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SYROS TO PRESENT ON SY-1425 IN COMBINATION WITH STANDARD-OF-CARE AND TARGETED THERAPIES IN GENOMICALLY DEFINED SUBSETS OF AML AND MDS PATIENTS

On May 18, 2017 Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of disease-driving genes, reported that the Company will present preclinical data on SY-1425, its oral first-in-class selective retinoic acid receptor alpha (RARα) agonist, in combination with hypomethylating agents and anti-CD38 therapies in genomically defined subsets of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) at the 22nd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) taking place June 22-25 in Madrid, Spain (Press release, Syros Pharmaceuticals, MAY 18, 2017, View Source;p=irol-newsArticle&ID=2273936 [SID1234519251]).

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Details on the presentation are as follows:

Date & Time: Friday, June 23, from 5:15 – 6:45 p.m. CEST
Presentation Title: Mechanistically Informed Combinations of SY-1425, a Potent and Selective RARα Agonist, with Hypomethylating or Anti-CD38 Targeted Agents in AML and MDS
Session Title: Acute myeloid leukemia – Biology 2
Presenter: Michael R. McKeown, Ph.D., Senior Scientist, Translational Medicine, Syros
Abstract Number: P188
Location: IFEMA – Feria de Madrid, Poster area (Hall 7)

SY-1425 is currently in a Phase 2 clinical trial exploring its safety and efficacy as both a monotherapy and in combination with azacitidine, a standard-of-care hypomethylating agent, in subsets of AML and MDS patients with high expression of RARA pathway-associated genes RARA and IRF8.

ERYTECH Provides Business Update and Financial Highlights For Q1 2017

On May 18, 2017 ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY) (Euronext Paris: ERYP), the French biopharmaceutical company developing ‘tumor starvation’ treatments for acute leukemia and other oncology indications with unmet medical needs, reported provided a financial and business update for the first quarter of 2017 ended March 31, 2017 (Press release, ERYtech Pharma, MAY 18, 2017, View Source;p=irol-newsArticle&ID=2274066 [SID1234519250]).

Business Highlights

ERYTECH reported positive Phase 2b data from the French multi-center study of Eryaspase for the treatment of metastatic pancreatic cancer. Results from the study showed significant improvement in both progression-free survival (PFS) and overall survival (OS). The study assessed eryaspase, L-asparaginase encapsulated in red blood cells, as a second-line treatment in combination with chemotherapy in 140-patients with metastatic pancreatic cancer. Eryaspase was added to the standard of care (gemcitabine or FOLFOX) and compared to the standard of care alone in a 2-to-1 randomization.
The company successfully raised €70.5 million in a private placement. ERYTECH issued 3,000,000 new ordinary shares. The company intends to utilize the proceeds from this capital raise to prepare the company for the further clinical development of its pipeline candidates, including the launch of a potential Phase 3 trial in pancreatic cancer and evaluation of clinical development opportunities for eryaspase (GRASPA) in other solid tumor indications. A portion of the capital will be used for general corporate purposes and working capital.
ERYTECH announced the launch of a single arm, multi-center, multi-national investigator-initiated Phase 2 study of eryaspase in approximately 30 acute lymphoblastic leukemia (ALL) patients at 23 sites across 7 Nordic and Baltic countries. The study aims to evaluate the biological activity, safety, and immunogenicity profile of eryaspase in combination with the NOPHO ALL 2008 multi-agent chemotherapy protocol as a second-line therapy in pediatric and adult ALL patients (1 to 45 years old) who experienced hypersensitivity reactions to PEG-asparaginase or silent inactivation.
ERYTECH presented promising preclinical findings on the anti-tumor activity of its new product candidate, erymethionase, at the 2017 ASCO (Free ASCO Whitepaper) GI Symposium and at AACR (Free AACR Whitepaper) 2017. Data obtained from the study demonstrated that erymethionase in combination with daily vitamin B6 supplementation can inhibit tumor growth in a murine model of human gastric adenocarcinoma.
The company entered into a collaboration with Fox Chase Cancer Center for the preclinical development of erymethionase in homocystinuria, a rare inherited disease caused by a deficiency in the enzyme cystathionine beta-synthase (CBS), which is critical for normal methionine metabolism. Under this collaboration, FCCC and ERYTECH will study the potential of erymethionase to lower homocysteine and methionine in the homocystinuria mouse model (CBS-deficient mice) developed at FCCC.
The company presented encouraging preclinical data supporting ERYMMUNE as a potentially strong immunotherapy at the World ADOPT Summit 2017 and 10th Symposium of Vaccinology. Study results showed that ERYMMUNE technology was responsible for a inducing an efficient and antigen-specific immune response for effective cancer immunotherapy.
Financial Highlights

ERYTECH’s key financial figures for the first quarter of 2017, compared with the same period of the previous year are summarized below:
Key figures (in thousands of euros):

Q1 (3 months)
2017 Q1 (3 months)
2016 Variation
Revenues 0 0 0
Other income 1,222 684 538
Total operating income 1,222 684 538
Operating expenses:
Research & development (5,847) (3,638) (2,209)
General & administrative (1,906) (1,473) (433)
Total operating expenses (7,753) (5,111) (2,642)
Operating loss (6,531) (4,427) (2,104)

Financial income 21 97 (77)
Income tax (13) 4 (17)
Net Loss (6,523) (4,325) (2,198)
Net loss for the first quarter of 2017 was €6.5 million, compared to net loss of €4.3 million for the same period of last year. The €2.2 million increase reflected the increased activity to advance the company’s preclinical and clinical development programs. The increase was driven by higher service and contracting fees, mostly related to the clinical and regulatory progress of product development projects, and higher personnel costs, following the staffing of key positions in the preclinical, clinical and pharmaceutical operations domains. Other income, which was mostly comprised of research and development tax credits and grants, increased in the same proportion.

As of March 31, 2017, ERYTECH had cash and cash equivalents totaling €30.5 million, compared with €40.6 million on March 31, 2016. Total net cash utilization was €7.1 million in the first quarter of 2017, which compares with net cash utilization of €5.1 million in the first quarter of 2016. The net loss of the period as well as the net cash utilization in the first quarter of 2017 reflected the increased activity in product development and supporting company’s operations.
A private placement to U.S. and European investors was completed in April 2017. The net proceeds of approximately €64.5 million will enable the company to fund the continued development of its product candidates, and mainly to finance the preparatory steps for the launch of contemplated Phase 3 studies in pancreatic cancer and adult ALL. The company is also sufficiently funded to assess the clinical development opportunities of eryaspase (GRASPA) for the treatment of other solid tumor indications, in addition to its ongoing preclinical and clinical programs.
Gil Beyen, ERYTECH’s Chief Executive Officer commented, "In the first quarter of 2017, we made tremendous progress in our clinical and preclinical R&D programs. We are very pleased with the highly positive results from our Phase 2b trial of eryaspase in metastatic pancreatic cancer patients. The findings from this trial further validate our eryaspase product candidate and our technology platform, and we are now determining next steps to advance the product candidate in pancreatic cancer and in other solid tumors. All of this without losing sight of our development in acute leukemia. The work for resubmission of our European Marketing Authorization Application in ALL is ongoing and the launch of an investigator initiated trial in collaboration with the Nordic Society of Pediatric Hematology and Oncology shows our commitment to bringing GRASPA to ALL patients in need. Next to eryaspase, we have made noteworthy advances in our preclinical programs, notably with erymethionase and our ERYMMUNE platform for which we presented promising preclinical results at different conferences. The very successful private placement in April confirms investors’ confidence in our programs and provides a strong basis to prepare the company for the implementation of its ambitious value-creation strategy. We look forward to accomplishing more milestones this year, including the resubmission of our European MAA for GRASPA in relapsed and refractory ALL, regulatory interactions regarding our further developments in ALL and pancreatic cancer both in Europe and the US, and the Phase 2 results of our AML study."

First Quarter 2017 Conference Call Details

Investors and analysts wishing to participate can access the call via the following teleconferencing numbers:

USA: +1 6467224907 United-Kingdom: +44 2030432440
Switzerland: +41 225809022 Germany: +49 69222229031
France: +33 172001510 Belgium: +32 24029640
Sweden: +46 850334664 Finland : +358 942599700
Netherlands: +31 107138194
Confirmation Code: 64683084#

The webcast can be followed live online via the link:
View Source;Name=&Conference=135308821&PIN=64683084

Following the live call, a replay will be available for 90 days. To listen to the replay, please dial:

USA: +1 877 64 230 18
United-Kingdom: +44(0) 2033679460
France: +33(0)1 72 00 15 00
Confirmation Code: 308821#

Additionally, an archive of the webcast will be available on the "Webcast" section of the Company’s investor relations site at www.erytech.com

Next financial updates:

Financial highlights for the 2nd quarter of 2017: September 11, 2017 (after market close), followed by a conference call and webcast on September 12, 2017 (3:00pm CET/9:00am ET)
Upcoming participations at investor conferences:

BioEquity Europe 2017, May 22-23, Paris
Biotech Agora Conference, May 23, Paris
Gilbert Dupont Annual Healthcare Conference, May 30, Paris
Jefferies 2017 Global Healthcare Conference, June 6-9, New-York
Journée Valeurs Moyennes (SFAF), June 13, Paris
European MidCap Spring Event, June 28, Paris

Bellicum Announces Clinical Presentations at the 22nd Congress of the European Hematology Association

On May 18, 2017 Bellicum Pharmaceuticals, Inc. (Nasdaq:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported that three abstracts have been accepted for presentation at the 22nd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) being held in Madrid, Spain on June 22-25, 2017 (Press release, Bellicum Pharmaceuticals, MAY 18, 2017, View Source;p=RssLanding&cat=news&id=2273891 [SID1234519217]).

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Bellicum’s presentation of the overall cohort of children with malignant and non-malignant diseases treated with BPX-501 was selected as one of the Congress’ five best abstracts, and will be reviewed during the Presidential Symposium.

Additional oral and poster presentations selected include clinical data on BPX-501 for the treatment of pediatric leukemias, hemoglobinopathies and erythroid disorders. The abstracts are now available online at the EHA (Free EHA Whitepaper) conference website.

EHA Presentation Details

Oral Presentation – Presidential Symposium
Title: BPX-501 Donor T-Cell Infusion (with Inducible Caspase 9 Suicide Gene) Facilitates HLA Haploidentical Stem Cell Transplant in Children with Both Hematological Malignancies and Non-Malignant Conditions
Session Title: Presidential Symposium
Date: Friday, June 23
Time: 3:45 – 4:00 PM CEST
Location: Hall A
Abstract Code: S146

Oral Presentation
Title: Impact of Post-Transplant Infusion of Donor T-Cells Genetically Modified with Inducible Caspase 9 Suicide Gene (BPX-501 Cells) on Children with Leukemia Given Alpha-Beta T-Cell Depleted Haplo-HSCT
Session Title: Stem cell transplantation – Clinical 1
Date: Saturday, June 24
Time: 5:00 – 5:15 PM CEST
Location: Room N103
Abstract Code: S495

Poster Presentation
Title: The Use of BPX-501 Donor T-Cell Infusion (with Inducible Caspase 9 Suicide Gene) Together with HLA-Haploidentical Stem Cell Transplant to Treat Children with Hemoglobinopathies and Erythroid Disorders
Session Title: Stem cell transplantation – Clinical 1
Date: Friday, June 23
Time: 5:15 – 6:45 PM CEST
Location: Poster Area (Hall 7)
Abstract Code: P381

Merck Continues to Grow Profitably in the First Quarter

On May 18, 2017 Merck, a leading science and technology company, reported significantly increased both net sales and EBITDA pre in the first quarter of 2017 (Press release, Merck KGaA, MAY 18, 2017, View Source [SID1234519246]).

In addition, the company today confirmed and specified its outlook for the full year.

"For Merck, 2017 is another year of many challenges as well as tremendous opportunities. I am confident that we will seize these opportunities by further driving our clear growth strategy for our three business sectors forward," said Stefan Oschmann, Executive Board Chairman and CEO of Merck. "We again achieved profitable growth in the first quarter. Two approvals for our immuno-oncology medicine Bavencio in the United States within a short period of time are a great success following long and hard work. We are also further developing our Life Science and Performance Materials business sectors with a targeted focus on innovative technologies. This will create long-term growth opportunities for us," said Oschmann.
Net sales rose by 5.3% to € 3.9 billion in the first quarter of 2017 (Q1 2016: € 3.7 billion). Merck grew in all three business sectors. Organically, Group sales increased by 3.1%, driven mainly by the Healthcare and Life Science business sectors. Currency effects had a positive effect of 2.6% on sales, while portfolio changes had a slightly negative impact. Accounting for 32% of Group sales, Asia-Pacific was the largest region.

EBITDA pre exceptionals, the key earnings indicator of the Group, rose by 14.5% to € 1.2 billion (Q1 2016: € 1.1 billion) thanks to the good operational performance of Healthcare and Life Science. Group EBIT fell by -11.1% to € 755 million (Q1 2016: € 849 million). This decline is due to an exceptional item in the year-earlier quarter when Merck sold its rights to Kuvan and realized a divestment gain of € 324 million.

Net income declined slightly in the first quarter of 2017 to € 521 million (Q1 2016: € 591 million) owing to the decrease in EBIT. Earnings per share decreased from € 1.36 to € 1.20. Earnings per share pre exceptionals rose in the first quarter of 2017 by 16.9% to € 1.80 (Q1 2016: € 1.54).

Merck reduced the net financial debt resulting from the Sigma-Aldrich acquisition by a further € 400 million to € 11.1 billion at the end of the first quarter, which compares with € 11.5 billion on December 31, 2016. As with major acquisitions in the past, Merck is aiming to rapidly and extensively reduce its debt. Merck had 51,480employees worldwide on March 31, 2017.

Healthcare starts off the year on a good strategic and financial footing
In the first quarter, the Healthcare business sector delivered solid organic sales growth of 4.4%. Including positive exchange rate effects of 2.0% and a negative portfolio impact of -1.0%, Healthcare increased sales by 5.4% to € 1.7 billion (Q1 2016: € 1.6 billion) in the first quarter of 2017.

Sales of the drug Rebif, which is used to treat relapsing forms of multiple sclerosis, saw an organic decline of -4.0% in the first quarter of 2017. Amid currency tailwinds of 2.4%, Rebif sales amounted to € 415 million (Q1 2016: € 422 million). In the first quarter, Merck generated organic sales growth of 4.3% with the oncology drug Erbitux. In addition, favorable exchange rate effects of 1.2% were incurred. Consequently, sales of Erbitux rose to € 218 million (Q1 2016: € 207 million). At € 171 million, Merck’s sales of the fertility medicine Gonal-f were lower than in the year-earlier quarter (Q1 2016: € 187 million). The organic sales decline of -9.6% resulted from the comparison with a strong year-earlier quarter and continued competitive pressure in Europe from biosimilars.

Despite higher marketing and selling expenses, EBITDA pre exceptionals of the Healthcare business sector rose in the first quarter by 24.5% to € 633 million (Q1 2016: € 508 million). The increase in EBITDA pre of Healthcare resulted from a one-time payment of € 116 million as compensation for future license payments (the year-earlier quarter included license income in the mid to high single-digit million euro range), higher royalty income for Avonex thanks to a patent granted in the United States in June 2016, as well as the milestone payment of € 37 million for the approval of Bavencio at the end of March.

On March 23, 2017, Merck received approval from the U.S. Food and Drug Administration (FDA) for its immuno-oncology drug Bavencio for the treatment of metastatic Merkel cell carcinoma (mMCC) in the United States. This was followed on May 9, 2017, by the approval of Bavencio to treat a common form of advanced bladder cancer. Moreover, on March 9, 2017, Merck announced that it is in advanced stages of negotiations to divest its Biosimilars business. On April 24, 2017, Merck then announced the divestment of its Biosimilars business to Fresenius. The decision was in line with the strategy of the Healthcare business sector of focusing on the discovery and development of innovative pharmaceuticals.
Life Science drives integration forward and increases profitability further
The Life Science business sector grew in the first quarter of 2017 organically by 3.3%, to which all regions and business areas contributed. In addition, exchange rate effects of 2.4% had a favorable impact, as did portfolio effects of 0.4%. In the first quarter of 2017, sales by the Life Science business sector thus rose overall by 6.1% to € 1.5 billion (Q1 2016: € 1.4 billion).

The Process Solutions business area, which markets products for the entire pharmaceutical production value chain, delivered organic sales growth of 4.8%. The Research Solutions business area, which focuses on academia and pharmaceutical research institutions, generated an organic sales increase of 1.0%. Sales by Applied Solutions, which serves clinical and diagnostic testing laboratories as well as the food and environmental industries, grew organically by 4.4%.

EBITDA pre exceptionals of the Life Science business sector rose in the first quarter by 13.3% to € 445 million (Q1 2016: € 393 million). Merck continued to make good progress with the integration of Sigma-Aldrich in the first quarter. The ongoing realization of synergies from the Sigma-Aldrich acquisition and good organic sales performance led to higher profitability. The EBITDA pre exceptionals margin of Life Science improved to 30.1% (Q1 2016: 28.1%).

In January, Merck announced the acquisition of BioControl Systems Inc., a global leader in food safety testing. BioControl’s established rapid detection technology and third-party validated testing platforms complement the portfolio of the Applied Solutions business area within Life Science.

Performance Materials: OLED materials business continues to generate strong growth
In the first quarter, net sales of the Performance Materials business sector grew by 3.6% to € 645 million (Q1 2016: € 622 million). A slight organic sales decline of
-0.9% was more than offset by positive foreign exchange effects of 4.5%. The organic decline, which stemmed from the Display Materials business, was compensated for by the positive organic development of the other three Performance Materials business units.

In the Display Materials business unit, the double-digit growth of the business with the innovative liquid crystal technology UB-FFS marked a new sales record in the first quarter. However, this could not fully offset the typical price declines and the normalization of market shares. Nevertheless, Merck maintained its leadership position. The Pigments & Functional Materials business unit delivered solid organic growth. The Integrated Circuit Materials business unit, which includes the business with materials used to manufacture integrated circuits as well as the SAFC Hitech business of Sigma-Aldrich, generated good organic sales growth. The strong sales increase in the Advanced Technologies business unit was primarily due to continued growth in the OLED materials business.

EBITDA pre exceptionals of Performance Materials fell in the first quarter by -3.7% to € 263 million (Q1 2016: € 273 million).

Merck is working to apply its liquid crystals expertise also in areas beyond displays, for instance liquid crystal windows. At the same time, Merck intends to sustainably secure its market and technology leadership in display materials.

Merck confirms and specifies outlook for 2017
With the publication of the results of 2016, Merck had provided an initial forecast of the development of net sales, EBITDA pre exceptionals and business free cash flow for the Merck Group and the individual business sectors in 2017. Following a solid first quarter, Merck forecasts net sales to increase to between € 15.5 billion and € 16.0 billion in 2017. Organically, Merck continues to expect a slight to moderate increase in comparison with the previous year, yet now assumes that currency changes will have a slightly positive effect of probably 1% to 2% on net sales. For 2017, Group EBITDA pre exceptionals is expected to be in a range of between € 4.4 billion and € 4.6 billion.

Forecast for FY 2017
€ million
Net sales
EBITDA pre exceptionals
Earnings per share pre exceptionals
Merck Group
~ 15,500 – 16,000
~ 4,400 – 4,600
€ 6.15 – 6.50
Healthcare
Slight organic growth,
low portfolio effect due to the divestment of the business in Pakistan
~ 1,900 – 2,000
Life Science
Solid organic sales growth, low portfolio effect due to the acquisition of BioControl
~ 1,780 – 1,850
Performance Materials
Slight organic sales decline
~ 1,050 – 1,130
Corporate and Other
–
~ -350 – -400

Merck Group – Key figures
€ million
Q1 2017
Q1 2016
Change
Net sales
3,861
3,665
5.3%
Operating result (EBIT)
755
849
-11.1%
Margin (% of net sales)
19.5%
23.2%
EBITDA
1,203
1,282
-6.2%
Margin (% of net sales)
31.2%
35.0%
EBITDA pre exceptionals
1,240
1,084
14.5%
Margin (% of net sales)
32.1%
29.6%
Earnings per share (€)
1.20
1.36
-11.8%
Earnings per share pre exceptionals (€)
1.80
1.54
16.9%
Net income
521
591
-11.8%
March 31, 2017
Dec. 31, 2016
Net financial debt
11,113
11,513
-3.5%

Novartis data at ASCO, ICML and EHA meetings demonstrate meaningful advancements in cancer care

On May 18, 2017 Novartis reported it will present data from across its oncology portfolio at the upcoming 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), being held June 2-6 in Chicago; the 14th International Conference on Malignant Lymphoma (ICML), being held June 14-17 in Lugano, Switzerland; and the 22nd Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), being held June 22-25 in Madrid (Press release, Novartis, MAY 18, 2017, View Source [SID1234519243]). With more than 75 abstracts accepted, data will highlight research across 34 compounds in key disease areas, including breast and lung cancers, melanoma, leukemia and other blood disorders, and myeloproliferative neoplasms (MPNs).

"Our presence at key medical congresses this year is marked by our innovation in targeted therapies and immuno-oncology in difficult to treat cancers," said Bruno Strigini, CEO, Novartis Oncology. "We are particularly excited to show the first data from the JULIET trial, which evaluates the use of CTL019 in relapsed/refractory diffuse large B-cell lymphoma. These results, along with the data that led to our filing for CTL019 in relapsed/refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia, demonstrate our commitment to research in this area."

Novartis data at the 2017 ASCO (Free ASCO Whitepaper) Annual Meeting will highlight the following:

Update on outcomes with Kisqali* (ribociclib) in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer:

Updated Results from MONALEESA-2, a Phase 3 Trial of First-Line Ribociclib + Letrozole in Hormone Receptor-Positive (HR+), HER2-Negative (HER2-), Advanced Breast Cancer (ABC) [Abstract #1038; Sunday, June 4, 8:00 AM CDT]
Health-Related Quality of Life (HRQoL) of Postmenopausal Women with Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Advanced Breast Cancer (ABC) Treated with Ribociclib + Letrozole: Results from MONALEESA-2 [Abstract #1020; Sunday, June 4, 8:00 AM CDT]

Data showing patient-reported quality of life outcomes for CTL019** (tisagenlecleucel), an investigational chimeric antigen receptor T cell (CAR-T) therapy, in relapsed/refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL):

Patient-Reported Quality of Life (QOL) Following CTL019 in Pediatric and Young Adult Patients (pts) with Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) [Abstract #10523; Sunday, June 4, 8:00 AM CDT]
New data evaluating long-term outcomes with Tafinlar (dabrafenib) and Mekinist (trametinib) combination therapy in patients with BRAF V600-mutated unresectable or metastatic melanoma as well as data from patients with other tumor types:

Five-Year Overall Survival (OS) Update from a Phase II, Open-Label Trial of Dabrafenib (D) and Trametinib (T) in Patients (pts) with BRAF V600-Mutant Unresectable or Metastatic Melanoma (MM) [Abstract #9505; Sunday, June 4, 9:24 AM CDT]
COMBI-MB: A Phase II Study of Combination Dabrafenib (D) and Trametinib (T) in Patients with BRAF V600-Mutant (mut) Melanoma Brain Metastases (MBM) [Abstract #9506; Sunday, June 4, 10:00 AM CDT]
Updated Survival of Patients (pts) with Previously Treated BRAF V600E-Mutant Advanced Non-Small Cell Lung Cancer (NSCLC) who Received Dabrafenib (D) or D + Trametinib (T) in the Phase II BRF113928 Study [Abstract #9075; Saturday, June 3, 8:00 AM CDT]
Efficacy of Dabrafenib (D) and Trametinib (T) in Patients (pts) with BRAF V600E-Mutated Anaplastic Thyroid Cancer (ATC) [Abstract #6023; Monday, June 5, 1:15 PM CDT]
New data on Zykadia (ceritinib) as well as the investigational compound EGF816 which highlight continued investigations in the treatment of mutation-driven lung cancer:

Ceritinib Plus Nivolumab (NIVO) in Patients (pts) with Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-Small Cell Lung Cancer (NSCLC) [Abstract #2502; Saturday, June 3, 1:39 PM CDT]
Genomic Profiling of Resistant Tumor Samples Following Progression on EGF816, a Third Generation, Mutant-Selective EGFR Tyrosine Kinase Inhibitor (TKI), in Advanced Non-Small Cell Lung Cancer (NSCLC) [Abstract #11506; Sunday, June 4, 9:48 AM CDT]
Adjuvant treatment of renal cell carcinoma (RCC) and safety and efficacy of combination therapy in treatment of advanced RCC:

Randomized Phase III Trial of Adjuvant Pazopanib Versus Placebo After Nephrectomy in Patients with Locally Advanced Renal Cell Carcinoma (RCC) (PROTECT) [Abstract #4507; Monday, June 5, 10:12 AM CDT]
A Phase I/II Study to Assess the Safety and Efficacy of Pazopanib (PAZ) and Pembrolizumab (PEM) in Patients (pts) with Advanced Renal Cell Carcinoma (aRCC) [Abstract #4506; Monday, June 5, 9:36 AM CDT]
Additional data presented at ASCO (Free ASCO Whitepaper) include:

Phase III Study of Lapatinib (L) Plus Trastuzumab (T) and Aromatase Inhibitor (AI) vs T+AI vs L+AI in Postmenopausal Women (PMW) with HER2+, HR+ Metastatic Breast Cancer (MBC): ALTERNATIVE [Abstract #1004; Saturday, June 3, 2:27 PM CDT]
Everolimus (EVE) Plus Endocrine Therapy in Patients with Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Advanced Breast Cancer (BC): First and Second-Line Data from the BOLERO-4 Study [Abstract #1010; Sunday, June 4, 8:00 AM CDT]
Cognitive Technology Addressing Optimal Cancer Clinical Trial Matching and Protocol Feasibility in a Community Cancer Practice [Abstract #6501; Monday, June 5, 8:12 AM CDT]
Sandoz, a Novartis division, the pioneer and global leader in biosimilars, will present data for Zarxio, the company’s filgrastim biosimilar:

Safety and Efficacy of Alternating Treatment with EP2006, a Filgrastim Biosimilar, and Reference Filgrastim for the Prevention of Severe Neutropenia, in Patients with Breast Cancer Receiving Myelosuppressive Chemotherapy [Abstract #10116; Saturday, June 3, 1:15 PM CDT]
Novartis data at the 14th Meeting of ICML will highlight data from the multi-center Phase II JULIET study evaluating the efficacy and safety of CTL019 in adult patients with r/r diffuse large B-cell lymphoma (DLBCL):

Global Pivotal Phase 2 Trial of the CD19-Targeted Therapy CTL019 in Adult Patients with Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL) – An Interim Analysis [Abstract #007; Wednesday, June 14, 3:40 PM CEST]
Novartis data at the 2017 EHA (Free EHA Whitepaper) Annual Congress will highlight the following:

Data evaluating CTL019** outcomes in r/r pediatric and young adult patients with B-ALL:

Global Registration Trial of Efficacy and Safety of CTL019 in Pediatric and Young Adult Patients with Relapsed/Refractory (R/R) Acute Lymphoblastic Leukemia (ALL): Update to the Interim Analysis [Abstract #S476; Saturday, June 24, 4:00 PM CEST]
Analysis of Safety Data from 2 Multicenter Trials of CTL019 in Pediatric and Young Adult Patients with Relapsed/Refractory (R/R) B-Cell Acute Lymphoblastic Leukemia (B-ALL) [Abstract #P517; Saturday, June 24, 5:30 PM CEST]
CTL019 Clinical Pharmacology and Biopharmaceutics in Pediatric Patients (pts) with Relapsed or Refractory (R/R) Acute Lymphoblastic Leukemia (ALL) [Abstract #S477; Saturday, June 24, 4:15 PM CEST]
New analyses of ENESTfreedom and ENESTop evaluating Treatment-free Remission (TFR) at 96-week follow-up in patients meeting rigorous criteria for treatment discontinuation:

Durable Treatment-free Remission (TFR) After Stopping Second-line Nilotinib (NIL) in Patients (Pts) with Chronic Myeloid Leukemia in Chronic Phase (CML-CP): ENESTop 96-Wk Update [Abstract #P257; Friday, June 23, 5:15 PM CEST]
Durable Treatment-free Remission (TFR) Following Frontline Nilotinib in Patients (Pts) with Chronic Myeloid Leukemia in Chronic Phase (CML-CP): ENESTfreedom 96-Wk Update [Abstract #P601; Saturday, June 24, 5:30 PM CEST]

Pooled survival analysis of two clinical trials evaluating Rydapt (midostaurin) in adult patients with advanced systemic mastocytosis:

Pooled Survival Analysis of Midostaurin Clinical Study Data (D2201 + A2213) in Patients with Advanced Systemic Mastocytosis (ADVSM) Compared with Historical Controls [Abstract #S788; Sunday, June 25, 9:00 AM CEST]
New data in myeloproliferative neoplasms, including a long-term analysis evaluating Jakavi (ruxolitinib)*** in patients with inadequately controlled polycythemia vera in a less advanced phase of the disease:

Ruxolitinib For The Treatment Of Inadequately Controlled Polycythemia Vera Without Splenomegaly: 80-Week Follow-Up From The RESPONSE-2 Trial [Abstract #S784; Sunday, June 25, 8:00 AM CEST]
Comparing The Safety And Efficacy Of Ruxolitinib (Rux) In Patients (Pts) With DIPSS Low/Intermediate-1-, Intermediate-2-, And High-Risk Myelofibrosis (MF) In JUMP, A Phase 3b, Expanded-Access Study [Abstract #E1333; Friday, June 23, 9:30 AM CEST]
Treatment and Management Of Patients With MPNs – Findings From the International MPN LANDMARK Survey [Abstract #P706; Saturday, June 24, 5:30 PM CEST]
Perception Of Symptom Burden and Treatment Goals Between Physicians and Patients With MPNs: An Analysis From the International MPN LANDMARK Survey [Abstract #E1320; Friday, June 23, 9:30 AM CEST]
Additional data presented at EHA (Free EHA Whitepaper) include:

Mediation by Patient-Reported Outcomes on the Association Between Film-Coated versus Dispersible Formulations of Deferasirox and Serum Ferritin Reduction: A Post-Hoc Analysis of the ECLIPSE Trial [Abstract #P286; Friday, June 23, 5:15 PM CEST]
Crizanlizumab, a P-selectin Inhibitor, Increases the Likelihood of Not Experiencing a Sickle Cell-Related Pain Crisis While on Treatment: Results from the Phase II SUSTAIN Study [Abstract #S454; Saturday, June 24, 12:15 PM CEST]

Throughout the 2017 ASCO (Free ASCO Whitepaper) Annual Meeting, ICML meeting and EHA (Free EHA Whitepaper) Annual Meeting, Novartis Oncology will host dedicated content on the Novartis Oncology website (View Source) that will feature unique insights and perspectives on emerging areas of cancer care and research.

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EGF816, CTL019 and crizanlizumab (SEG101, formerly SelG1) are investigational compounds. Efficacy and safety have not been established. There is no guarantee these compounds will become commercially available.