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Onco-this-Week

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In the current edition of Onco-this-Week Richa Tewari highlights the priority review to combination of Pembrolizumab and chemotherapy in 1L squamous Non-Small Cell Lung Cancer patients and CHMP recommendations to Kymriah (tisagenlecleucel), Yescarta (axicabtagene ciloleucel), Neratinib, and Vyxeos (daunorubicin/cytarabine) in respective patient segments. In our trivia section, we focus on the National Comprehensive Cancer Network (NCCN) guidelines, where you can find out how the NCCN facilitates the decision making by clinicians to aid the management of cancer. Stay tuned for our next week’s edition of OTW Trivia where we will start a series on regulatory designations. 

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DRUG APPROVAL

European Commission approves expanded indication for Dasatinib to include treatment of children with Philadelphia Chromosome-Positive CML in Chronic Phase based on data from CA180-226 trial

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“Treatment options for pediatric patients with CML are limited, as are formulations that correspond with the unique demands of children with cancer,” said Fouad Namouni, M.D., head of development, Oncology, Bristol-Myers Squibb. “Our decision to pursue an expanded indication for Sprycel in this new patient population and as a new formulation is indicative of our commitment to extending the potential of our medicines to address the unmet needs of patients with cancer, regardless of the incidence of the disease.”

 

Durvalumab approved in Japan as adjuvant maintenance therapy for unresectable Stage III NSCLC based on Ph III PACIFIC trial data

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Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit said: “Non-small cell lung cancer is a leading cause of death in Japan, and we are dedicated to bringing new treatment options to patients as quickly as possible. As the only immunotherapy approved in the curative-intent, Stage III lung cancer setting, Imfinzi has the potential to change the treatment paradigm for patients diagnosed with this disease.”

 

Olaparib approved in Japan for BRCA-mutated metastatic breast cancer

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Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca, said: “Earlier this year, Lynparza became the first PARP inhibitor available in Japan for advanced ovarian cancer. Now patients in Japan with BRCA-mutated, metastatic breast cancer will also have the opportunity to benefit from Lynparza. This latest approval underlines our ongoing efforts to make Lynparza available across multiple cancers as quickly as possible to patients around the world.”

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: “Metastatic breast cancer is a complex disease with remaining unmet medical need. This approval is significant for breast cancer patients as the evaluation of BRCA mutations, in addition to hormone receptor and HER2 status, now becomes an important step in the management of the disease.”

 

REGULATORY NEWS

Priority review granted to Pembrolizumab + Chemotherapy in 1L sqNSCLC patients based on Ph III KEYNOTE-407 Trial data; PDUFA: Oct. 30, 2018

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“KEYTRUDA has already been established as an important treatment option for non-small cell lung cancer in the first-line setting, and with our broad development program in lung cancer, we are committed to improving survival for as many patients as we can,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We are pleased that our application for squamous cell carcinoma – a historically challenging-to-treat disease – is under priority review with the FDA.”

 

Neratinib secured positive CHMP opinion for extended adjuvant treatment of HER2+ early stage breast cancer

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Puma Biotechnology, Inc. announced that on June 28, 2018 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorisation for the medicinal product NERLYNX® (neratinib) for the extended adjuvant treatment of adult patients with early stage HR+, HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy. The CHMP recommendation would now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).

Nivolumab secures positive CHMP opinion for the adjuvant treatment of adult patients with Melanoma

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“This positive opinion supports the potential of Opdivo in the adjuvant setting to prevent relapse and progression to an advanced stage,” said Arvin Yang, M.D., Ph.D., development lead, melanoma and genitourinary cancers, Bristol-Myers Squibb. “We look forward to the upcoming EC decision and the potential opportunity to bring Immuno-Oncology treatment options to more patients across the European Union.”

Kymriah secures first CHMP opinion for a CAR-T cell therapy in two distinct indications – DLBCL in adults and B-cell ALL in children

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“The positive CHMP opinion for Kymriah is a watershed moment for pediatric and adult patients in Europe with aggressive blood cancers,” said Liz Barrett, CEO, Novartis Oncology. “This truly transformative therapy helps address a profound unmet need, and Novartis is proud that our leadership in CAR-T innovation will make a meaningful difference to patients in the EU.”

Yescarta (axicabtagene ciloleucel) secures positive CHMP opinion for the treatment of R/R DLBCL and PMBCL, after two or more lines of systemic therapy

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“This CHMP positive opinion is an important milestone for those patients in the European Union living with DLBCL or PMBCL,” said Alessandro Riva, MD, Gilead’s Executive Vice President, Oncology Therapeutics & Head, Cell Therapy. “The recommendation brings axicabtagene ciloleucel one step closer to adult patients who currently have few or no treatment options available to them and we are focused on providing access to this innovative treatment as quickly as possible.”

Vyxeos secures positive CHMP opinion for high risk newly diagnosed, t-AML or AML-MRC

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“Jazz is committed to bringing new and clinically meaningful treatment options to patients on a global basis, and we now look forward to bringing Vyxeos to adults with AML in the European Union,” said Allen Yang, M.D., Ph.D., vice president, hematology/oncology therapeutic area head, and acting chief medical officer at Jazz Pharmaceuticals. “If approved by the European Commission, Vyxeos will become the first chemotherapy treatment option specifically for European patients with therapy-related AML or AML with myelodysplasia-related changes.”

EMA validation received for Rucaparib’s label expansion to include maintenance treatment in recurrent ovarian cancer patients based on Ph III ARIEL data

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“We are very pleased to receive validation of the variation to the Rubraca marketing authorization by the EMA, which brings us a step forward in making rucaparib available to more women with recurrent ovarian cancer in Europe,” said Patrick J. Mahaffy, CEO and President of Clovis Oncology.

OSE Immunotherapeutics Receives IDMC Approval to Continue “Atalante 1” Ph III NSCLC Clinical Trial of Tedopi®

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“While checkpoint inhibitors are now considered as the standard of care in first- and second-line treatment of advanced NSCLC, there is a strong clinical need for patients in immune escape after such treatment. Our  Tedopi® neoepitope product is well positioned to benefit NSCLC patients experiencing treatment failure after checkpoint inhibitors, as there is currently no approved treatment for these patients,” said Alexis Peyroles, CEO of OSE Immunotherapeutics.

Immutep submits IND for LAG-3Ig fusion protein IMP321 + Pembrolizumab in NSCLC and head and neck cancers

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Immutep Limited submitted its IND application to the United States Food and Drug Administration for eftilagimod alpha also known as (efti or IMP321) in June 2018.

If granted by the FDA, the IND application will allow Immutep to ship efti across U.S. State borders to U.S. clinical investigators participating in the Company’s planned TACTI-002 Phase II clinical study, making it an important step in the clinical trial preparations. This is the first IND application for efti in the U.S. following the encouraging pre-IND meeting in November last year.

The IND application incorporates information pertaining to completed pharmacology and toxicology studies for efti, along with manufacturing information and proposed clinical protocol for the TACTI-002 trial.

The Company continues to progress its preparations for the TACTI-002 clinical trial in the United States, Europe and Australia. Immutep expects to commence the TACTI-002 trial in the second half of 2018 and to report the first data from the trial in 2019.

 

RESULTS

Ph III CELESTIAL data published in NEJM

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“Patients with this form of advanced liver cancer have very limited treatment options once their disease progresses following treatment with sorafenib,” said Ghassan K. Abou-Alfa, M.D., Memorial Sloan Kettering Cancer Center, New York and lead investigator on CELESTIAL. “These results suggest that, if approved, cabozantinib could become an important addition to the treatment landscape that may help slow disease progression and, critically, improve survival for these patients.”

“The publication of the CELESTIAL trial results in a peer-reviewed publication as prestigious as NEJM further validates the importance of these data for the advanced liver cancer community,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “We’re working closely with the FDA as they review our sNDA in order to bring CABOMETYX to this growing patient population as quickly as possible.”

Ph III IMpassion130 study showed Atezolizumab + nab-Paclitaxel significantly reduced the risk of disease worsening or death in metastatic TNBC patients

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“IMpassion130 is the first positive Phase III immunotherapy study in triple negative breast cancer, an aggressive disease with limited treatment options,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Highly encouraged by these results, we plan to submit to health authorities globally with the aim of bringing this combination to people with triple negative breast cancer as soon as possible.”

 

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. He is currently 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 current 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.

Cover Image: (Description)A scanning electron color-enhanced image showing a clump of prostate cancer cells. (Technical Details) B0006629 2007 Collection: Medical Photographic Library Copyrighted work available under Creative Commons by-nc-nd 2.0 UK: England & Wales, see http://creativecommons.org/licenses/by-nc-nd/2.0/uk/

The contents of Club SciWri are the copyright of PhD 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.

 

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. The research conducted by authors and editors is a voluntary effort to popularize science for the public on behalf of 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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