June 23, 2017
AbbVie has announced the presentation of results from the pivotal Phase 2 study of VENCLYXTO™ (venetoclax), a first-in-class oral B-cell lymphoma-2 (BCL-2) inhibitor. VENCLYXTO monotherapy responses in 158 patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and 17p deletion showed that 77 percent (95% confidence interval [CI]: 69.9, 83.5) achieved an overall response rate (ORR = complete remission [CR] + complete remission with incomplete marrow recovery [Cri] + partial remission [PR] + nodular partial remission [nPR]) (primary endpoint), 18 percent achieved a complete remission (CR +CRi) (secondary endpoint), 53 percent achieved a partial remission (PR), 6 percent achieved an nPR, and 27 percent achieved blood minimal residual disease (MRD) negativity, as measured by flow cytometry.

  • Novartis pivotal CTL019 6-month follow-up data show durable remission rates in children, young adults with r/r B-cell ALLJune 23, 2017Novartis has announced updated results from the ELIANA clinical trial demonstrating CTL019 (tisagenlecleucel) remission rates are maintained at six months in relapsed/refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). These data from this pivotal trial of CTL019 show that 83% of patients achieved complete remission (CR) or CR with incomplete blood count recovery within three months of infusion. Results from this study of CTL019 – an investigational chimeric antigen receptor T cell (CAR-T) therapy – were presented at the European Hematology Association (EHA) Annual Meeting.

 

June 24, 2017

Ra Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focusing on the development of next-generation therapeutics for the treatment of complement mediated diseases, has announced a novel class of orally bioavailable small molecules that bind to C5 with high affinity and inhibit its cleavage into C5a and C5b. These findings demonstrate the feasibility of an orally-administered therapy for complement-mediated disorders and support the continued advancement of these molecules.

June 26, 2017

ImmunoGen, Inc., a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, presented data from the ongoing Phase 1 study evaluating single agent IMGN779 in patients with relapsed or refractory adult acute myeloid leukemia (AML) whose tumors express CD33. The first-in-human data demonstrate the safety and tolerability of IMGN779 across seven dose levels, with no dose limiting toxicities (DLTs), as well as evidence of dose-dependent biological and anti-leukemia activity.

June 27, 2017

Patients with multiple myeloma receive bisphosphonates regularly to protect their bones against lytic lesions. However, a recent study suggests that the novel agent denosumab (Xgeva, Amgen) could be used instead. In a head-to-head comparison with zoledronic acid in a trial involving more than a thousand patients, denosumab was noninferior and showed an advantage in significantly reducing the risk for renal adverse events. These findings were presented at the European Hematology Association (EHA) 2017 Congress.

 

June 24, 2017

In this Phase 1/2 study by Takeda Pharmaceutical Company Limited, patients with newly diagnosed multiple myeloma received weekly oral ixazomib (1.68 – 3.95 mg/m2 in Phase 1 and 4.0 mg in Phase 2) plus lenalidomide and dexamethasone for up to twelve, 28-day induction cycles. Of the 65 enrolled patients, 42 continued on study treatment without withdrawing early for SCT. After initial therapy, 25 patients went on to receive weekly, single-agent ixazomib at the last tolerated dose given during induction until disease progression or unacceptable toxicity.

June 29, 2017

The first known trial of combined ublituximab (TG-1101), ibrutinib (Imbruvica), and umbralisib (TGR-1202) showed that the combination was well tolerated and had activity across heavily pretreated patients with high-risk B-cell malignancies, investigators from TG Therapeutics reported during the 2017 EHA Congress.

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