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Onco-This-Week
7th May , 2019
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Drugs Approved
FDA approves Ivosidenib + Azacitidine in 1L IDH1m+ unfit AML patients based on Ph Ib data
“Despite several new AML medicines approved in the last two years, many newly diagnosed patients are still not eligible for existing therapies or combination regimens because of age and other comorbidities,” said Chris Bowden, M.D., chief medical officer at Agios. “With today’s additional TIBSOVO® approval, we are now able to provide a targeted, oral therapy to patients with an IDH1 mutation who may not have other treatment options. In addition, we are continuing our work to expand the utility of TIBSOVO® in newly diagnosed AML patients in ongoing Phase 3 trials in combination with both intensive chemotherapy and azacitidine." Read on to know more...
 
FDA approves trastuzumab emtansine in adjuvant HER2-positive early breast cancer patients based on Ph III KATHERINE results
“This approval is a significant treatment advance for HER2-positive early breast cancer. By working closely with the FDA and participating in the Real-Time Oncology Review pilot programme, we are able to make Kadcyla available for people with residual invasive disease after neoadjuvant therapy much sooner than anticipated,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “With every step forward in reducing the risk of disease recurrence, we come closer to the goal of helping each person with early breast cancer have the greatest opportunity for cure.” Read on...
Regulatory News
NDA accepted for ARi Darolutamide in nmCRPC patients based on Ph III ARAMIS trial data; Priority review granted
"Bayer is committed to addressing treatment gaps that exist along the continuum of care for men with prostate cancer," said Scott Z. Fields, M.D., senior vice president and head of Oncology Development at Bayer's Pharmaceutical Division. "With the NDA acceptance and Priority Review designation, we are an important step closer to bringing darolutamide to patients as quickly as possible."
Click Here for more.....
Onco-Trial Results

Long-term effectiveness of PRRT 90Y-DOTATOC and 177Lu-DOTATATE established in malignant SSR+ NETs

“This study clearly demonstrates the long-term efficacy of PRRT over more than a decade in patients with metastatic tumor disease of neuroendocrine origin,” explain Michael Gabriel, MD, and Irene J. Virgolini, MD, of the Department of Nuclear Medicine at the Medical University of Innsbruck in Austria. They add that the research shows, “PRRT can be repeatedly used with limited side effects. From this perspective, a relatively stable tumor situation can be achieved over many years in a large number of patients. None of the patients who were still alive at the end of the observation period were dialysis-dependent, and most of the patients showed a still very high KPI (key performance indicator), which underlines the positive effect of PRRT in terms of the quality of life.”

HTLV 2019: Encouraging preliminary data observed from Ph I trial of miRNA-155 inhibitor Cobomarsen in ATLL patients

“We are encouraged by the additional data announced today from our Phase 1 cobomarsen trial in ATLL patients,” stated Paul Rubin, M.D., Executive Vice President, R&D, at miRagen.  “Patients with the aggressive subtypes of ATLL have a very poor prognosis with few potential long-term treatment options.  The continued durability of disease stabilization observed in patients treated with cobomarsen, combined with the favorable tolerability profile, supports our belief that cobomarsen may be a meaningful potential treatment option for patients with aggressive forms of ATLL.”
"We are excited by the compelling efficacy demonstrated in the interim data of cosibelimab, with greater than 40% objective response rates in non-small cell lung cancer and cutaneous squamous cell carcinoma, as well as the strikingly high rate of patients with target lesion reductions across diverse tumor types," said James F. Oliviero, President and Chief Executive Officer of Checkpoint Therapeutics. "The goal of this study was to demonstrate that cosibelimab has a safety and efficacy profile consistent with marketed PD-(L)1 inhibitors, so we are thrilled to report these strong results for our potentially differentiated anti-PD-L1 antibody." 
Onco-Trial Status
“We are working with investigational sites to resume enrollment based on the amended protocol, through which we have sought to enhance the safety of patients participating in the study,” said Paul Foster, M.D., senior vice president and chief medical officer at Xencor.
“Clinical observations suggest cabozantinib promotes an immune-permissive environment, which could present an opportunity for additive or synergistic effects with immune checkpoint inhibitors,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “The mechanisms of action of single agent cabozantinib and the combination of nivolumab and ipilimumab are complementary, and each has demonstrated efficacy in advanced renal cell carcinoma. The further combination of these agents as a triplet regimen may offer promise to previously untreated patients with intermediate- or poor-risk disease, who are known to have poor treatment outcomes.”
Click Here for more exciting news on ongoing Trials....
Q1-2019 Financial Results 
  1. Amgen to present data on KRAS G12C inh AMG 510, BCMA-targeting BiTE AMG 420 and PSMA-targeting BiTE as announced in Q1 2019 results
  2. Pfizer reports Q1 2019 financial results and clinical programs updates
  3. Merck reports Q1 2019 financial results and clinical programs updates
  4. Incyte reports Q1 2019 financial results and clinical programs updates
  5. Lilly Oncology announces Q1 2019 results; shelves Prexasertib and LY3023414
  6. MacroGenics shares Q1 2019 results and updates from Margetuximab, B7-H3, PD-1 franchise and Flotetuzumab programs
  7. Mirati Therapeutics presents Q1 2019 results; intial clinical update on MRTX849 expected in H2 2019
  8. Arcus Bioscience announces Q1 2019 results and pipeline updates
  9. Idera Pharmaceutical reports Q1 results and provides updates on Tilsotolimod program
  10. CRISPR Therapeutics provides financial results for Q1 2019 and updates on CTX110 program
  11. AbbVie reports Q1 2019 financial results and 2018 events
  12. AstraZeneca announces Q1 2019 results
  13. BMS announces Q1 2019 results; Ph II CheckMate-714 trial fails to meet its primary endpoints
  14. Daiichi Sankyo announced consolidated financial results for year ended March 31, 2019 (Fiscal 2018)
  15. Seattle Genetics reports Q12019 financial results
Conference Coverage
ASCO 2019
  1. Abstracts from pivotal stage Oraxol (Oral paclitaxel and HM30181A) program and preliminary results from Oratecan (Oral irinotecan and HM30181A) Ph I trial to be presented
  2. TLR9 agonist SD-101 data to be presented
  3. Bria-IMT data from Ph I/IIa trial in advanced breast cancer patients to be presented
  4. NSCLC and AML clinical updates from AXL inhibitor Bemcentinib program to be presented
  5. Pembrolizumab monotherapy meets primary endpoint of non-inferior OS vs chemo in PD-L1+ve pts; Pembrolizumab + chemotherapy found not superior in OS vs chemo in Ph III KEYNOTE-062 trial in 1L GEJ/Gastric cancer pts
  6. TLR9 agonist SD-101 + Pembrolizumab data from Ph Ib/II trial in PD-(L)1 naive or ref melanoma, SCCHN patients to be presented
  7. Top studies to be presented at ASCO (including 5-yr survival data of Pembro in mNSCLC patients in KEYNOTE-001 trial)
  8. Updates from STING agonist ADU-S100 and anti-APRIL antibody BION-1301 to be presented
  9. Updates from CASSIOPEIA, MAIA, COLUMBA, CASTOR, POLLUX, CEPHEUS, SGNTV-001, innovaTV 208, COMPLEMENT 1 and PERSEUS trials to be presented
  10. PV10 updates from Ph I and Ib trials in mNET and cutaneous melanoma patients to be presented
ELCC 2019
  1. mOS NR at 20-month follow-up with Atezolizumab with Bev and Chemo in 1L non-sq and 2L EGFR/ALK+ mNSCLC in Ph III IMpower150 trial
  2. Updated Entrectinib data in overall and CNS positive cohorts from Ph I ALKA-372-001, STARTRK-1 and Ph II STARTRK-2 trials presented
  3. 77% ORR with Osimertinib in 1L EGFR+ NSCLC patients in Ph I AURA trial; supports Ph III FLAURA trial results and approval
ESMO GI 2019
  1. Update on allogeneic and autologous NKG2D-based CAR-T candidates in refractory mCRC patients to be presented
Editors' Desk
Content Editors 
Concept and Design Team
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The sponsors do not have any influence on the nature or kind of the news/analysis reported in Onco-this-Week. 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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Cover Image : Pixabay
Content Editors: Richa Tewari , Esha Sehanobish , Mayur Vadhvani and Abhinav Dey 
Concept and Design: Ananda Ghosh and Nisha Peter
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