TG Therapeutics reported interim data from the ongoing single-arm marginal zone lymphoma, or MZL, cohort of its Phase 2b clinical trial known as UNITY-NHL. The MZL cohort of UNITY-NHL is designed to investigate umbralisib as a single agent in patients with relapsed or refractory MZL. Umbralisib is an investigational, oral, once daily PI3K delta inhibitor with unique inhibition of CK1 epsilon and is currently under development for the treatment of non-Hodgkin lymphoma, or NHL, and chronic lymphocytic leukemia, or CLL. The MZL cohort of UNITY-NHL enrolled patients with relapsed or refractory MZL who had received prior treatment with one or more lines of therapy including at least one anti-CD20 regimen. In August 2018, the trial completed enrollment with 69 treated patients. The interim data reported included safety and tolerability data on all 69 treated patients and efficacy data on 42 patients who were enrolled at least 9 cycles prior to the data cut-off date. The primary endpoint is overall response rate, or ORR, as assessed by IRC using criteria adopted from the International Working Group criteria for malignant lymphoma. Overall, there was 88% clinical benefit rate by IRC. All patients achieving a complete response by IRC remain on study and 86% of patients had a reduction in tumor burden The median time to initial response was 2.7 months. Interim safety data were presented for all 69 treated patients with a median duration of exposure of 6.9 months. No unexpected toxicities were observed. The most common adverse events were diarrhea, nausea and fatigue, with the majority of events grade 1 in severity. The most frequent grade 3 or higher adverse events were neutropenia, diarrhea and ALT/AST increase, observed in 13%, 10% and 10% of patients, respectively. A subgroup analysis of patients treated for greater than six cycles was also conducted to evaluate long-term incidence of key toxicities of interest occurring after six cycles of treatment. Median duration of treatment of this subgroup was 10.1 months. In this subgroup, grade 3 or higher adverse events of interest were rare, limited to two patients with diarrhea and one patient with pneumonitis, with no events of ALT/AST elevation, pneumonia or colitis.
Monday, April 1, 2019
Pulmatrix in term sheet with Cipla Technologies to develop Pulmazole
Pulmatrix announced its entry into a Binding Term Sheet with Cipla Technologies, a subsidiary of Cipla for the co-development and commercialization of Pulmazole – an inhaled iSPERSE formulation of the anti-fungal drug itraconazole for the treatment of allergic bronchopulmonary aspergillosis in patients with asthma. The Binding Term Sheet lays the groundwork for entry into a definitive agreement with Cip Tec during the second quarter. Per the Binding Term Sheet, subject to entry into the definitive agreement, Cip Tec will make an upfront payment of $22M to Pulmatrix in exchange for an assignment of all rights to Pulmazole to Cip Tec. However, following this assigning, Pulmatrix will retain the right to receive 50% of the free cash flow from future sales of Pulmazole. In addition, Pulmatrix will remain primarily responsible for the implementation of the clinical development of Pulmazole and Cip Tec will be responsible for implementation of the commercialization of the product. Entry into a definitive agreement is contingent upon, Pulmatrix having at least $15M in unencumbered funds.
Evolus expects CHMP opinion on Nuceiva during April committee meeting
Evolus announced it expects the European Medicines Agency, or EMA, Committee for Medicinal Products for Human Use, or CHMP, to adopt a formal opinion on the Nuceiva marketing authorization application, or MAA, during the April committee meeting. Nuceiva is being evaluated by the EMA for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown, when the severity of the above facial lines has an important psychological impact in adults below 65 years of age.
Aslan data show comparable activity to Dupixent, says Piper Jaffray
Aslan Pharmaceuticals reported preliminary Phase I single-ascending dose data on intravenous ASLAN004 demonstrating the IL13 receptor antibody to be safe and well tolerated in healthy volunteers with no discontinuations due to adverse events, Piper Jaffray analyst Edward Tenthoff tells investors in a research note. ASLAN004 caused complete inhibition of phosphorylation of STAT6 within one hour lasting for greater than 29 days, adds the analyst. He believes these results present the opportunity for once-monthly dosing of ASLAN004 with comparable activity to Regeneron’s (REGN) Dupixent. Tenthoff reiterates an Overweight rating on Aslan Pharmaceuticals with a $7 price target.
Myriad traded lower on ‘minor’ United Healthcare change, says Piper Jaffray
Shares of Myriad Genetics closed Friday down 4% after United Healthcare (UNH) added a Current Procedural Terminology code and simplified the coverage rationale on its existing medical policy for pharmacogenetics, Piper Jaffray analyst William Quirk tells investors in a research note. The updated policy does not include a review of the Genesight dossier/Guided study, says the analyst. He views the change at United Healthcare as “minor” and keeps an Overweight rating on Myriad Genetics. Quirk continues to look for positive Genesight coverage.
Roche combo with chemo shows anti-tumor activity in early breast cancer trial
Roche’s ipatasertib in combination with Tecentriq and chemotherapy shows promising anti-tumour activity in triple-negative breast cancer in early phase trial
- Data from Phase Ib study to be presented at American Association for Cancer Research (AACR) 2019 annual congress
- 73% overall response rate (ORR) irrespective of PD-L1 status or PI3KCA/AKT1/PTEN alteration status
Roche (SIX: RO, ROG; OTCQX: RHHBY) will today present the initial results from a Phase Ib study evaluating the efficacy and safety for the combination of ipatasertib, Tecentriq® (atezolizumab) and chemotherapy (paclitaxel or nab-paclitaxel (Abraxane® [paclitaxel albumin-bound particles for injectable suspension]) as a first-line treatment option for people with advanced triple-negative breast cancer (TNBC). Combination treatment demonstrated a confirmed objective response rate (ORR) of 73% (95% CI 53-88%), irrespective of tumour biomarker status. The median duration of follow-up was 6.1 months (range 3.1-10.6). Grade ≥3 adverse events occurred in 14 people (54%); the most common all-grade adverse events were diarrhea (88%; grade ≥3 19%) and rash (69%; grade ≥3 27%).
‘We are enthusiastic about the potential of this combination in triple-negative breast cancer, an aggressive type of breast cancer,’ said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. ‘These early results support the contribution of ipatasertib to our combination treatment approach in TNBC and reinforce our vision to develop medicines that may benefit patients with this challenging disease.’
Trial enrolment for the Phase 1b study is ongoing. Later this year, Roche will initiate a pivotal multi-center, randomised, double-blind Phase III study investigating the combination of ipatasertib, atezolizumab and paclitaxel as first-line therapy for locally advanced/metastatic triple-negative breast cancer.
Takeda Gets EMA Nod for Subcutaneous Ulcerative Colitis, Crohn’s Application
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (‘Takeda’) today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Line Extension Application for a subcutaneous (SC) formulation of the gut-selective biologic vedolizumab for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD). Takeda proposes to make vedolizumab SC available in both pre-filled syringe and pen options.
‘This regulatory application marks an important milestone in our continued commitment to delivering innovative medicines and treatment modalities that meet the diverse needs of patients living with ulcerative colitis and Crohn’s disease across Europe,’ said Adam Zaeske, Head, GI Franchise, Europe and Canada Business Unit, Takeda. ‘If approved, a subcutaneous formulation of vedolizumab, together with the currently available intravenous option, will provide greater choice, enhancing the patient experience in line with their treatment preferences and lifestyle.’
Subscribe to:
Posts (Atom)