ASH 2018 Newsroom

  Chronic Lymphocytic Leukaemia
Alliance: ibrutinib-containing regimens are superior to chemoimmunotherapy
In the phase III Alliance North American Intergroup Study A041202, patients were randomised 1:1:1 to receive either single-agent ibrutinib (n=182; median age: 71 years), a chemoimmunotherapy regimen consisting of bendamustine plus rituximab (BR; n=183; median age: 70 years) or a combination ibrutinib plus rituximab (n=182; median age: 71 years).
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Reference: Woyach et al. 2018. Ibrutinib alone or in combination with rituximab produces superior progression free survival (PFS) compared with bendamustine plus rituximab in untreated older patients with chronic lymphocytic leukaemia (CLL): Results of Alliance North American Intergroup Study A041202. Oral presentation presented at: ASH 2018 Congress; 1–4 December; San Diego, California.

Myelodysplastic Syndromes
Luspatercept reduces transfusion burden in patients with anaemia
In the phase III MEDALIST trial, patients with Revised International Prognostic Scoring System (IPSS-R)-defined very low-, low-, or intermediate-risk myelodysplastic syndromes (MDS) were randomised 2:1 to receive either 1 mg/kg luspatercept (n=153) or placebo (n=76) every 21 days.
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Reference: Fenaux et al. 2018. The MEDALIST Trial: Results of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Luspatercept to Treat Anemia in Patients with Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes (MDS) with Ring Sideroblasts (RS) Who Require Red Blood Cell (RBC) Transfusions. Oral presentation presented at: ASH 2018 Congress; 1–4 December; San Diego, California.

  Acute Lymphoblastic Leukaemia
Tisagenlecleucel confers durable remission rates in paediatric and young patients
Tisagenlecleucel is the first approved CAR T cell therapy in the USA for refractory or relapsed patients with B cell acute lymphoblastic leukaemia (ALL) aged 25 years or younger. At ASH 2018, the 11-months follow-up data of the first global pivotal CAR T-cell trial (ELIANA) was presented.
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Reference: Grupp et al. 2018. Updated Analysis of the Efficacy and Safety of Tisagenlecleucel in Pediatric and Young Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia. Oral presentation presented at: ASH 2018 Congress; 1–4 December; San Diego, California.
  Diffuse Large B Cell Lymphoma
FLYER: sparing chemotherapy improves safety without compromising efficacy
In the international, multicentre, phase III FLYER study, patients (median age: 48 years) without bulky disease (≥7.5 cm) and favourable prognosis were randomised 1:1 to receive either a combination of 4 cycles of CHOP-like chemotherapy plus rituximab and additional 2 cycles of single-agent rituximab (4x R-CHOP + 2x R) (n=293) or standard 6 cycles of CHOP plus rituximab (6x R-CHOP) (n=295). 
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Reference: Poeschel et al. 2018. Excellent Outcome of Young Patients (18-60 years) with Favourable-Prognosis Diffuse Large B-Cell Lymphoma (DLBCL) Treated with 4 Cycles CHOP Plus 6 Applications of Rituximab: Results of the 592 Patients of the Flyer Trial of the Dshnhl/GLA. Oral presentation presented at: ASH 2018 Congress; 1–4 December; San Diego, California.
  Thromboprophylaxis in Cancer Patients
Rivaroxaban thromboprophylaxis shows promising activity in ambulatory cancer patients
In the randomised, multicentre, phase IIIb CASSINI trial, cancer patients (n=841) initiating a systemic therapy, who were at high risk of venous thromboembolism (VTE), were randomised 1:1 to receive either 10 mg rivaroxaban once daily or placebo up to 180 days.
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Reference: Khorana et al. 2018. Rivaroxaban Thromboprophylaxis in High-Risk Ambulatory Cancer Patients Receiving Systemic Therapy: Results of a Randomized Clinical Trial (CASSINI). Oral presentation presented at: ASH 2018 Congress; 1–4 December; San Diego, California.
  Primary Hemophagocytic Lymphohistiocytosis
Emapalumab as a new therapeutic option for paediatric patients with primary hemophagocytic lymphohistiocytosis
In the single arm, pivotal phase II/III NI-0501-04 study, 34 patients with a median age of 0.85 years at diagnosis received 1 mg/kg emapalumab every 3–4 days for 4 to 8 weeks.
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Reference: Locatelli et al. 2018. Safety and Efficacy of Emapalumab in Pediatric Patients with Primary Hemophagocytic Lymphohistiocytosis. Oral presentation presented at: ASH 2018 Congress; 1–4 December; San Diego, California.
  Multiple Myeloma
The addition of daratumumab to lenalidomide and dexamethasone improves outcomes
In the phase III MAIA study, 737 patients (median age: 73 years) ineligible for transplant were randomised 1:1 to daratumumab plus lenalidomide and dexamethasone (D-Rd) or lenalidomide and dexamethasone (Rd).
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Reference: Facon et al. 2018. Phase 3 Randomized Study of Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) in Patients With Newly Diagnosed Multiple Myeloma (NDMM) Ineligible for Transplant (MAIA). Oral presentation presented at: ASH 2018 Congress; 1–4 December; San Diego, California.
  Chronic Lymphocytic Leukaemia
Ibrutinib plus rituximab shows a better efficacy and safety profile than standard chemoimmunotherapy
In the phase III PCI-32765 study, patients without prior treatment (median age: 58 years) were randomised 2:1 to receive either ibrutinib plus rituximab (IR) or the combination of fludarabine, cyclophosphamide and rituximab (FCR). In the intent-to-treat population, the IR regimen compared with the FCR regimen led to improved progression-free survival (PFS) (HR: 0.35 [95% CI: 0.22–0.5]).
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Reference: Shanafelt et al. 2018. Ibrutinib & Rituximab Improves Progression Free and Overall Survival Relative to FCR in Younger Patients with Previously Untreated Chronic Lymphocytic Leukemia (CLL). Oral presentation presented at: ASH 2018 Congress; 1–4 December; San Diego, California.
Diffuse Large B Cell Lymphoma
Tisagenlecleucel confirms high efficacy
In the single arm, phase II JULIET study, previously treated adult patients with relapsed or refractory disease were infused with a single dose of tisagenlecleucel (n=115; median age: 56 years). At ASH 2018, un update follow-up analysis (median: 19 months) of the JULIET trial was presented.
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Reference: Stephen et al. 2018. 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. Oral presentation presented at: ASH 2018 Congress; 1–4 December; San Diego, California.