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Gilead Sciences to Acquire Kite Pharma for $11.9 Billion

On August 28, 2017 Gilead Sciences, Inc. (Nasdaq: GILD) and Kite Pharma, Inc. (Nasdaq: KITE) reported that the companies have entered into a definitive agreement pursuant to which Gilead will acquire Kite for $180.00 per share in cash (Press release, Kite Pharma, AUG 28, 2017, View Source [SID1234520318]). The transaction, which values Kite at approximately $11.9 billion, was unanimously approved by both the Gilead and Kite Boards of Directors and is anticipated to close in the fourth quarter of 2017. The transaction will provide opportunities for diversification of revenues, and is expected to be neutral to earnings by year three and accretive thereafter.

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Kite is an industry leader in the emerging field of cell therapy, which uses a patient’s own immune cells to fight cancer. The company has developed engineered cell therapies that express either a chimeric antigen receptor (CAR) or an engineered T cell receptor (TCR), depending on the type of cancer. Kite’s most advanced therapy candidate, axicabtagene ciloleucel (axi-cel), is a CAR T therapy currently under priority review by the U.S. Food and Drug Administration (FDA). It is expected to be the first to market as a treatment for refractory aggressive non-Hodgkin lymphoma, which includes diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL) and primary mediastinal B-cell lymphoma (PMBCL). The FDA has set a target action date of November 29, 2017 under the Prescription Drug User Fee Act (PDUFA). A marketing authorization application (MAA) has also been filed for axi-cel for the treatment of relapsed/refractory DLBCL, TFL and PMBCL with the European Medicines Agency (EMA), representing the first submission in Europe for a CAR T therapy. Approval in Europe is expected in 2018. Kite has additional candidates in clinical trials in both hematologic cancers and solid tumors, including KITE-585, a CAR T therapy candidate that targets BCMA expressed in multiple myeloma.

"The acquisition of Kite establishes Gilead as a leader in cellular therapy and provides a foundation from which to drive continued innovation for people with advanced cancers," said John F. Milligan, PhD, Gilead’s President and Chief Executive Officer. "The field of cell therapy has advanced very quickly, to the point where the science and technology have opened a clear path toward a potential cure for patients. We are greatly impressed with the Kite team and what they have accomplished, and share their belief that cell therapy will be the cornerstone of treating cancer. Our similar cultures and histories of driving rapid innovation in order to bring more effective and safer products to as many patients as possible make this an excellent strategic fit."

Research and development as well as the commercialization operations for Kite will remain based in Santa Monica, California, with product manufacturing remaining in El Segundo, California.

"From the release of our pivotal data for axi-cel, to our potential approval by the FDA, this is a year of milestones. Each and every accomplishment is a reflection of the talent that is unique to Kite. We are excited that Gilead, one of the most innovative companies in the industry, recognized this value and shares our passion for developing cutting-edge and potentially curative therapies for patients," said Arie Belldegrun, MD, FACS, Chairman, President and Chief Executive Officer of Kite. "CAR T has the potential to become one of the most powerful anti-cancer agents for hematologic cancers. With Gilead’s expertise and support, we hope to fulfill that potential by rapidly accelerating our robust pipeline and next-generation research and manufacturing technologies for the benefit of patients around the world."

Benefits of the Transaction

Near-term Product Opportunity

Axi-cel approval for refractory aggressive non-Hodgkin lymphoma is expected in Q4 2017 in the United States and in 2018 in Europe
U.S. commercial launch and manufacturing preparations complete
Building infrastructure in Europe
Robust Pipeline and Technology Platform to Drive Future Growth

Multiple development programs ongoing to broaden axi-cel utilization in earlier lines of therapy in aggressive NHL and other B-cell malignancies
Advancing additional CAR Ts to treat multiple myeloma and acute myeloid leukemia
Progressing TCRs for potential use in solid tumors
Positions Gilead to be a Global Leader in Oncology and Cell Therapy

Cell therapy has generated compelling clinical data in patients for whom all other treatments have failed
Axi-cel, coupled with Kite’s leading manufacturing capabilities and its portfolio of next-generation technologies and therapy candidates, will serve as a foundation for Gilead’s efforts to build an industry-leading cell therapy franchise
Leverages Gilead’s Core Capabilities to Maximize the Value of Kite’s Portfolio

Ability to drive continuous scientific and medical innovation that improves or replaces existing products
Demonstrated ability to scale complicated manufacturing processes to meet patient demand
Rapid design and execution of clinical development programs that shorten development timelines
Successful track record of launching innovative, specialty medicines
Transaction Terms

Under the terms of the merger agreement, a wholly-owned subsidiary of Gilead will promptly commence a tender offer to acquire all of the outstanding shares of Kite’s common stock at a price of $180.00 per share in cash. Following successful completion of the tender offer, Gilead will acquire all remaining shares not tendered in the offer through a second step merger at the same price as in the tender offer.

The consummation of the tender offer is subject to various conditions, including a minimum tender of at least a majority of outstanding Kite shares on a fully diluted basis, the expiration or termination of the waiting period under the Hart Scott Rodino Antitrust Improvements Act, and other customary conditions.

Gilead plans to finance the transaction with a combination of cash on hand, bank debt and senior unsecured notes. The tender offer is not subject to a financing condition.

The $180.00 per share acquisition price represents a 29 percent premium to Kite’s closing on Friday, August 25, and a 50 percent premium to the company’s 30-day volume weighted average stock price.

BofA Merrill Lynch and Lazard are acting as financial advisors to Gilead. Centerview Partners is acting as exclusive financial advisor to Kite. Jefferies LLC and Cowen and Company, LLC also provided advice to Kite. Skadden, Arps, Slate, Meagher & Flom is serving as legal counsel to Gilead and Sullivan & Cromwell LLP and Cooley LLP are serving as legal counsel to Kite.

FDA grants Priority Review for Roche’s Gazyva in previously untreated follicular lymphoma

On august 28, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Gazyva (obinutuzumab) in combination with chemotherapy followed by Gazyva alone for people with previously untreated follicular lymphoma, one of the most common blood cancers among adults (Press release, Hoffmann-La Roche, AUG 28, 2017, View Source [SID1234520315]). Follicular lymphoma, a slow-growing (indolent) form of non-Hodgkin lymphoma, is incurable and characterized by cycles of remission and relapse.
"Follicular lymphoma becomes harder to treat each time it returns, and the goal of initial treatment is to prevent the cancer from progressing for as long as possible," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "Based on the GALLIUM study, Gazyva-based treatment significantly improved progression-free survival over the current standard of care, and we are committed to bringing this potential new option to patients as soon as possible."

The sBLA is based on results of the GALLIUM study, which is the first Phase III study in previously untreated follicular lymphoma to show superior progression-free survival (PFS) over Rituxan (rituximab)-based treatment, the current standard of care. Adverse events (AEs) with either Gazyva or Rituxan were consistent with those seen in previous studies.

The FDA is expected to make a decision on approval under Priority Review by 23 December, 2017. Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease. Additional submissions of the GALLIUM data to health authorities around the world are ongoing.

About the GALLIUM study
GALLIUM (NCT01332968) is a global Phase III open-label, multicenter, randomized two-arm study examining the efficacy and safety of Gazyva plus chemotherapy followed by Gazyva alone for up to two years, as compared head-to-head against Rituxan plus chemotherapy followed by Rituxan alone for up to two years. Chemotherapies used were CHOP, CVP or bendamustine and were selected by each participating study site prior to beginning enrollment.

GALLIUM included 1401 patients with previously untreated indolent non-Hodgkin lymphoma (iNHL), of which 1202 patients had follicular lymphoma. The primary endpoint of the study was investigator-assessed progression-free survival (PFS) in patients with follicular lymphoma, with secondary endpoints including PFS assessed by independent review committee (IRC) in patients with follicular lymphoma, PFS in the overall study population (iNHL), response rate (overall response, ORR; and complete response, CR), overall survival (OS) and safety. The study is being conducted in cooperation with the GLSG (Germany), the East German Study Group Hematology and Oncology (OSHO; Germany) and the NCRI (United Kingdom). Results after a follow-up period of 41.1 months showed:
Gazyva-based treatment reduced the risk of disease worsening or death (PFS, as assessed by investigator) by 32 percent compared to Rituxan-based treatment (HR=0.68; 95 percent CI 0.54-0.87; p=0.0016).

IRC-assessed PFS was consistent with investigator-assessed PFS. As assessed by IRC, Gazyva-based treatment reduced the risk of disease worsening or death by 28 percent compared to Rituxan-based treatment (HR=0.72; 95 percent CI 0.56-0.93; p=0.0018). Median PFS has not yet been reached in either treatment arm.

The most common Grade 3-5 AEs that occurred more often in the Gazyva arm compared to the Rituxan arm were low white blood cell count (neutropenia, 46.7 percent vs. 39.5 percent), infections (20.3 percent vs. 16.4 percent), infusion-related reactions (IRRs, 12.4 percent vs. 6.7 percent), low platelet count (thrombocytopenia, 6.1 percent vs. 2.7 percent), new tumors (second malignancies, 4.7 percent vs. 2.7 percent) and cardiac events (3.9 percent vs. 2.8 percent).

GALLIUM is the third positive Phase III study for Gazyva, following the CLL11 study in patients with previously untreated chronic lymphocytic leukaemia (CLL) and the GADOLIN study in patients with indolent (slow-growing) non-Hodgkin lymphoma whose disease progressed during or within six months of prior Rituxan-based therapy.

About Gazyva (obinutuzumab)
Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein expressed on certain B cells, but not on stem cells or plasma cells. Gazyva is designed to attack and destroy targeted B-cells both directly and together with the body’s immune system.

Gazyva is marketed as Gazyvaro in the EU and Switzerland. Gazyva/Gazyvaro is currently approved in more than 80 countries in combination with chlorambucil, for people with previously untreated chronic lymphocytic leukaemia (CLL), and in combination with bendamustine for people with certain types of previously treated follicular lymphoma. The approvals in CLL were based on the CLL11 study, showing significant improvements with Gazyva/Gazyvaro plus chlorambucil across multiple clinical endpoints, including PFS, overall response rate (ORR), complete response rate (CR), and minimal residual disease (MRD) when compared head-to-head with MabThera/Rituxan plus chlorambucil.

The approvals in certain types of previously treated follicular lymphoma were based on the phase III GADOLIN study, in people with follicular lymphoma who did not respond to or who progressed during or within six months of prior MabThera/Rituxan-based therapy, showing a significant improvement in PFS and overall survival (OS) with Gazyva/Gazyvaro-based therapy compared to bendamustine alone.

Additional combination studies investigating Gazyva/Gazyvaro with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are underway across a range of blood cancers.

About Follicular Lymphoma
Follicular lymphoma is the most common indolent (slow-growing) form of non-Hodgkin lymphoma (NHL), accounting for about one in five cases of NHL1. It is considered incurable and relapse is common. Every day, more than 50 people in Europe are diagnosed with this type of NHL2. It is estimated that more than 75,000 people are diagnosed with follicular lymphoma each year worldwide2.
About Roche in haematology

Faslodex receives US FDA approval as monotherapy for expanded use in breast cancer

On August 28, 2017 AstraZeneca reported that the US Food and Drug Administration (FDA) has approved Faslodex (fulvestrant) 500mg as monotherapy for expanded use in women with hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, who have gone through menopause and have not received previous endocrine therapy (Press release, AstraZeneca, AUG 28, 2017, View Source [SID1234520314]).

The FDA approval is based on data from the Phase III FALCON trial, which were published in the November 2016 issue of The Lancet.

Jamie Freedman, Executive Vice President, Head of the Oncology Business Unit, AstraZeneca said: "We’re pleased that the landmark FALCON trial results demonstrated the efficacy of Faslodex as initial monotherapy treatment for women who are living with HR+ HER2- advanced breast cancer. This approval, building on more than 15 years of clinical experience, means more patients can have the opportunity to receive Faslodex earlier in the treatment journey."

Matthew Ellis, MD, PhD, Director of the Lester and Sue Smith Breast Center, part of the NCI-designated Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine, said: "This study provides evidence that using fulvestrant as the first option for previously untreated hormone receptor-positive advanced breast cancer will prolong the time before the disease advances and alternative therapies are required."

The FALCON trial was designed to demonstrate superiority and included 462 postmenopausal women with HR+ metastatic or locally-advanced breast cancer. The results showed a statistically-significant increase in investigator-assessed median progression-free survival (PFS), representing a 20% reduction in the risk of disease progression or death – median PFS of 16.6 months in patients who received Faslodex, compared to 13.8 months in patients receiving the aromatase inhibitor anastrozole 1mg (HR: 0.797; 95% CI: 0.637-0.999; p=0.049).

Faslodex is a hormonal therapy that targets the oestrogen receptor (ER), which can influence the growth of HR+ metastatic breast cancer (MBC), and helps to slow cancer growth by blocking the ER and targeting it for degradation. The most common adverse reactions (≥10%) of any grade reported in patients in the Faslodex arm were arthralgia, hot flash, fatigue, and nausea.

About FALCON

The FALCON (Fulvestrant and AnastrozoLe COmpared in hormonal therapy-Naïve advanced breast cancer) trial is a Phase III, randomised, double-blind, multicentre trial comparing the antitumour effects and tolerability profile of a 500mg dose of Faslodexplus placebo with a 1mg dose of anastrozole plus placebo, in postmenopausal women with HR+, locally-advanced or metastatic breast cancer who have not been treated previously with any hormonal medicine.

The FALCON trial was designed on the basis of positive results from the Phase II FIRST trial, which demonstrated a median overall survival nearly six months longer with Faslodex compared to anastrozole.

About Advanced Breast Cancer

Advanced/metastatic breast cancer refers to Stage III and IV breast cancer. Stage III disease may also be referred to as locally-advanced breast cancer, while metastatic disease is the most-advanced stage of breast cancer (Stage IV), and occurs when cancer cells have spread beyond the initial tumour site to other organs of the body outside the breast. Since there is no cure for the disease, the goal of current treatment is to delay disease worsening or death.

About Faslodex

First approved in 2002, Faslodex was used as a monotherapy for the treatment of postmenopausal women with HR+ MBC whose cancer had progressed following prior anti-oestrogen therapy. In 2016, FDA approved Faslodex in combination with palbociclib for the treatment of women with HR+, HER2- advanced or MBC, whose cancer has progressed after endocrine therapy.

On 26 July 2017, the European Commission (EC) approved Faslodex for the treatment of oestrogen-receptor positive, locally-advanced breast cancer in postmenopausal women not previously treated with endocrine therapy.

Novartis announces analysis published in The Lancet showing ACZ885 reduced lung cancer mortality by 77% in the CANTOS study with further studies planned

On August 27, 2017 Novartis reported primary data from the Canakinumab Anti-inflammatory Thrombosis Outcomes Study (CANTOS), a Phase III study evaluating the role of ACZ885, an interleukin-1ß antibody, in people with a prior heart attack and inflammatory atherosclerosis as measured by high-sensitivity C-reactive protein (hsCRP), a known marker of inflammation, at levels of >=2mg/L (Press release, Novartis, AUG 27, 2017, View Source [SID1234520317]). An additional pre-planned analysis showed that ACZ885 reduced the rate of lung cancer incidence and mortality among study participants. Effects were dose-dependent with a relative risk reduction of 67% finding for lung cancer (HR 0.33 [95% CI: 0.18-0.59]) and 77% for lung cancer mortality (HR 0.23 [95% CI: 0.10-0.54]) observed among patients receiving the 300mg dose of ACZ885 every three months[1]. As part of the study design, all cases of cancers were reviewed by an independent panel of oncologists unaware of study drug allocation. Details of the lung cancer analysis were presented today, alongside the cardiovascular outcomes data, at the European Society of Cardiology (ESC) Congress and published simultaneously in The Lancet[1],[2]. The details of the cardiovascular findings were also presented at ESC and simultaneously published in The New England Journal of Medicine[3].

"The results of CANTOS are exciting because we now have clear evidence that in addition to lowering cholesterol, targeting inflammation reduces patients’ risk of cardiovascular disease, and perhaps even lung cancer," said Paul Ridker, MD, CANTOS Study Chairman and
Director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital. "From a cardiologist perspective, these findings represent a novel approach to the treatment of heart disease with the potential to also help patients with certain cancers."

"By targeting the IL-1ß pathway, CANTOS study findings provide further insights into the role of inflammation in lung cancer and medical researchers additional data to conduct trials to prove this important hypothesis," said Howard A. "Skip" Burris, MD, President of Clinical Operations and Chief Medical Officer, Sarah Cannon Research Institute (Nashville, TN) and Chair of the CANTOS Cancer Adjudication Committee.

"These data are a significant milestone because they show that selectively targeting inflammation with ACZ885 reduces cardiovascular risk and that ACZ885 may also be an important immuno-oncology therapy targeting IL-1ß for lung cancer," said Vas Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. "We look forward to submitting the CANTOS cardiovascular data to regulatory authorities for approval and initiating additional phase III studies in lung cancer."

IL-1ß is a key cytokine in the inflammatory pathway known to drive the continued progression of inflammatory atherosclerosis. By inhibiting the tumor micro-environment mediated by interleukin-1ß, the CANTOS study data analysis explored whether ACZ885, a monoclonal antibody that targets and inhibits the action of IL-1ß, could have an impact on the occurrence and progression of cancer.

With more than 10,000 patients enrolled in the study over the last six years, CANTOS was one of the largest and longest-running clinical trials in Novartis’ history. Trial participants with a prior history of atherosclerosis, a hsCRP level of >=2mg/L, and who were free of previously-diagnosed cancer, received either placebo or one of three doses of ACZ885 (50mg, 150mg, and 300mg subcutaneously every 3 months). All participants received current standard of care therapies, with 91% of participants taking lipid-lowering statins. During a median follow up of 3.7 years, as compared to placebo, ACZ885 resulted in dose dependent reduction in hsCRP of 26 to 41% and a dose-dependent reduction in IL-6 of 25 to 43% (p=<0.0001). For all cancer related mortality (n=196 across treatment), ACZ885 resulted in a significant reduction compared to placebo at the 300mg dose (HR 0.49: [95% CI: 0.31-0.75] p=0.0009). Incident lung cancer (n=129 across treatment) was reduced at the 300mg dose versus placebo (HR 0.33 [95% CI: 0.18-0.59]; p=<0.0001) and the 150mg dose versus placebo (HR 0.61 [95% CI: 0.39-0.97]; p=0.034). Lung cancer mortality was significantly less common at the 300mg dose versus placebo (HR 0.23 [95% CI: 0.10-0.54] p=0.0002)[1].

The overall rates of adverse events (AEs), serious AEs, and discontinuations due to AEs were similar to placebo across all ACZ885 doses. In the six year-long study, serious infections were reported in 11.7% vs 10.2% and malignancies were reported in 6.7% vs 7.1% of participants (ACZ885 300mg vs placebo, respectively). Fatal infections occurred in about one per 1,000 patients in placebo. Although rare, this occurrence was higher in the combined ACZ885 group than placebo. On the other hand, cancer deaths were cut in half by ACZ885 such that there was a non-significant reduction in death from any cause[1].

Over the last decade, the development of immuno-oncology agents have become a primary therapeutic category in fighting certain types of cancers and have improved the outcome for patients, especially those living with lung cancer. Novartis is exploring a number of immunotherapy approaches including priming or educating the immune system so that it can recognize cancer as a threat, attempting to unleash immune cells that have already been primed, and investigating ways to make the tumor more accessible to immune cells. This scientific research is helping the medical community to understand how cancer is responding to therapy – including which patients may benefit from treatments.

About CANTOS (NCT01327846)
The Canakinumab Anti-inflammatory Thrombosis Outcomes Study (CANTOS) (NCT01327846) is a randomized, double-blind, placebo-controlled, event-driven Phase III study designed to evaluate the efficacy, safety and tolerability of quarterly subcutaneous injections of ACZ885 (also known as canakinumab) in combination with standard of care in the prevention of recurrent cardiovascular (CV) events among 10,061 people with a prior myocardial infarction (MI) and with a high-sensitivity C-reactive protein (hsCRP) level of >=2mg/L. The study evaluated three different doses of ACZ885 vs placebo. The primary endpoint of the study was time to first occurrence of major adverse CV event (MACE), a composite of CV death, non-fatal MI, and non-fatal stroke. Secondary endpoints included time to first occurrence of the composite CV endpoint consisting of CV death, non-fatal MI, non-fatal stroke and hospitalization for unstable angina requiring unplanned revascularization; time to new onset type 2 diabetes among people with pre-diabetes at randomization; time to occurrence of non-fatal MI, non-fatal stroke or all-cause mortality; and time to all-cause mortality. The median follow-up time was 3.7 years. The study ran for approximately six years.
In agreement with the US Food and Drug Administration in 2010, incident cancers were adjudicated by a blinded independent oncology monitoring committee. Data on incident cancers, including cancer deaths, were collected as serious adverse events and analyzed in a prospective fashion. History of cancer was an exclusion criteria to study enrollment (baseline CT scans were not conducted) and diagnosis of cancer led to a discontinuation of treatment with ACZ885 as per protocol.

About ACZ885 (canakinumab)
ACZ885 (canakinumab) is a selective, high-affinity, fully human monoclonal antibody that inhibits IL-1ß, a key cytokine in the inflammatory pathway known to drive the continued progression of inflammatory atherosclerosis. ACZ885 works by blocking the action of IL-1ß for a sustained period of time, therefore inhibiting inflammation that is caused by its over-production. ACZ885 is the first and only investigational treatment which has shown that selectively targeting inflammation significantly reduces cardiovascular risk.

TESARO Announces Nine Data Presentations at the 2017 European Society for Medical Oncology (ESMO) Annual Meeting

On August 25, 2017 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported that data from nine abstracts will be presented at the 2017 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) annual meeting, September 8 to September 12, 2017, in Madrid (Press release, TESARO, AUG 25, 2017, View Source [SID1234520316]).

"We are excited that a wealth of data from the landmark ENGOT-OV16/NOVA trial will be presented at this year’s ESMO (Free ESMO Whitepaper) Annual Meeting," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "Patient-reported quality of life data for patients treated with niraparib versus placebo will be featured in an oral presentation and the results of two post-hoc analyses, the observed exposure-response relationship of niraparib in gBRCAmut and non-gBRCAmut patients, and the safety and efficacy of niraparib in elderly patients, will be subjects for poster discussions. In addition, data from the Phase 1/2 trial of niraparib plus pembrolizumab in patients with triple-negative breast cancer or recurrent platinum-resistant ovarian cancer (TOPACIO) will be highlighted in a poster discussion. Finally, a poster will be presented detailing results from the Phase 1 study of TSR-042, our anti-PD-1 antibody."

Please plan to visit TESARO at Booth #53 for information about VARUBY and our pipeline.

Presentation Details (all times local):

ZEJULA (niraparib)

Friday, September 8, 2017, 4:00 PM to 5:30 PM
Quality of life in recurrent ovarian cancer patients treated with niraparib: Results from the ENGOT-OV16/NOVA TRIAL
Proffered Paper Session, Abstract: 930O, Location: Cordoba Auditorium

Saturday, September 9, 2017, 9:15 AM to 10:45 AM
Safety and efficacy of niraparib in elderly patients (Pts) with recurrent ovarian cancer (OC)
Poster Discussion Session, Abstract: 934PD, Location: Cartagena Auditorium

Saturday, September 9, 2017, 9:15 AM to 10:45 AM
The exposure-response relationship of niraparib in patients (pts) with gBRCAmut and non-gBRCAmut: results from the Phase 3 ENGOT-OV16/NOVA Trial
Poster Discussion Session, Abstract:933PD, Location: Cartagena Auditorium

Saturday, September 9, 2017, 1:15 PM to 2:15 PM
Modeling and impact of organ function on the population pharmacokinetics (PK) of niraparib, a selective poly (ADP-ribose) polymerase (PARP)—1 and —2 inhibitor
Poster Display Session, Abstract: 964P, Location: Hall 8

Saturday, September 9, 2017, 1:15 PM to 2:15 PM
A randomized, double-blind, placebo-controlled multicenter phase 3 trial of niraparib maintenance treatment in patients with advanced ovarian cancer following frontline chemotherapy (PRIMA)
Poster Display Session, Abstract: 986TiP, Location: Hall 8

Saturday, September 9, 2017, 1:15 PM to 2:15 PM
A phase 1 study to evaluate the safety and tolerability of bevacizumab-niraparib combination therapy and determine the recommended phase 2 dose (RP2D) in women with platinum-sensitive epithelial ovarian cancer (ENGOT-OV24/AVANOVA1)
Poster Display Session, Abstract: 953P, Location: Hall 8

Saturday, September 9, 2017, 1:15 PM to 2:15 PM
Disease burden during the "watchful waiting" period in patients with recurrent ovarian cancer
Poster Display Session, Abstract: 962P, Location: Hall 8

Monday, September 11, 2017, 9:15 AM to 10:45 AM
Dose-finding combination study of niraparib and pembrolizumab in patients (pts) with metastatic triple-negative breast cancer (TNBC) or recurrent platinum-resistant epithelial ovarian cancer (OC) (TOPACIO/Keynote-162)
Poster Discussion Session, Abstract: 1143PD, Location: Bilbao Auditorium

Niraparib is marketed in the United States under trade name ZEJULA. Niraparib has not been approved by any regulatory agencies outside of the United States.

The TOPACIO trial is being conducted in collaboration with Merck Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc., which is providing support for the trial.

TSR-042 (anti-PD-1 antibody)

Sunday, September 10, 2017, 1:15 PM to 2:15 PM
Safety, pharmacodynamic, and pharmacokinetic profile of TSR-042, an anti—PD—1 monoclonal antibody, in patients with advanced solid tumors
Poster Display Session, Abstract: 1185P, Location: Hall 8

About ZEJULA (Niraparib)
Niraparib is marketed in the United States under trade name ZEJULA. ZEJULA (niraparib) is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect. Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including some fatal cases, was reported in patients treated with ZEJULA. Discontinue ZEJULA if MDS/AML is confirmed. Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia), as well as cardiovascular effects (hypertension and hypertensive crisis) have been reported in patients treated with ZEJULA. Monitor complete blood counts to detect hematologic adverse reactions, as well as to detect cardiovascular disorders, during treatment. ZEJULA can cause fetal harm and females of reproductive potential should use effective contraception. Please see full prescribing information, including additional important safety information, available at www.zejula.com.

About TSR-042

TSR-042 is a monoclonal antibody targeting PD-1 and was developed as part of the collaboration between TESARO and AnaptysBio, Inc. This collaboration was initiated in March of 2014, and is focused on the development of monospecific antibody drugs targeting PD-1, TIM-3 (TSR-022), and LAG-3 (TSR-033), in addition to a bi-specific antibody drug candidate targeting PD-1/LAG-3.