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Top News From ASH 2015: Slideshow

Megan Brooks; Zosia Chustecka; Allison Shelley; Darbe Rotach; Betsy Hansen; Roxanne Nelson  |  December 17, 2015

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Slide 1

Progress in the treatment of many blood disorders, as well as blood cancers, greeted attendees here at the American Society of Hematology (ASH) 57th Annual Meeting, held December 5 to 8 in Orlando, Florida.

Slide 2

Among the highlights of the meeting:

  • Midostaurin improves survival in acute myeloid leukemia
  • Three-drug combo now standard in newly diagnosed myeloma
  • Ixazomib is first oral triplet for multiple myeloma
  • Rituximab plus chemo: New standard of care in BCP-ALL?
  • Antibiotic prophylaxis during ALL induction halves infection
  • Missing doses of oral drug in ALL maintenance chemo
  • CAR T-cells offer hope even after stem-cell transplant
Slide 3

Midostaurin in AML: First Targeted Agent Improves Survival

There hasn't been a new drug approved for acute myeloid leukemia (AML) since 1990, but one may be coming soon, at least for a subgroup of patients. In a trial of 717 patients with newly diagnosed AML and the FLT3 mutation, the addition of midostaurin (Novartis) to standard treatment led to significant improvement in both overall and event-free survival, reported Richard Stone, MD, from the Dana-Farber Cancer Center in Boston. Median overall survival was 74.7 months in the midostaurin group vs 25.6 months in the placebo group (P = .0076). The 5-year survival rate was 50.9% in the midostaurin group vs 43.9% in the placebo group. The event-free survival was 8 months in the midostaurin group vs 3.6 months in the placebo group (P = .0032). The 5-year event-free survival rate was 27.5% with midostaurin vs 19.3% with placebo. Dr Stone said the results suggest that midostaurin plus standard chemotherapy offers a new standard of care for AML patients with the FLT3 mutations.

Slide 4

Three-Drug Combo Now Standard in Newly Diagnosed Myeloma

Triplet therapy with a proteasome inhibitor, an immunomodulatory drug, and a steroid, "has come of age," and is the new standard of care for newly diagnosed multiple myeloma, declared Sagar Lonial, MD, from the Winship Cancer Institute at Emory University in Atlanta. He highlighted randomized data from the SWOG S0777 study, reported here by Bruce Durie, MD, from the Cedars-Sinai Comprehensive Cancer Center in Los Angeles. The trial of 474 patients not intended for stem cell transplantation showed the superiority of the triplet combination of bortezomib (Velcade, Millennium/Takeda), lenalidomide (Revlimid, Celgene), and dexamethasone over the doublet of lenalidomide plus dexamethasone. Median progression-free survival was 43 months for the triplet vs 31 months for the doublet. Median overall survival was not reached for the triplet vs 63 months for the doublet. At about 80 months of follow-up, there had been 67 deaths of 242 patients in the triplet group vs 96 deaths in 234 patients in the doublet group. The overall survival was improved for the triplet vs the doublet (hazard ratio, 0.666; P = .0114).

Image courtesy of Wikimedia

Slide 5

Ixazomib in First Oral Triplet for Multiple Myeloma

Ixazomib (Ninlaro, Millennium/Takeda) is the first available oral proteasome inhibitor, and it offers patients with multiple myeloma the option of taking an all-oral treatment regimen. Data from the phase 3 TOURMALINE-MM1 trial that led to FDA approval of ixazomib were presented to a packed hall. The trial was conducted in 26 countries and involved 722 patients with relapsed and/or refractory multiple myeloma. All patients had received at least one previous therapy, and half had already undergone stem cell transplantation and were progressing. Results showed that a triplet combination with ixazomib, lenalidomide (Revlimid), and dexamethasone significantly improved progression-free survival, compared with the doublet of lenalidomide and dexamethasone. Median progression-free survival was 20.6 months with the triplet vs 14.7 months in the control group (hazard ratio, 0.742; P = .012). The trial is ongoing, and with a median follow-up of 23 months so far, and the data on overall survival are immature, noted lead author Philippe Moreau, MD, from the University of Nantes in France.

Slide 6

Rituximab Plus Chemo: New Standard of Care for BCP-ALL?

Rituximab (Rituxan, Genentech/Roche) is already a mainstay of therapy in lymphoma and has also shown activity in mature B-cell acute lymphocytic leukemia (ALL). New data now support its use in another form of ALL. The new data show that adding rituximab to chemotherapy significantly improved event-free survival in patients with B-cell precursor ALL. At a median follow-up of 30 months, patients who received rituximab had a lower incidence of relapse than those who did not (18% in the rituximab group vs 30.5% in the control group). In addition, 65% of the patients receiving rituximab group achieved 2-year event-free survival, compared with 52% of control subjects. "Adding rituximab to standard therapy should thus become a standard of care for these patients," said lead author Sébastien Maury, MD, from Hôpital Henri Mondor in Créteil, France.

Slide 7

Antibiotic Prophylaxis During ALL Induction Halves Infection

A new study supports prophylactic antibiotic therapy to guard against serious infections for all children with acute lymphoblastic leukemia (ALL) during the aggressive induction phase of chemotherapy. Giving these children prophylactic antibiotics can more than halve the incidence of bacterial infection, although this result comes from a comparison with historic control subjects. Antibiotic prophylaxis did not appear to increase rates of other treatment-related mortality, fungal infection, or infection with Clostridium difficile. Although acknowledging that larger randomized trials are needed to confirm the findings, senior author Lewis Silverman, MD, from the Dana-Farber Cancer Institute in Boston, described the results as "very exciting.... The use of antibacterial prophylaxis appears to have made a profound difference to our patients."

Image from iStock

Slide 8

First-Line Ibrutinib Improves Survival in Frail CLL Patients

Ibrutinib (Imbruvica, Pharmacyclics/AbbVie), already approved for patients with pretreated chronic lymphocytic leukemia (CLL), also works when used up-front, new results show. In the RESONATE-2 study, ibrutinib was superior to chlorambucil in older treatment-naive patients with CLL or small lymphocytic lymphoma (SLL). "There was a 91% reduction in risk of progression (by investigator) and an 84% reduction in risk of death with ibrutinib, as compared with chlorambucil," said lead author Alessandra Tedeschi, MD, from Azienda Ospedaliera Niguarda Cà Granda in Milan, Italy. Treatment with ibrutinib also significantly improved bone marrow function and showed a favorable benefit–risk profile in the first-line treatment of patients with CLL/SLL vs traditional chemotherapy. One of the really important points of this study was that the researchers recruited primarily elderly patients who were felt to be unsuited to receive more aggressive treatments, which would be the standard regimen for most CLL patients, commented Tait D. Shanafelt, MD, from the Mayo Clinic in Rochester, Minnesota.

Slide 9

Missing Doses of Oral Drug in ALL Maintenance Chemo

Durable remissions in childhood acute lymphocytic leukemia (ALL) require about 2 years of maintenance chemotherapy that includes daily doses of oral 6-mercaptopurine (6MP). But a new study shows that children and their parents often report that the drug has been taken when, in fact, it hasn't. About 25% of children or their caregivers over-reported 6MP intake, whereas only 12% were identified as "perfect reporters," where the report correlated with electronic monitoring of when the drug was taken. The remaining 64.4% of children and caregivers fell in between the two ends of the spectrum. Over-reporting was more likely in patients who were nonadherent to 6MP, those 12 years and older, those from a minority race, and those in households with lower parental education. "Subjective over-reporting of 6MP intake during maintenance therapy for childhood ALL is common, particularly in nonadherent patients, and should be used with caution," said lead author Wendy Landier, PhD, CRNP, from the University of Alabama at Birmingham.

Slide 10

Idelalisib in CLL Trial Stopped Because of "Overwhelming Efficacy"

Another phase 3 trial has shown efficacy for idelalisib (Zydelig, Gilead) in relapsed or refractory chronic lymphocytic leukemia (CLL). The drug was approved last year for use with rituximab (Rituxin, Genentech/Roche) in this setting. In the new trial, known as Study 115, idelalisib was combined with rituximab and bendamustine. The three-drug regimen proved superior to bendamustine/rituximab alone, increasing both progression-free and overall survival. The trial was stopped early because of "overwhelming efficacy," trialists said here. "There was a 67% reduction of the risk of progression or death and a 45% reduction in death from relapsed/refractory CLL," said lead author Andrew D. Zelenetz, MD, PhD, from the Memorial Sloan Kettering Cancer Center in New York City. The results were consistent across patients with or without high-risk features. Idelalisib manufacturer Gilead Sciences intends to file the new data for a supplementary approval.

Slide 11

CLL Patients With "Dismal" Prognosis Respond to Venetoclax

The novel agent venetoclax (formerly ABT-199/GDC-0199, AbbVie/Genentech/Roche) has demonstrated impressive responses in relapsed/refractory poor-prognosis CLL patients. The overall response rate was 79.4% in this population of CLL patients harboring the 17p deletion, and 84.7% of this group maintained their response at 12 months. "This is a very special population with the most dismal outcome," said lead author Stephan Stilgenbauer, MD, from the University of Ulm in Germany, who discussed the findings during a press briefing. "These patients have not only relapsed on conventional treatment, they were homogeneously defined by the presence of the 17p deletion and they are resistant to conventional therapy. Based on these data, venetoclax may be an attractive component to incorporate into novel combinations or to sequence in patients with this very high-risk disease characterized by 17p deletion," said Dr Stilgenbauer.

Slide 12

CAR T-Cells Offer Hope Even After Stem-Cell Transplantation

A new application of chimeric antigen-receptor (CAR) T-cells was reported here by James Kochenderfer, MD, from the National Cancer Institute in Bethesda, Maryland, who was one of the first to report success with CAR T-cells in lymphomas. Although some observers have suggested that the CAR T-cell approach could be an alternative to or used as a bridge to stem-cell transplantation, the results Dr Kochenderfer presented show that the approach can also be used in patients who have already undergone transplantation but continue to progress. The researchers used donor lymphocytes (from the original donor of the stem-cell transplantation), but then genetically modified the T-cells to express an anti-CD19 CAR. Patients received a single infusion of these anti-CD19 CAR T-cells without any chemotherapy. The trial involved 20 patients with B-cell malignancies that progressed after transplantation. Overall, nine of the 20 patients had a complete or partial response. The best responses were seen in patients with acute lymphocytic leukemia. Good responses were also seen in chronic lymphocytic leukemia.

Slide 13

For more information

News coverage of ASH 2015

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