Onco Actu du 3 décembre 2018 - Spécial ASH

	5.8 ASH
ASH Highlights for Sunday, December 2, 2018 [OBR] Six presentations were given today at the plenary session at the 2018 American Society of Hematology (ASH) Annual Meeting. We take a look at three presentations related to malignant hematology.
ASH18: Cancer drug trials in need of modernization, NCI director says [BiopharmaDive] The difficulty, Sharpless said, is that genetically defined trials can be much more complicated to administer, requiring the screening of hundreds or thousands of patients to enroll a study with narrowly defined inclusion criteria.
	5.8.1 ASH - Communiqués
Major Trials Show Benefits of New Therapy Regimens for Cancer and Blood Disorders [ASH] Large-scale Phase III trials highlight key advances in lymphoma, leukemia, myelodysplastic syndromes, and beta thalassemia.
	5.8.2 ASH - Pharma
ASH18: Trial successes back Celgene belief in luspatercept [BiopharmaDive] In MEDALIST, which will be presented Sunday, nearly 40% of patients with a certain subtype of low- or intermediate-risk MDS were able go at least eight weeks without a blood transfusion, compared to just 13% of those on placebo.
Celgene Corporation and Acceleron Pharma Announce Results of the Phase 3 MEDALIST Trial Evaluating Luspatercept in Patients with Myelodysplastic Syndromes at the ASH 2018 Plenary Session [Celgene] Regulatory submissions planned in the United States and Europe in the first half of 2019.
	5.8.4 ASH - CAR T
ASH18: Bluebird's follow-on CAR-T finds initial success, but durability will be key test [BiopharmaDive] With bb21217, Bluebird and Celgene tweaked their manufacturing process to create what they say will be a more potent and longer-lasting therapy. It will take more time to see whether the data support that belief, but the early findings appear to have potential.
Kite Announces Two-Year Data for Yescarta® (Axicabtagene Ciloleucel) in Patients With Refractory Large B-Cell Lymphoma [Gilead] Data Presented at the Annual Meeting of the American Society of Hematology (ASH) and Simultaneously Published in The Lancet Oncology.
ASH18: CAR-T shows up in early CLL test [BiopharmaDive] Treatment with JCAR017, the main asset picked up in the biotech's $9 billion buyout of Juno, led to a response in 13 out of 16 patients with relapsed refractory CLL or small lymphocytic leukemia (SLL) who had been previously treated with Imbruvica.
ASH: Gilead, Novartis tout long-term data for CAR-T slow starters Yescarta, Kymriah [FiercePharma] “When we first showed our initial results, they said, ‘The results were incredible, but we need to see the one-year data,’” and after Kite came through with the one-year data, doctors wanted to see two-year data, he said.
Novartis announces longer-term analyses from pivotal Kymriah® trials that showed durable responses are maintained in patients with advanced blood cancers [Novartis] In the updated analysis from ELIANA, Kymriah demonstrated an 82% remission rate within 3 months in pediatric patients with r/r ALL; relapse-free survival was 62% at 24 months, with median duration of remission still not reached.
bluebird bio and Celgene Corporation Present Initial Data from Ongoing Phase 1 Clinical Study of Next-Generation Anti-BCMA CAR T Cell Therapy bb21217 in Patients with Relapsed/Refractory Multiple Myeloma at ASH Annual Meeting [bluebirdbio] Higher dose of bb21217 being assessed in the ongoing Phase 1 study.
ASH 2018: A first stem cell transplant after CAR T-Cell therapy reduces relapses in ALL [ecancer News] This is one of the first studies to evaluate the potential role stem cell transplantation plays in long-term outcomes after CD19 CAR T-cell therapy for paediatric patients, said lead study author Corinne Summers, MD, of the Seattle Children's Hospital and Fred Hutchinson Cancer Research Centre.
#ASH18: Gilead posts impressive survival rates for Yescarta — but sales remain lean [EndPoints] Two years in for the Zuma-1 study, researchers point to an impressive 83% overall response rate for 101 patients, with 58% achieving a complete response, meaning there’s no sign of the disease.
#ASH18: Bluebird and Celgene didn’t ‘break’ their next-gen BCMA CAR-T, so now they’ll double down on the dose and root for real durability [EndPoints] In a small group of 12 heavily pretreated multiple myeloma patients, 10 of them achieved an objective response: 3 complete responses, 2 “very good” partial responses and 4 partials that were a step down from that.
#ASH18: Celgene offers up a stellar complete response rate for JCAR017. Will anyone notice? [EndPoints] Working with an “exploratory” endpoint on ORRs, the researchers involved in Celgene’s study for JCAR017 came up with an ORR of 81% with 43% in complete remission with undetectable cancer — and CRs tend to be very durable for CAR-Ts.
CAR T-Cell Therapies Show Durable Responses, New Research Also Explores Combination Therapies to Extend and Enhance Treatment Responses [ASH] Five studies being presented today at the 60th American Society of Hematology (ASH) Annual Meeting and Exposition spotlight the long-term effectiveness of these therapies in some patients, analyze how combination therapies might affect treatment responses, and examine if transplantation following CAR T-cell therapy affects remission rate.
More than half of patients alive two years after receiving CAR-T therapy for diffuse large B-cell lymphoma in ZUMA-1 trial [MD Anderson Cancer Center] ‘Real-world’ study separate from ZUMA-1 trial mirrors reports with similar response rates.
High-cost Gilead cell therapy proves durable for some lymphoma patients [Reuters] At the hematology meeting, Novartis reported 19-month follow-up on Kymriah in lymphoma patients, showing that more than half were responding to the therapy.
	5.8.5 ASH - Myélome multiple
ASH: Takeda maintenance data sets up Ninlaro for new myeloma nod [FiercePharma] If Ninlaro can ultimately snag an FDA go-ahead based on the data, just under 8,000 new U.S. patients per year could be eligible for treatment, Jay Humphrey, Takeda’s VP of U.S. marketing, estimated—though only three-quarters of eligible patients now receive a maintenance therapy in the real world.
Takeda to Present Positive Data from TOURMALINE-MM3, First Pivotal Phase 3 Placebo Controlled Trial Evaluating Proteasome Inhibitor Treatment in Maintenance Setting [Takeda] Maintenance Therapy with NINLARO™ (ixazomib) Improved Progression-Free Survival in Adult Patients with Multiple Myeloma Following Autologous Stem Cell Transplant.
DARZALEX® (daratumumab) Combination Regimens Show Positive Results for Newly Diagnosed and Relapsed Patients with Multiple Myeloma [Johnson&Johnson] Updated Phase 3 ALCYONE results, featured as oral presentation at ASH 2018, show improved progression-free survival in newly diagnosed patients.
	5.8.6 ASH - Leucémies
Celgene Corporation Announces Initial Phase 1/2 Liso-cel Data in Patients with Relapsed/Refractory CLL, Including Those with High-Risk Disease, Previously Treated with Ibrutinib, at ASH 2018 [Celgene] Eighty one percent overall response rate and 43% complete response rate observed in heavily pre-treated patients.
AbbVie Presents New Data from Phase 3 MURANO Trial of VENCLEXTA®/VENCLYXTO® (venetoclax) in Combination with Rituximab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia Who Completed the Fixed Treatment Course [AbbVie] Of the 130 patients who completed rituximab plus the 24-month fixed duration of venetoclax and remained off therapy for a median of 9.9 months, the estimated PFS rate at six and 12 months were 92 percent and 87 percent, respectively.
IMBRUVICA® (ibrutinib) Data in Chronic Lymphocytic Leukemia (CLL) Show up to Seven Years of Progression-free Survival (PFS) in 80 Percent of Previously Untreated Patients, the Longest Follow-up for a Bruton's Tyrosine Kinase Inhibitor to Date [AbbVie] Nearly nine out of 10 (89 percent) CLL/SLL patients at time of the seven-year analysis treated with ibrutinib achieved a clinical response rate with stable or improved complete response rates.
Tolero Pharmaceuticals Presents Updated Clinical Data from Ongoing Phase 2 Zella 201 Study Evaluating Investigational Agent Alvocidib in Patients with MCL-1 Dependent Relapsed or Refractory AML at ASH 2018 [Tolero] Updated findings from Stage 1 of the study have shown that alvocidib in combination with cytarabine and mitoxantrone displayed encouraging clinical activity in patients with MCL-1-dependent R/R AML.
ASH 2018: Rapid genetic screening shows feasibility of precision medicine for acute myeloid leukaemia [ecancer News] The results represent the first findings from the Beat AML study, a multi-arm, multi-site collaborative trial designed to test precision medicine approaches for improving the generally poor prognosis among patients with AML.
	5.8.7 ASH - Lymphomes
Seattle Genetics Highlights Multiple Data Sets Evaluating the Combination of ADCETRIS® (Brentuximab Vedotin) and Opdivo® (Nivolumab) at ASH Annual Meeting [Seattle Genetics] In the Hodgkin lymphoma setting, ADCETRIS plus Opdivo data continue to support investigation of this combination regimen in multiple ongoing studies.
Seattle Genetics Highlights Additional Analyses from ECHELON-1 Phase 3 Clinical Trial of ADCETRIS® (Brentuximab Vedotin) in Newly Diagnosed Advanced Hodgkin Lymphoma at ASH Annual Meeting [Seattle Genetics] Three-Year Progression-Free Survival Data Demonstrate ADCETRIS plus AVD Benefit of 83.1 Percent Compared to 76.0 Percent in ABVD Arm.
Pfizer Presents Positive 26-Week Data For PF-05280586, A Potential Biosimilar To Rituximab, At The American Society Of Hematology Annual Meeting [Pfizer] 26-week data from the ongoing 52-week REFLECTIONS B328-06 study met its primary endpoint, demonstrating comparable safety and efficacy for patients with indolent follicular lymphoma.
Celgene Corporation Announces Results of AUGMENT Evaluating REVLIMID® In Combination with Rituximab (R²) In Patients with Relapsed/Refractory Indolent Lymphoma At ASH 2018 [Celgene] Positive trend in overall survival was observed.
#ASH18: Regeneron’s bispecific REGN1979 offers eye-catching 80% CR rate in follicular lymphoma, spurring swift shift to pivotal study [EndPoints] This bispecific hunts the B cell marker CD20 as well as the CD3 component of the T cell receptor, which they knew three years ago worked very well in monkeys. t’s not doing too shabby in humans, either.