LEUKEMIAS

Danielle Brander, MD, highlights how recent advances are changing the field of CLL and what it means for physicians and their patients.

Guadecitabine failed to improve complete response rate and overall survival in treatment-naïve adult patients with AML who are not candidates for intensive induction chemotherapy, missing the coprimary endpoints of the phase III ASTRAL-1, according to Astex Pharmaceuticals and Otsuka Pharmaceutical.

Quizartinib has been granted a breakthrough therapy designation by the FDA&nbsp;for the treatment of adult patients with relapsed/refractory&nbsp;<em>FLT3</em>-ITD&ndash;positive acute myeloid leukemia.

The FDA issued several approvals in July, including in colorectal cancer, breast cancer, prostate cancer, and acute myeloid leukemia.&nbsp;Here&rsquo;s a look back on the FDA happenings for the month of July 2018.

Susan M. O&#39;Brien, MD, associate director for clinical sciences at UC Irvine Health, shares her insights on why CAR T cells are not as successful in chronic lymphocytic leukemia as compared to lymphoma or acute lymphocytic leukemia. She also discusses what she believes must change in order for this therapy to move up in the treatment landscape for CLL.

Jacqueline D. Barrientos, MD, MS,&nbsp;discusses the current treatment landscape for CLL. She also highlights some of the biggest challenges for physicians and gave her insight on how to move forward in the field.

Anthony R. Mato, MD, MSCE,&nbsp;discusses the next steps for umbralisib and the biggest challenges still facing patients with CLL.

Ivosidenib (Tibsovo) has been granted approval by the FDA for the treatment of&nbsp;adult patients with relapsed/refractory <em>IDH1</em>-mutant acute myeloid leukemia.

Danielle M. Brander, MD, assistant professor of medicine at Duke University School of Medicine and member of the Duke Cancer Institute, discusses a major challenge in the field of chronic lymphocytic leukemia. She says the biggest challenge to overcome in the treatment of patients with CLL is navigating areas where research is not yet mature.&nbsp;

While the approval of new agents represents a great step forward in the treatment of&nbsp;chronic lymphocytic leukemia (CLL), physicians are now challenged with how to best utilize these new treatment options,&nbsp;according to a presentation by Anthony Mato, MD, MSCE, at the 2nd Annual Live Medical Crossfire: Hematologic Malignancies.

The FDA has received a supplemental New Drug Application for venetoclax in combination with&nbsp;a hypomethylating agent or low-dose cytarabine as a frontline treatment for&nbsp;patients with acute myeloid leukemia who are ineligible for intensive chemotherapy, Genentech, the manufacturer of the BCL-2 inhibitor, has announced.

An updated analysis of obinutuzumab alone or in combination with chemotherapy for patients with treatment-na&iuml;ve or relapsed/refractory chronic lymphocytic leukemia detected no new safety signals. Investigators in the phase IIIb GREEN trial also found overall response rates greater than 80% at 3 months post-treatment in some patients.

Romyelocel-L (human myeloid progenitor cells) has been granted a Regenerative Medicine Advanced Therapy designation by the FDA for the prevention of bacterial and fungal infections in patients with acute myeloid leukemia undergoing induction chemotherapy, according to Cellerant Therapeutics, Inc, the manufacturer of the therapy. RMAT designation holds similar advantages to breakthrough therapy designation.

CPX-351, a fixed-combination of daunorubicin and cytarabine, has been recommended for approval by the&nbsp;European Medicines Agency&rsquo;s Committee for Medicinal Products for Human Use for the treatment of adult patients with newly diagnosed therapy-related acute myeloid leukemia or AML with myelodysplasia-related changes.

Based on data from the phase II BRIGHT 1003 study, the FDA has granted a priority review to a new drug application for glasdegib for use in combination with chemotherapy for the frontline treatment of patients with acute myeloid leukemia, according to Pfizer, the developer of the investigational oral smoothened inhibitor.

William B. Donnellan, MD, was recently promoted to director of Leukemia/Myelodysplastic Syndrome Research at the Sarah Cannon Research Institute in Nashville, Tennessee. Donnellan has served as an investigator of hematologic malignancies since 2014 at the Sarah Cannon Research Institute.

According to long-term follow-up data from the phase III CLL11 study, treatment with obinutuzumab combined with chlorambucil&nbsp;reduced the risk of death by 24% versus rituximab plus chlorambucil in treatment-na&iuml;ve patients with chronic lymphocytic leukemia with comorbidities. These findings were presented&nbsp;at the 2018 European Hematology Association Congress.

Neil E. Kay, MD,&nbsp;a professor of medicine at the Mayo Clinic, discusses the challenges that arise when treating a patient with relapsed chronic lymphocytic leukemia (CLL). Most times, responses in this setting are short lived.

Matthew S. Davids, MD, MMSc,&nbsp;discusses the findings with duvelisib plus fludarabine-cyclophosphamide-rituximab as a frontline therapy for&nbsp;younger patients with CLL, as well as the potential future for this agent in the treatment of patients with CLL.

Based on survival data from the phase III TOWER study, blinatumomab has been granted full marketing authorization by the&nbsp;European Commission for&nbsp;the treatment of adult patients with Philadelphia&nbsp;chromosome-negative relapsed/refractory B-cell precursor acute lymphoblastic leukemia,&nbsp;according to Amgen, the developer of the anti-CD19 immunotherapy.

Michael R. Grunwald, MD,&nbsp;discusses new and emerging agents in AML and ALL, as well as sequencing and toxicity challenges with these treatments.<br /> &nbsp;

An overall response rate of&nbsp;41.6% (95% CI, 32.9-50.8) was induced with the use of ivosidenib in patients with&nbsp;<em>IDH1</em>-positive relapsed/refractory acute myeloid leukemia, according to data presented at the 2018 ASCO Annual Meeting&nbsp;and published simultaneously online in the <em>New England Journal of Medicine</em>.

Based on data from the phase III MURANO trial, venetoclax has been granted a regular approval by the FDA&nbsp;for the treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, with or without 17p deletion, who has received at least 1 prior therapy.

According to results presented at the 2018 ASCO Annual Meeting,&nbsp;moxetumomab pasudotox, a first-in-class recombinant immunotoxin targeting CD22, demonstrated deep and durable responses in a substantial proportion of pretreated patients with relapsed/refractory hairy cell leukemia.

Treatment-naive patients with chronic lymphocytic leukemia achieved high rates of&nbsp;minimal residual disease&ndash;negative status of 77% with peripheral blood testing after 6 cycles from treatment with ibrutinib (Imbruvica) and venetoclax (Venclexta). Additionally, patients in the CAPTIVATE trial, wihch was presented during the 2018 ASCO Annual Meeting, achieved an objective response rate of 100%.