LEUKEMIAS

The advent of an era of targeted immunotherapy and CAR T-cell therapies for the treatment of adult patients with acute lymphoblastic leukemia may reduce the need for hematopoietic stem cell transplant in certain cases.<br /> &nbsp;

Marcelo C. Pasquini, MD, discusses the rationale for analyzing real-world data for the use of tisagenlecleucel, a chimeric antigen receptor T-cell therapy, as a treatment for patients with acute lymphoblastic leukemia and diffuse large B-cell lymphoma. This CD19 CAR T cell was approved 2 years ago for use in both ALL and DLBCL.

Due to treatment benefit observed in pediatric patients with acute lymphoblastic leukemia,&nbsp;2 clinical trials investigating blinatumomab (Blincyto) versus chemotherapy were stopped early, according to the drug developer Amgen.

Umbralisib and ublituximab in combination with pembrolizumab was well tolerated among patients with relapsed/refractory chronic lymphocytic leukemia and Richter&rsquo;s transformation, according to a phase I/II trial presented at the 18th International Workshop on CLL. Responses were durable in high-risk patients who are BTK-refractory, including 2 complete responses in patients with RT.

In an interview with&nbsp;<em>Targeted Oncology</em>, Marcelo C. Pasquini, MD, discussed the importance of obtaining real-world data and establishing registries for collecting patient outcomes, and how real-world data compare with data from pivotal trials. He also explained the challenges with accessibility to CAR T-cell therapies.

The PI3K-delta inhibitor umbralisib demonstrated a favorable toxicity profile as treatment for patients with chronic lymphocytic leukemia who have become intolerant to a prior kinase inhibitor, of either BTK or PI3K inhibition, according to results from a phase II study presented at the 18th International Workshop on CLL.

In an interview with <em>Targeted Oncology</em>, Neil P. Shah, MD, PhD, discussed the latest advancements in the treatment landscape of chronic myeloid leukemia, including the introduction of tyrosine kinase inhibitors. He also addressed some of the challenges both oncologists and patients face in this space.<br /> &nbsp;

Gail Roboz, MD, discusses the use of FLT3 inhibitors as treatment of patients with acute myeloid leukemia, which can be a heterogenous and difficult-to-treat disease. There is a lot of optimism for new drugs and targets in AML, but the disease itself remains tough to treat, according to Roboz.

Tanya Siddiqi, MD, discusses how she sees acalabrutinib fitting into the treatment landscape for patients with chronic lymphocytic leukemia following the results from the phase III ASCEND trial.

The presence of novel combinations and oral targeted therapies are rising in the frontline treatment setting for patients with chronic lymphocytic leukemia, regardless of age. According to Nitin Jain, MD, ongoing phase III trials will bring additional modifications to the treatment landscape.

In an interview with&nbsp;<em>Targeted Oncology </em>during the 2019 SOHO Annual Meeting, John F. DiPersio, MD, PhD, discussed the challenges in research surrounding immunotherapies for AML, including DARTs, BiTEs, ADCs, and CARs.

In the phase III QUAZAR AML-001 trial, an investigational oral azacitidine therapy, CC-486, induced a statistically significant improvement in overall survival compared with placebo when used as a maintenance therapy in the treatment of patients with newly diagnosed acute myeloid leukemia who achieved a complete response or CR with incomplete blood count recovery following treatment with induction chemotherapy.

To improve the efficacy of chimeric antigen receptor T-cell therapies, Nirali N. Shah, MD, MHSc, suggested including new constructs that target more than 1 antigen in patients with acute lymphoblastic leukemia, during a presentation at the 2019 SOHO Annual Meeting.<br /> &nbsp;

The FDA has granted a fast track designation to magrolimab for the treatment of patients with acute myeloid leukemia and myelodysplastic syndrome.

Here&#39;s a look back on the FDA happenings for the month of August 2019, including FDA approvals, priority reviews, and breakthrough designations.

The addition of ixazomib to a combination of mitoxantrone, etoposide, and cytarabine demonstrated a promising rate of responses among patients with relapsed or refractory acute myeloid leukemia, according to the results of a phase I/II trial.

David Bond, MD, discusses 2 key findings from a recent study investigating the risk of developing a second cancer in patients with chronic lymphocytic leukemia treated with a BTK inhibitor.

In an interview with <em>Targeted Oncology</em>, Robert L. Redner, MD, highlighted the new agents available for the treatment of AML and some of the ongoing studies that could impact clinical practice.

In an interview with&nbsp;Targeted Oncology, Alessandra Tedeschi, MD, discussed the 5-year data she presented at the 2019 EHA Meeting for frontline ibrutinib as a treatment for patients with CLL. She also highlighted other research that may also benefit elderly patients with CLL, including the emerging combination of venetoclax and obinutuzumab.

In an interview with <em>Targeted Oncology, </em>James&nbsp;McCloskey, MD, explained the need for consideration of elderly patients when designing clinical trials for <em>IDH</em>-mutated AML and other considerations when treating this patient population.

The FDA has granted a breakthrough therapy designation to acalabrutinib monotherapy for the treatment of adult patients with chronic lymphocytic leukemia.&nbsp;The breakthrough designation was given based on the results of interim analyses from 2 phase III trials: ELEVATE-TN and ASCEND.&nbsp;

Patients with relapsed or refractory acute myeloid leukemia typically have low response rates to chemotherapy. However, some subsets of patients, particularly those with targetable mutations, may have long-term survival when given a novel FLT3 inhibitor like gilteritinib, as seen in the ADMIRAL trial, says Mark J. Levis, MD, PhD.

In the phase I/II TRANSCEND CLL 004 study, chimeric antigen receptor T-cell therapy lisocabtagene maraleucel led to undetectable minimal residual disease in patients with relapsed/refractory chronic lymphocytic leukemia.

Take a look back on the FDA happenings, including approvals, fast track designations, priority reviews, and more from the month of July 2019.

In an interview with&nbsp;Targeted Oncology, Richard M. Stone, MD, discussed the biggest controversies across a number of patient populations in AML. He also highlighted some areas of research he finds particularly exciting for the treatment of patients with AML.