ASH 2016: Novartis presenterar framsteg på flera sjukdomsområden inom hematologi

På årets upplaga av den internationella hematologikongressen American Society of Hematology, ASH, som hålls i San Diego 3-6 december, publicerar Novartis ett antal spännande nyheter. Bland annat presenteras flera studier på Jakavi (ruxolitinib) som behandling vid myelofibros, varav en med femårsdata. Dessutom presenteras post hoc data på treatment free remission hos patienter med kronisk myeloid leukemi, KML, som bytt behandling från imatinib till Tasigna (nilotinib).

Resultaten som presenteras på ASH speglar framstegen inom bolagets forskningsprogram inom bland annat leukemi, lymfom, myelofibros, och kroniskt järnöverskott och styrker Novartis engagemang i utvecklingen av behandlingar som förbättrar och förlänger livet hos människor som lever med dessa sjukdomar. 

Dessutom presenteras resultat kring effekt, säkerhet, och patienters livskvalitet för flera av Novartis etablerade läkemedel. Bland annat data kring möjlighet att stoppa KML-behandlingen med nilotinib, poolade femårsdata för möjlig överlevnad hos patienter med myelofibros som behandlats med Jakavi (ruxolitinib) samt patienter med kronisk immuntrombocytopeni, som behandlats med Revolade (eltrombopag), rapportering av livskvalitet.

Tasigna(nilotinib)

• Treatment-Free Remission in Patients with Chronic Myeloid Leukemia in Chronic Phase According to Reasons for Switching from Imatinib to Nilotinib: Subgroup Analysis from ENESTop (Abstract #792, Oral Presentation, Monday, December 5, 11:45 am PST)
• ENESTPath: A Phase III Study to Assess the Effect of Nilotinib Treatment Duration on Treatment-Free Remission (TFR) in Patients with Chronic Phase-Chronic Myeloid Leukemia Previously Treated with Imatinib: 24-Month Analysis of the First 300 Patients in the Induction/Consolidation Phase (Abstract #3094, Poster Presentation, Sunday, December 4, 6:00 - 8:00 pm PST)

Jakavi(ruxolitinib)

• A Pooled Overall Survival Analysis of 5-Year Data from the COMFORT-I and COMFORT-II Trials of Ruxolitinib for the Treatment of Myelofibrosis (Abstract #3110, Poster Presentation, Sunday, December 4, 6:00 - 8:00 pm PST)
• The Impact of Myeloproliferative Neoplasms (MPNs) on Patients' Quality of Life and Productivity: Results from the International MPN LANDMARK Survey (Abstract #4267, Poster Presentation, Monday, December 5, 6:00 - 8:00 pm PST)
• Effects of Long-Term Ruxolitinib (RUX) on Bone Marrow (BM) Morphology in Patients with Myelofibrosis (MF) Enrolled in the COMFORT-I Study (Abstract #1949, Poster Presentation, Saturday, December 3, 5:30 - 7:30 pm PST)
• Safety and Efficacy of Ruxolitinib for the Final Enrollment of JUMP: An Open-Label, Multicenter, Single-Arm, Expanded-Access Study in Patients with Myelofibrosis (N = 2233) (Abstract #3107, Poster Presentation, Sunday, December 4, 6:00 - 8:00 pm PST)

Revolade(eltrombopag)

• Patient-Reported Health-Related Quality of Life Improves Over Time in Patients with Chronic Immune Thrombocytopenia Receiving Long-Term Treatment with Eltrombopag (Abstract #3750, Poster Presentation, Monday, December 5, 6:00 - 8:00 pm PST)

Exjade(deferasirox)

• Improved Patient-Reported Outcomes with a Film-Coated Versus Dispersible Tablet Formulation of Deferasirox: Results from the Randomized, Phase II ECLIPSE Study (Abstract #850, Oral Presentation, Monday, December 5, 3:30 pm PST)
• New Film-Coated Tablet Formulation of Deferasirox is Well Tolerated in Patients with Thalassemia or MDS: Results of the Randomized, Phase II ECLIPSE Study (Abstract #1285, Poster Presentation, Saturday, December 3, 5:30 - 7:30 pm PST)

Värt att notera är att Novartis även presenterar forskningsdata på redan godkända behandlingar inom nya sjukdomsområden. Bland annat en studie där eltrombopag testas som behandling vid myelodysplastiska syndrom (MDS).

• Thrombopoietin (TPO) Receptor Agonist Eltrombopag in Combination with Azacitidine (AZA) for Primary Treatment of Myelodysplastic Syndromes (MDS) Patients with Thrombocytopenia: Outcomes from the Randomized, Placebo-Controlled, Phase III SUPPORT Study (Abstract #163, Oral Presentation, Saturday, December 3, 2:00 pm PST)

PÅ ASH kommer också data på substanser och immunoterapier som ingår i kliniska prövningsprogram inom olika terapiområden att presenteras. Bland annat inom KML, ALL och akut myeloid leukemi, AML.

ABL001

• Expanded Phase I Study Update of ABL001, a Potent, Allosteric Inhibitor of BCR-ABL, Reveals Significant and Durable Responses in Patients with CML-Chronic Phase with Failure of Prior TKI Therapy (Abstract #625, Oral Presentation, Monday, December 5, 7:00 am PST)

CTL019

• Efficacy and Safety of CTL019 in the First US Phase II Multicenter Trial in Pediatric Relapsed/Refractory Acute Lymphoblastic Leukemia: Results of an Interim Analysis (Abstract #2801, Poster Presentation, Sunday, December 4, 6:00 - 8:00 pm PST)
• Treatment with Chimeric Antigen Receptor Modified T Cells Directed Against CD19 (CTL019) Results in Durable Remissions in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphomas of Germinal Center and Non-Germinal Center Origin, "Double Hit" Diffuse Large B Cell Lymphomas, and Transformed Follicular to Diffuse Large B Cell Lymphomas (Abstract #3026, Poster Presentation, Sunday, December 4, 6:00 - 8:00 pm PST)

PKC412 (midostaurin)

• Radius: A Phase II, Randomized Trial of Standard of Care (SOC) with or without Midostaurin to Prevent Relapse Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients with FLT3-ITD Mutated Acute Myeloid Leukemia (Abstract #2248, Poster Presentation, Saturday, December 3, 5:30 - 7:30 pm PST)

Dessutom kommer Novartis division för biosimilarer, Sandoz, att presentera pivotala fas III-data för en biosimilar för rituximab, GP2013.

• A Phase III Efficacy and Safety Study of the Proposed Rituximab Biosimilar GP2013 versus Rituximab in Patients with Previously Untreated Advanced Follicular Lymphoma (Abstract #1809, Poster Presentation, Saturday, December 3, 5:30 - 7:30 pm PST)

Presskontakt Novartis:

Nicklas Rosendal, kommunikationschef Novartis, 070-889 33 34