HEMATOLOGY

Based on results of a phase I trial presented at the 2017 ASH Annual Meeting, a new drug applicaton for ivosidenib has been submitted for FDA approval for the treatment of patients with relapsed/refractory IDH1-mutant acute myeloid leukemia, according to a statement from Agios Pharmaceuticals, the company developing the targeted therapy.

The label for nilotinib (Tasigna) has been updated by the FDA with a provision stating patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) who have received the BCR-ABL tyrosine kinase inhibitor could be eligible to stop treatment after having recieved for at least 3 years and having achieved the specific predetermined criteria.<br /> <br /> &nbsp;

Managing Relapsed Chronic Myeloid Leukemia

Bosutinib (Bosulif) has been approved by the FDA as a first-line treatment for&nbsp;patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML).

Tatyana Feldman, MD,&nbsp;John Theurer Cancer Center, Hackensack University Medical Center, discusses the phase III Echelon-1 study, which found brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine (AVD) demonstrated superior modified progression-free survival (PFS) versus ABVD in patients with previously untreated stage III or IV Hodgkin lymphoma.&nbsp;

In patients with&nbsp;chronic lymphocytic leukemia (CLL), the addition of ibrutinib to standard frontline chemoimmunotherapy induced negative minimum residual disease (MRD) status in bone marrow for 83% of patients, according to results from a preliminary clinical study presented at the 2017 ASH Annual Meeting.

Rapid and durable responses were induced with the combination of selinexor, weekly bortezomib (Velcade), and low-dose dexamethasone (Vd), according to results of a dose escalation/expansion trial of patients with relapsed/refractory multiple myeloma (RRMM) presented at the 2017 ASH Annual Meeting.

After 4 years of follow-up, a majority of patients with polycythemia vera (PV) that responded to treatment with ruxolitinib (Jakafi) maintained their responses, results from a randomized trial showed.

Ivosidenib (AG-120), an IDH1 inhibitor, demonstrated an objective response rate (ORR) of 41.6% in patients&nbsp;with relapsed/refractory&nbsp;<em>IDH1</em>-mutant acute myeloid leukemia (AML), according to findings from a single-arm phase I study.&nbsp;

Srdan Verstovsek, MD, of MD Anderson Cancer Center, discusses a study of sotatercept (ACE-011) alone and in combination with ruxolitinib in patients with myeloproliferative neoplasm (MPN)-associated myelofibrosis and anemia.

Joshua Richter, MD, Hackensack University Medical Center, discusses a tool which explored the incidence and survival impact of self-reported symptoms and psychologic distress among patients with multiple myeloma during the 2017 ASH Annual Meeting.

Andre Goy, MD, chairman and director, chief of Lymphoma, and director of Clinical and Translational Cancer Research at John Theurer Cancer Center, Hackensack Medical Center, discusses long-term follow-up results for ibrutinib (Imbruvica) in relapsed/refractory mantle cell lymphoma.

Michael Wang, MD,&nbsp;discusses the impact of acalabrutinib on patients with MCL, ongoing progress in the field, and The University of Texas MD Anderson Cancer Center&rsquo;s Lymphoma Moonshot Program.

Andre Goy, MD, shed light on some of these studies as well as future treatment options for patients with MCL.

Cristina Gasparetto, MD, associate professor, head of the myeloma program, Duke University Medical Center, discusses a phase 1b study to assess the combination of selinexor and daratumumab in patients with relapsed/refractory multiple myeloma previously exposed to proteasome inhibitors and immunomodulatory drugs during the 2017 ASH Annual Meeting.

Ian Flinn, MD, Director of the Blood Cancer Research Program, Sarah Cannon Research Institute, discusses the safety, efficacy, and MRD negativity of a combination of venetoclax (Venclexta) and obinutuzumab (Gazyva) in patients with previously untreated chronic lymphocytic leukemia (CLL) during the 2017 ASH Annual Meeting.<br /> &nbsp;

Treatment with the novel PD-1 inhibitor cemiplimab induced responses in half of the patients with&nbsp;Hodgkin lymphoma in a phase I study of patients with B-lymphoid malignancies; among patients with&nbsp;B-cell non-Hodgkin lymphoma treated with the monotherapy, the overall response rate was 11.1%, according to a poster presentation at the 2017 ASH Annual Meeting.&nbsp;

Treatment with&nbsp;tisagenlecleucel (Kymriah) continues to excite the possibilities seen with chimeric antigen receptor T-cell therapy with impressive responses seen with the therapy in patients with&nbsp;relapsed/refractory diffuse large B-cell lymphoma. In the phase II JULIET trial, an overall response rate of 53.1%&nbsp;was observed, according to findings presented at the ASH Annual Meeting.&nbsp;

Pembrolizumab (Keytruda) has received a priority review from the FDA for a supplemental biologics license application (sBLA) for the treatment of&nbsp;adult and pediatric patients with relapsed/refractory primary mediastinal large B-cell lymphoma (PMBCL), according to a press release from Merck,&nbsp;the manufacturer of pembrolizumab. The findings were first presented at the 14th International Conference on Malignant Lymphoma and updated data were recently presented at the 2017 ASH Annual Meeting.

Ruben A. Mesa, MD, Director of the UT Health San Antonio Cancer Center, discusses &nbsp;4-year follow-up results from the phase III RESPONSE trial, which investigated ruxolitinib (Jafaki) with best available therapy for the treatment of polycythemia vera (PV) during the 2017 ASH Annual Meeting.

Adding rituximab (Rituxan) to ibrutinib (Imbruvica) in patients with chronic lymphocytic leukemia (CLL) did not improve progression-free survival (PFS) or overall survival (OS) versus ibrutinib alone, despite there being a faster time to complete remission.