LEUKEMIAS

Venetoclax in combination with azacytidine demonstrated a statistically significant improvement in overall survival and achieved a satisfactory composite complete remission rate in previously untreated patients with acute myeloid leukemia, meeting the co-primary end points of the phase III VIALE-A study. Genentech, the developer of venetoclax, announced the positive news in a press release, also noting that safety profiles of both drugs were consistent with prior reports.

Bendamustine debulking followed by ofatumumab and ibrutinib demonstrated an overall response rate of 92% in patients with chronic lymphocytic leukemia, meeting the primary end point of the phase II CLL2-BIO trial, and was well-tolerated with no new safety signals. Results from the study were published in Haematologica.

After demonstrating promising results that were comparable to targeted therapies in the first 2 cohorts of a phase I clinical trial, the combination of cladribine, cytarabine, granulocyte-colony stimulating factor, and mitoxantrone plus the antibody radiation conjugate lintuzumab-Ac225 in patients with relapsed/refractory acute myeloid leukemia is now being explored in a third cohort.

Alexey V. Danilov, MD, PhD, discusses important studies in the chronic lymphocytic leukemia space and questions whether combination or sequential therapy is better for patients with chronic lymphocytic leukemia.

In an interview with Targeted Oncology, Alexey V. Danilov, MD, PhD, discussed the ELEVATE-TN trial and other potentially practice-changing BTK inhibitor combinations expected to emerge in chronic lymphocytic leukemia.

The combination of venetoclax plus low-dose cytarabine did not demonstrate a statistically significant improvement in overall survival compared with LDAC plus placebo in patients with acute myeloid leukemia who were ineligible for intensive chemotherapy at the time of a planned analysis, missing the primary end point of the phase III VIALE-C trial.

In an interview with <em>Targeted Oncology</em>, Rajneesh Nath, MD, discussed the background and rationale for the phase III SIERRA trial. He also explained what this research means for the treatment landscape of acute myeloid leukemia.&nbsp;

Jeff P.&nbsp;Sharman, MD, discusses what differentiates acalabrutinib from other BTK inhibitors available in chronic lymphocytic leukemia.

Next-generation sequencing in patients with chronic lymphocytic leukemia treated with the combination of chlorambucil and ofatumumab showed that the presence of&nbsp;TP53,&nbsp;SF3B1,&nbsp;and&nbsp;NOTCH1&nbsp;mutations were predictive of reduced efficacy, according to the results of the phase III COMPLEMENT1 trial published in&nbsp;Haematologica.

Courtney D. DiNardo, MD, MSCE, explains the rationale for the phase II AG221-AML-005 trial.

Following the FDA approval of gemtuzumab ozogamicin with induction and consolidation therapy in newly diagnosed CD33-positive acute myeloid leukemia, investigators led by Richard F. Schlenk, MD, hypothesized that patients with NPM1-mutated acute myeloid leukemia,&nbsp;which occurs in 20% to 30% of the patient population,&nbsp;could also derive benefit from gemtuzumab.

In an interview with&nbsp;Targeted Oncology,&nbsp;Paul M. Barr, MD, discussed the rationale and preliminary findings for the phase I/II study evaluating umbralisib and ublituximab plus venetoclax in patients with relapsed/refractory chronic lymphocytic leukemia. He also explained how the role of combination therapy continues to evolve in this space.

In an interview with&nbsp;Targeted Oncology, Jennifer Woyach, MD, discussed the rationale for evaluating a response-dependent treatment discontinuation strategy for older patients with previously untreated chronic lymphocytic leukemia. She highlighted the importance of determining an optimal discontinuation strategy in this patient population.

Dasatinib, a second-generation Abl-tyrosine kinase inhibitor, used concurrently with an intensive chemotherapy regimen yields superior outcomes compared with imatinib plus chemotherapy in pediatric patients with Philadelphia chromosome-positive acute lymphoblastic leukemia, according to the results from the first randomized phase III clinical trial comparing the 2 drugs in this patients&nbsp;<a>population</a>.

The autologous dendric cell vaccine targeting Wilms tumor-1 antigens with or without preferentially Expressed Antigen in Melanoma was well tolerated and feasible in patients with acute myeloid leukemia, meeting the co-primary end points of the phase I/II clinical trial.

Jennifer A. Woymach, MD, provides background information on the AO41702 study, which evaluates targeted therapy ibrutinib or ibrutinib plus rituximab in elderly patients with previously untreated chronic lymphocytic leukemia.<br /> &nbsp;

Adam Fisch, MD, PhD, a clinical fellow in molecular genetic pathology at the Brigham&rsquo;s Women&rsquo;s Hospital, discusses the key points from a patient case he presented at the 2019 Association for Molecular Pathology Annual Meeting and Expo, in which the patient with acute myeloid leukemia harboring a FLT3-TKD mutation lost the mutation following relapse on gilteritinib.

In an interview with&nbsp;Targeted Oncology, Courtney D. DiNardo, MD, discussed the interim analysis results from the ongoing phase II trial evaluating the combination of enasidenib plus azacitidine in newly diagnosed patients with acute myeloid leukemia.

Lori Leslie, MD, discusses toxicities and outcomes observed in patients with chronic lymphocytic leukemia treated with acalabrutinib in real-word clinics.

Results from a phase I/Ib trial showed revealed that preliminary activity was seen with IMGN632, an investigational anti-CD123 antibody-drug conjugate, given to patients with relapsed/refractory acute myelogenous leukemia or blastic plasmacytoid dendritic cell neoplasm, according to data presented at the 2019 ASH Annual Meeting.

In an interview with Targeted Oncology, Jeff P. Sharman, MD, discussed the updated ELEVATE-TN data and ongoing research that is poised to define the optimal role of acalabrutinib in CLL at the 2019 ASH Annual Meeting.

Naval Daver, MD, explains the rationale for the phase II QUAZAR trial, which assessed the efficacy and safety of azacitidine in patients with acute myeloid leukemia.

In an interview with&nbsp;Targeted Oncology, Pinkal Desai, MD, discussed the latest advancements in the treatment landscape for patients with AML, particularly for the older population. She also highlighted emerging treatment options that undergoing investigation now in clinical trials.

Interim phase II trial data showed that the combination of enasidenib, an oral small molecule inhibitor of mutant&nbsp;IDH2&nbsp;proteins, and azacitidine, significantly improves complete remission and overall responses in patients with newly diagnosed acute myeloid leukemia with&nbsp;IDH2&nbsp;mutations compared with azacitidine alone, according to results presented at the 2019 American Society of Hematology Annual Meeting.

Jeff P.&nbsp;<a>Sharman</a>, MD, discusses the safety profile of acalabrutinib that was demonstrated in&nbsp;<a href="https://www.targetedonc.com/conference/ash-2019/patients-with-cll-treated-on-the-elevatetn-trial-experience-improved-pfs-with-acalabrutinib"><strong>the phase III ELEVATE-TN trial</strong></a>. The trial&nbsp;&nbsp;evaluated acalabrutinib&nbsp;&nbsp;as a single agent or in combination with obinutuzumab versus obinutuzumab&nbsp;&nbsp;plus chlorambucil in patients with treatment-na&iuml;ve chronic lymphocytic leukemia.