Novartis Onkologi visar bredd på världens största blodcancerkonferens – från små molekyler till ny behandlingsteknologi

Novartis bidrar med ett stort antal abstracts på världens största hematologikonferens, ASH 2015 som i år anordnas i Orlando, med start nu på lördag. På konferensen presenteras nya resultat kring såväl innovativa terapier i tidig klinisk fas som Novartis etablerade hematologiska behandlingar.

Nedan följer ett urval av de abstracts som Novartis presenterar under American Society of Hematology (ASH) 57^th annual meeting som denna gång hålls i Orlando, Florida 5–8 december.

Ett prioriterat fokus för Novartis är att utveckla terapier för patienter med ovanliga och svårbehandlade blodcancerformer. Ett exempel är akut myeloid leukemi (AML), ett sjukdomsområde med särskilt stort behov av nya behandlingar. Cirka en tredjedel av alla patienter med AML bär på mutationen FLT3 som är knuten till en sämre prognos^1,2. På årets ASH presenteras data från kliniska studier med PKC412 (midostaurin) som är riktad mot FLT3-positiv AML.

• The Multi-Kinase Inhibitor Midostaurin (M) Prolongs Survival Compared with Placebo (P) in Combination with Daunorubicin (D)/Cytarabine (C) Induction (ind), High-Dose C Consolidation (consol), and As Maintenance (maint) Therapy in Newly Diagnosed Acute Myeloid Leukemia (AML) Patients (pts) Age 18-60 with FLT3 Mutations (muts): An International Prospective Randomized (rand) P-Controlled Double-Blind Trial (CALGB 10603/RATIFY [Alliance]) (Abstract #6, Plenary Session, Sunday, December 6, 2:00 – 4:00 pm EST)
• Midostaurin in Combination with Intensive Induction and As Single Agent Maintenance Therapy after Consolidation Therapy with Allogeneic Hematopoietic Stem Cell Transplantation or High-Dose Cytarabine (NCT01477606) (Abstract #322, Oral Presentation, Sunday, December 6, 5:15 pm EST)

Den nya substansen, ABL 001, är en molekyl som binder till och inhiberar BCR-ABL, vilket är det protein som driver tillväxten av tumörceller hos patienter med kronisk myeloid leukemi (KML).

• ABL001, a Potent, Allosteric Inhibitor of BCR-ABL, Exhibits Safety and Promising Single- Agent Activity in a Phase I Study of Patients with CML with Failure of Prior TKI Therapy (Abstract #138, Oral Presentation, Saturday, December 5, 5:15 pm EST)

Novartis utvecklar i samarbete med Perelman School of Medicine vid University of Pennsylvania, cellterapier som baseras på chimär antigenreceptor (CAR) och nu presenteras nya lovande kliniska forskningsresultat för T-cellsterapin CTL019.

• Durable Remissions in Children with Relapsed/Refractory ALL Treated with T Cells Engineered with a CD19-Targeted Chimeric Antigen Receptor (CTL019) (Abstract #681, Oral Presentation, Monday, December 7, 3:15 pm EST)
• Sustained Remissions Following Chimeric Antigen Receptor Modified T Cells Directed Against CD19 (CTL019) in Patients with Relapsed or Refractory CD19+ Lymphomas (Abstract #183, Oral Presentation, Sunday, December 6, 8:00 am EST)
• Successful Translation of Chimeric Antigen Receptor (CAR) Targeting CD19 (CTL019) Cell Processing Technology from Academia to Industry (Abstract #3100, Poster Presentation, Sunday, December 6, 6:00 – 8:00 pm EST)

Novartis kommer även att presentera långtidsdata kring effekt och säkerhet för flera av sina etablerade läkemedel, däribland Tasigna (nilotinib) mot kronisk myeloisk leukemi, Jakavi (ruxolitinib) mot myelofibros och polycytemia vera, samt Farydak (panobinostat) mot myelom.

Jakavi (ruxolitinib)

• Long-Term Efficacy and Safety in COMFORT-II, a Phase 3 Study Comparing Ruxolitinib with Best Available Therapy for the Treatment of Myelofibrosis: 5-Year Final Study Results (Abstract #59, Oral Presentation, Saturday, December 5, 10:30 am EST)
• Safety and Efficacy of Ruxolitinib in an 1869-Patient Cohort of JUMP: An Open-Label, Multicenter, Single-Arm, Expanded-Access Study in Patients with Myelofibrosis (Abstract #2799, Poster Presentation, Sunday, December 6, 6:00 – 8:00 pm EST)
• Demographics, Baseline (BL) Characteristics, and Disease Symptom Burden in RESPONSE-2: A Randomized, Phase 3 Study of Ruxolitinib in Polycythemia Vera Patients (pts) Who Are Resistant to or Intolerant of Hydroxyurea (HU) (Abstract #2807, Poster Presentation, Sunday, December 6, 6:00 – 8:00 pm EST)
• Continued Treatment With Ruxolitinib Provides Additional Hematocrit Control and Spleen Volume Responses in Patients with PV Treated in the RESPONSE Study (Abstract #2804, Poster Presentation, Sunday, December 6, 6:00 – 8:00 pm EST)

Tasigna (nilotinib)

• Dose-Optimized Nilotinib (NIL) in Patients (pts) with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CML-CP): Final results from ENESTxtnd study (Abstract #344, Oral Presentation, Sunday, December 6, 4:45 pm EST)
• Impact of Age on Efficacy and Toxicity of Nilotinib in Patients with Chronic Myeloid Leukemia in Chronic Phase (CML-CP): ENEST1st Sub-Analysis (Abstract #479, Oral Presentation, Monday, December 7, 8:00 am EST)
• International Scale (IS)-Standardized BCR-ABL1 Digital Polymerase Chain Reaction (dPCR) Assays Using ABL1, BCR, and GUS Control Genes for Measuring Deep Molecular Response (MR) in Chronic Myeloid Leukemia (CML) (Abstract #136, Oral Presentation, Saturday, December 5, 4:45 pm EST)
• Quantification of BCR-ABL with Digital PCR Results in a Significantly Lower Rate of Deep Molecular Response when Compared to RT-qPCR in CML Patients Treated in the ENEST1st Trial (Abstract #135, Oral Presentation, Saturday, December 5, 4:30 pm EST)

Farydak(panobinostat)

• Final Analysis of Overall Survival from the Phase 3 Panorama 1 Trial of Panobinostat Plus Bortezomib and Dexamethasone Versus Placebo Plus Bortezomib and Dexamethasone in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma (Abstract #3026, Poster Presentation, Sunday, December 6, 6:00 – 8:00 pm EST)
• Analysis of Outcomes Based on Response in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma Treated with Panobinostat or Placebo in Combination with Bortezomib and Dexamethasone in the Panorama 1 Trial: Updated Analysis Based on Prior Treatment (Abstract #4230, Poster Presentation, Monday, December 7, 6

Under hela ASH 2015 kommer Novartis Oncology lyfta utvalda presentationer med extra nyhetsvärde på sin hemsida http://www.novartisoncology.com.

Presskontakt Novartis:

Nicklas Rosendal, kommunikationschef Novartis, 070-889 33 34

Referenser

1. Levis M. FLT3 mutations in acute myeloid leukemia: what is the best approach in 2013? Hematology Am Soc Hematol Educ Program. 2013;2013:220–6.

2. Yanada M, Matsuo K, Suzuki T, Kiyoi H, Naoe T. Prognostic significance of FLT3 internal tandem duplication and tyrosine kinase domain mutations for acute myeloid leukemia: a meta-analysis. Leukemia. 2005;19(8):1345–49.