On May 11, 2017 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that the results of the Japanese phase III study (J-ALEX) of Alecensa, in patients with ALK fusion gene positive non-small cell lung cancer (NSCLC), were published in the electronic version of "The Lancet" on May 11, 2017 (Press release, Chugai, MAY 10, 2017, View Source [SID1234519004]). Schedule your 30 min Free 1stOncology Demo! (http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)30565-2/fulltext)
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The initial results of the J-ALEX study were presented at a session of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting held in Chicago, on June 6, 2016.
"The publication of the J-ALEX study results in ‘The Lancet’ assures the firm position of Alecensa in the first line therapy of patient with ALK fusion gene positive NSCLC," said Dr. Yasushi Ito, Senior Vice President, Head of Project & Lifecycle Management Unit. "We believe that Alecensa will also contribute to improving the outcomes for patients in first line therapy, as well as second line therapy in the future."
The J-ALEX study was an open-label, randomized phase III study that compares the efficacy and safety between Alecensa and crizotinib. The J-ALEX study enrolled 207 ALK-inhibitor naïve patients with ALK fusion gene positive advanced or recurrent NSCLC, who either had not undergone chemotherapy or had undergone one chemotherapy regimen. The primary endpoint of the J-ALEX study was progression free survival (PFS) as assessed by an independent review board. The secondary endpoints included overall survival, objective response rate, safety, and other endpoints.
The PFS hazard ratio of the Alecensa arm to the crizotinib arm was 0.34 (99.7% CI: 0.17-0.71, stratified log-rank p<0.0001) and Alecensa demonstrated significantly prolonged PFS. Median PFS was not reached (95% CI: 20.3-Not Estimated) in the Alecensa arm while it was 10.2 months (95%CI: 8.2-12.0) in the crizotinib arm. In the Alecensa arm, constipation (35%) was an adverse event (AE) with >30% frequency, while in the crizotinib arm nausea (74%), diarrhea (73%), vomiting (58%), visual disturbance (55%), dysgeusia (52%), constipation (44%), ALT elevation (32%), and AST elevation (31%) were each seen in >30% patients. Grade 3-4 AEs occurred in 26% of the Alecensa arm and in 52% of the crizotinib arm, there were no treatment-related deaths in either arm.
In February 2016, Chugai carried out a prospectively-defined interim analysis and had an independent data monitoring committee examine the results. Since the results showed that the Alecensa arm significantly prolonged the PFS, the committee decided to recommend an early discontinuation of the J-ALEX study.
Based on the results of the J-ALEX study, Alecensa was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration in September 2016 for first line therapy of patients with ALK-positive non-small cell lung cancer.
Author: [email protected]
Astellas Announces Decision to Discontinue ASP8273 Treatment and Close Randomization for Clinical Study Protocol 8273-CL-0302
On May 11, 2017 Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") reported the discontinuation of ASP8273 treatment arm in the the late-stage SOLAR trial evaluating the efficacy and safety of ASP8273 versus erlotinib/gefitinib for the 1st line treatment metastatic or advanced unresectable non-small cell lung cancer (NSCLC) harboring sensitizing epidermal growth factor receptor (EGFR) mutation (Press release, Astellas, MAY 11, 2017, View Source [SID1234519003]).
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Following a recommendation by the trial’s Independent Data Monitoring Committee (IDMC), Astellas is voluntarily closing study randomization and is informing investigators that ASP8273 treatment must be discontinued. Astellas is also planning to terminate future development programs for ASP8273 in NSCLC following its governance process.
"We are disappointed to be discontinuing the ASP8273 program and want to thank the patients and physicians involved in the program for their commitment to seeking new treatments for patients with non-small cell lung cancer," said Steven Benner, M.D., senior vice president and global therapeutic area head, oncology development, Astellas.
No new patients are being enrolled in ASP8273 trials and all patients currently receiving ASP8273 are encouraged to speak with their physician about their treatment.
InhibOx relauches as Oxford Drug Design
On May 10, 2017 InhibOx reported that it has relaunched as Oxford Drug Design to reflect its transition to a biotechnology company focused on internal drug discovery (Press release, Oxford Drug Design, MAY 10, 2017, View Source [SID1234533622]). Our lead antibacterial programme has identified compounds with the potential to be developed into therapies for Gram-negative bacterial infections, including against strains resistant to multiple current antibacterial drug classes. In the European Union alone, drug-resistant bacteria are estimated to cause 25,000 deaths and cost more than .5 billion every year in healthcare expenses and productivity losses. Compound design is supported by a proprietary technology platform in cheminformatics, 3D molecular similarity and computer-aided drug design that has been built up over 10 years of research and development.
The potential of our programme has been validated by the award of a prestigious Innovate UK Biomedical Catalyst grant to accelerate programme progression.
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10-Q – Quarterly report [Sections 13 or 15(d)]
Titan Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .
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10-Q – Quarterly report [Sections 13 or 15(d)]
Mannkind has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Mannkind, 2017, MAY 10, 2017, View Source [SID1234521709]).
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