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novartis ag-sponsored adr (NVS) Key Developments

Novartis AG Highlights New CTL019 Clinical Data Showing Complete Remissions in Children and Young Adults with Relapsed/Refractory Acute Lymphoblastic Leukemia

Novartis AG announced new CTL019 clinical data showing complete remissions in children and young adults with relapsed/refractory acute lymphoblastic leukemia. Findings from continued clinical studies of investigational chimeric antigen receptor (CAR) therapy, CTL019, demonstrate its potential role in the treatment of certain types of lymphocytic leukemia. In one long-term study of pediatric patients with acute lymphoblastic leukemia (ALL), results showed that 36 of 39 pediatric patients with relapsed/refractory (r/r) ALL, or 92%, experienced complete remissions (CR) with CTL019([1]). These results, which will be presented in an oral session at the 56th American Society of Hematology (ASH) annual meeting in San Francisco, continue to increase scientific understanding of CTL019 (Abstract #380, December 8, 10:45 AM)([1]) . Additional abstracts will be presented at ASH that evaluate the efficacy and safety of CTL019 in the treatment of B cell cancers including ALL, chronic lymphocytic leukemia (CLL) and B cell non-Hodgkin lymphoma (NHL). Additional highlights of the pediatric r/r ALL study include findings that patients have ongoing CR. Median follow-up was 6 months. Sustained remissions were achieved up to one year or more with 6-month event-free survival of 70% and overall survival of 75%, in most cases without further therapy([1]) . The probability of six-month CTL019 persistence was 68%, which was accompanied by B cell aplasia, a pharmacodynamic marker of CTL019 persistence and function([2]) . Persistence of CTL019 cells detected by flow cytometry and/or qPCR, and accompanied by B cell aplasia, continued for up to 30 months after infusion in patients with ongoing responses. All responding patients developed cytokine release syndrome (CRS) at peak T cell expansion. Treatment for CRS was required for hemodynamic or respiratory instability in 33% of patients and CRS was managed with an IL-6 receptor antagonist, together with corticosteroids in five patients. These events were delayed, and few patients experienced infusional toxicities, including infusion-associated fever. Also included among the presentations at ASH is a study investigating CTL019 in the treatment of individuals with CD19+ B cell lymphomas that reveals complete responses in patients with advanced, relapsed or refractory diffuse large B-cell lymphoma and follicular lymphoma. In addition, data will be presented on three cases of refractory cytokine release syndrome (CRS) in adult patients with ALL. Additional CTL019 Highlights at ASH include: Randomized, Phase II Dose Optimization Study of Chimeric Antigen Receptor Modified T Cells Directed Against CD19 (CTL019) in Patients with Relapsed, Refractory CLL. Cytokine Release Syndrome (CRS) after Chimeric Antigen Receptor (CAR) T Cell Therapy for Relapsed/Refractory (R/R) CLL. Humoral Immunity and Plasma Cell Changes in Patients Responding to CD19-Specific Chimeric Antigen Receptor (CAR)-Modified T-cell Adoptive Immunotherapy. Novel Chimeric Antigen Receptor T cells for the Treatment of CD19-negative Relapses Occurring after CD19-targeted Immunotherapies. Novel Chimeric Antigen Receptor T Cells for the Treatment of Hodgkin Lymphoma. CTL019 uses CAR technology to reprogram a patient's own T cells to "hunt" cancer cells that express specific proteins, called CD19. After they have been reprogrammed, the T cells (now called CTL019) are re-introduced into the patient's blood; they proliferate and bind to the targeted CD19+ cancer cells and potentially kill these tumor cells. Because CTL019 is an investigational therapy, the safety and efficacy profile has not yet been established. Access to investigational therapies is available only through carefully controlled and monitored clinical trials. These trials are designed to better understand the potential benefits and risks of the therapy. Because of uncertainty of clinical trials, there is no guarantee that CTL019 will ever be commercially available anywhere in the world. After CTL019 infusion, cytokine release syndrome (CRS) occurs when the engineered cells become activated and multiply in the patient's body resulting in the release of cytokines. During CRS, patients typically experience varying degrees of flu-like symptoms with high fevers, nausea, muscle pain, and in some cases, low blood pressure and breathing difficulties. CRS severity correlates with disease burden. Additionally, CRS also can occur in other non-CAR therapy settings including some monoclonal antibodies.

Novartis AG Announces Joint Venture with GlaxoSmithKline plc

Novartis AG has agreed to divest Habitrol, its nicotine replacement therapy patch, to settle FTC charges that its consumer health care products joint venture with GlaxoSmithKline would likely be anticompetitive. GSK currently sells its own nicotine replacement patch, Nicoderm CQ. Under the terms of the proposed joint venture agreement, GSK will control the joint venture and contribute, among other products, its nicotine patch business. Novartis will have a 36.5% interest in the joint venture, and without the divestitures required by the proposed order, would continue to own the Habitrol business, which had U.S. sales of more than $58 million in 2013. Consumers use nicotine patches to reduce their nicotine intake gradually while quitting smoking. According to the FTC’s complaint, Novartis and GSK are the only companies that market branded nicotine patches in the United States, and two of only three companies that supply private label patches to retailers. Without the divestiture contained in the proposed settlement, Novartis’s ownership of both Habitrol and a substantial interest in the joint venture that sells GSK’s nicotine patches would substantially reduce competition and lead to higher prices for Habitrol and Novartis’s private-label patches.

Novartis Announces Results from the Pivotal Phase III FUTURE 1 and FUTURE 2 Studies

Novartis announced results from the pivotal Phase III FUTURE 1 and FUTURE 2 studies showing AIN457 (secukinumab) met primary endpoints demonstrating statistically significant improvement of the signs and symptoms of psoriatic arthritis (PsA) versus placebo. PsA is part of a spectrum of long-term diseases impacting joints, known as spondyloarthritis (SpA). There is a high unmet need for new treatment options for patients with PsA and approximately 45% of people are dissatisfied with their treatments. Secukinumab binds to and neutralizes interleukin-17A (IL-17A), which has been shown to play an important role in the development of inflammatory diseases. These results are being presented at the American College of Rheumatology (ACR) Annual Meeting in Boston. Statistically significant improvements in signs and symptoms of PsA were achieved with secukinumab versus placebo at Week 24, as measured by a 20% reduction in the American College of Rheumatology (ACR20) response criteria, a standard tool used to assess improvement. Between 50% to 54% of secukinumab patients achieved ACR20 in both FUTURE 1 (p<0.0001) and FUTURE 2 (p<0.0001). This is in comparison to 17.3% and 15.3% of placebo patients who achieved ACR20, respectively. Exploratory analyses in FUTURE 1 showed more secukinumab-treated patients in the 75 mg (20.3%) and 150 mg (20.8%) dose groups experienced ACR20 responses by Week 1 versus placebo (5.4%) (p<0.0001). In FUTURE 2, more secukinumab-treated patients in the 150 mg (42.0%) and 300 mg (37.0%) dose groups experienced ACR20 responses by Week 3 (150 mg p<0.0001;300 mg p<0.001) versus placebo (15.3%); secukinumab-treated patients who received the 75 mg (23.2%) dose did not achieve a statistically significant response. In an additional exploratory analysis in FUTURE 1, a majority of secukinumab-treated patients achieving ACR20 responses at Week 24 also maintained the response at Week 52 with continued treatment. Additional analyses evaluated clinical benefits in patients who had not been previously treated with anti-TNF therapies (anti-TNF naïve) and also in patients who had an inadequate or no response to anti-TNFs. Those who had prior exposure to anti-TNFs included 29.5% (FUTURE 1) and 35.0% (FUTURE 2) of study participants. In FUTURE 1, patients on secukinumab had significantly less progression of joint structural damage compared to placebo, as evaluated by erosion and joint narrowing scores. Improvements in joint damage were shown in both anti-TNF naïve patients and in the patients with inadequate or no response to anti-TNFs. Additionally, secukinumab demonstrated significant improvements in skin psoriasis in both FUTURE 1 and FUTURE 2 compared to placebo. Secukinumab was well tolerated in both studies, with a safety profile generally consistent with that observed in the psoriasis clinical trial program involving nearly 4,000 patients. In FUTURE 1, the most common adverse events (AEs) were nasopharyngitis, headache, upper respiratory tract infection, hypercholesterolaemia (increased lipid levels), and nausea. In FUTURE 1, 60.4% (75 mg), 64.9% (150 mg) and 58.4% (placebo) of patients reported an AE. Serious adverse event (SAE) rates were 2.5%, 4.5%, and 5.0%, respectively. In FUTURE 2, the most common AEs were upper respiratory tract infection, nasopharyngitis, headache, nausea, diarrhea, and urinary tract infection. In FUTURE 2, 53.8% of patients in the pooled secukinumab group and 58.2% in the placebo group reported an AE. SAE rates were 3.3% and 2.0%, respectively. FUTURE 1 and FUTURE 2 are multi-center, randomized, placebo-controlled Phase III studies to evaluate the efficacy of IL-17A inhibition with secukinumab in PsA. In FUTURE 1, patients received an intravenous loading dose of 10 mg/kg every two weeks for the first four weeks of treatment, followed by monthly subcutaneous dose of 75 mg or 150 mg compared to placebo. FUTURE 2 patients received a subcutaneous loading dose of 75 mg, 150 mg, or 300 mg of secukinumab every week for the first four weeks of treatment, followed by the same monthly subcutaneous maintenance dose compared to placebo. The intravenous loading period used in FUTURE 1 was designed to provide high systemic exposure for induction of response, in keeping with the initial proof of concept study in PsA with secukinumab. FUTURE 2 utilized an administration route (subcutaneous loading dose) and dose range (up to 300 mg) that is more consistent with the psoriasis program. A combined total of more than 1,000 patients were enrolled in the studies.

Novartis Announces Results from MEASURE 1 and MEASURE 2 Pivotal Phase III Studies of AIN457 (secukinumab) in Ankylosing Spondylitis

Novartis announced results from the MEASURE 1 and MEASURE 2 pivotal Phase III studies of AIN457 (secukinumab) in ankylosing spondylitis (AS). In the studies, secukinumab met the primary endpoint demonstrating statistically significant improvements versus placebo in the signs and symptoms of AS. AS is a common type of spondyloarthritis (SpA), a spectrum of long-term inflammatory diseases impacting joints. Detailed study results will be presented during a plenary session (MEASURE 1) and in a poster presentation (MEASURE 2) at the American College of Rheumatology (ACR) Annual Meeting in Boston. Statistically significant improvements in signs and symptoms of AS were achieved with secukinumab versus placebo at Week 16, as measured by at least 20% improvement in the Assessment of Spondyloarthritis International Society criteria (ASAS20), a standard tool used to assess clinical improvement in AS. More than 60% of secukinumab 150 mg treated patients achieved an ASAS20 response in MEASURE 1 (p<0.0001) and MEASURE 2 (p<0.001). This is in comparison to 28.7% and 28.4% of placebo patients who achieved an ASAS20 response in MEASURE 1 and MEASURE 2, respectively.

QIAGEN N.V. Enters into Master Collaboration Agreement with Novartis AG

QIAGEN N.V. announced it has entered into a master collaboration agreement with Novartis AG to enable the development and commercialization of companion diagnostics to be paired with existing Novartis pharmaceutical products as well as compounds in its development pipeline. The non-exclusive agreement with Novartis creates a framework for collaborations that would include developing QIAGEN companion diagnostics to guide treatment decisions for Novartis pharmaceutical products. The scope of the collaboration can cover all QIAGEN platforms, indications or biomarkers. The collaboration with Novartis is the ninth master framework agreement reached by QIAGEN for the development of companion diagnostics, underscoring its position as the preferred partner to pharma companies. QIAGEN is pursuing more than 20 collaborative projects with Pharma and biotech companies to develop, validate and market companion diagnostics designed to guide the treatment of cancers and other diseases. Around the world, QIAGEN already markets companion diagnostics based on molecular biomarkers, and the company has a growing portfolio of novel targets in development. The companion diagnostic programs span a range of platforms for molecular testing. A number of the diagnostics are real-time PCR assays for analysis on QIAGEN's Rotor-Gene Q, a component of the QIAsymphony family of automated instruments.


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