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Onco-this-Week
30th July, 2019
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MedNess This Week

HIGHLIGHTS
Drug Approvals

FDA approves rituximab biosimilar, Ruxience (rituximab-pvvr) to treat NHL, CLL and granulomatosis with polyangiitis and microscopic polyangiitis
“Biosimilars like Ruxience have the potential to deliver real value in healthcare, improving access to and affordability of an important cancer treatment which could help more patients receive optimal care,” said Andy Schmeltz, global president of Pfizer Oncology, in a statement. “The FDA approval marks our third oncology biosimilar to be approved in the US this year, reinforcing our commitment to bring these important medicines to patients living with cancer.”
Regulatory News

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2019
A day of several positive CHMP opinions: 
  • Bristol-Myers Squibb's Elotuzumab plus pomalidomide and low-dose dexamethasone (EPd) in adult RRMM patients who have received at least two prior therapies, including lenalidomide and PI based on Ph II ELOQUENT-3 trial results 
  • Servier and Taiho Oncology, Inc.'s LONSURF (trifluridine/tipiracil) as monotherapy in metastatic gastric cancer/GEJ adenocarcinoma pts previously treated with at least two prior systemic treatments based on Ph III TAGS trial results 
  • Roche's Atezolizumab + chemo combination in ED-SCLC patients based on Ph III IMpower133 trial results 
  • And the more important of all: Recommendation for a conditional marketing authorisation for Bayer's larotrectinib in solid tumor patients with NTRK gene fusion - is EU going to get its first ever tumor-agnostic drug approval? The question is not 'if', but 'how soon'...
BLA submitted to FDA for the accelerated approval of Enfortumab vedotin, for patients with locally advanced or metastatic urothelial cancer
Seattle Genetics and Astellas Pharma US submit BLA to FDA for the accelerated approval of Nectin-4 targeting ADC, Enfortumab vedotin, for patients with locally advanced or metastatic urothelial cancer, based on results from the first cohort of patients in Ph II EV-201 trial
  • Around 45% ORR and mDOR of 7.5 months observed in PD-(L)1-refractory population
  • Enfortumab vedotin was granted Breakthrough Therapy designation based on Ph I results
  • Confirmatory Ph III EV-301 trial to support global registrations
Click Here for more Regulatory News
Onco-Trial Results

Ph III KEYNOTE-522 trial of Pembrolizumab + chemotherapy meets primary endpoint of pCR improvement in TNBC patients
“These findings from this innovatively designed trial with KEYTRUDA mark the first time an anti-PD-1 therapy plus chemotherapy has demonstrated a statistically significant improvement in pathological complete response rate as a neoadjuvant, or pre-surgical, segment of treatment for triple-negative breast cancer,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “TNBC is an aggressive malignancy with a high rate of recurrence within the first five years of diagnosis. We are encouraged by these results and plan to discuss these data with health authorities and to present these findings at an upcoming medical congress.”
Favorable safety data reported for dose-escalation run-in of trans sodium crocetinate (TSC) in Ph III INTACT trial in Glioblastoma multiforme patients
“We are pleased this run-in study is consistent with our previous findings as to the safety of TSC,” said David Kalergis, Diffusion’s chief executive officer. “We are hopeful these run-in safety data, along with compelling data from our Phase 2 study showing a nearly four-fold improvement in survival at two years with TSC when used with radiation therapy in the inoperable GBM patient subgroup, will attract the attention of potential partners for continuing the development of the GBM indication. GBM patients have a poor prognosis and limited treatment options. We believe TSC has great potential to improve these patients’ outcomes and extend survival.”
BMS reports mixed results from Ph III CheckMate-227 trial in frontline NSCLC
HIT:
  • Nivolumab + Ipilimumab significantly extended OS vs chemo alone in PD-L1+ve patients
  • OS benefit seen in PD-L1neg patients too
  • BMS to submit application to regulatory bodies
MISS:
  • Nivolumab + chemo arm fails to show improvement over chemo (mOS: 19 vs 16 months)
Click Here for more Trial Results
Onco-Trial Status/Progress

Ph II Olaparib + AZD6738 program in gastric cancer and Ph I MEDI-3726 program in prostate cancer shelved
AstraZeneca shelves Ph II Olaparib + ATR inhibitor AZD6738 program in gastric cancer and PhI PSMA-targeting ADC MEDI-3726 program in prostate cancer, as announced in H1 2019 results.
First patient enrolled in the recently-approved adjuvant setting arm of Ph II trial of VAL-083 for the treatment of MGMT-unmethylated Glioblastoma multiforme
"Treating patients with MGMT promoter unmethylated glioblastoma is particularly challenging," commented principal investigator Dr. Barbara O'Brien, assistant professor of Neuro-Oncology at the MD Anderson Cancer Center.  "These tumors are inherently resistant to temozolomide, leaving physicians and patients without viable alternative treatments, so I'm particularly pleased that we have added this additional trial arm to our ongoing study.  Better therapies are greatly needed for both newly-diagnosed and recurrent glioblastoma, and VAL-083 has so far shown a favorable safety profile and provided early, but encouraging, results from the trial that is currently underway."
 
Click Here for more Progress/status of ongoing trials
MedNess Plus
FDA approves an antibacterial drug to treat complicated urinary tract and intra-abdominal infections in adult patients
“The FDA remains focused on facilitating the development of safe and effective new antibacterial drugs to give patients more options to fight serious infections,” said Ed Cox, M.D., M.P.H., director for the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. “It is important that the use of Recarbrio be reserved for situations when there are limited or no alternative antibacterial drugs for treating a patient’s infection.” 
FDA grants Priority Review for crizanlizumab, an investigational sickle cell medicine from Novartis
"The FDA's decision to give crizanlizumab priority review reflects the impact that this medicine could have for the many thousands of US sickle cell adult patients who experience painful vaso-occlusive crises," said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis. "We are looking forward to the opportunity, if crizanlizumab is approved, to reimagine medicine in sickle cell disease for patients who live with this condition every day of their lives." 
FDA approves the first generics of Lyrica to manage neuropathic pain, postherpetic neuralgia and other conditions
“Today’s approval of the first generics for pregabalin, a widely-used medication, is another example of the FDA’s longstanding commitment to advance patient access to lower cost, high-quality generic medicines,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The FDA requires that generic drugs meet rigorous scientific and quality standards. Efficiently bringing safe and effective generics to market so patients have more options to treat their conditions is a top priority for the FDA.” 
 
Click Here for more on MedNess Plus...
MedNess Business
Onco-News

Boehringer Ingelheim acquires AMAL Therapeutics to significantly enrich its cancer immunology portfolio with novel cancer vaccines platform
“Acquiring AMAL is part of Boehringer Ingelheim’s long-term strategy to enhance our existing position as an innovator of novel cancer therapies, including immuno-oncology treatments, which leverage cutting-edge scientific discoveries and their applications,” said Michel Pairet, member of Boehringer Ingelheim’s Board of Managing Directors with responsibility for the company’s Innovation Unit. “We want to pioneer new paradigms of biology-based care for cancer patients, and the technologies and expertise developed at AMAL are critical to our efforts.”
Bayer, Bristol-Myers Squibb and Ono Pharmaceutical to investigate regorafenib and nivolumab as combination therapy in MSS mCRC patients
"The data seen in REGONIVO warrant further exploration of the combination of regorafenib and nivolumab in patients with colorectal cancer. Regorafenib has proven its efficacy and positive safety profile as a third-line monotherapy and we are excited to enter into a clinical collaboration to evaluate this combination with the hope to deliver an additional therapeutic benefit to patients," said Scott Z. Fields, M.D., senior vice president and head of Oncology Development at Bayer's Pharmaceuticals Division.
BioPharma and MedTech

Editas and Allergen gets approval for first in vivoCRISPR gene editing trial for rare eye disease
Editas Medicine and Allergen plc have received the first ever FDA approval for in vivoclinical trial using CRISPR-based gene editing. The clinical phase 1/2 trial has been approved for the treatment of Leber congenital amaurosis 10 (LCA10), a rare form of inherited blindness resulting from mutations in CEP290gene. A single dose of the experimental product, AGN-151587 or EDIT-101, will be injected into the patients’ eye behind the retina following virectomy. Unlike this therapy that is done inside the patients body, CRISPR Therapeutics and Vertex are conducting the first out-of-the-body clinical trial using CRISPR-based gene editing for beta-thalassemia. 
Jobs at Editas Medicine
Jobs at Allergen plc
 
Italian pharma Zambon acquires Sofinnova’s Breath Therapeutics in a €500M deal
Sofinnova Partners sold its portfolio company Breath Therapeutics to Italian Pharma Zambonfor an upfront payment of €140M in a deal that can rise to €500M depending on the clinical outcomes. With this deal, Zambon acquires Breath’s two programs, BOSTON-1 and BOSTON-2, both in phase 3 trial for the treatment of Bronchiolitis Obliterans Syndrome (BOS) with the immunosuppressant Liposomal Cyclosporine A. The debilitating condition often results after lung transplant and affects about 30,000 people. 
Jobs at Zambon
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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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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