On October 8, 2018 Eli Lilly and Company (NYSE: LLY) reported that it will present new data from its clinical development program at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress in Munich, Germany, October 19-23 (Press release, Eli Lilly, OCT 8, 2018, View Source [SID1234529809]). Data presented showcase how Lilly is taking a global, patient-centric research approach to drive advances in cancer care. Data include presentations on abemaciclib, pemetrexed and ramucirumab, as well as investigational compound pegilodecakin – used as a single agent and in combination with chemotherapy and with checkpoint inhibitor therapy – across multiple tumor types. Pegilodecakin joined the Lilly Oncology pipeline with the company’s acquisition of ARMO BioSciences earlier this year.

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Key abemaciclib data include findings from the Phase 3 MONARCH 2 trial evaluating abemaciclib plus fulvestrant in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. Additionally, results will be presented from Lilly’s ongoing immuno-oncology clinical collaboration with Merck (known as MSD outside the U.S. and Canada) on the KEYNOTE-189 trial evaluating pemetrexed plus platinum chemotherapy in combination with pembrolizumab in the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC). Ramucirumab data include Phase 3 findings from several patient populations with aggressive disease such as the REACH-2 study of ramucirumab as a single agent in the second-line treatment of people with hepatocellular carcinoma (HCC), also known as liver cancer, and the RANGE study evaluating ramucirumab in combination with docetaxel in patients with locally advanced or unresectable or metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy. Pegilodecakin data include new results from an early-phase study in patients with renal cell, non-small cell lung, pancreatic, ovarian and breast cancers.

"The breadth and depth of our data being presented at ESMO (Free ESMO Whitepaper) underscores this year’s congress theme of ‘securing access to optimal cancer care’ by demonstrating how we are working to develop innovative new medicines that will make a difference to patients and doctors," said Maura Dickler, M.D., vice president, late phase development, Lilly Oncology. "We’re also excited to share data for the first time from our promising next generation clinical immunotherapy asset pegilodecakin, which examines its potential in several tumor types in combination with existing treatments and as a monotherapy. We are encouraged by the results and look forward to further investigating pegilodecakin in a wide range of settings."

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

Abemaciclib

Abstract #329P: Abemaciclib with fulvestrant in patients with HR+, HER2- advanced breast cancer (ABC) that exhibited primary or secondary resistance to prior endocrine therapy (ET)

Monday, October 22; 12:45-1:45 p.m. CEST; Exhibit Hall A3
Abstract #339P: Management of abemaciclib associated adverse events in patients with hormone receptor positive (HR+), HER2- advanced breast cancer: analysis of the MONARCH trials

Monday, October 22; 12:45-1:45 p.m. CEST; Exhibit Hall A3
Pegilodecakin

Abstract #1130O: Responses and Durability of Clinical Benefit in Renal Cell Carcinoma Treated with Pegilodecakin in Combination with Anti-PD-1 Inhibitors

Monday, October 22; 12:18-12:30 p.m. CEST; Exhibit Hall A2 ­– Room 18
Abstract #1145P: Responses and Durability of Cinical Benefit in Triple Negative Breast Cancer Patients Treated With Pegilodecakin Monotherapy or in Combination With Platinum Plus Taxane-Based Chemotherapy

Saturday, October 20; 12:30-1:30 p.m. CEST; Exhibit Hall A3
Abstract #1144P: Responses and Durability of Clinical Benefit in Non-Small Cell Lung Cancer Treated with Pegilodecakin in Combination With Anti-PD-1 Inhibitors

Saturday, October 20; 12:30-1:30 p.m. CEST; Exhibit Hall A3
Abstract #1143P: Responses and Durability of Clinical Benefit in Pancreatic Ductal Adenocarcinoma (PDAC) Patients Treated With Pegilodecakin (AM0010) in Combination With 5-FU/LV and Oxaliplatin (FOLFOX)

Saturday, October 20; 12:30-1:30 p.m. CEST; Exhibit Hall A3
Abstract #1146P: Durability of Clinical Benefit in Metastatic Epithelial Ovarian Cancer Patients Treated With Pegilodecakin Monotherapy or in Combination With Platinum Plus Taxane-Based Chemotherapy

Saturday, October 20; 12:30-1:30 p.m. CEST; Exhibit Hall A3
Abstract #1180P: Combination of Pegilodecakin and Docetaxel Shows Synergy in Tumor Rejection in Immune Resistant TNBC model

Saturday, October 20; 12:30-1:30 p.m. CEST; Exhibit Hall A3
Pemetrexed

Abstract #1464P: KEYNOTE-189 study of pembrolizumab (pembro) plus pemetrexed (pem) and platinum vs placebo plus pem and platinum for untreated, metastatic, nonsquamous NSCLC: does choice of platinum affect outcomes?

Saturday, October 20; 12:30-1:30 p.m. CEST; Exhibit Hall A3
Abstract #1381PD: Gefitinib With or Without Pemetrexed in Nonsquamous (NS) Non-Small Cell Lung Cancer (NSCLC) With EGFR Mutation (mut): Final Overall Survival (OS) Results From a Randomized Phase II Study

Friday, October 19; 2:00-4:00 p.m. CEST; ICM – Room 14b
Ramucirumab

Abstract #622PD: Ramucirumab as second-line treatment in patients with advanced hepatocellular carcinoma (HCC) and elevated alpha-fetoprotein (AFP) following first-line sorafenib: patient reported outcome results across two phase 3 studies (REACH-2 and REACH)

Friday, October 19; 3:45-5:25 p.m. CEST; ICM – Exhibit Hall B3 – Room 21
Abstract #708P: Relationship between change in α-fetoprotein (AFP) and patient (pt) survival in hepatocellular carcinoma (HCC): a real-world electronic medical records (EMR) database study

Sunday, October 21; 12:45-1:45 p.m. CEST; Exhibit Hall A3
Abstract #865PD: RANGE, a phase 3, randomized, placebo-controlled, double-blind trial of ramucirumab (RAM) and docetaxel (DOC) in platinum-refractory urothelial carcinoma (UC): overall survival results

Saturday, October 20; 2:45-4:05 p.m. CEST; ICM – Room 1
Abstract #616PD: Quality-of-life (QoL) results from RAINFALL: A randomized, double-blind, placebo (PL)-controlled phase 3 study of cisplatin (Cis) plus capecitabine (Cape) or 5FU with or without ramucirumab (RAM) as first-line therapy for metastatic gastric or gastroesophageal junction (G-GEJ) cancer

Friday, October 19; 3:45-5:30 p.m. CEST; Exhibit Hall B3 – Room 21

On October 8, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) and Seattle Genetics, Inc. (Nasdaq: SGEN) reported that updated clinical data from the innovaTV 201 Phase II study evaluating tisotumab vedotin in patients with recurrent and/or metastatic cervical cancer will be presented as a poster at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress taking place in Munich, Germany from October 19 to 23, 2018 (Press release, Genmab, OCT 8, 2018, View Source [SID1234529808]). Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) designed to target the Tissue Factor antigen, which is expressed on a broad range of solid tumors.

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"We look forward to presenting an update on the expanded cervical cancer cohort data showing that tisotumab vedotin continues to demonstrate tolerability and clinical activity in heavily pretreated patients with cervical cancer. We anticipate publishing the final data from this cohort in the future," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "In the past year, the development program of tisotumab vedotin has also been expanded with additional trials and indications, and we are excited about the continued growth of this program."

"In the recurrent and metastatic cervical cancer setting, there remains an unmet need for new treatment options," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "We are pleased to be collaborating with Genmab to advance tisotumab vedotin in the potentially pivotal innovaTV 204 clinical trial in cervical cancer and to evaluate its potential in a broad range of other solid tumors."

Details of Poster Presentation:

Title: A Phase IIa study of tisotumab vedotin in patients with previously treated recurrent or metastatic cervical cancer: updated analysis of full cervical expansion cohort
Presenter: Nicole Concin, M.D. Medical University of Innsbruck, Austria
Abstract #: 963P
Session: Poster Display Session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC – early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research
Date and Time: October 20, 12:30-13:30 CEST
Location: Hall A3 Poster Area

The abstract is available on the ESMO (Free ESMO Whitepaper) website at www.esmo.org.

About the innovaTV 201 (GEN701) Study

The innovaTV 201 study is a 170 patient, two-part Phase I/II study of tisotumab vedotin in eight types of solid tumors: ovarian, cervical, endometrial, bladder, prostate, esophageal, lung, and head and neck. Part 1 is a classical 3+3 dose escalation design testing various doses of tisotumab vedotin once every three weeks to establish the recommended Phase II (RP2D) and maximum tolerated dose as well as the safety profile of tisotumab vedotin. Part 2 of the study investigates all eight indications in parallel expansion cohorts. The cervical cancer cohort includes 55 patients. Patients receive 2.0 mg/kg (=RP2D) of tisotumab vedotin once every three weeks. The primary objective of this part of the study is to further investigate the safety profile of tisotumab vedotin and preliminary efficacy.

About Tisotumab Vedotin

Tisotumab vedotin is an antibody-drug conjugate (ADC) composed of Genmab’s human antibody that binds to Tissue Factor (TF) and Seattle Genetics’ ADC technology that utilizes a cleavable linker and the cytotoxic drug monomethyl auristatin E (MMAE). TF is a protein involved in tumor cell signaling and angiogenesis. Based on its high expression on many solid tumors and its rapid internalization, TF was selected as a target for an ADC approach. Tisotumab vedotin is being evaluated in ongoing or planned Phase II trials in recurrent and/or metastatic cervical cancer, ovarian cancer and other solid tumors. Tisotumab vedotin is being co-developed by Genmab and Seattle Genetics.

On October 8, 2018 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported that it will present final results from the Phase 1 study of AB928, its dual adenosine receptor antagonist, in healthy volunteers during a poster display session at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, being held October 19-23, 2018, in Munich, Germany (Press release, Arcus Biosciences, OCT 8, 2018, View Source [SID1234529806]). The safety data to be presented will demonstrate that in this study, there was no evidence of the physiological effects of blocking adenosine that have been observed clinically with earlier adenosine receptor antagonists. Physiological effects associated with the earlier adenosine receptor antagonists that were initially designed for CNS indications may potentially limit their optimal dosing in the oncology setting.

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The pharmacokinetic and pharmacodynamic correlations generated from this study, which will be described in the poster presentation, were used to guide dose selection in the Company’s four Phase 1/1b trials in patients.

Details of the poster presentation are as follows:

Abstract Number: 1880P
Poster Title: Final results of the Phase 1 study in healthy volunteers of AB928, a dual antagonist of the A2aR and A2bR adenosine receptors being studied as an activator of anti-tumor immune response.
Poster display session: Biomarkers, Gynecological cancers, Hematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC – early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research (ID 259)
Session Date and Time: Saturday, Oct. 20, 2018, 12:30 – 1:30 pm CEST
Location: Hall A3

The poster will be available at www.arcusbio.com/publications.

About AB928

AB928 is an orally bioavailable, highly potent antagonist of the adenosine 2a and 2b receptors. The activation of these receptors by adenosine interferes with the activity of key populations of immune cells and inhibits an optimal anti-tumor immune response. By blocking these receptors, AB928 has the potential to reverse adenosine-induced immune suppression within the tumor microenvironment. AB928 was designed specifically for the oncology setting, with a profile that includes potent activity in the presence of high concentrations of adenosine and a minimal shift in potency due to non-specific protein binding, both essential properties for efficacy in the tumor microenvironment. AB928 has other attractive features, including high penetration of tumor tissue and low penetration through the healthy blood-brain barrier. In a Phase 1 trial in healthy volunteers, AB928 has been shown to be safe and well tolerated and to have pharmacokinetic and pharmacodynamic profiles consistent with a once-daily dosing regimen. The Company has initiated four phase 1/1b trials evaluating AB928 in combination with other agents in selected tumor types.

On October 8, 2018 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that initial findings from the FORWARD II expansion cohort of mirvetuximab soravtansine in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress from October 19-23, 2018 in Munich, Germany (Press release, ImmunoGen, OCT 8, 2018, View Source [SID1234529805]). The poster will include initial safety and preliminary anti-tumor activity for 46 patients with platinum-resistant ovarian cancer (PROC), of whom 35 have medium or high folate receptor alpha (FRα) expression.

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Encouraging activity and favorable tolerability data from the FORWARD II dose-escalation cohort assessing mirvetuximab soravtansine in combination with KEYTRUDA in 14 heavily pre-treated patients with platinum-resistant epithelial ovarian cancer (EOC) were presented in March at the Society of Gynecologic Oncology (SGO) Annual Meeting. These findings supported enrollment of additional patients in an expansion cohort with full doses of both agents to further evaluate this combination in PROC.

"Based on the data presented at SGO, we advanced mirvetuximab soravtansine plus pembrolizumab into an expansion cohort focusing on PROC patients with medium and high FRα expression," said Anna Berkenblit, M.D., Vice President and Chief Medical Officer of ImmunoGen. "We look forward to presenting initial findings at ESMO (Free ESMO Whitepaper), as we evaluate several combinations that may ultimately enable us to treat more women with ovarian cancer."

Details of ImmunoGen’s poster presentation are as follows:

Title: "Mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), with pembrolizumab in platinum-resistant ovarian cancer (PROC): Initial results of an expansion cohort from FORWARD II, a Phase Ib study" (presentation number 949P)
Date: October 20, 2018
Time: 12:30 CEST
Lead author: Ursula Matulonis, M.D., Director and Program Leader, Gynecologic Oncology Program, Dana-Farber Cancer Institute, Boston, MA

Mirvetuximab soravtansine is an ADC comprised of a FRα-binding humanized antibody linked to the tubulin-disrupting maytansinoid DM4. This agent activates monocytes and upregulates immunogenic cell death markers on ovarian tumor cells, providing a rationale for combining with immune checkpoint blockade. Mirvetuximab soravtansine is being evaluated in combination with pembrolizumab in patients with PROC

On October 8, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported that its Chief Scientific Officer Christopher G. Twitty, PhD, will give a presentation during the Advances In Immuno-Oncology Congress being held in San Diego, October 11-12 (Press release, OncoSec Medical, OCT 8, 2018, View Source [SID1234529803]).

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Dr. Twitty’s presentation, titled Intratumoral IL-12 in Combination with Pembrolizumab to Treat Metastatic Melanoma in Patients Unlikely to Respond to Anti PD-1 Therapies: Insights Gained from a Biomarker Program, will discuss ongoing research of TAVO (tavokinogene telseplasmid) in combination with KEYTRUDA(pembrolizumab) as a potential treatment for metastatic melanoma.

The Immuno-Oncology USA Congress will feature over 20 presentations from companies at the forefront of immune-oncology, each presenting insights on new technologies, clinical discoveries and future targets in immuno-oncology research, from cancer vaccines to checkpoint inhibitors, alongside in-depth discussion of patient stratification and clinical development.

"Melanoma is but one of the many types of cancers where the largest part of the immune checkpoint market has yet to be unlocked due to poor/failed/no responses to checkpoint monotherapy, the so-called ‘cold tumor’ problem, which is well known to this audience," said Dr. Twitty, Chief Scientific Officer of OncoSec. "We are excited to share our finding with them indicating TAVO’s ability to recruit more tumor infiltrating lymphocytes (TILs) into the tumors, paving the way for checkpoints to be effective in the largest, but still unresponsive, segment of the checkpoint market."

Details of the presentation are as follows:

Session Title: Translational Immuno-Oncology and Clinical Development

Presentation Title: Intratumoral IL-12 in combination with pembrolizumab to treat metastatic melanoma in patients unlikely to respond to anti PD-1 therapies: Insights gained from a biomarker program

Date and Time: Thursday, October 11, 2018 12:00 PM – 12:30 PM PST

Location: The San Diego Convention Center, Conference Room 5