On April 27, 2017 AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas – respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as in infection and neuroscience reported financial results for the first quarter ended March 31, 2017 (Press release, AstraZeneca, APR 27, 2017, View Source [SID1234518737]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Financial Summary

$m
% change
Actual1
CER2
Total Revenue
5,405
(12)
(10)
Product Sales
4,843
(13)
(12)
Externalisation Revenue
562
2
3

Reported Operating Profit
917
(12)
(23)
Core3 Operating Profit
1,667
5
(2)

Reported Earnings Per Share (EPS)
$0.42
(17)
(35)
Core EPS
$0.99
4
(4)

● The Product Sales performance mainly reflected the residual impact of the US Crestor patent expiry
● One third of Externalisation Revenue was represented by sustainable and ongoing income4
● Continued good progress on cost control, reflecting the evolving shape of the business:
– Reported R&D costs declined by 2% (up by 2% at CER) to $1,453m; Core R&D costs declined by 6% (3% at CER) to $1,338m
– Reported SG&A costs declined by 11% (8% at CER) to $2,300m; Core SG&A costs declined by 14% (12% at CER) to $1,829m
● Reported EPS declined by 17% (35% at CER); Core EPS increased by 4% (down by 4% at CER)
● Financial guidance for 2017 confirmed

Commercial Highlights
The Growth Platforms grew by 4% (5% at CER) and represented 66% of Total Revenue:
● Emerging Markets: 7% growth (9% at CER), becoming AstraZeneca’s largest sales region
● Respiratory: A decline of 2% (stable at CER), with growth offset by the performance of Symbicort in the US
● New CVMD5: Growth of 5% (6% at CER), with competitive pressures in the US continuing
● Japan: Growth of 5% (3% at CER), partly reflecting the ongoing successful launch of Tagrisso and the performance of Symbicort
● New Oncology6: Sales of $236m (Q1 2016: $99m), accompanied by regulatory approval for Tagrisso in China

Achieving Scientific Leadership
The table below highlights the number of successes in the late-stage pipeline since the last results announcement:

Regulatory Approvals
Tagrisso – lung cancer (US, EU; full approval)
Tagrisso – lung cancer (CN)
Forxiga – type-2 diabetes (CN)
Qtern – type-2 diabetes (US)
Siliq – psoriasis (US; by partner)
Regulatory Submission Acceptances
Lynparza – ovarian cancer (2nd line) (US) (Priority Review)
Bydureon – type-2 diabetes (autoinjector) (US)
Symbicort – COPD exacerbations (US)
benralizumab – severe, uncontrolled asthma (JP)
Phase III or Major Data Readouts
Lynparza – breast cancer
Farxiga – type-2 diabetes (CVD-REAL real-world study)
Other Key Developments
Orphan Drug Designation: Lynparza – ovarian cancer (JP)
Complete Response Letter: ZS-9 (sodium zirconium cyclosilicate) – hyperkalaemia (US)
Orphan designation: inebilizumab – neuromyelitis optica spectrum disorder (EU)

Pascal Soriot, Chief Executive Officer, commenting on the results said:
"Our good start to the year supported our guidance for 2017. Notably, Emerging Markets became our largest region, representing 32% of sales. The pipeline continued to deliver in what we expect will be a pivotal year for AstraZeneca as we announced important developments, in particular in Oncology. In addition to the availability of positive data for Lynparza in ovarian and breast cancer, we also received full approvals in the US and Europe for Tagrisso in lung cancer and launched this important medicine in record time in China. While we were disappointed to receive the Complete Response Letter for ZS-9, we remain confident in this treatment for hyperkalaemia.

"The Total Revenue performance reflected the transitional impact of recent patent expiries, which is expected to recede in the second half of the year. Importantly, we anticipate the significant progress of the pipeline to continue, including our Immuno-Oncology and targeted treatments. We will also maintain our commitment to drive efficiency across the company to support our efforts to bring new medicines to patients."

FY 2017 Guidance: Confirmed
The Company provides guidance on Total Revenue and Core EPS only. All commentary in this section is at CER and is unchanged from the prior results announcement:

Total Revenue
A low to mid single-digit percentage decline
Core EPS
A low to mid teens percentage decline*
*The Core EPS guidance anticipates a normalised effective Core tax rate in FY 2017 of 16-20% (FY 2016: 11%)

Guidance is subject to base-case assumptions of the progression of the pipeline and the extensive level of news flow listed on the following page. Variations in performance between quarters can be expected to continue, with year-on-year comparisons expected to ease in H2 2017, when the impact of the entry in July 2016 of multiple Crestor generic medicines in the US will annualise.

The Company presents Core EPS guidance only at CER. It is unable to provide guidance on a Reported/GAAP basis because the Company cannot reliably forecast material elements of the Reported/GAAP result, including the fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal settlement provisions. Please refer to the section ‘Cautionary Statements Regarding Forward-Looking Statements’ at the end of this announcement.

In addition to the unchanged guidance above, the Company also provides indications in other areas of the Income Statement. The sum of Externalisation Revenue and Other Operating Income in FY 2017 is anticipated to be ahead of that in FY 2016. Sustainable and ongoing income is expected to increase further as a proportion of total Externalisation Revenue in FY 2017. Core R&D costs are expected to be broadly in line with those in FY 2016 and the Company anticipates a further reduction in Core SG&A costs in FY 2017, reflecting the evolving shape of the business. A full explanation of these items is listed in the Operating & Financial Review.

FY 2017 Currency Impact
Based only on average exchange rates in Q1 2017 and the Company’s published currency sensitivities, the Company expects a low single-digit percentage adverse impact from currency movements on Total Revenue and a minimal impact on Core EPS. Further details on currency sensitivities are contained within the Operating and Financial Review.

Notes

1. All growth rates are shown at actual exchange rates, unless stated otherwise.
2. Constant exchange rates. These are non-GAAP measures because they remove the effects of currency movements from Reported results.
3. Core financial measures. These are non-GAAP measures because, unlike Reported performance, they cannot be derived directly from the information in the Group Financial Statements. See the Operating and Financial Review for a definition of Core financial measures and a reconciliation of Core to Reported financial measures.
4. Sustainable and ongoing income is defined as Externalisation Revenue, excluding upfront receipts.
5. New Cardiovascular and Metabolic Diseases, incorporating Brilinta and Diabetes.
6. New Oncology comprises Tagrisso, Lynparza and Iressa (US).

Pipeline: Forthcoming Major News Flow
Innovation is critical to addressing unmet patient needs and is at the heart of the Company’s growth strategy. The focus on research and development is designed to yield strong results from the pipeline.

Q2 2017
Faslodex – breast cancer (1st line): Regulatory decision (JP)
Lynparza – ovarian cancer (2nd line): Regulatory submission (EU)durvalumab (durva) – bladder cancer: Regulatory decision (US)
acalabrutinib – blood cancer: Data readout, regulatory submission (US) (Phase II)#
Bevespi – COPD: Regulatory submission (EU)
Mid-2017
durva +/- tremelimumab (treme) – lung cancer (MYSTIC): Data readout
H2 2017
Faslodex – breast cancer (1st line): Regulatory decision (US, EU)
Lynparza – ovarian cancer (2nd line): Regulatory decision (US)
Lynparza – breast cancer: Regulatory submission
Lynparza – ovarian cancer (1st line): Data readout
Tagrisso – lung cancer (1st line): Data readout
durvalumab – lung cancer (PACIFIC): Data readout, regulatory submission (US)durva +/- treme – lung cancer (ARCTIC): Data readout, regulatory submission
durva +/- treme – lung cancer (MYSTIC): Regulatory submission
durva +/- treme – head & neck cancer (KESTREL): Data readout
moxetumomab – leukaemia: Data readout

Bydureon – cardiovascular (CV) outcomes trial: Data readout, regulatory submission

benralizumab – severe, uncontrolled asthma: Regulatory decision (US)
tralokinumab – severe, uncontrolled asthma: Data readout
2018
Lynparza – ovarian cancer (1st line): Regulatory submission
Tagrisso – lung cancer (1st line): Regulatory submission
durva + treme – lung cancer (NEPTUNE): Data readout
durva +/- treme – head & neck cancer (KESTREL): Regulatory submission
durva +/- treme ­ head & neck cancer (EAGLE): Data readout, regulatory submission
durva +/- treme – bladder cancer (DANUBE): Data readout, regulatory submission
moxetumomab – leukaemia: Regulatory submission
selumetinib – thyroid cancer: Data readout, regulatory submission

Bydureon – autoinjector: Regulatory decision (US)
roxadustat – anaemia: Data readout (AstraZeneca-sponsored trials), regulatory submission

Duaklir – COPD: Regulatory submission (US)benralizumab – severe, uncontrolled asthma: Regulatory decision (EU, JP)
benralizumab – COPD: Data readout, regulatory submission
tralokinumab – severe, uncontrolled asthma: Regulatory submission
PT010 – COPD: Data readout, regulatory submission

anifrolumab – lupus: Data readout
The term ‘data readout’ in this section refers to Phase III data readouts, unless specified otherwise.

#Potential fast-to-market opportunity ahead of randomised, controlled trials.

On April 27, 2017 Novocure (NASDAQ: NVCR) reported financial results for the three months ended March 31, 2017, highlighting year-over-year and sequential growth in active patients and net revenues (Press release, NovoCure, APR 27, 2017, View Source [SID1234518736]). Novocure is an oncology company developing a profoundly different approach to cancer treatment utilizing a proprietary therapy called TTFields, the use of electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

First quarter 2017 highlights include:


Three months ended March 31,
2017 2016 % Change

Non-financial
Prescriptions received in period(1) 894 755 18%
Active patients at period end(2) 1,266 797 59%

Financial, in millions
Net revenues $ 34.9 $ 13.1 167%
Net loss $ (18.0 ) $ (35.4 ) 49%

Cash and cash equivalents at the end of period $ 84.6 $ 115.9
Short-term investments at the end of period $ 104.7 $ 119.8
(1) A "prescription received" is a commercial order for Optune that is received from a physician certified to treat patients with Optune for a patient not previously on Optune. Orders to renew or extend treatment are not included in this total.
(2) An "active patient" is a patient who is on Optune under a commercial prescription order as of the measurement date, including patients who may be on a temporary break from treatment and who plan to resume treatment in less than 60 days.
"Our growth continued in the first quarter 2017. It was the ninth consecutive quarter of active patient growth since the first presentation of our EF-14 data in newly diagnosed glioblastoma (GBM). At the end of the quarter, we had more than 1,260 active patients on therapy," said Asaf Danziger, Novocure’s Chief Executive Officer. "Our 167% year-over-year revenue growth was driven by an expanding global base of active patients as well as coverage and contracting success in the U.S."

"We are pleased with the progress we made this quarter and remain committed to bringing Optune to all the patients who may benefit from it," continued Mr. Danziger. "The final analyses of our EF-14 phase 3 pivotal trial presented at AACR (Free AACR Whitepaper) showed a consistent improvement in overall survival when Optune was added to standard temozolomide chemotherapy for the treatment of newly diagnosed GBM. The improvement in overall survival was maintained at two, three, four and five years. The four and five year survival rates of Optune-treated patients were more than double those of patients treated with temozolomide alone. We believe that Optune plus temozolomide is an essential combination treatment for patients with newly diagnosed GBM."

"Beyond GBM, our data continue to support that TTFields may be well suited for combination with standard of care treatments for a variety of additional solid tumor types," said William Doyle, Novocure’s Executive Chairman. "As committed as we are to bringing Optune to patients with GBM, we are equally focused on advancing TTFields for additional solid tumor indications."

First Quarter 2017 Operating Statistics and Financial Update

There were 1,266 active patients on Optune at March 31, 2017, an increase of 469 active patients, or 59 percent, compared to March 31, 2016. The increase in active patients was driven both by prescription growth and by an increase in the percentage of newly diagnosed GBM patients who started Optune in prior periods and who typically have a longer duration of treatment with Optune. In the first quarter 2017, more than 55 percent of Optune prescriptions were for newly diagnosed GBM.

In the United States, there were 933 active patients on Optune at March 31, 2017, an increase of 234 active patients, or 33 percent, compared to March 31, 2016.
In Germany and other EMEA markets, there were 331 active patients on Optune at March 31, 2017, an increase of 233 active patients, or 238 percent, compared to March 31, 2016.
Additionally, 894 prescriptions were received in the quarter ended March 31, 2017, an increase of 139 prescriptions, or 18 percent, compared to the same period in 2016. The increase in prescriptions was driven primarily by commercial activities in our currently active markets.

In the United States, 685 prescriptions were received in the quarter ended March 31, 2017, an increase of 1 prescription compared to the same period in 2016.
In Germany and other EMEA markets, 206 prescriptions were received in the quarter ended March 31, 2017, an increase of 135 prescriptions, or 190 percent, compared to the same period in 2016.
In Japan, there were 3 prescriptions received in the quarter ended March 31, 2017.
We continued to work with payers in the United States to expand coverage of Optune for the treatment of both newly diagnosed and recurrent GBM. As of March 31, 2017, payers administering plans for more than 187 million lives had issued positive coverage policies stating that Optune is approved for the treatment of newly diagnosed or recurrent GBM, an increase of approximately 7 million lives since January 1, 2017, including new policies with Highmark Blue Cross Blue Shield, Blue Cross Blue Shield of Idaho, and Dean Health Plan.

For the three months ended March 31, 2017, net revenues increased to $34.9 million compared to $13.1 million for the same period in 2016, representing 167 percent growth. This growth was primarily driven by increased Optune adoption and the transition to accrual-based revenue recognition for a portion of our billings.

For the three months ended March 31, 2017, net revenues included $14.7 million in accrual-based net revenues. For the three months ended March 31, 2017, gross billings totaled $73.2 million, and 23% of first quarter 2017 gross billings qualified for accrual-based net revenue recognition. We continue to recognize revenue on a cash basis for payers with which we do not have contractual arrangements or sufficient history to reliably estimate their individual payment patterns and for which we cannot reliably estimate the amount that would ultimately be collected. We believe there will be an extended period of time during which our revenue will be a mix of cash-based and accrual-based revenue.

For the three months ended March 31, 2017, cost of revenues increased to $11.7 million compared to $8.0 million for the same period in 2016, representing an increase of 46 percent. This was primarily driven by an increase in active Optune patients, resulting in increased transducer array shipments and increased field equipment depreciation expenses, as well as increased personnel costs to establish infrastructure necessary to support an increasing volume of shipments to patients.

Research, development and clinical trials expenses for the three months ended March 31, 2017, were $9.4 million compared to $11.4 million for the same period in 2016, representing a decline of 18 percent. This was primarily due to a decrease in clinical trial expenses resulting from the conclusion of our EF-14 phase 3 pivotal trial in newly diagnosed GBM.

Sales and marketing expenses for the three months ended March 31, 2017, were $14.8 million compared to $13.3 million for the same period in 2016, representing an increase of 11 percent. This was primarily due to increased personnel costs, reflecting our expanding commercial operations in the U.S. and Germany, partially offset by a decrease in advertising and professional services related to the launch of Optune for newly diagnosed GBM.

General and administrative expenses for the three months ended March 31, 2017, were $12.4 million, representing an increase of 1 percent compared to the same period in 2016. This was primarily due to increased headcount partially offset by a decrease in professional services and other expenses.

Personnel costs for the three months ended March 31, 2017, included $4.6 million in non-cash share-based compensation expenses, comprised of $0.1 million in cost of revenues; $0.9 million in research, development and clinical trials; $0.7 million in sales and marketing; and $2.9 million in general and administrative expenses. Total non-cash share-based compensation expenses for the first quarter 2016 were $5.5 million.

Net losses for the three months ended March 31, 2017, were $18.0 million compared to net losses of $35.4 million for the same period in 2016.

At March 31, 2017, we had $84.6 million in cash and cash equivalents and $104.7 million in short-term investments, for a total balance of $189.3 million in cash, cash equivalents and short-term investments. At March 31, 2017, we had $100.0 million of principal indebtedness outstanding under our Loan and Security Agreement with Biopharma Secured Investments III Holdings Cayman LP.

Anticipated clinical milestones

Trial initiations:

Phase 3 pivotal trial in locally advanced pancreatic cancer (2H 2017)
Phase 3 pivotal trial in recurrent ovarian cancer (2018)
Top-line data readouts:

Phase 2 pilot STELLAR trial in mesothelioma (2018)
Phase 3 pivotal METIS trial in brain metastases (2020)
Phase 3 pivotal LUNAR trial in non-small cell lung cancer (2021)

On April 27, 2017 Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX), reported the expansion of ENCORE 601/KEYNOTE 142, the ongoing Phase 2 clinical collaboration with a subsidiary of Merck, known as MSD outside the United States and Canada, to include a cohort of patients with microsatellite stable colorectal cancer (Press release, Syndax, APR 27, 2017, View Source [SID1234518726]). This trial is designed to evaluate the safety, tolerability and efficacy of Syndax’s entinostat, an oral, small molecule that targets immune regulatory cells, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

"Microsatellite stable colorectal cancers comprise approximately 85% of colorectal cancers, have limited treatment options once the disease advances, and have been unresponsive to anti-PD-1 monotherapy," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "This expansion of ENCORE 601/KEYNOTE 142 is based in part on the previously communicated clinical responses we observed for the entinostat-KEYTRUDA combination in advanced melanoma patients that had progressed on prior anti-PD-1 therapy."

ENCORE 601 continues to evaluate the combination of entinostat and KEYTRUDA in patients with advanced melanoma or non-small cell lung cancer (NSCLC) who have experienced disease progression following treatment with an anti-PD-1 therapy, and patients with NSCLC who are naïve to treatment with a PD-1 or PD-L1 antagonist. In March 2017, Syndax announced that the melanoma cohort achieved the pre-specified criteria required to advance to the second stage of the trial, and re-opened enrollment of that cohort. The Company will present results from the first stage of the melanoma cohort at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June. A decision on whether the two NSCLC cohorts can proceed to the second stage of the trial is expected in 2Q17.

Financial and other terms of the initial agreement, as well as the amendment covering the expanded collaboration between Syndax and Merck, were not disclosed.

On April 27, 2017 Mateon Therapeutics, Inc. (OTCQX:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported that four presentations regarding the company’s preclinical drug development programs will be presented at the Tumor Microenvironment Workshop being held from April 27-29, 2017 at the Palms Hotel in Miami, Florida (Press release, Mateon Therapeutics, APR 27, 2017, View Source [SID1234518725]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

"These presentations highlight new potential applications for our vascular disrupting agents, which are currently in clinical development for other indications," stated William D. Schwieterman, M.D., Mateon’s President and Chief Executive Officer. "The workshop will also show selected potential applications for our earlier-stage research programs."

Titles of the presentations by Mateon and/or its collaborators include the following:

Combining Vascular Disrupting Agents with Checkpoint Inhibitors to Improve Tumour Immunogenicity. Pernille B. Elming, M.D., Thomas R. Wittenborn, Ph.D., and Michael R. Horsman, Ph.D., Department of Experimental Clinical Oncology, Aarhus University Hospital, Aarhus, Denmark .

Targeting Tumor-Associated Hypoxia with Bioreductively Activatable Prodrug Conjugates of Small-Molecule Inhibitors of Tubulin Polymerization. Blake A. Winn, Ph.D.,1 Laxman Devkota, Ph.D.,1 Yifan Wang, M.S.,1 Tracy E. Strecker, Ph.D.,1 Jeni Gerberich, B.S.,2 Ralph P. Mason, Ph.D.,2 Mary Lynn Trawick, Ph.D.,1 Kevin G. Pinney, Ph.D.1

1Department of Chemistry and Biochemistry, Baylor University, Waco, Texas
2Department of Radiology, University of Texas Southwestern Medical Center, Dallas, Texas

Cathepsin inhibition impairs M2 macrophage pro-tumor functions. Samantha S. Dykes, Ph.D. and Dietmar W. Siemann, Ph.D., Department of Radiation Oncology, University of Florida, Gainesville, FL

The small molecule Cathepsin L and K inhibitor KGP-94 impairs the Tumor-Associated Macrophage-mediated metastatic phenotype of osteosarcoma under hypoxia. Henrietta Fasanya and Dietmar Siemann, Ph.D., Department of Radiation Oncology, University of Florida, Gainesville, Florida

On April 27, 2017 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported that following the recent identification of a fixed dose and patient-centric dosing schedule, the ongoing clinical trial of TSR-042 has been expanded to enroll patients with metastatic microsatellite instability high (MSI-H) endometrial cancer who have progressed following one or two prior chemotherapy treatments (Press release, TESARO, APR 27, 2017, View Source [SID1234518720]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

During the first 12 weeks of treatment, TSR-042 is administered once every three weeks, followed by a single dose administration every six weeks until disease progression. The intent of this study is to support a request for accelerated approval and Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA). The primary endpoints of this trial are overall response rate (ORR) and duration of response, and secondary endpoints include disease control rate, progression free survival (PFS), and overall survival (OS). The addition of cohorts for patients with other tumor types is also planned. This is the first clinical development program within a broader plan that includes potential label expansion trials of TSR-042 in multiple cancers in combination with ZEJULA, TSR-022, TESARO’s anti-TIM-3 antibody, and TSR-033, TESARO’s anti-LAG-3 antibody.

"TSR-042 was the first antibody from our immuno-oncology portfolio to enter clinical trials, and following identification of a fixed dose and schedule, we are pleased to be advancing TSR-042 into a registration program," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "With the recent approval of ZEJULA in the U.S., the initiation of this development program furthers our commitment to women with gynecologic tumors, including ovarian, fallopian tube, and peritoneal cancer. We intend to continue our efforts with future combination studies of TSR-042 and ZEJULA, and to someday eliminate these terrible diseases and benefit women who were until recently largely underserved by new therapeutic options."

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.

About Endometrial Cancer
Endometrial cancer is the most common type of uterine cancer, accounting for more than 95 percent of cases. Endometrial cancer develops in the lining of the uterus, called the endometrium. The annual number of new cases of endometrial cancer is estimated at 325,000 worldwide. The most common histologic form is endometrioid adenocarcinoma originating in the glandular tissue, which represents about 75-80% of diagnosed cases. In 2017, SEER1 estimates 61,380 patients will be diagnosed with endometrial cancer, with approximately 30% or 18,414 being stage III/IV patients. Based on genomic characterization studies of endometrial cancer, 20-25% of patients have tumors with a microsatellite instability phenotype (MSI-H)2. Microsatellite instability arises from a failure to repair replication-associated errors due to a defective DNA mismatch repair system. This failure allows persistence of mismatch mutations all over the genome, but especially in regions of repetitive DNA known as microsatellites, leading to increased mutational load that has been demonstrated to improve responses to anti-PD-1 therapies.3,4