On March 5, 2019 TESARO, an oncology-focused business within GSK, reported that data for dostarlimab (anti-PD-1 antibody, formerly TSR-042) and Zejula (niraparib) will be presented at the 2019 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer being held March 16-19 in Honolulu, Hawaii (Press release, TESARO, MAR 5, 2019, View Source [SID1234534006]).

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"At this year’s SGO meeting, data will be presented from the GARNET trial of dostarlimab in recurrent endometrial cancer patients, including patients with recurrent MSS endometrial cancer, for which limited treatment options exist today," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "We are on track to submit a BLA for dostarlimab by the end of the year. Data will also be presented from several studies of Zejula in patients with ovarian cancer, including safety data from the fully enrolled Phase 3 PRIMA study of Zejula as a first-line maintenance therapy for ovarian cancer regardless of BRCA status."

Please plan to visit TESARO at Booth #207 for information on the expanded development program for Zejula, dostarlimab and our broader pipeline.

Oral Presentations Information (all times local):

Dostarlimab (TSR-042)

Tuesday, March 19, 2019, 7:45 AM to 9:00 AM
Preliminary safety, efficacy, and pharmacokinetic/pharmacodynamic characterization from GARNET, a phase I/II clinical trial of the anti–PD-1 monoclonal antibody, TSR-042, in patients with recurrent or advanced MSI-H and MSS endometrial cancer (EC)
Oral in the Scientific Plenary VI, Abstract: 33, Location: Kamehameha 3

Zejula (niraparib)

Saturday, March 16, 2019, 6:45 AM to 7:45 AM
Time without symptoms or toxicity in patients with recurrent ovarian cancer receiving niraparib maintenance treatment versus placebo: A TWIST analysis of the ENGOT-OV16/NOVA trial
Oral in the Scientific Plenary I, Abstract: 1, Location: Kamehameha 3

Saturday, March 16, 2019, 6:45 AM to 7:45 AM
Baseline platelet count and body weight as predictors of early dose modification in the QUADRA trial of niraparib monotherapy for the treatment of heavily pretreated (≥4th line), advanced, recurrent high-grade serous ovarian cancer (OC)
Oral in the Scientific Plenary I, Abstract: 2, Location: Kamehameha 3

Saturday, March 16, 2019, 6:45 AM to 7:45 AM
A prospective evaluation of tolerability of niraparib dosing based upon baseline body weight and platelet count: Blinded pooled interim safety data from the ENGOT-OV26/PRIMA study
Oral in the Scientific Plenary I, Abstract: 3, Location: Kamehameha 3

Niraparib is marketed in the United States and Europe under trade name Zejula.

About Zejula (niraparib)
Zejula (niraparib) is a poly (ADP-ribose) polymerase (PARP) 1/2 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 tumour relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumour 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 GARNET
The ongoing Phase I/II GARNET trial is evaluating dostarlimab as monotherapy in patients with advanced solid tumors. GARNET included a weight-based dose escalation study (Part 1) and a fixed-dose safety study (Part 2A), both of which have been completed. Results of these studies were used to determine the recommended Phase 2 dose (RP2D; 500 mg Q3W for the first 4 cycles then 1000 mg Q6W). Part 2B of the study includes four large expansion cohorts: MSI-H endometrial cancer, MSI-H non-endometrial cancer, MSS endometrial cancer, and non-small cell lung cancer (NSCLC).

About dostarlimab
Dostarlimab (TSR-042) is an investigational humanized anti-programmed death (PD)-1 monoclonal antibody that binds with high affinity to the PD-1 receptor and effectively blocks its interaction with the ligands PD-L1 and PD-L2. Dostarlimab is the only anti-PD-1 therapy administered as monotherapy every 3 weeks for 4 doses then every 6 weeks thereafter. Dostarlimab 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 (TSR-075).

On March 5, 2019 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, reported that Susan M. Molineaux, Ph.D, the company’s founder, president and chief executive officer, will present at the Cowen & Company 39th Annual Healthcare Conference at 10:40 a.m. ET on Tuesday, March 12, 2019 in Boston (Press release, Calithera Biosciences, MAR 5, 2019, View Source [SID1234535226]). The presentation will be webcast live and available for replay for up to 30 days at www.calithera.com in the Investor Relations section.

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On March 5, 2019 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on the development of cellular immunotherapies to treat cancer based on its novel T cell technology platforms, reported that Charles Wilson, Chief Executive Officer, will present a corporate overview at the Cowen and Company 39th Annual Health Care Conference 2019 on Tuesday, March 12, 2019 at 11:20 a.m. ET in Boston, Massachusetts (Press release, Unum Therapeutics, MAR 5, 2019, https://investors.unumrx.com/news-releases/news-release-details/unum-therapeutics-present-cowen-and-company-39th-annual-health [SID1234533950]).

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The presentation will be webcast live, and available for replay on the "Events" section of Unum’s investor relations webpage (investors.unumrx.com/events) where it will be archived for approximately 90 days.

On March 5, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported that 2018 fourth quarter and full year financial results will be released after the market close on March 12, 2019 (Press release, Inovio, MAR 5, 2019, View Source [SID1234533967]). Following the release, the Company will host a live conference call and webcast at 4:30 p.m. ET, to provide a general business update, financial results, and 2019 cash burn guidance.

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A live and archived version of the audio presentation will be available online at View Source This is a listen-only event but will include a live Q&A with analysts.

A replay of the conference call will be accessible one hour after the call at 877-344-7529 (domestic) or 412-317-0088 (international) using replay access code 10129375.

On March 5, 2019 Dova Pharmaceuticals, Inc. (Nasdaq: DOVA), a pharmaceutical company focused on acquiring, developing, and commercializing drug candidates for diseases where there is a high unmet need, reported its operating and financial results for the fourth quarter and full year ended December 31, 2018 (Press release, Dova Pharmaceuticals, MAR 5, 2019, View Source [SID1234533984]).

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"Following the management changes announced in December 2018, we worked expeditiously to implement changes to our commercialization strategy for DOPTELET. We are encouraged with the initial feedback and results from these efforts and remain confident in the significant commercial opportunity for DOPTELET," said Dr. David Zaccardelli, President and Chief Executive Officer of Dova. "In addition, we are pleased by the FDA acceptance of DOPTELET’s supplemental New Drug Application (sNDA) for review in the treatment of chronic ITP which would provide a new treatment option for patients with ITP as well as a long-term growth opportunity for DOPTELET. Finally, we remain well-positioned financially, with over $100 million in cash and equivalents as of December 31, 2018 to fund our operations."

DOPTELET Launch Highlights

The US sales team was restructured on January 4, 2019, now comprised of 44 sales representatives and 5 regional directors. This team is accountable for driving DOPTELET sales in hepatology, hematology, and interventional radiology, while Dova’s co-promotion partner, Salix, has responsibility for GI, colorectal surgeon and proctology practices.

New DOPTELET marketing efforts are underway and Dova expects to launch a revised strategy in the second quarter of 2019.

Additional key hires were made on the commercial team including the head of sales and VP of marketing.

From launch through December 31, 2018, a total of 694 health care professionals have prescribed DOPTELET to their patients with an increasing number of repeat prescribers.

More than 21,000 calls were conducted, reaching more than 8,700 unique health care providers during the fourth quarter of 2018.

For prescriptions in the fourth quarter that have gone through the adjudication process with the payers, 83% of those prescriptions were approved. On average the time to decision for a prescription was 6.3 business days in the quarter.

Inventory held by specialty pharmacies in Dova’s contracted network decreased by approximately 34% from October 1, 2018 to December 31, 2018. The inventory decrease was driven by shipments to patients more than doubling in the fourth quarter of 2018 as compared to the prior quarter.

Fourth Quarter Highlights

The U.S. Food and Drug Administration (FDA) accepted for review Dova’s sNDA for DOPTELET for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment. The sNDA for ITP is primarily supported by safety and efficacy data from two Phase 2 clinical trials and a randomized, placebo-controlled Phase 3 clinical trial that met its primary and secondary efficacy endpoints with high statistical significance. The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is June 30, 2019.

Following the submission in April 2018 of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for DOPTELET for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure, Dova expects a decision date for the MAA in the third quarter of 2019.

Enrollment remains ongoing for the Phase 3 clinical trial for the treatment of patients with chemotherapy-induced thrombocytopenia (CIT). Due to Dova’s decision to focus on developing DOPTELET for ITP and CIT, Dova has discontinued enrollment in the clinical trial evaluating the treatment of a broader population of patients with thrombocytopenia undergoing surgery (PST) and a post-marketing registry study for CLD patients.

On December 17, 2018, Dr. David Zaccardelli was appointed President and Chief Executive Officer, and Jason Hoitt was appointed Chief Commercial Officer.

Fourth Quarter and Full Year Financial Results

Dova reported a net loss of $19.3 million for the fourth quarter of 2018, compared to a net loss of $9.3 million for the same period in 2017. For the full year ended December 31, 2018, Dova reported net loss of $72.3 million compared to a net loss of $30.0 million for the same period in 2017.

Net product sales were $2.8 million and $7.7 million for the fourth quarter of 2018 and the full year ended December 31, 2018, respectively.

Cost of product sales were $0.3 million and $1.2 million for the fourth quarter of 2018 and full year ended December 31, 2018, respectively.

Research and development expenses were $5.5 million in the fourth quarter of 2018, compared to $2.7 million for the same period in 2017. The increase was primarily due to the initiation of clinical trials to evaluate DOPTELET for the treatment of PST and CIT in 2018. For the full year ended December 31, 2018, research and development expenses were $18.3 million compared to $15.7 million in the same period in 2017. Non-cash stock-based compensation included in research and development expenses for the year ended December 31, 2018 amounted to $2.1 million.

Selling, general and administrative expenses were $16.1 million in the fourth quarter of 2018, compared to $6.5 million for the same period in 2017. The increase was primarily due to staffing and other costs associated with the launch of DOPTELET as well as additional costs necessary for operating as a public entity. For the full year ended December 31, 2018, general and administrative expenses were $61.9 million compared to $13.5 million for the same period in 2017. Non-cash stock-based compensation included in selling, general and administrative expenses for the year ended December 31, 2018 amounted to $10.1 million.

As of December 31, 2018, Dova had $104.6 million in cash and equivalents compared to $94.8 million as of December 31, 2017.

Company to Host Conference Call

Dova will host a conference call today, March 5, 2019 at 9:00 a.m. ET to discuss fourth quarter and full year ended December 31, 2018 financial results as well as recent operational highlights. A question-and-answer session will follow Dova’s remarks.

To participate on the live call, please dial 866-550-8145 (domestic) or +1-430-775-1344 (international) and provide the conference ID 4964448 five to 10 minutes before the start of the call.

A live audio webcast of the call will also be available via the "Investor Relations" page of the Dova website, www.dova.com. Please log on through Dova’s website approximately 10 minutes before the scheduled start time. A replay of the webcast will be archived on Dova’s website for 90 days following the call.

Indication and Important Safety Information

INDICATION

DOPTELET (avatrombopag) is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

DOPTELET is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease. Portal vein thrombosis has been reported in patients with chronic liver disease treated with TPO receptor agonists. In the ADAPT-1 and ADAPT-2 clinical trials, there was 1 treatment-emergent event of portal vein thrombosis in a patient (n=1/430) with chronic liver disease and thrombocytopenia treated with DOPTELET.

Consider the potential increased thrombotic risk when administering DOPTELET to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions (Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency or Protein C or S deficiency).

DOPTELET should not be administered to patients with chronic liver disease in an attempt to normalize platelet counts.

CONTRAINDICATIONS:

None

ADVERSE REACTIONS:

Most common adverse reactions (≥ 3%) were: pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral.

Please see full Prescribing Information for DOPTELET (avatrombopag) www.doptelet.com