On May 18, 2016 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported the presentation of five abstracts at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, June 3 to June 7, 2016, in Chicago (Press release, TESARO, MAY 18, 2016, View Source [SID:1234512599]). In addition, TESARO will host an investor and analyst briefing in Chicago on Saturday, June 4 at 6:15 PM local time in conjunction with the ASCO (Free ASCO Whitepaper) annual meeting.

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"Delayed chemotherapy-induced nausea and vomiting can be a debilitating side effect of chemotherapy. Because symptoms occur outside the clinic, patients don’t always report their experiences with delayed CINV. The two post-hoc analyses to be presented highlight increased control of CINV for patients who received VARUBI while being treated with chemotherapy for gynecologic and breast cancers," said Mary Lynne Hedley, Ph.D., President and COO, TESARO. "In addition, posters describing currently ongoing studies, including a Phase 1 trial of niraparib plus bevacizumab in patients with ovarian cancer (AVANOVA), a Phase 1 trial of niraparib plus pembrolizumab in patients with triple-negative or recurrent ovarian cancer (KEYNOTE-162) and a Phase 3 trial of niraparib as a maintenance therapy in patients who have responded to first-line, platinum-based chemotherapy (PRIMA) will be presented."

Please visit TESARO at Booth #14159 for information about VARUBI and our pipeline. TESARO will also be providing information on homologous recombination deficiency (HRD) and ovarian cancer at Booth #21047.

Presentation Details:

(VARUBI) Rolapitant

Monday, June 6, 2016, 1:00 PM to 4:30 PM
Rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer.
Abstract: 10121, Poster Board: 109, Location: S Hall A

Monday, June 6, 2016, 1:00 PM to 4:30 PM
Rolapitant for control of chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic cancer.
Abstract: 10122, Poster Board: 110, Location: S Hall A

Niraparib

Monday, June 6, 2016, 1:00 PM to 4:30 PM
A phase 1 study of bevacizumab in combination with niraparib in patients with platinum-sensitive epithelial ovarian cancer: The ENGOT-OV24/AVANOVA1 trial.
Abstract #5555, Poster Board #378, Location: S Hall A

Monday, June 6, 2016, 1:00 PM to 4:30 PM
Phase 1/2 study of niraparib plus pembrolizumab in patients with triple-negative breast cancer or recurrent ovarian cancer (KEYNOTE-162).
Abstract #TPS5599, Poster Board #421a, Location: S Hall A

Monday, June 6, 2016, 1:00 PM to 4:30 PM
A randomized, double-blind phase 3 trial of niraparib maintenance treatment in patients with HRD+ advanced ovarian cancer after response to front-line platinum-based chemotherapy.
Abstract #TPS5606, Poster Board #424b, Location: S Hall A

Niraparib is an investigational product candidate that has not been approved by any regulatory agencies.

Investor Briefing and Webcast
TESARO will host an investor and analyst briefing in Chicago on Saturday, June 4 at 6:15 PM local time in conjunction with the ASCO (Free ASCO Whitepaper) annual meeting. At this briefing, TESARO management will provide a business overview and pipeline update and will answer questions from investors and analysts. This event will be webcast live and archived for 30 days, and may be accessed from the TESARO Investor Events and Presentations webpage at www.tesarobio.com.

About VARUBI (Rolapitant)
VARUBI is a substance P/neurokinin-1 (NK-1) receptor antagonist indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. VARUBI is contraindicated in patients receiving thioridazine, a CYP2D6 substrate. The inhibitory effect of a single dose of VARUBI on CYP2D6 lasts at least seven days and may last longer. Avoid use of pimozide; monitor for adverse events if concomitant use with other CYP2D6 substrates with a narrow therapeutic index cannot be avoided. Please see full prescribing information, including additional important safety information, available at www.varubirx.com.

On May 18, 2016 Merck KGaA, Darmstadt, Germany, and Pfizer reported that avelumab* presentations across seven different tumor types, including two oral presentations, will be featured at the 52nd American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 3–7, 2016, in Chicago, IL (Press release, Merck KGaA, MAY 18, 2016, View Source;newsType=1 [SID:1234512553]). The avelumab presentations, from the rapidly accelerating JAVELIN clinical development program, include new study results from a number of difficult-to-treat cancers, including data from the pivotal Phase II trial of avelumab being investigated as second-line treatment for metastatic Merkel cell carcinoma (MCC). Additional data include highlights from mesothelioma, adrenocortical carcinoma, non-small cell lung cancer, and urothelial bladder, gastric and ovarian cancers, as well as updated safety data.

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"One of our key highlights for ASCO (Free ASCO Whitepaper) will be the new avelumab data in second-line metastatic Merkel cell carcinoma," said Luciano Rossetti, Executive Vice President, Global Head of Research & Development at the biopharma business of Merck KGaA, Darmstadt, Germany, which in the US and Canada operates as EMD Serono. "As there are currently no approved treatments for this rare and aggressive cancer, these clinically meaningful data represent a breakthrough for this difficult-to-treat tumor type."

Since ASCO (Free ASCO Whitepaper) 2015, the collaboration between Merck KGaA, Darmstadt, Germany, and Pfizer has made significant progress. The JAVELIN development program for avelumab now includes 30 ongoing clinical programs and nine pivotal studies. As of May 2016, JAVELIN now includes approximately 2,200 patients, being treated across more than 15 tumor types.

"These data add to the growing body of evidence for avelumab, indicating efficacy and a favorable safety profile in multiple cancers, which supports ongoing development," said Chris Boshoff, M.D., PhD., Vice President and Head of Early Development, Translational and Immuno-Oncology at Pfizer Oncology. "Through our comprehensive JAVELIN clinical development program for avelumab, we are making meaningful advances for a broad range of patients with cancer."

Avelumab is an investigational, fully human antibody specific for a protein found on tumor cells called PD-L1, or programmed death ligand. As a checkpoint inhibitor, avelumab is thought to have a dual mechanism of action which is believed to enable the immune system to find and attack cancer cells. By binding to PD-L1, avelumab is thought to prevent tumor cells from using PD-L1 for protection against white blood cells such as T-cells, exposing them to anti-tumor responses. Avelumab is also thought to help white blood cells such as natural killer (NK) cells find and attack tumors in a process known as ADCC, or antibody-dependent cell-mediated cytotoxicity.

A list of accepted avelumab abstracts is included below. The abstracts are also available on the ASCO (Free ASCO Whitepaper) website.

Title Lead Author
Abstract
ID /
Poster
No.

Presentation
Date / Time
Session
Oral Presentations
Mesothelioma
Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced unresectable mesothelioma from the JAVELIN Solid Tumor Phase Ib trial: safety, clinical activity, and PD-L1 expression
Hassan R
Abstract
ID: 8503

Sunday, June 5
8:00 a.m. CDT
Arie Crown Theater

Lung Cancer –
Metastatic
Disease
Merkel Cell Carcinoma
Avelumab (MSB0010718C; anti-PD-L1) in patients with metastatic Merkel cell carcinoma previously treated with chemotherapy: results of the Phase II JAVELIN Merkel 200 trial
Kaufman H
Abstract
ID: 9508

Monday, June 6
1:15 p.m. CDT
Arie Crown Theater

Melanoma/Skin
Cancers
Poster Discussions
Gastric/Gastro-esophageal
Junction Cancer
Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced gastric or gastroesophageal junction cancer from the JAVELIN Solid Tumor Phase Ib trial: analysis of safety, clinical activity
Chung HC
Abstract
ID: 4009
Poster No.: 1

Saturday, June 4
8:00 a.m. CDT
Hall A

Gastrointestinal
(Noncolorectal)
Cancer
Urothelial Carcinoma
Avelumab (MSB0010718C; anti-PD-L1) in patients with metastatic urothelial carcinoma from the JAVELIN Solid Tumor Phase Ib trial: analysis of safety, clinical activity, and PD-L1 expression
Apolo A
Abstract ID:
4514
Poster
No.: 137

Monday, June 6
1:00 p.m. CDT
Hall A

Genitourinary
(Nonprostate)
Cancer
Adrenocortical Carcinoma
Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced adrenocortical carcinoma from the JAVELIN Solid Tumor Phase Ib trial: safety and clinical activity
Le Tourneau C
Abstract
ID: 4516
Poster
No.: 138

Monday, June 6
1:00 p.m. CDT
Hall A

Genitourinary
(Nonprostate)
Cancer
Poster Presentations
NSCLC
Avelumab (MSB0010718C; anti-PD-L1) as a first-line treatment for patients with advanced NSCLC from the JAVELIN Solid Tumor Phase Ib trial: safety, clinical activity, and PD-L1 expression
Verschraegen C
Abstract
ID: 9036
Poster
No.: 359

Saturday, June 4
8:00 a.m. CDT
Hall A

Lung Cancer –
Non-Small Cell
Metastatic
Gastric Cancer
Maintenance therapy with avelumab (MSB0010718C; anti-PD-L1) vs continuation of first-line chemotherapy in patients with unresectable, locally advanced or metastatic gastric cancer: the Phase III JAVELIN Gastric 100 trial
Moehler M
Abstract ID:
TPS4134
Poster No.:
124b

Saturday, June 4
8:00 a.m. CDT
Hall A

Gastrointestinal
(Noncolorectal)
Cancer
Gastric Cancer
Avelumab (MSB0010718C; anti-PD-L1) + best supportive care (BSC) vs BSC ± chemotherapy as third-line treatment for patients with unresectable, recurrent, or metastatic gastric cancer: the Phase III JAVELIN Gastric 300 trial
Bang Y-J
Abstract ID:
TPS4135
Poster No.:
125a

Saturday, June 4
8:00 a.m. CDT
Hall A

Gastrointestinal
(Noncolorectal)
Cancer
NSCLC
Avelumab (MSB0010718C; anti-PD-L1) vs platinum-based doublet as first-line treatment for metastatic or recurrent PD-L1–positive non-small-cell lung cancer: the Phase III JAVELIN Lung 100 trial
Reck M
Abstract ID:
TPS9105
Poster No.:
425a

Saturday, June 4
8:00 a.m. CDT
Hall A

Lung Cancer—
Non‐Small Cell
Metastatic
Advanced Cancer
Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced cancer: safety data from 1300 patients enrolled in the Phase Ib JAVELIN Solid Tumor trial
Kelly K
Abstract ID:
3055
Poster No.:
377

Sunday, June 5
8:00 a.m. CDT
Hall A

Developmental
Therapeutics—
Immunotherapy
Advanced Malignancies
Avelumab (MSB0010718C; anti-PD-L1) in combination with other cancer immunotherapies in patients with advanced malignancies: the Phase Ib/II JAVELIN Medley study
Ribas A
Abstract ID:
TPS3106
Poster No.:
422b

Sunday, June 5
8:00 a.m. CDT
Hall A

Developmental
Therapeutics—
Immunotherapy
Ovarian Cancer
Avelumab (MSB0010718C; anti-PD-L1) in patients with recurrent/refractory ovarian cancer from the JAVELIN Solid Tumor Phase Ib trial: safety and clinical activity
Disis ML
Abstract ID:
5533
Poster No.:
356

Monday, June 6
1:00 p.m. CDT
Hall A

Gynecologic
Cancer
Ovarian Cancer
Avelumab (MSB0010718C; anti-PD-L1) ± pegylated liposomal doxorubicin vs pegylated liposomal doxorubicin alone in patients with platinum-resistant/refractory ovarian cancer: the Phase III JAVELIN Ovarian 200 trial
Pujade Lauraine E
Abstract ID:
TPS5600
Poster No.:
421b

Monday, June 6
1:00 p.m. CDT
Hall A

Gynecologic
Cancer
Renal Cell Carcinoma
Avelumab (MSB0010718C; anti-PD-L1) in combination with axitinib as first-line treatment for patients with advanced renal cell carcinoma
Larkin J
Abstract ID:
TPS4580
Poster No.:
199a

Monday, June 6
1:00 p.m. CDT
Hall A

Genitourinary
(Nonprostate)
Cancer

*Avelumab is the proposed nonproprietary name for the anti-PD-L1 monoclonal antibody (MSB0010718C). Avelumab is under clinical investigation and has not been proven to be safe and effective. There is no guarantee any product will be approved in the sought-after indication by any health authority worldwide.

About Avelumab

Avelumab (also known as MSB0010718C) is an investigational, fully human anti-PD-L1 IgG1 monoclonal antibody. By inhibiting PD-L1 interactions, avelumab is thought to enable the activation of T-cells and the adaptive immune system. By retaining a native Fc-region, avelumab is thought to potentially engage the innate immune system and induce antibody-dependent cell-mediated cytotoxicity (ADCC). In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.

On May 19, 2016 Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; President: Masayo Tada; hereinafter called "Sumitomo Dainippon Pharma") reported that clinical data of napabucasin (BBI608) and amcasertib (BBI503) will be presented at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago from June 3 to June 7, 2016 (Press release, Dainippon Sumitomo Pharma, MAY 18, 2016, View Source [SID:1234512577]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Napabucasin: 6 presentations
1. ABSTRACT #3564, Poster #261: Saturday, June 4 from 8:00 a.m. – 11:30 a.m.: BBI608-246: NCT02024607: Phase Ib extension study of cancer stemness inhibitor BB608 (Napabucasin) administered in combination with FOLFIRI +/- Bevacizumab (Bev) in patients (pts) with advanced colorectal cancer (CRC). The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

2. ABSTRACT #4128, Poster #120: Saturday, June 4 from 8:00 a.m. – 11:30 a.m.: BBI608-118: NCT02231723: A Phase Ib extension study of cancer stemness inhibitor BB608 (Napabucasin) in combination with Gemcitabine and nab-Paclitaxel (nab-PTX) in patients (pts) with metastatic pancreatic cancer. The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

3. ABSTRACT #9093, Poster #416: Saturday, June 4 from 8:00 a.m. – 11:30 a.m.: BBI608-201: NCT01325441: A Phase Ib/II Study of Cancer Stemness Inhibitor Napabucasin (BB608) Combined with Weekly Paclitaxel in Advanced Non-Small Cell Lung Cancer. The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

4. ABSTRACT #1094, Poster #199: Sunday, June 5 from 8:00 a.m. – 11:30 a.m.:BBI608-201: NCT01325441: A Phase Ib/II Study of Cancer Stemness Inhibitor Napabucasin (BB608) Combined with Weekly Paclitaxel in Advanced Triple Negative Breast Cancer. 2 The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

5. ABSTRACT #5578, Poster #401: Monday, June 6 from 1:00 p.m. – 4:30 p.m.:BBI608-118: NCT01325441: A Phase Ib/II Study of Cancer Stemness Inhibitor Napabucasin (BB608) Combined with Weekly Paclitaxel in Platinum Resistant Ovarian Cancer. The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

6. ABSTRACT #TPS4144, Poster #129b: Saturday, June 4 from 8:00 a.m. – 11:30 a.m.:BBI608-336: NCT02178956: The BRIGHTER trial: A phase III randomized double-blind study of BBI-608 + weekly paclitaxel versus placebo (PBO) + weekly paclitaxel in patients (pts) with pretreated advanced gastric and gastro-esophageal junction (GEJ) adenocarcinoma.
The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

Amcasertib: 1 presentation
1. ABSTRACT #6018, Poster #340: Saturday, June 4 from 1:00 p.m. – 4:30 p.m. (Poster Session) Saturday, June 4 from 4:45 p.m. – 6:00 p.m. (Poster Discussion Session):BBI503-101: NCT01781455: Phase I Extension Clinical Study of BB503, a First-in-Class Cancer Stemness Kinase Inhibitor, in Adult Patients with Advanced Head and Neck Cancer.
The abstract is now available on the official website of ASCO (Free ASCO Whitepaper) (View Source)

On May 18, 2016 TG Therapeutics, Inc. (Nasdaq:TGTX), reported that updated data has been selected for presentation at the upcoming 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), to be held from June 3 – 7, 2016, at McCormick Place in Chicago, Illinois (Press release, TG Therapeutics, MAY 18, 2016, View Source [SID:1234512600]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Poster Presentation & Discussion Session:

Title: Long-term follow-up of the PI3Kδ inhibitor TGR-1202 to demonstrate a differentiated safety profile and high response rates in CLL and NHL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab
Abstract Number: 7512 (Poster Board # 68)
Presentation Date & Time: Monday, June 6, 2016 8:00 AM – 11:30 AM CT
Track: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Presenter: Howard A. Burris MD, Sarah Cannon Research Institute/Tennessee Oncology
Discussion Session:
1:15 PM – 2:45 PM CT, at Room E354b
A copy of the ASCO (Free ASCO Whitepaper) abstracts were made available today, May 18, 2016 at 5:00pm ET through the ASCO (Free ASCO Whitepaper) meeting website at www.asco.org. Following each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com.

On May 17, 2016 Amgen (NASDAQ:AMGN) reported a new public service announcement (PSA) featuring Breakaway from Cancer ambassador Patrick Dempsey in an effort to increase awareness of the importance of education and support services available for those impacted by cancer (Press release, Amgen, MAY 17, 2016, View Source;p=RssLanding&cat=news&id=2169080 [SID:1234512485]).

In 2016 alone, it is estimated that almost 1.7 million Americans will be diagnosed with cancer.[1] One person alone can’t beat cancer, it takes a team. The Breakaway from Cancer non-profit partner organizations – Prevent Cancer Foundation, Cancer Support Community, Patient Advocate Foundation and National Coalition for Cancer Survivorship – collectively offer a broad range of support services to people affected by cancer, complementing those provided by a patient’s team of healthcare professionals.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The new Breakaway from Cancer public service announcement delivers its message through an impactful, straightforward video featuring four individuals with real-life cancer journeys. The PSA will first air during the 11th annual Amgen Tour of California, the nation’s largest and most prestigious professional cycling race.

Dempsey, who lost his mother to ovarian cancer, was motivated to join Breakaway from Cancer in 2007 by her courage and his family’s experience in rallying around her. In 2008, he founded the Patrick Dempsey Center for Cancer Hope & Healing in Maine and continues to work with Breakaway from Cancer to deliver the message that no one should fight cancer alone.

Cancer survivors join Dempsey in the PSA to share their messages of hope. Jackie Crowell, a cancer survivor and former professional cyclist, shares that resources help everyone affected by cancer – patients, caregivers and family members. Debra Parson, a caregiver to her brother during his cancer journey, explains that there is help navigating healthcare and insurance questions. Cancer survivor and long-time Breakaway from Cancer supporter Blaine Mauldin shares that finding a community is important.

Founded in 2005, Breakaway from Cancer aims to increase awareness of important resources available to those impacted by cancer – from prevention to survivorship.

"Amgen’s mission is to serve patients and we are proud to recognize individuals who make a positive difference in the fight against cancer," said Raymond C. Jordan, senior vice president of Corporate Affairs at Amgen. "Similar to the sport of cycling where it takes a team to achieve success, one person alone cannot beat cancer. Amgen is proud to be a part of the team to help empower patients with education, resources and hope through Breakaway from Cancer."

As part of the Breakaway from Cancer initiative, cancer survivors will participate in a variety of activities during the Amgen Tour of California, May 15-22, 2016, including start activities each stage of the race. At the conclusion of each race day, a local cancer survivor will present Amgen’s Breakaway from Cancer Most Courageous Rider jersey to the professional rider who best exemplifies the character of those engaged in the fight against cancer—courage, sacrifice, inspiration, determination, and perseverance.

All Breakaway from Cancer programs benefit the initiative’s four nonprofit partners – Prevent Cancer Foundation, Cancer Support Community, Patient Advocate Foundation and National Coalition for Cancer Survivorship. Representatives of these four organizations will travel with the Amgen Tour of California, hosting a Breakaway from Cancer information booth at the Lifestyle Festival held at each stage along the race route.

More information about Breakaway from Cancer, including valuable resources offered by Amgen’s partners, is available at www.breakawayfromcancer.com.

About Breakaway from Cancer
Amgen is leading the race to dramatically improve patients’ lives through its national initiative, Breakaway from Cancer. Founded in 2005 by Amgen, Breakaway from Cancer aims to increase awareness of important resources available to people affected by cancer – from prevention through survivorship. Breakaway from Cancer is a collaboration between Amgen and four nonprofit partner organizations: Prevent Cancer Foundation, Cancer Support Community, Patient Advocate Foundation, and National Coalition for Cancer Survivorship. These organizations offer a broad range of support services complementing those provided by a patient’s team of healthcare professionals. For more information, please visit www.breakawayfromcancer.com or follow us on www.twitter.com/breakawaycancer.