On November 2, 2018 Novartis reported that it will present new research that may transform the way serious blood diseases and a certain type of breast cancer are treated at the upcoming 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in San Diego, December 1-4 and the 41st Annual San Antonio Breast Cancer Symposium (SABCS), December 4-8 (Press release, Novartis, NOV 2, 2018, View Source [SID1234530686]). Nearly 150 abstracts will be presented across both congresses, underscoring the strength of the Novartis pipeline and portfolio in hematology and oncology.

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"Novartis Oncology has a purpose-driven legacy built on an unwavering commitment to help patients live better and longer lives," said Liz Barrett, CEO, Novartis Oncology. "The breadth and depth of our data at these scientific forums demonstrates how we are acting on our vision to reimagine cancer in a meaningful way for patients by relentlessly pursuing scientific advancements and exploring novel combination treatment options to help those living with hard-to-treat diseases."

Novartis data at the 2018 ASH (Free ASH Whitepaper) Annual Meeting will highlight the following:

Updates on outcomes with Kymriah (tisagenlecleucel) in adult relapsed or refractory (r/r) patients with diffuse large b-cell lymphoma (DLBCL) and pediatric and young adult patients with r/r acute lymphoblastic leukemia (ALL)*:

Updated analysis of the efficacy and safety of tisagenlecleucel in pediatric and young adult patients with relapsed/refractory acute lymphoblastic leukemia [Abstract #895; Monday, December 3, 4:30 PM PT]
Sustained disease control for adult patients with relapsed or refractory diffuse large b-cell lymphoma: an updated analysis of JULIET, a global pivotal Phase 2 trial of tisagenlecleucel [Abstract #1684; Saturday, December 1, 6:15 PM PT]
New post-hoc analysis of the SUSTAIN study evaluating crizanlizumab in patients with sickle cell disease:

Established prevention of vaso-occlusive crises with crizanlizumab is further improved in patients who follow the standard treatment regimen: post-hoc analysis of the Phase II SUSTAIN study [Abstract #1082; Saturday, December 1, 6:15 PM PT]
First reported data for investigational compound asciminib (ABL001) in chronic myeloid leukemia (CML) patients with T315I genetic mutation that causes resistance to most BCR-ABL tyrosine kinase inhibitors (TKIs) approved to treat CML:

Asciminib (ABL001), a specific allosteric BCR-ABL1 inhibitor, in patients with chronic myeloid leukemia and the T315I mutation in a Phase 1 trial [Abstract #792; Monday, December 3, 4:00 PM PT]
New data evaluating dabrafenib and trametinib combination treatment in hairy cell leukemia (HCL):

Treatment with combination of dabrafenib and trametinib in patients with recurrent/refractory BRAF V600E-mutated hairy cell leukemia (HCL) [Abstract #391; Sunday, December 2, 12:00 PM PT]
Data evaluating Promacta/Revolade (eltrombopag) in patients with immune thrombocytopenia (ITP):

Bleeding related episodes, thrombotic events and platelet counts among immune thrombocytopenia patients receiving second line therapy [Abstract #2436; Sunday, December 2, 6:00 PM PT]
Treatment of ITP with eltrombopag in patients who have received prior rituximab: a post hoc analysis of the EXTEND study [Abstract #1152; Saturday, December 1, 6:15 PM PT]
Final results from the ITP World Impact Survey (I-WISh) about the burden of disease and impact of ITP on patient quality of life and productivity:

Patients with immune thrombocytopenia (ITP) frequently experience severe fatigue but it is under-reported by physicians: Results from the ITP World Impact Survey
(I-WISh) [Abstract #2273; Saturday, December 1, 6:15 PM PT]
Patients with immune thrombocytopenia (ITP) experience impaired quality of life (QoL), with negative effects on their daily activities, social interactions, emotional well-being and working lives: Results from the ITP World Impact Survey (I-WISh) [Abstract #4804; Monday, December 3, 6:00 PM PT]
New analyses evaluating Rydapt (midostaurin) in patients with FLT3-mutated acute myeloid leukemia (AML):

Prognostic impact of insertion site in acute myeloid leukemia with FLT3 internal tandem duplication: results from the RATIFY study [Abstract #435; Sunday, December 2, 5:00 PM PT]
RATIFY: prognostic impact of FLT3 tyrosine kinase domain (TKD) and NPM1 mutation status in patients with newly diagnosed acute myeloid leukemia (AML) treated with midostaurin or placebo plus standard chemotherapy [Abstract #2668; Sunday, December 2, 6:00 PM PT]
RADIUS: A phase 2 randomized trial investigating standard of care ± midostaurin after allogeneic stem cell transplant in FLT3-ITD-mutated AML [Abstract #662; Monday, December 3, 10:45 AM PT]
New data evaluating Exjade/Jadenu (deferasirox) in patients with low- and int-1-risk myelodysplastic syndromes (MDS) and chronic iron overload:

Safety and efficacy, including event-free survival, of deferasirox versus placebo in iron-overloaded patients with low- and int-1-risk myelodysplastic syndromes (MDS): outcomes from the randomized, double-blind TELESTO study [Abstract #234; Saturday, December 1, 5:15 PM PT]
New data evaluating Jakavi (ruxolitinib)** for patients with polycythemia vera who are resistant to or intolerant of hydroxyurea:

Long-term efficacy and safety (5 Years) in RESPONSE, a Phase 3 study comparing ruxolitinib (rux) with best available therapy (BAT) in hydroxyurea (HU)-resistant/intolerant patients (pts) with polycythemia vera (PV) [Abstract #1753; Saturday, December 1, 6:15 PM PT]
Additional data presented at ASH (Free ASH Whitepaper) include:

Complete responses in relapsed/refractory acute myeloid leukemia (AML) patients on a weekly dosing schedule of XmAb14045, a CD123 x CD3 T cell-engaging bispecific antibody: initial results of a phase 1 study [Abstract #763; Monday, December 3, 2:45 PM PT]
Sandoz, a Novartis division and the pioneer and global leader in biosimilars will present data for the company’s pegfilgrastim, filgrastim and rituximab biosimilars:

Cost simulation for the US of febrile neutropenia hospitalization due to pegfilgrastim on-body injector failure compared to single-injection pegfilgrastim and daily injections with reference and biosimilar filgrastim in non-Hodgkin lymphoma [Abstract #2251; Saturday, December 1, 6:15 PM PT]
Subcutaneous versus intravenous rituximab in non-Hodgkin lymphoma treated with R-CHOP: economic modeling for the US [Abstract #4776; Monday, December 3, 6:00 PM PT]
Novartis data at the 2018 SABCS Annual Symposium will highlight the following:

New data evaluating Kisqali (ribociclib)*** in broad range of patients with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer:

Biomarker analysis by baseline circulating tumor DNA alterations in the MONALEESA-3 study [Abstract #PD2-05; Wednesday, December 5, 5:00 PM CT]
Ribociclib + endocrine therapy in patients with hormone receptor-positive, HER2-negative advanced breast cancer presenting with visceral metastases: Subgroup analysis of phase III MONALEESA trials [Abstract #P6-18-07; Saturday, December 8, 7:00 AM CT]
Ribociclib with endocrine therapy for premenopausal patients with hormone receptor-positive, HER2-negative advanced breast cancer: Biomarker analyses from the phase III randomized MONALEESA-7 trial [Abstract #PD2-08; Wednesday, December 5, 5:00 PM CT]
Ribociclib treatment benefit in patients with advanced breast cancer with >=1 dose reduction: Data from the MONALEESA-2, -3, and -7 trials [Abstract #P6-18-06; Saturday, December 8, 7:00 AM CT]
Additional updates on investigational treatments, BYL719 (alpelisib) and LSZ102:

Alpelisib + fulvestrant for advanced breast cancer: Subgroup analyses from the Phase III SOLAR-1 trial [Abstract #GS3-08; Thursday, December 6, 11:15 AM CT]
Phase 1/1b study of novel oral selective estrogen receptor degrader (SERD) LSZ102 for estrogen receptor-positive (ER+) advanced breast cancer (ABC) with progression on endocrine therapy (ET) [Abstract #PD1-08; Wednesday, December 5, 5:00 PM CT]
Sandoz will present US real-world evidence data surrounding cost-effectiveness through use of the company’s biosimilar filgrastim-sndz:

Potential Medicare beneficiary out-of-pocket cost reductions through use of biosimilar filgrastim-sndz over reference filgrastim among breast cancer patients: a simulation model analysis [Abstract #675; Friday, December 7, 5:00 PM CT]
Throughout the 2018 ASH (Free ASH Whitepaper) Annual Meeting and SABCS Annual Symposium, Novartis will host dedicated content on View Source that will feature unique insights and perspectives on emerging areas of cancer care and research.

Product Information
Approved indications for products vary by country and not all indications are available in every country. The product safety and efficacy profiles have not yet been established outside the approved indications. Because of the uncertainty of clinical trials, there is no guarantee that compounds will become commercially available with additional indications.

For full prescribing information, including approved indications and important safety information about marketed products, please visit View Source

Asciminib (ABL001), crizanlizumab (SEG101), alpelisib (BYL719) and LSZ102 are investigational compounds. Efficacy and safety have not been established. There is no guarantee these compounds will become commercially available.

On November 2, 2018 Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology and immunology, reported that management will attend the following conferences (Press release, Aclaris Therapeutics, NOV 2, 2018, View Source [SID1234530678]):

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Dr. Neal Walker, President and Chief Executive Officer, will present at the Credit Suisse 27th Annual Healthcare Conference in Scottsdale, AZ on Thursday, November 15, 2018 at 8:00 AM MST. Management will also host investor meetings on Thursday, November 15, 2018.

Dr. Neal Walker, President and Chief Executive Officer, will present at the Evercore ISI Healthcare Conference in Boston, MA on Tuesday, November 27, 2018 at 3:05 PM EST. Management will also host investor meetings on Tuesday, November 27, 2018.

Dr. Neal Walker, President and Chief Executive Officer, will present at the 30th Annual Piper Jaffray Healthcare Conference in New York, NY on Wednesday, November 28, 2018 at 3:30 PM EST. Management will also host investor meetings on Wednesday, November 28, 2018.
A live webcast of the Credit Suisse 27th Annual Healthcare Conference, Evercore ISI Healthcare Conference, and the 30th Annual Piper Jaffray Healthcare Conference presentations may be accessed through the Company’s web site, www.aclaristx.com, on the ‘Events and Presentations’ section. An archived version of the presentation will be available for 30 days.

On November 2, 2018 Nordic Nanovector ASA (OSE: NANO) reported that the first patient has been dosed in the Archer-1 trial investigating Betalutin (177Lu-satetraxetan-lilotomab) in combination with rituximab (RTX) in second-line follicular lymphoma (2L FL) (Press release, Nordic Nanovector, NOV 2, 2018, View Source [SID1234530667]).

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Rituximab is a CD20-targeting monoclonal antibody that is administered to patients with newly-diagnosed or relapsed FL as a single agent or in combination with chemotherapy. Over time, patients may develop resistance to RTX, thus alternative targets are important. In addition, developing novel "chemo-free" regimens for patients as an alternative to chemotherapy is desirable.

Archer-1 is a Phase 1b open-label, single-arm, multi-centre dose-escalation trial to assess the safety and preliminary activity of combining CD37-targeted Betalutin with CD20-targeted RTX in 20-25 patients with relapsed/refractory FL who have received one or more prior therapies. Starting doses of Betalutin and lilotomab are 10MBq/kg and 40mg, respectively, with the option for dose escalation. Following Betalutin dosing, patients will receive four weekly doses of RTX (375mg/m2). The primary endpoint is safety, and secondary endpoints include overall response rate, duration of response, progression free survival and overall survival.

The rationale for Archer-1 was provided by preclinical data recently published in the European Journal of Haematology in July 2018 (reference below). These data demonstrate that treatment with the combination of Betalutin and RTX significantly prolonged overall survival in a murine model of NHL compared to treatment with either agent alone, possibly by reverting downregulation of CD20 and resistance to RTX.

Eduardo Bravo, Nordic Nanovector CEO, commented: "Archer-1 presents an opportunity to investigate the potential of a novel dual CD37/CD20-targeting combination approach in 2L FL patients. If the preclinical results translate to patients, this may indicate a new way to administer biologic therapy in FL."

Reference

Repetto-Llamazares, A.H.V. et al. Combination of 177Lu-lilotomab with rituximab significantly improves the therapeutic outcome in preclinical models of non-Hodgkin’s lymphoma. Eur J Haematol. 2018 View Source

For further information, please contact:

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About Betalutin

Betalutin is a tumour-seeking anti-CD37 antibody (lilotomab) conjugated to a low-intensity radionuclide (lutetium-177). It has shown promising efficacy and safety in the first part of the Phase 1/2 LYMRIT 37-01 clinical study in relapsed/refractory follicular lymphoma (R/R FL). A global, randomised Phase 2b trial, PARADIGME, in third line (3L) FL patients who are refractory to anti-CD20 immunotherapy (including rituximab, RTX) is currently on-going. Betalutin is also being investigated in the Phase 1b Archer-1 study in combination with RTX in second-line FL patients, and in the Phase 1 LYMRIT 37-05 study in patients with R/R diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin’s lymphoma (NHL). Betalutin has been granted Fast Track designation in the US and Promising Innovative Medicine (PIM) Designation in the UK for the treatment of patients with R/R FL. Betalutin also received Orphan Drug designations for FL in both the USA and Europe in 2014. Betalutin is selective for CD37, which is highly expressed on the surface of B-cell non-Hodgkin’s lymphoma (NHL) cells. When bound to CD37 on tumour cells, Betalutin is internalised, causing DNA damage and cell death.

On November 2, 2018 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported that it will announce its 2018 third quarter results on Friday, November 9, 2018 (Press release, Bavarian Nordic, NOV 2, 2018, View Source [SID1234530666]).

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The management of Bavarian Nordic will host a conference call at 2:00 pm CET (8:00 am EST) on the same day to present the interim results followed by a Q&A session. A live and replay version of the call and relevant slides will be available at http://bit.ly/2Rv5ulo.

To join the Q&A session dial one of the following numbers and state the participant code 8332812: Denmark: +45 35 15 81 21, UK: +44 (0) 330 336 9411, US: +1 323-794-2551.

On November 2, 2018 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported that the first patient has been dosed in a clinical study evaluating CV301, the Company’s targeted immunotherapy candidate, and durvalumab, AstraZeneca’s PD-L1 inhibitor, in combination with maintenance chemotherapy for patients with metastatic colorectal or pancreatic cancers (Press release, Bavarian Nordic, NOV 2, 2018, View Source [SID1234530665]).

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Bavarian Nordic’s CV301 targets tumor-associated antigens, CEA and MUC1, which are overexpressed on multiple solid tumors, including colorectal and pancreatic cancers. Preclinical data has shown that vaccination resulted in the induction of tumor specific T-cells that infiltrated the tumor resulting in the upregulation of PD-L1 on tumor cells. The upregulation of PD-L1 is a marker indicating the tumor is under attack from T-cells, presenting an opportunity for a greater response in patients who might otherwise not benefit from treatment with a checkpoint inhibitor alone.

CV301 is administered in an innovative manner designed to generate a potent and durable T-cell response. Patients receive an enhanced priming regimen of the highly attenuated, non-replicating vaccinia virus MVA-BN-CV301 in 4 different injection sites on days 1 and 29, followed by boosters of the recombinant fowlpox virus FPV-CV301 at tapering intervals during the course of the treatment with durvalumab and maintenance chemotherapy.

The investigator-sponsored trial is being led by Dr. Michael Pishvaian, Associate Professor in the Department of Hematology/Oncology at the Lombardi Comprehensive Cancer Center at Georgetown University Medical Center in Washington, D.C., with material support from Bavarian Nordic and AstraZeneca. The clinical trial is being conducted at several other top cancer centers including the Mayo Clinic, Indiana University and Emory University. The trial will begin with a small lead-in study to determine the safety and tolerability of the combination, as well as the recommended Phase 2 dose of durvalumab in combination with CV301 and maintenance chemotherapy. The Phase 2 portion of the study will consist of two parallel trials, enrolling up to 26 patients with metastatic disease for each disease setting. The primary endpoint for both arms of the study will be progression-free survival (PFS) with multiple secondary endpoints, including objective response rate (ORR), overall survival (OS), and disease control rate (DCR).

"We are excited to continue demonstrating CV301’s potential in multiple cancers and combinations, particularly in a treatment setting in which checkpoint inhibition alone has yet to show significant benefit. The combination of a targeted cancer vaccine with a checkpoint inhibitor could result in a novel approach to fighting colorectal and pancreatic cancers, which are among the most difficult-to-treat malignancies to date," said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic.

Additional information on the study is available at: View Source

About CV301
CV301 is an active immunotherapy candidate that targets two tumor-associated antigens, CEA and MUC1, long known to be overexpressed in most solid tumors. The poxvirus-based prime/boost vaccine incorporates a modified version of vaccinia (MVA-BN, a proprietary technology of Bavarian Nordic) as a priming dose, followed by multiple fowlpox boosts, and encodes the TRICOM costimulatory molecules. Preclinical data shows that antigen specific vaccination results in T cell infiltration into areas of antigen expression and upregulation of PD-L1 on antigen expressing tumor cells. The upregulation of PD-L1 is a marker indicating the tumor is under attack from T-cells, presenting an opportunity for a greater response in patients who might otherwise not benefit from treatment with a checkpoint inhibitor alone.