All The Most Important Pharmaceutical News Stories Of The Week – March 2018 – Week #3
MorphoSys Reports Updated Data from L-MIND Study of MOR208 plus Lenalidomide in Aggressive Lymphoma (r/r DLBCL)
March 13, 2018
MorphoSys AG has reported updated data from the ongoing single-arm phase 2 clinical trial known as L-MIND. L-MIND is designed to investigate the antibody MOR208 plus lenalidomide in patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL) who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT). MOR208 is an investigational Fc-engineered monoclonal antibody directed against CD19 and is currently in clinical development in blood cancer indications.
AbbVie Announces Positive Topline Results from Second Phase 3 Study Evaluating Investigational Elagolix in Women with Uterine Fibroids
March 13, 2018
AbbVie, in cooperation with Neurocrine Biosciences, Inc., has announced that the Phase 3 ELARIS UF-II study (M12-817) of elagolix met its primary endpoint. Results from the second of two pivotal Phase 3 studies demonstrated at month six that elagolix (300 mg twice daily), in combination with low-dose hormone (add-back) therapy (estradiol 1.0 mg / norethindrone acetate 0.5 mg), reduced heavy menstrual bleeding with 76.2 percent (p<0.001) of women with uterine fibroids achieving clinical response compared to placebo (10.1 percent), as measured by the alkaline hematin method. Clinical response was defined as menstrual blood loss volume of less than 80 mL during month six and a 50 percent or greater reduction in menstrual blood loss volume from baseline to month six. The study also met all ranked secondary endpoints (p<0.02) at month six.
Research from Bristol-Myers Squibb’s Innovative Oncology Development Program to Be Presented at AACR 2018 Demonstrates Commitment to Advancing Precision Medicine Research for Patients with Cancer
March 14, 2018
Bristol-Myers Squibb Company has announced the presentation of new data showcasing advances in the science of Immuno-Oncology at the American Association for Cancer Research (AACR) Annual Meeting in Chicago from April 14-18. Investigations of novel agents and Opdivo (nivolumab)-based combinations will be featured in 24 abstracts, including six late-breaking or oral presentations, across seven therapeutic areas. Abstracts to be presented include the first disclosure of data from the Phase 3 CheckMate -227 trial evaluating the combination of Opdivo plus Yervoy (ipilimumab) in first-line non-small cell lung cancer patients with high tumor mutational burden (?10 mutations/megabase), as well as two-year overall survival data from pivotal studies of Opdivo in bladder and head and neck cancers. The Company will also present the first clinical data on its investigational anti-CD73 antibody in combination with Opdivo.
March 15, 2018
Adaptimmune Therapeutics plc, has reported three partial responses (two confirmed and one to be confirmed), and one stable disease in the first four patients dosed with NY-ESO SPEAR T-cells in a second solid tumor: myxoid/ round cell liposarcoma (MRCLS). Patients tolerated treatment well with cytokine release syndrome (CRS) managed following standard treatment guidelines. GlaxoSmithKline plc exercised its option to exclusively license the right to research, develop, and commercialize NY-ESO SPEAR T-cell therapy program in September 2017. Transition of this program to GSK is ongoing.
Janssen Announces U.S. FDA Breakthrough Therapy Designation for Erdafitinib in the Treatment of Metastatic Urothelial Cancer
March 15, 2018
Janssen has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for erdafitinib in the treatment of urothelial cancer. Urothelial cancer, most frequently in the bladder, is the sixth most common type of cancer in the U.S. A Breakthrough Therapy Designation is granted to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition. The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.
Alexion Announces Positive Top-Line Results Showing Successful Phase 3 Clinical Study Of ALXN1210 In Complement Inhibitor Treatment-Naïve Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
March 15, 2018
Alexion Pharmaceuticals, Inc. has announced that the pivotal Phase 3 study of ALXN1210, the Company’s investigational long-acting C5 complement inhibitor, demonstrated non-inferiority to Soliris® (eculizumab) in complement inhibitor treatment-naïve patients with paroxysmal nocturnal hemoglobinuria (PNH) based on the co-primary endpoints of transfusion avoidance and normalization of lactate dehydrogenase (LDH) levels, a direct marker of complement-mediated hemolysis in PNH. The study also demonstrated non-inferiority on all four key secondary endpoints: percentage change from baseline in LDH levels, change from baseline in quality of life as assessed by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale, proportion of patients with breakthrough hemolysis, and proportion of patients with stabilized hemoglobin levels. In addition, numeric results for all six endpoints favored ALXN1210. There were no notable differences in the safety profiles for ALXN1210 and Soliris®.
March 15, 2018
Ionis Pharmaceuticals and Akcea Therapeutics, Inc., an affiliate of Ionis, have announced an exclusive, worldwide license by Ionis to Akcea for inotersen and AKCEA-TTR-LRx, formerly IONIS-TTR-LRx, in a transaction potentially worth up to approximately $1.7 billion to Ionis plus profit sharing payments.This transaction strengthens the companies’ ability to successfully launch inotersen upon approval by leveraging the commercial preparations carried out by Ionis along with Akcea’s commercial infrastructure and capabilities. The newly combined Akcea team is preparing to launch inotersen in the U.S. and EU following planned approvals in mid-2018 to treat people with hereditary transthyretin amyloidosis, or hATTR, a systemic, progressive and fatal disease. The companies are also developing AKCEA-TTR-LRx for hereditary and wild-type forms of ATTR. AKCEA-TTR-LRx is planned to enter clinical development in 2018.
Lundbeck to acquire Prexton Therapeutics adding foliglurax in clinical phase II to its pipeline of innovative treatments for patients suffering from Parkinson’s disease
March 16, 2018
H. Lundbeck A/S (Lundbeck) and Prexton Therapeutics BV (Prexton) have announced signing of a definitive agreement in which Lundbeck will acquire Prexton. Under terms of the agreement, Lundbeck will pay EUR 100 million upfront and is furthermore required to later pay up to EUR 805 million in development and sales milestones to the group of current owners. By acquiring Prexton, Lundbeck will obtain global rights of an attractive compound (foliglurax) which currently is in clinical phase II testing for symptomatic treatment of OFF-time reduction in Parkinson’s disease and dyskinesia including Levodopa Induced Dyskinesia (LID). First data from the ongoing clinical phase II programme is expected to be available during the first half of 2019.
FDA Approves Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) for the Treatment of Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
March 16, 2018
Global biotherapeutics leader CSL Behring has announced that the U.S. Food and Drug Administration (FDA) approved Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) as the first and only subcutaneous immunoglobulin (SCIg) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment. The approval was based on data from the Phase III PATH (Polyneuropathy and Treatment with Hizentra) study, which is the largest controlled clinical study in CIDP patients to date. CIDP is a rare autoimmune disorder that affects the peripheral nerves and may cause permanent nerve damage.
Top Pharma News of the Week – March 19th last edit: 2018-03-20T20:44:32+00:00 da