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Onco-this-Week
20th August, 2019
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MedNess This Week

HIGHLIGHTS
Drug Approvals
Entrectinib gets FDA approval in ROS1+ve mNSCLC and NTRK gene fusion-positive solid tumors
“Rozlytrek’s FDA approval for two rare types of cancer is an important advance for patients, combining a targeted medicine and genomic testing to bring this new treatment option to patients who are waiting,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Rozlytrek is the first FDA-approved treatment that selectively targets both ROS1 and NTRK fusions, and, importantly, has also shown responses in these rare cancer types that have spread to the brain.”
European Commission approved Ibrutinib + obinutuzumab in 1L CLL patients and Ibrutinib + Rituximab in Waldenström's macroglobulinemia (WM) patients
“The data supporting both the CLL and WM approvals show significant improvements in progression free survival with the use of ibrutinib-based therapy versus the standard of care study comparators respectively,” said Dr Alessandra Tedeschi, Medical Director, Department of Hematology, Niguarda Hospital, Milan, Italy, and investigator in both the iNNOVATE and iLLUMINATE studies. “These approvals therefore provide healthcare professionals with new chemotherapy-free options for patients with these complex blood cancers.”
Fedratinib gets FDA approval in intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis patients
“Myelofibrosis can cause patients to suffer in many ways, including experiencing debilitating symptoms,” said Ruben Mesa, M.D., FACP, Director of the Mays Cancer Center at UT Health San Antonio Cancer Center MD Anderson. “There has not been a new treatment approved for this disease in nearly a decade. With INREBIC, physicians and patients now have another option available for myelofibrosis.”
Regulatory News
FDA granted Breakthrough Therapy Designation (BTD) for Acalabrutinib as a monotherapy treatment for adult CLL patients based on Ph III ELEVATE-TN and ASCEND trials data
José Baselga, Executive Vice President, Oncology R&D, said: “This is an important regulatory milestone for our work in haematology and for patients living with chronic lymphocytic leukaemia, a life-threatening disease. The Breakthrough Therapy Designation acknowledges the growing body of evidence that supports Calquence as a highly-selective Bruton tyrosine kinase inhibitor with the potential to offer patients a new, differentiated, chemotherapy-free treatment option with a favourable safety profile.”
Positive top-line results from Ph I and pivotal Ph III INVICTUS trial to support potential NDA submission to FDA for ripretinib for the treatment of patients with advanced, heavily-treated GIST patients
“We believe the updated data from our ongoing Phase 1 clinical study, with the additional six months of maturity from our last Phase 1 data cut-off, continue to support ripretinib’s potential across the broad range of KIT and PDGFRα mutations known to occur in patients with GIST following therapy with imatinib,” said Steve Hoerter, President and Chief Executive Officer of Deciphera. “In the updated data from the second-line cohort, we believe ripretinib has demonstrated encouraging clinical benefit based on the objective response rate, disease control rate and median progression free survival rates observed. These results strengthen our confidence in the INTRIGUE pivotal Phase 3 clinical study comparing ripretinib to sunitinib, the standard of care for patients receiving second-line treatment for GIST.”
Onco-Trial Results
Ph III PAOLA-1 trial of Olaparib in advanced ovarian cancer patients in 1L maintenance women met primary endpoint of PFS improvement
José Baselga, Executive Vice President, Oncology R&D, said: “The positive results from the PAOLA-1 trial demonstrate a clear potential benefit of adding Lynparza to the standard-treatment bevacizumab for women with advanced ovarian cancer. Following positive results from the SOLO-1 trial for women with a BRCA gene mutation, the PAOLA-1 trial marks yet another positive Phase III trial for Lynparza as a 1st-line maintenance treatment for women with advanced ovarian cancer. We look forward to discussing the results with global health authorities as soon as possible.”
Olaparib + Temozolomide combination showed clinical efficacy in R/R SCLC patients
“Small cell lung cancer, which accounts for about 15 percent of all lung cancers, historically has very poor outcomes, and novel treatment strategies are needed for this aggressive cancer type,” said Anna Farago, MD, PhD, assistant professor of medicine at Harvard Medical School and Massachusetts General Hospital Cancer Center in Boston. “This combinatorial therapy showed encouraging results in patients with relapsed SCLC, representing a new potential therapeutic strategy for these patients who typically have few effective treatment options.”
Updated results on twenty patients from the Ph II trial of VAL-083 in 1L MGMT-unmethylated Glioblastoma multiForme (GBM) patients reported
Dr. David Reardon, clinical director of the Center for Neuro-Oncology at the Dana-Farber Cancer Institute and Professor of Medicine at the Harvard Medical School, and Dr. John de Groot, Professor and Chairman ad interim in the Department of Neuro-Oncology at The University of Texas MD Anderson Cancer Center (MDACC), are considered key opinion leaders in the brain cancer field and currently serve as DelMar Scientific Advisory Board members.  Dr. Reardon commented, "Both John and I agree that we desperately need something better to offer our patients and we feel that VAL-083 has some promise and potential."
Onco-Trial Status/Progress
Ph I/II FIDES-02 trial of pan-FGFR inhibitor derazantinib initiated in patients with advanced urothelial cancer, including metastatic, or recurrent surgically unresectable disease, expressing FGFR gene aberrations
Dr. Marc Engelhardt, Chief Medical Officer, said: "We are very pleased starting this new study with derazantinib in urothelial cancer. Patients with advanced urothelial cancer currently have limited treatment options and there is a high unmet medical need, especially for targeted therapies in this common type of cancer. FGFR gene aberrations occur in about 15 to 20 percent of advanced urothelial cancers and have been established as oncogenic drivers." He added: "This is the first clinical study in which we are exploring derazantinib in combination with atezolizumab. This combination may become a promising new targeted treatment approach for patients with urothelial cancer. Based on in vitro data, derazantinib has the potential to enhance the response to atezolizumab's PD-L1 checkpoint inhibition."
Patient enrollment completed in ongoing Ph Ib/II CLASSICAL-Lung trial of pepinemab (VX15/2503) + avelumab in NSCLC patients
Maurice Zauderer, Ph.D., president and chief executive officer of Vaccinex, commented, “With the important milestone of full enrollment achieved, we anticipate the study’s primary completion by the end of 2019, with top-line results expected in the first half of 2020.”
Click Here for more Progress/status of ongoing trials
MedNess Business
Onco-News

Oncologie and Merck announced a collaborative Phase 2 clinical trial study to investigate Oncologie’s Bavituximab, an antibody that blocks phosphatidylserine, and Merck’s KEYTRUDA® in patients with advanced gastric or gastroesophageal cancer. The Phase 2 study is expected to enroll about 80 patients and aims to determine the safety and efficacy of combinatorial therapy in patients who have failed at least one line of treatment. 

"Gastric cancer is an area of significant unmet medical need in many parts of the world and we are committed to understanding the clinical benefit of Bavituximab and KEYTRUDA in this difficult-to-treat cancer," said Laura Benjamin, Ph.D., Founder and CEO of Oncologie. "This collaboration reflects a shared commitment to the goal of improving the lives of cancer patients in meaningful ways."

Jobs at Oncologie
Jobs at Merck & Co.

Monopar Therapeutics files IPO to raise $40 million for targeting radiotherapy side effects

Monopar Therapeutics, an Illinois-based biopharmaceutical company, has filed for an IPO to raise $40 million to target radiation-induced severe oral mucositis in cancer patients receiving radiation therapy. The cash will enable Monopar to start phase 3 trial this year for its candidate molecule Validive that is designed to deliver high concentration of API clonidine, an alpha-2 adrenergic receptor agonist, to the oropharynx which is the site of irradiation in the treatment of oropharyngeal cancer. Monopar will run an adaptive design trial and perform an interim analysis at 12 months followed by confirmatory second trial to de-risk the program.
BioPharma and MedTech

Juvenescence raises $100 million for longevity drug development

Juvenescence has raised $100 million to create therapeutics and technologies to combat diseases related to aging and to increase human longevity. The company has raised $165 million in last 18 months and is poised to create a longevity ecosystem bringing scientists, drug developers, machine learning experts and financial experts to develop 12 therapeutic candidates.

Click Here for more collaborations, acquisitions, mergers and licensing...
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Mayur Vadhvani, PhD
Business News
Abhi Dey
Consulting Editor
Arundithi Ananthanarayanan
I-cube
Nisha Peter, PhD
Managing Editor
Ananda Ghosh, PhD
Founder
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Disclaimer
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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