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MedNess: bite-size biopharma and medtech news

4th February, 2020

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Regulatory News
MAA to EU for Opdivo (nivolumab) + Yervoy (ipilimumab) combination in 1L TMB high NSCLC patients based on data from Ph 3 CheckMate -227 trial withdrawn; FDA application still in progress
“CheckMate -227 is a robust Phase 3 study of more than 1,700 patients. Opdivo plus Yervoy demonstrated a statistically and clinically significant overall survival benefit compared to chemotherapy for patients with first-line NSCLC. The durable survival benefit seen in CheckMate -227 is an important result for patients and we are disappointed with the CHMP’s position,” said Samit Hirawat, M.D., Chief Medical Officer, Bristol-Myers Squibb.
FDA grants priority review for NDA for selpercatinib (LOXO-292) in patients with advanced RET fusion-positive NSCLC, RET-mutant MTC and RET fusion-positive thyroid cancer; PDUFA: Q3, 2020
"We are pleased the FDA granted priority review status for the NDA for selpercatinib. This represents an important step toward providing a new precision therapy for people living with certain RET-driven cancers," said Anne White, president of Lilly Oncology. "Combined with the recent opening of our two Phase 3 selpercatinib clinical trials, we are thrilled with the positive momentum of this program and hope to deliver a practice-changing treatment to patients with RET-driven cancers as soon as possible."
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Trial Results
FAILED TRIAL: Ph 2/3 DISTINCT trial of Unituxin® (dinutuximab) R/R SCLC patients did not meet its primary efficacy objective of OS improvement
"We thank the principal investigators, patients and their families for participating in the DISTINCT study," said Gil Golden, M.D., Ph.D., Chief Medical Officer of United Therapeutics. "We're clearly disappointed with the DISTINCT results but we'll continue to seek out underappreciated avenues in our core therapeutic areas addressing rare diseases in oncology and pulmonary hypertension. In addition, we look forward to announcing the results of our INCREASE study by the end of the first quarter or shortly thereafter."
NUBEQA® (darolutamide) + ADT achieved the secondary endpoint of OS in nmCRPC cancer patients in Ph 3 ARAMIS trial
  • Phase III ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) trial investigated NUBEQA® (darolutamide) in men with non-metastatic castration-resistant prostate cancer (nmCRPC)
  • NUBEQA® (darolutamide) + ADT show a significant improvement in overall survival (OS) in patients receiving NUBEQA plus androgen deprivation therapy (ADT) compared to placebo plus ADT.
  • Results of ARAMIS previously published show a statistically significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS) of darolutamide plus ADT compared to placebo plus ADT; however OS data were not yet mature at the time of the MFS analysis. Detailed data on the updated OS and other additional endpoints as well as an update on longer term safety will be presented at an upcoming scientific meeting.
  • NUBEQA plus ADT demonstrated a statistically significant improvement in MFS, with a median MFS of 40.4 months versus 18.4 months with placebo plus ADT [HR=0.41, 95% CI (0.34, 0.50), p<0.0001].
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Trial/Program Status
First patient dosed in CSPC’s Chinese study of COPIKTRA® (Duvelisib) in R/R Follicular Lymphoma patients
"Building on CSPC’s strong track record of successfully developing and commercializing oncology products in China, we are pleased that this CSPC trial is now underway as they work to provide a new option for patients with follicular lymphoma in China, where there are limited options for this difficult to treat disease," said Brian Stuglik, Chief Executive Officer of Verastem Oncology. "The first patient dosed in this trial is a critical step in our mission to bring COPIKTRA to patients around the world."
Cohort 1 enrollment completed with no DLTs observed in Ph 1 ATTCK-34-01 trial of ACTR707 + trastuzumab in HER2+ advanced cancer patients
“Understanding the significant unmet need in advanced HER2+ malignancies, ACTR707 was engineered to potentially avoid the on-target, off-tumor toxicity that has hindered the development of traditional CAR T cells for solid tumor cancers,” said Jessica Sachs, M.D., Chief Medical Officer of Unum Therapeutics. “We are excited to continue this dose-escalation trial, having passed the DLT safety thresholds in this first, low-dose Cohort and we look forward to reporting additional data from multiple dose cohorts during 2020.”
Collated by : Richa Tewari, PhD
MedNess Plus
FDA announces actions to further the development of medical measures to counteract the spread of the novel Coronavirus
“We have a vital mission to protect and promote public health and the FDA is closely collaborating with our domestic and international public health partners to mitigate the impact of the novel coronavirus that emerged in Wuhan, China,” said FDA Commissioner Stephen M. Hahn, M.D. “We are actively leveraging the vast breadth of the FDA’s expertise and have begun employing the full range of our public health authorities to facilitate the development and availability of investigational medical products to help address this urgent public health situation.” “We are committed to keeping the American people informed as we prepare and respond to emerging public health threats, including the novel coronavirus,” said FDA Deputy Commissioner of Policy, Legislation and International Affairs Anna Abram. “The agency is committed to ensuring safe and effective medical countermeasures are available as quickly as possible to protect public health.”
FDA accepts Priority Review for the sBLA for Dupixent® in the treatment of moderate-to-severe atopic dermatitis in children aged 6 to 11 years
FDA recently accepted the Priority review for the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in the treatment of children 6 to 11 years with moderate-to-severe atopic dermatitis. It intends to be used as an add-on medication in case the topical prescription therapies are inadequate or are not supposed to be used. The decision was given in favor of Regeneron Pharmaceuticals Inc. and Sanofi. The probable action date for FDA’s decision is May 26, 2020. Dupixent has already been granted a Breakthrough Therapy Designation status for the treatment of severe atopic dermatitis in children of the same age group who do not respond adequately to the available topical medications. Dupixent has also been approved for the treatment of moderate-to-severe atopic dermatitis in patients 12 years and older. It is also used as a maintenance therapy along with the usual asthma medicines for the treatment of people aged 12 years and older with moderate-to-severe eosinophilic or oral steroid dependent asthma attacks.
FDA approves Palforzia for treatment of peanut allergy in children
“Peanut allergy affects approximately 1 million children in the U.S. and only 1 out of 5 of these children will outgrow their allergy. Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Even with strict avoidance, inadvertent exposures can and do occur. When used in conjunction with peanut avoidance, Palforzia provides an FDA-approved treatment option to help reduce the risk of these allergic reactions in children with peanut allergy.”
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Collated by : Esha Sehanobish, PhD
Medness Business
Onco-News
Verastem Oncology obtained worldwide development and commercialization rights to the RAF/MEK inhibitor CH5126766 (CKI27) from Chugai
“Based on the single-agent defactinib results in KRAS mutant NSCLC, we conducted an internal pre-clinical effort to identify drug classes that were synergistic with defactinib and saw the highest level of synergy in combination with MEK inhibitors and, specifically, with CH5126766,” said Dan Paterson, President and Chief Operating Officer of Verastem Oncology. “The exciting early clinical results led to our decision to enter into a partnership with Chugai for CH5126766 and accelerate the combination development program for patients with KRAS mutant cancers, which are highly aggressive and recurrent. We plan to initiate discussions with regulatory authorities about our development plans and to define the registration path early this year.”
FORMA reports achievement of early-stage clinical development milestones for assets licensed exclusively to Boehringer Ingelheim and Bristol-Myers Squibb
Frank Lee, CEO of FORMA said, "FORMA has a deep history of collaboration, and I’m excited about the achievement of these clinical milestones announced today. Our partnership with BI was among the early drug discovery initiatives focused on difficult-to-drug protein-protein interactions in cancer. We are gratified to see this pan-KRAS inhibitor, which BI licensed following early discovery work by FORMA, advance into the clinic and potentially offer a much-needed new therapy for patients with limited treatment options."
Sanofi announces the successful acquisition of Synthorx Inc.
Sanofi announces the successful acquisition of Synthorx, Inc. for $68 per share in cash. Sanofi completed this acquisition through the merger of Purchaser (its wholly owned subsidiary Thunder Acquisition Corp.) with and into Synthorx thus the latter becoming a surviving corporation and becoming an indirect and wholly owned subsidiary of Sanofi.
“The acquisition of Synthorx perfectly aligns with our R&D strategy, enhancing our position as an emerging leader in the area of oncology and immunology,” says Paul Hudson, Chief Executive Officer, Sanofi. “We gain access to both great scientists and science with THOR-707, an engineered not-alpha IL-2 for the treatment of solid tumors which induces strong immunological responses in vivo, additional intriguing pre-clinical assets, and a powerful platform that complements our ongoing oncology and immunology research.
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Arundithi Ananthanarayanan
I-cube
Debarati Banik
HealthIT
Mayur Vadhvani, PhD
Consulting Editor
Abhi Dey
Consulting Editor
Nisha Peter, PhD
Managing Editor
Ananda Ghosh, PhD
Founder
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The editors take care to share authentic information.  In case of any discrepancies please write to medness.newsletter@gmail.com
The sponsors do not have any influence on the nature or kind of the news/analysis reported in MedNess. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of Medness. Examples of analysis performed within this article are only examples. They should not be utilized in real-world analytic products as they are based only on very limited and dated open source information. Assumptions made within the analysis are not reflective of the position of anyone volunteering or working for Medness. This blog is strictly for news and information. It does not provide medical advice, diagnosis or treatment nor investment suggestions. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
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