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This edition of Onco-this-Week is Sponsored by

North America Immigration Law Group & Nano-Tag Biotechnologies

REGULATORY NEWS

Positive CHMP opinions for both Lenalidomide and Pomalidomid-based triplet combination regimens for multiple myeloma patients


“The CHMP positive opinions for our IMiD combinations, RVd and PVd represent very good news for patients with multiple myeloma in Europe,” said Nadim Ahmed, President, Hematology/Oncology for Celgene. “We look forward to potential EMA approvals, which would make these new triplet regimens available to patients, as we aim to improve patient outcomes across multiple stages of their disease.”

Breakthrough Therapy Designation granted to Ivosidenib + Azacitidine combination in IDH1 m+ adult unfit 1L AML patients


“Outcomes for newly diagnosed AML patients ineligible for intensive chemotherapy are still poor, and there are no approved options specifically for patients with an IDH1 mutation,” said Chris Bowden, M.D., chief medical officer at Agios. “The Breakthrough Therapy designation provides further support that combining azacitidine and ivosidenib for these patients has the potential to be a compelling treatment option.”

 

sBLA submitted to FDA for Daratumumab + VTD in 1L autologous stem cell transplant eligible Multiple myeloma patients based on Ph III CASSIOPEIA trial data


“This submission marks an important step in the pursuit of potential treatments for newly diagnosed patients living with multiple myeloma, as DARZALEX has the potential to improve clinical outcomes in combination with a standard regimen,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Vice President, Hematologic Malignancies Disease Area Leader, Janssen Research & Development, LLC. “We look forward to working closely with the FDA during review of the submission with the goal of bringing a new treatment option to newly diagnosed patients who are transplant eligible.”

Type II variation application submitted to the EMA for Daratumumab + VTD in 1L autologous stem cell transplant eligible Multiple myeloma patients based on Ph III CASSIOPEIA trial data


“With this submission we move another step closer to potentially expanding the DARZALEX label. This gives us hope that a new population of patients with multiple myeloma in first line may be able to gain access to DARZALEX,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

FDA BLA Submission for [Fam-] Trastuzumab Deruxtecan (DS-8201) in HER2 Positive metastatic Breast Cancer post T-DM1 to be accelerated to H1 2019


“We are pleased to confirm the acceleration of the [fam-] trastuzumab deruxtecan clinical development program for this potential indication in patients with HER2 positive metastatic breast cancer pretreated with T-DM1 ahead of schedule,” said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. “Simultaneously, we are committed to our aggressive development strategy evaluating the potential of [fam-] trastuzumab deruxtecan across a spectrum of HER2 expressing cancers including breast, gastric, lung and colorectal.”

 

TRIAL RESULTS

Positive topline results announced from Ph II EV-201 trial of Enfortumab vedotin in locally advanced or metastatic urothelial cancer


“After progression on platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor, patients with locally advanced or metastatic urothelial cancer are left with no approved standard of care treatment options,” said Steven Benner, M.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development at Astellas. “These data are very encouraging, and we look forward to discussing the data with relevant health authorities.”

Positive results observed in Ph II lurbinectedin monotherapy trial in relapsed SCLC patients


Ph II trial of Lurbinectidin met its primary endpoint of ORR in relapsed SCLC patients, as per by both investigator review and IRC (Independent Review Committee) review. Results to be announced in a major medical conference.

Ph II DECIDE trial of DPX-Survivac continues to show promising data in ovarian cancer patients


“This initial phase 2 data confirms the earlier trends we saw in the phase 1b portion of the study,” said Frederic Ors, Chief Executive Officer. “It supports the potential of DPX-Survivac as a monotherapy and the use of our patient selection strategy. We are encouraged by these early initial results and are committed to advancing this program quickly with the goal of providing an additional treatment option to patients with advanced ovarian cancer.”

 

TRIAL STATUSES

Patient enrolment completed in Ph II innovaTV 204 trial of tisotumab vedotin in recurrent or metastatic cervical cancer patients


“Cervical cancer is a devastating disease with a significant need to develop improved therapies for patients with metastatic disease who have progressed after treatment,” said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. “Completing enrollment in this potentially pivotal phase 2 trial marks an important step forward in evaluating tisotumab vedotin for women with previously treated recurrent and/or metastatic cervical cancer.”

Patient enrolment initiated in Ph II trial of Tesetaxel-checkpoint inhibitors combinations in mTNBC patients and in HER2neg metastatic breast cancer patients


“Taxane-IO combinations hold great promise for patients living with TNBC,” said Sara Tolaney, M.D., M.P.H., Associate Director, Susan F. Smith Center for Women’s Cancers, Director, Clinical Trials, Breast Oncology at Dana-Farber Cancer Institute and Principal Investigator of CONTESSA TRIO. “This study will investigate the safety and antitumor activity of tesetaxel, an orally administered taxane with a distinct tolerability and pharmacokinetic profile, in combination with three approved PD-(L)1 inhibitors. CONTESSA TRIO also will investigate tesetaxel monotherapy in elderly patients with MBC, a patient population in need of easier-to-take and better tolerated therapies.”

Ph II trial of MT-3724 initiated in CD20-targeting engineered toxin bodies (ETBs) in R/R DLBCL patients


“We have been highly encouraged by the responses observed in the Phase I/Ib study of MT-3724 in heavily pretreated DLBCL patients,” said Eric Poma, Ph.D., CEO and CSO of Molecular Templates. “This Phase II study largely replicates the Phase Ib expansion cohort, but with more clinical sites for enrollment, an independent data safety monitoring board, and independent central review for efficacy. Given the high level of unmet need in advanced DLBCL, we hope that this study will confirm that MT-3724 provides a meaningful benefit for this difficult to treat patient population.”

Enrolment started in Ph I/II trial of Telaglenastat + PARP Inhibitor Talazoparib in patients with advanced or metastatic solid tumors


“The initiation of this clinical trial of telaglenastat in combination with talazoparib marks the first of two clinical trials that will evaluate telaglenastat with approved Pfizer therapeutics as part of this collaboration,” said Susan Molineaux, PhD, president and chief executive officer of Calithera. “We believe these new combination trials have the potential to broaden the opportunities for telaglenastat to improve patient outcomes.”

Patient enrolment on track in pivotal Ph III INSPIRE trial of Rigosertib in high risk R/R MDS patients


“We are pleased to have passed the 75 percent completion of enrollment milestone and are on track with our anticipated timeline for completion of accrual to the INSPIRE study in the second half of 2019,” said Dr. Richard Woodman, Onconova’s Chief Medical Officer and Senior Vice President of Research & Development. “Rigosertib has the potential to be the first new MDS treatment in more than 15 years for a condition afflicting an estimated 59,000 patients in the United States.”

 

COLLABORATIONS

AstraZeneca and Daiichi Sankyo to develop and commercialize HER2-targeting ADC, Trastuzumab deruxtecan (DS-8201; [fam-] trastuzumab deruxtecan)


Pascal Soriot, Chief Executive Officer, said: “We believe that trastuzumab deruxtecan could become a transformative new medicine for the treatment of HER2-positive breast and gastric cancers. In addition, it has the potential to redefine breast cancer treatment as the first therapy for HER2-low expressing tumours. It also has the potential to treat other HER2-mutated or HER2-overexpressing cancers, including lung and colorectal cancers. We are proud to be working with Daiichi Sankyo, a long-term collaborator of AstraZeneca in other disease areas.”

 

About the Author: 

Richa earned her PhD at the National Brain Research Centre, India. For her thesis, she worked on the dreaded Glioblastoma multiforme. That was her first in-depth exposure to academic research in cancer biology. After her PhD, she expanded her research experience by working in the field of immunology at UCLA, USA. After her return to India, Richa switched to a corporate setting but continued her engagement with the cancer field. She is currently loving her work, which affords her the opportunity to continue developing her knowledge in the biomedical field of cancer. Outside of work, she enjoys watching, identifying and photographing birds.

Editor and Blog Design:

Abhi Dey

Abhi graduated from the Molecular Biophysics Unit of IISc (Bangalore, India) in 2011. As a Biomedical Scientist, he has worked with all three life-forms in his 13-year research career, viz., particulate, unicellular and multicellular. Currently, he is a Lead Scientist at MicroCures Inc. Previously, he served as an Assistant Scientist at Emory University (Atlanta, GA) studying mechanisms of tumor recurrence in kids with brain tumors. As a postdoctoral fellow, he was the recipient of two Young Investigator Awards from Alex Lemonade Stand Foundation (Philadelphia, PA) and Rockland Immunochemicals. His research has been funded by Northwestern Mutual Foundation (Milwaukee, WI), CURE Childhood Cancer Foundation (Atlanta, GA) and American Association for Cancer Research (AACR).  When he is not on the bench you will find him spending time with his family or exploring the world through traveling and blogging.

Image Sources: Wikipedia and Twitter

Cover image: “The image shows a section of a developing wild type mouse mammary gland immunostained for vimentin (red), beta-catenin (green) and DNA (blue). This is an example of a control image for experiments demonstrating the functions of the Elf5 protein. See: Chakrabarti et al. 2012. Elf5 inhibits the epithelial-mesenchymal transition in mammary gland development and breast cancer metastasis by transcriptionally repressing Snail2. Nat Cell Biol 14:1212-1222.” Source

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Disclaimer

The authors and editors for Onco-this-week declare no financial benefits or remuneration from the sponsors. The sponsorships support the non-profit organization PhD Career Support Group (PhD CSG). The research conducted by authors and editors is a voluntary effort to popularize science for the public on behalf of PhD CSG. 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 Club SciWri or PhD CSG. 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 Club SciWri or PhD CSG. This blog is strictly for news and information. It does not provide medical advice, diagnosis or treatment. 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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The contents of Club SciWri are the copyright of Ph.D. Career Support Group for STEM PhDs (A US Non-Profit 501(c)3, PhDCSG is an initiative of the alumni of the Indian Institute of Science, Bangalore. The primary aim of this group is to build a NETWORK among scientists, engineers, and entrepreneurs).

This work by Club SciWri is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

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