint inhibitors alone.

On May 17, 2017 Eli Lilly and Company (NYSE: LLY) reported that new research demonstrating advances in the Company’s oncology pipeline and product portfolio will be presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, June 2-6, 2017 (Press release, Eli Lilly, MAY 17, 2017, View Source [SID1234519185]). Data underscore a strategic focus on targeting the biology of cancer to find new ways to fight cancer and transform care for patients. Highlights include oral presentation of Phase 3 data for abemaciclib, an investigational cyclin-dependent kinase (CDK)4 & 6 inhibitor for breast cancer, as well as new data from the Company’s ongoing immuno-oncology clinical collaborations with Merck (known as MSD outside the U.S. and Canada) in two trials that are evaluating pemetrexed-plus-carboplatin and ramucirumab, respectively, in combination with Merck’s pembrolizumab.

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"We are pleased to share how we are building foundational therapeutics with the goal of delivering medicines that help people with cancer live longer and healthier lives," said Levi Garraway, M.D., Ph.D., senior vice president, global development and medical affairs, Lilly Oncology. "We are particularly excited about the latest results from the abemaciclib MONARCH clinical development program, in which we have endeavored to raise the bar with a potential next-generation CDK4 & 6 inhibitor that we believe may improve outcomes for patients living with breast cancer."

"With abemaciclib we hoped to develop an oral CDK4 & 6 inhibitor that could be taken without interruption. In preclinical research, continued disruption was shown to stop tumor cells from entering the cell cycle, which prevents tumor cell growth and, ultimately, promotes tumor cell death that may translate into clinical benefit for breast cancer patients," said Alfonso de Dios, senior research fellow, discovery chemistry research & technologies, Lilly.

Abemaciclib Data at ASCO (Free ASCO Whitepaper)
Detailed data from the Phase 3 MONARCH 2 study, which evaluated abemaciclib in combination with fulvestrant in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer, will be presented in an oral presentation. The intent-to-treat population of 669 patients in MONARCH 2 had experienced disease progression on or within 12 months of receiving endocrine treatment in the neoadjuvant or adjuvant setting or while receiving first-line endocrine therapy for metastatic disease.

Additionally, abemaciclib has been shown in preclinical and Phase 1 studies to cross the blood-brain barrier, making this an area of interest for further study. This year’s meeting will allow Lilly to share preliminary Phase 2 data evaluating a CDK4 & 6 inhibitor in patients with new or progressive brain metastases secondary to advanced breast cancer, lung cancer or melanoma.

Select studies, along with the times and locations of their data sessions, are highlighted below.

Abemaciclib

Abstract #1000: Oral Presentation: Breast Cancer—Metastatic: Saturday, June 3, 2017; 1:15-4:15 p.m. CDT
MONARCH 2: Abemaciclib in combination with fulvestrant in patients with HR+/HER2- advanced breast cancer who progressed on endocrine therapy
Author/Speaker: George W. Sledge, M.D., F.A.S.C.O., Stanford University School of Medicine
Location: Hall D1
Abstract #1019: Breast Cancer—Metastatic: Sunday, June 4, 2017; 8:00-11:30 a.m. CDT
Abemaciclib for the treatment of brain metastases (BM) secondary to hormone-receptor-positive (HR+), HER2- breast cancer
Author/Speaker: Sara M. Tolaney, M.D., M.P.H., Dana-Farber Cancer Institute
Location: Hall A (Poster Board #11)
Poster Discussion Session: Sunday, June 4, 2017; 4:45-6:00 p.m. CDT, Hall B1
Abstract #TPS1109: Breast Cancer—Metastatic: Sunday, June 4, 2017; 8:00-11:30 a.m. CDT
A Phase 2 randomized study to compare abemaciclib plus trastuzumab with or without fulvestrant to standard of care chemotherapy plus trastuzumab in hormone-receptor-positive, HER2-positive, advanced breast cancer (monarcHER)
Author/Speaker: Sara M. Tolaney, M.D., M.P.H., Dana-Farber Cancer Institute
Location: Hall A (Poster Board #99b)
Abstract #TPS4150: Gastrointestinal (Noncolorectal) Cancer: Saturday, June 3, 2017; 8:00-11:30 a.m. CDT
A Phase 2 study of abemaciclib as a monotherapy and in combination with other agents in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC)
Author/Speaker: E. Gabriela Chiorean, M.D., Fred Hutchinson Cancer Research Center
Location: Hall A (Poster Board #132b)
Fruquintinib

Abstract #3508: Oral Presentation: Gastrointestinal (Colorectal) Cancer: Monday, June 5, 2017; 3:00-6:00 p.m. CDT
A randomized, double-blind, placebo-controlled, multi-centered Phase 3 trial comparing fruquintinib versus placebo plus best supportive care in Chinese patients with metastatic colorectal cancer (FRESCO)
Author/Speaker: Jin Li, M.D., Fudan University Shanghai Cancer Center, Shanghai Medical College
Location: Hall D2
Immuno-Oncology Collaborations with pemetrexed-plus-carboplatin or ramucirumab

Abstract #9094: Lung Cancer—Non-Small Cell Metastatic: Saturday, June 3, 2017; 8:00-11:30 a.m. CDT
First-line carboplatin and pemetrexed (CP) with or without pembrolizumab (pembro) for advanced nonsquamous NSCLC: Updated results of KEYNOTE-021 cohort G
Author/Speaker: Vassiliki Papadimitrakopoulou, M.D., The University of Texas MD Anderson Cancer Center
Location: Hall A (Poster Board #420)
Abstract #4046: Gastrointestinal (Noncolorectal) Cancer: Saturday, June 3, 2017; 8:00-11:30 a.m. CDT
Ramucirumab (R) plus pembrolizumab (P) in treatment naive and previously treated advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: A multi-disease Phase 1 study
Author/Speaker: Ian Chau, M.D., F.R.C.P, Royal Marsden Hospital
Location: Hall A (Poster Board #38)
Olaratumab

Abstract #TPS2599: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics: Monday, June 5, 2017; 8:00-11:30 a.m. CDT
A Phase 1, open-label, dose-escalation study of olaratumab as a single agent and in combination with doxorubicin, vincristine/irinotecan, or high-dose ifosfamide in pediatric patients with relapsed or refractory solid tumors
Author/Speaker: Leo Mascarenhas, M.B.B.S., M.D., M.S., Children’s Center for Cancer and Blood Diseases, Children’s Hospital Los Angeles, University of Southern California
Location: Hall A (Poster Board #89b)
Emibetuzumab

Abstract #9019: Lung Cancer—Non-Small Cell Metastatic: Saturday, June 3, 2017; 8:00-11:30 a.m. CDT
A randomized, controlled, open-label Phase 2 study of erlotinib (E) with or without the MET antibody emibetuzumab (Emi) as first-line treatment for EFGRmt non-small cell lung cancer (NSCLC) patients who have disease control after an eight-week lead-in treatment with erlotinib
Author/Speaker: Giorgio V. Scagliotti, M.D., Ph.D., Department of Oncology – University of Torino
Location: Hall A (Poster Board #345)
Poster Discussion Session: Saturday, June 3, 2017; 3:00-4:15 p.m. CDT, Hall D2
Galunisertib

Abstract #4097: Gastrointestinal (Noncolorectal) Cancer: Saturday, June 3, 2017; 8:00-11:30 a.m. CDT
A Phase 2 study of galunisertib (TGF-B R1 inhibitor) and sorafenib in patients with advanced hepatocellular carcinoma (HCC)
Author/Speaker: Robin Kate Kelley, M.D., University of California, San Francisco
Location: Hall A (Poster Board #89)
LY3023414

Abstract #1064: Breast Cancer—Metastatic: Sunday, June 4, 2017; 8:00-11:30 a.m. CDT
Safety and tolerability of the dual PI3K/mTOR inhibitor LY3023414 in combination with fulvestrant in treatment refractory advanced breast cancer patients
Author/Speaker: Anna M. Varghese, M.D., Memorial Sloan-Kettering Cancer Center
Location: Hall A (Poster Board #56)
LY3009120

Abstract #2507: Oral Presentation: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics: Saturday, June 3, 2017; 1:15-4:15 p.m. CDT
A first-in-human dose Phase 1 study of LY3009120 in advanced cancer patients
Author/Speaker: David S. Hong, M.D., The University of Texas MD Anderson Cancer Center
Location: E450ab
LY3022855

Abstract #2523: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics: Monday, June 5, 2017; 8:00-11:30 a.m. CDT
A Phase 1 study of LY3022855, a colony-stimulating factor-1 receptor (CSF-1R) inhibitor, in patients (pts) with advanced solid tumors
Author/Speaker: Afshin Dowlati, M.D., University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Case Western Reserve University
Location: Hall A (Poster Board #15)
LY3039478

Abstract #6024: Head and Neck Cancer: Monday, June 5, 2017; 1:15-4:45 p.m. CDT
Notch pathway inhibition with LY3039478 in adenoid cystic carcinoma (ACC)
Author/Speaker: Caroline Even, Institut Gustave Roussy
Location: Hall A (Poster Board #12)
Poster Discussion Session: Monday, June 5, 2017; 4:45-6:00 p.m. CDT, S406