Novartis Highlights CTL019 Data Showing its Potential in the Treatment of Specific Types of Hard-To-Treat Non-Hodgkin Lymphoma
Jun 1 15
Novartis announced that it is highlighting data from an ongoing Phase II clinical study of CTL019, an investigational chimeric antigen receptor (CAR) T cell therapy, that indicate its potential in the treatment of specific types of hard-to-treat non-Hodgkin lymphoma. Findings from the ongoing study conducted by the University of Pennsylvania'sPerelman School of Medicine (Penn) in adults with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) found an overall response rate (ORR) of 100% in patients with FL and 50% in patients with DLBCL. Thirteen of 19 evaluable patients responded to the therapy. Eleven achieved a complete response (CR) and two experienced a partial response (PR) to treatment. These results will be presented in an oral session at the 51stAmerican Society of Clinical Oncology (ASCO) Annual Meeting on June 1, 2015. Study results include 19 adult patients (12 with DLBCL and seven with FL) who were evaluable for response. The study found that six patients with a PR to treatment at three months achieved a CR by six months. Two patients with a PR experienced disease progression at 6 and 12 months after treatment. Median patient follow-up is 274 days for the patients with DLBCL and 290 days for the patients with FL. In the study, two patients developed cytokine release syndrome (CRS) of grade 3 or higher at peak T cell expansion. Additional CTL019 data being presented at ASCO include the preliminary safety and efficacy findings of a Phase I study investigating the use of CTL019 in the treatment of multiple myeloma. This study adds to the growing body of data on CARTs and supports the advancement of the expanding pre-clinical and early clinical research pipeline at Novartis. Novartis has initiated a Phase II multi-center global study of CTL019 in pediatric patients with r/r acute lymphoblastic leukemia (ALL). This study has opened in the United States, with the intention of expanding into other countries as soon as possible. Further, Novartis has begun to process patient cells at its cell processing facility in Morris Plains, N.J., and will utilize the facility in the Phase II multi-center global study. The facility is the first US Food and Drug Administration (FDA)-approved Good Manufacturing Practices quality site for a cell therapy.
Novartis Presents for Zykadia and Combination of Tafinlar and Mekinist in Certain NSCLC Patients with Unmet Needs
Jun 1 15
Novartis announced new data from two Phase II studies of Zykadia (ceritinib), as well as one Phase II study of Tafinlar (dabrafenib) in combination with Mekinist (trametinib) in certain patients with non-small cell lung cancer (NSCLC). The results of the Zykadia studies – ASCEND-2 and ASCEND-3 – reinforce the efficacy of the medicine in patients with anaplastic lymphoma kinase-positive (ALK+) NSCLC who had received previous treatment with an ALK inhibitor and in those receiving an ALK-targeted therapy for the first time. Overall response rates (ORR) seen in these trials were 38.6% and 63.7%, respectively, based upon investigator assessment. Comparable ORR results were observed in patients with ALK+ NSCLC who entered the studies with brain metastases (33% and 58%, respectively). Separately, the study of dabrafenib in combination with trametinib in patients with metastatic BRAF V600E-mutation positive NSCLC who had failed at least one round of chemotherapy demonstrated an ORR of 63% in this population3. ASCEND-2 is a Phase II single-arm, open-label, multicenter study which included 140 adults with ALK+ NSCLC who had been previously treated with chemotherapy and crizotinib. In addition to the ORR of 38.6% [95% CI: 30.5, 47.2%], patients in the trial demonstrated a median duration of response (DOR) of 9.7 months [95% CI: 7.1, 11.1 months] and a median progression-free survival (PFS) of 5.7 months [95% CI: 5.4, 7.6 months], based on investigator assessment, following treatment with Zykadia. The most frequent adverse events (incidence >50%) were nausea (81.4%), diarrhea (80.0%), and vomiting (62.9%)1. In the single-arm, two-stage, Phase II trial, patients with metastatic NSCLC who had the BRAF V600E mutation and failed at least one line of chemotherapy took 150 mg of Tafinlar twice daily and 2 mg of Mekinist once daily. The primary endpoint of the trial was investigator-assessed ORR. The ORR among 24 patients evaluable for efficacy was 63% [95% CI: 40.6, 81.2%], with responses being observed by the first scan (6 weeks), and disease control rate for >12 weeks was 88% [95% CI: 67.6, 97.3%]. Independent review response rates were consistent with investigator-assessed response. The most common adverse events (incidence >20%) among patients included in this analysis were pyrexia, diarrhea, nausea, vomiting, decreased appetite, asthenia, cough, peripheral edema, and rash3.
Rani Therapeutics Enters into a Collaboration with Novartis to Evaluate its Novel Oral Biotherapeutics Drug Delivery Platform
May 26 15
Rani Therapeutics announced that it has entered into a collaboration with Novartis to evaluate Rani's novel oral biotherapeutics drug delivery platform. The companies ave agreed to begin feasibility studies to evaluate how selected Novartis' proprietary biologics can be delivered into the bloodstream using Rani's unique route of administration. After successful completion of the feasibility studies, which will be conducted by Rani Therapeutics over the next 18-24 months, Novartis will have the right to enter into a more extensive collaboration with Rani and/or license Rani's technology for specific fields of use. Rani has developed a technology platform to convert injectable drugs such as TNF-alpha Inhibitors, interleukin antibodies, and basal insulin among others into pills. The company has demonstrated similar exposure to subcutaneous injections in pre-clinical studies, and has recently begun developing partnerships with pharmaceutical companies to test its platform with selected drugs.