- AbbVie Announces Pivotal Phase 2 Trial Evaluating VENCLYXTO™ (venetoclax) in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)
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.
- Deep and Durable Responses with Weekly Ixazomib, Lenalidomide and Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma
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.