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MedNess: bite-size biopharma and medtech news

2nd December, 2019
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Drug Approval
KEYTRUDA® (pembrolizumab) + chemotherapy approved in China for 1L squamous mNSCLCbased on results from Ph III KEYNOTE-407 trial
“In KEYNOTE-407, KEYTRUDA in combination with chemotherapy significantly improved both overall survival and progression-free survival in patients with metastatic squamous non-small cell lung cancer,” said Prof. Ying Cheng, director of Jilin Cancer Hospital. “Lung cancer is the leading cause of cancer death in China, so this approval represents an important milestone for the patients and families facing this difficult-to-treat disease.”
XTANDI® (enzalutamide) approved in China based on Ph III Asian PREVAIL study in mCRPC patients
“Currently the treatment options are limited in China for men with metastatic castration-resistant prostate cancer,” said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development, Astellas. “The approval of enzalutamide in China brings us one step closer to offering physicians a meaningful treatment option in an area where there is a high medical need.”
Regulatory News
FDA accepts sBLA; grants Priority Review for Imfinzi (durvalumab) in 1L ED SCLC patients based on results from Ph III CASPIAN trial; PDUFA Q1 2020
  • Results from the Phase III CASPIAN trial published in The Lancet
  • Imfinzi + standard-of-care chemotherapy (etoposide with either cisplatin or carboplatin) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) vs. SoC
  • Risk of death reduced by 27% (HR 0.73)
  • mOS: 13.0 months for Imfinzi plus chemotherapy vs. 10.3 months for SoC
  • OS@18 months: 33.9% following treatment with Imfinzi plus chemotherapy vs. 24.7% receiving SoC
  • Imfinzi already approved in unresectable, Stage III NSCLC patients after chemoradiation therapy based on results from Ph III PACIFIC trial
FDA accepts sBLA; grants priority review to KEYTRUDA in BCG-unresponsive, high-risk, NMIBC patients based on results from Ph II KEYNOTE-057 trial; PDUFA: Jan 2020
“Merck is steadfast in its commitment to patients with bladder cancer, including advancing research to meet unmet medical needs. Patients with high-risk, non-muscle invasive bladder cancer sometimes make an informed decision to decline, or are medically ineligible for radical cystectomy, and there are currently limited non-surgical treatment options approved by the FDA for these patients who are BCG-unresponsive,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We look forward to participating in the advisory committee meeting and to continuing to work with the FDA as they review this supplemental application for KEYTRUDA.”
FDA accepts NDA for FGFR inhibitor pemigatinib for 2L+ locally advanced or metastatic cholangiocarcinoma patients with FGFR2 fusions or rearrangements, based on data from the FIGHT-202 trial; PDUFA: May 2020
“There is a significant need for new therapies for patients with cholangiocarcinoma, who have limited treatment options beyond first-line chemotherapy and often face a poor prognosis,” said Peter Langmuir, M.D., Group Vice President, Targeted Therapeutics, Incyte. “We are very pleased that the FDA has accepted our NDA for Priority Review which we believe represents an important step toward providing the first treatment option for patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements. We intend to work closely with the FDA to bring this innovative targeted therapy to patients suffering from this devastating disease as soon as possible.”
Click Here for more Regulatory News
Trial Results
Positive OS and PFS results presented from Ph III IMbrave150 trial of Tecentriq® (atezolizumab) + Avastin® (bevacizumab) in 1L HCC patients
“For the first time in a decade, we are seeing a treatment that has improved overall survival for people with unresectable hepatocellular carcinoma compared with the current standard of care,” said Levi Garraway, M.D., Ph.D, Chief Medical Officer and Head of Global Product Development. “Tecentriq in combination with Avastin could transform the treatment of this aggressive disease, and we are working closely with global health authorities in the hope of bringing this treatment option to patients as soon as possible.”
Updated results presented from Ph Ib trial of PV-10® + KEYTRUDA® for treatment of checkpoint-naïve advanced melanoma at SMR 2019 Congress
Dominic Rodrigues, Vice Chair of the Company's Board of Directors, said, "These maturing data reinforce the complementary mechanistic and orthogonal safety profiles of PV-10 and checkpoint inhibition. The data demonstrate that minimal PV-10 intervention can achieve substantial tumor destruction and bring net tumor burden within the range of effective checkpoint blockade activation. We believe additional PV-10 treatment, as part of combination therapy with either single-agent or dual-agent checkpoint blockade, can lead to even greater improvements in clinical response and treatment durability."
Click Here for more Trial Results
Trial Status/Progress
First patient dosed in Ph I trial of anti-PD-1/HER2 bispecific antibody in China
Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, said: "IBI315, as one of our pivotal drug candidates in our pipeline of cancer immunotherapies, is the world's first PD-1/HER2 bispecific antibody that has entered clinical development. The development of IBI315 is therefore highly valuable and we hope that this new therapeutic bispecific antibody will offer a novel and more effective solution to patients' unmet medical needs and ultimately benefit more patients."
Ph II trial of CPI-613® (devimistat) in R/R Burkitt’s Lymphoma/Leukemia patients expanded
“Burkitt’s lymphoma is a rare disease, with approximately 1,200 people in the United States diagnosed annually, so treatment options for these patients are very limited,” said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals. “The disease is highly aggressive and has a high rate of relapse. Expanding our clinical trial will increase access and create hope for patients and their loved ones across the country.”
MedNess Business
Onco-News

Onconova signs an exclusive agreement with Knight Therapeutics to commercialize Rigosertib in Canada
Canada-based Knight Therapeutics have entered into exclusive agreement with Onconova Therapeutics to commercialize Phase 3 lead candidate Rigosertib against myelodysplastic syndrome. According to the agreement, Onconova will receive up to CAD 33.95 million in clinical, regulatory and sales-based milestone payments.
"We are pleased to add Knight to our roster of global partners for rigosertib," said Dr. Steven Fruchtman, President and Chief Executive Officer of Onconova. "We are eager to work with Knight’s team, which has successfully partnered with a number of biotechnology companies to commercialize innovative medicines in Canada.”
Bio-Pharma and MedTech

Eleven drug companies led by Pfizer and Novartis set aside $2 billion for gene therapy manufacturing
Pfizer and Novartis are leading the initiative along with nine other companies to invest in manufacturing of gene therapy products for various diseases. With a total investment of $2 billion, Pfizer’s contribution stands at $600 million whereas Novartis will contribute $500 million. The construction of such units comes in response to “rising prices and delays related to relying on third-party contract producers”. 
“There’s so little capacity and capability at contract manufacturers for the novel gene therapy processes being developed by companies,” said David Lennon, president of AveXis, Novartis’s gene therapy division. “We need internal manufacturing capabilities in the long term.”
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 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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