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In the top three news from Onco-this-Week Richa Tewari highlights Breakthrough Therapy designation to Rucaparib for treatment of BRCA1/2-mutated metastatic castration-resistant prostate cancer patients, Orphan Drug Designation in Japan to Axicabtagene Ciloleucel for treatment of aggressive R/R B-Cell Lymphoma and Commencement of Ph III global registrational trial of anti-FGFR2b mAb Bemarituzumab in 1L advanced gastric/GEJ cancers. Our trivia section features QnA on ESMO (European Society for Medical Oncology) Guidelines and know how they ensure best standards of cancer care through evidence-based medicine in Europe.  Also featured is the news about 3 more special status designations for treatment of glioblastoma, neuroendocrine tumors and pancreatic cancer. Check out what they are.- Abhi Dey

 

 

  1. Breakthrough Therapy Designation to Rucaparib for treatment of BRCA1/2-mutated mCRPC patients. It will be interesting to see if Rucaparib can emulate its ovarian cancer success story in prostate cancer settings. The basis of BTD is preliminary data from TRITON2 study which is studying effect of Rucaparib in HRD+, next-gen AR-targeted therapies-treated mCRPC patients, to be presented at ESMO 2018 meeting. Will Racaparib meet the challenge of lack of data regarding the OS benefit for CRPC patients? Will it be able to emerge as a standard-of-care treatment in patients with mCRPC (with DNA repair deficiency) who progress after prior abiraterone- or enzalutamide-based therapy? Only time would tell.
  2. Orphan Drug Designation in Japan to Axicabtagene Ciloleucel for treatment of aggressive R/R B-Cell Lymphoma. After approval in USA and Europe based on ZUMA-1 trial data, axicabtagene ciloleucel is hoped to show similar results in Japanese patients in a prospective trial similar to ZUMA-1. Will Daiichi Sankyo be able to emulate success of California-based Kite Pharma, Inc., a Gilead company, from which it received exclusive development, manufacturing and commercialization rights for axicabtagene ciloleucel in Japan? There will be an interest on pricing of axicabtagene ciloleucel therapy, if it proves to be efficacious in Japanese patients as well.
  3. Commencement of Ph III global registrational trial of anti-FGFR2b mAb Bemarituzumab in 1L advanced gastric/GEJ cancers. With approximately 10% of GC/GEJ patients having FGFR2b overexpression and its association with a worse prognosis, Five Prime and Zai Lab companies would be hoping for Bemarituzumab to replicate its success story of heavily-treated GC/GEJ patients in frontline settings. Bemarituzumab combined with chemotherapy may become THE targeted therapy this segment is looking for and there will be a lot of hope from this registrational trial to fill the huge unmet need.

This edition of Onco-this-Week is Sponsored by

North America Immigration Law Group & Nano-Tag Biotechnologies

 

 

REGULATORY NEWS

Rucaparib receives Breakthrough Therapy Designation for treatment of BRCA1/2-mutated mCRPC patients based on initial data from Ph II TRITON2 study


“We are committed to the rapid development of Rubraca in mCRPC and we are obviously pleased to receive Breakthrough Therapy designation. We look forward to presenting the data that served as the basis of our BTD application at the ESMO conference later this month,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We hope the decision by the FDA to grant this Breakthrough Therapy designation for Rubraca offers encouragement to the prostate cancer community, and we will do our best to make Rubraca available to eligible prostate cancer patients as quickly as possible.”

“We are pleased the FDA has granted Breakthrough Therapy designation to Rubraca in mCRPC,” said Howard R. Soule, Ph.D., Executive Vice President and Chief Scientific Officer of the Prostate Cancer Foundation. “There is tremendous need for new therapeutic options in advanced prostate cancer. In particular, we are enthusiastic about the potential for targeted therapies that may provide more meaningful benefit to patients with specific genetic mutations.”

 

LABEL EXPANSION: FDA approves Carfilzomib QW 70 mg/m2 + Dexamethasone (Kd70) for RRMM patients based on Ph III ARROW study


“In the fight against multiple myeloma, we are committed to continued evidence generation and innovation to serve patients. KYPROLIS now offers patients with relapsed or refractory multiple myeloma the option of a more convenient dosing regimen that provides better outcomes with a comparable safety profile,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “We’re pleased that the FDA has recognized the importance of bringing more treatment options to cancer patients more quickly through its pilot programs and proud to participate with this KYPROLIS data.”

“While great progress has been made in the last decade, multiple myeloma remains an incurable disease characterized by a recurring pattern of remission and relapse, and it is important that patients have treatment options that meet their individual needs,” said David S. Siegel, M.D., Ph.D., chief of the Division of Multiple Myeloma at John Theurer Cancer Center at Hackensack University Medical Center. “The availability of a more convenient once-weekly dosing regimen, with superior efficacy, comparable safety, and longer duration of therapy versus the twice-weekly regimen studied in the trial could allow patients to spend more time outside of the infusion center.”

 

TRIAL RESULTS

Bacterial clostridium novyi-NT spores therapy showed manageable toxicities and early clinical efficacy in patients with treatment-refractory solid tumor malignancies in Ph I trial

“Even after a single injection of this bacterial therapy, we see biological and, in some patients, clinically meaningful activity,” said Filip Janku, MD, PhD, associate professor at the Department of Investigational Cancer Therapeutics (Phase I Clinical Trial Program), The University of Texas MD Anderson Cancer Center, Houston. “This strategy is feasible, has manageable adverse effects, and could be clinically meaningful in patients with few therapeutic options.”


“We were extremely encouraged by the results of this trial, especially in patients with advanced sarcomas, where immunotherapy hasn’t proven very efficacious,” Janku said. “This bacteriolytic strategy has the potential to be clinically meaningful, especially in combination with checkpoint inhibitors, for patients with advanced solid tumors.”

 

AdHER2/neu DC Vaccine Shows Early Promise for Patients with HER2-positive cancers in Ph I trial


“Immunotherapy marshals the exquisite specificity of the immune system to destroy cancer, and some types may have potentially fewer side effects than traditional chemotherapy,” said Jay A. Berzofsky, MD, PhD, chief of the Vaccine Branch at the Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland. “We are using a vaccine approach to generate an immune response to HER2, which is found at high levels on and drives the growth of several types of cancer, including breast, ovarian, lung, colorectal, and gastroesophageal cancers.

 

Preliminary data from Ph I Toca 6 trial in advanced solid tumor patients presented

“The encouraging preliminary immune activity data from the Toca 6 trial continue to support the proposed mechanism of action for Toca 511 & Toca FC and its potentbiial in the treatment of multiple cancers,” said Asha Das, M.D., chief medical officer of Tocagen. “We look forward to advancing expansion opportunities for our lead product in patients with solid tumors.”


Preliminary safety and efficacy data announced from ongoing Ph IIa trial of RX-3117 + nab-paclitaxel in1L metastatic pancreatic cancer patients

“These preliminary data are encouraging, showing that the combined administration of RX-3117 and Abraxane in newly diagnosed metastatic pancreatic cancer patients appears to be safe and well tolerated and showing evidence of clinical activity,” said Dr. Ely Benaim, M.D., chief medical officer of Rexahn. “As of September 19, 2018, there was one complete response and three partial responses from the first 14 evaluable patients. In addition, there were eight patients with stable disease who had tumor reductions of up to 16% and who are still being actively dosed. We are encouraged by this preliminary data reflecting a disease control rate of 86% and an overall response rate of 29%. We look forward to completing the study enrollment and plan to report the final data in 2019.”


“The safety profile of RX-3117 continues to be encouraging as it can be administered at its recommended Phase 2 dose together with the maximal labeled dose of Abraxane without producing an increase in severe adverse events,” said Peter D. Suzdak, Ph.D., chief executive officer of Rexahn. “This differs from current standard of care where the doses of both gemcitabine and Abraxane, when given in combination, may have to be reduced to avoid grade 3 and 4 dose limiting toxicities.”

 

SPECIAL STATUSES

PDE-4/10 / MIF dual inhibitor MN-166 (ibudilast) gets orphan designation for Glioblastoma

Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, “We are very pleased that the FDA has granted orphan-drug designation for MN-166 as adjunctive therapy to temozolomide for the treatment of GBM, a rare cancer with a high recurrence rate and poor prognosis.”


HSP90 inhibitor SNX-5422 granted Orphan Drug Status for neuroendocrine tumors; agreement reached with FDA on key elements of Ph III trial


“While survival for all NETs has improved over time there remains an urgent need for new treatment options,” said Steve Hall, Ph.D., President and Chief Executive Officer of Esanex, Inc. “Based on positive results presented at the North American Neuroendocrine Society (NANETS) annual meeting in 2017, we believe that SNX-5422 has the potential to provide a new therapeutic approach for patients living with NETs. We are pleased with the outcome of our End-of-Phase 2 discussions with the FDA. We appreciate the valuable guidance the FDA has already provided us and look forward to continuing a constructive relationship as we advance our Phase 3 registration program.”

 

Japan MHLW Grants Orphan Drug Designation to Axicabtagene Ciloleucel for Treatment of Certain Types of B-Cell Lymphoma


“Receiving Orphan Drug designation is an important step in expediting the development of axicabtagene ciloleucel in Japan and underscores the unmet needs of patients with these aggressive forms of relapsed or refractory B-cell lymphomas,” said Kouichi Akahane, PhD, MBA, Executive Officer, Head of Oncology Function, R&D Division, Daiichi Sankyo. “This designation represents the third Orphan Drug designation granted for an investigational therapy in our oncology pipeline, demonstrating our commitment to transforming innovative science into value for patients. We look forward to working closely with the Japan Health Authority to bring this important cell therapy to patients in Japan as soon as possible.”

 

Corcept Therapeutics receives orphan designation for selective cortisol modulator Relacorilant for pancreatic cancer patients


“We are pleased the FDA has granted relacorilant orphan drug status for the treatment of pancreatic cancer. Pancreatic cancer has a poor prognosis and patients have few treatment options,” said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer. “The data we have generated so far in this indication have been very encouraging. Five of nine patients who received the minimum therapeutic dose in our Phase 1/2 trial of relacorilant plus nab-paclitaxel demonstrated durable disease control. By year-end we expect to have learned enough to determine a potential path toward a pivotal study in this indication.”

 

TRIAL STATUSES

Ph II PAC203 study to continue following interim data review in myelofibrosis patients

“Continuing the PAC203 study with all three treatment arms allows us to obtain the maximum amount of data to determine the optimal dose for our planned Phase 3 registrational study, which is expected to address a patient population with severe thrombocytopenia,” said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma.


“The PAC203 study is on track to complete its objective and we continue to expect to complete enrollment by the end of 2018. We plan to present clinical data at an upcoming medical conference, potentially at the ASCO conference in 2019.”

 

Topline analysis of Ph III TIVO-3 trial in 2L+ RCC patients initiated

“Initiation of the topline analysis of the TIVO-3 trial brings us one step closer to potentially realizing the strategy we laid out in 2015, which included commercialization of tivozanib in the United States and Europe, and exploration of tivozanib’s clinical potential in immunotherapy combinations,” said Michael Bailey, president and chief executive officer of AVEO.


“With the introduction of immunotherapy as a treatment for earlier-line RCC, survival among patients is extending well beyond disease progression on first- and second-line treatment, which we believe may substantially increase the third-plus-line opportunity for tivozanib. TIVO-3 has the potential to serve as the first prospective Phase 3 randomized dataset in this setting, creating an evidencebased guidepost for sequencing therapies in refractory disease.  We look forward to announcing the topline results of TIVO-3 in the coming weeks.”

 

First patient dosed in Ph III global registrational trial of anti-FGFR2b mAb Bemarituzumab in 1L advanced gastric and gastroesophageal junction cancers

“We are very pleased to have dosed the first patient in our FIGHT gastric cancer trial in China, where Zai Lab is responsible for the regulatory and development timeline for this global study,” said Helen Collins, M.D., Senior Vice President and Chief Medical Officer of Five Prime. “Tumors overexpressing FGFR2b are associated with a poor prognosis, and a targeted therapy that provides improved efficacy when added to standard therapy could transform treatment options for these patients. Bemarituzumab has demonstrated encouraging monotherapy activity in the late-line setting, and we hope to provide greater benefit by combining with chemotherapy in the front-line setting.”


“This is the first time that the first patient dosed in a global registrational trial came from China as a result of the collaboration between a U.S. biotechnology company and a Chinese biotechnology company,” said Dr. Yongjiang Hei, CMO of Zai Lab. “Gastric cancer is the fifth most common cancer in the world and the second most common in China. There is an urgent need globally, and particularly in China, where we are responsible for both development and commercialization, for more effective and well-tolerated targeted therapies for gastric cancer patients. We are pleased that the clinical trial application (CTA) was approved three months ahead of schedule, which will help accelerate the global FIGHT trial in our collaboration with Five Prime.”

 

Q: What are ESMO Clinical Practice Guidelines (CPGs)?

A: Akin to NCCN guidelines in USA, the ESMO Clinical Practice Guidelines (CPGs) are set of recommendations in Europe for the best standards of cancer care, based on the findings of evidence-based medicine.

Q: What do ESMO Clinical Practice Guidelines (CPGs) include?

A: ESMO Clinical Practice Guidelines (CPGs) include information on incidence, diagnosis, staging and risk assessment, treatment and response evaluation and follow-up.

Q: Who makes ESMO Clinical Practice Guidelines?

A: The ESMO Guidelines Committee (GLC) is responsible for the production and update of ESMO Clinical Practice Guidelines and Consensus Statements. GLC has strict procedures in place in order to produce high-quality and well-formulated guidelines. These procedures provide clear instruction and are readily available to authors, editors and panel members.

Q: Which new ESMO Clinical Practice Guidelines were made available online in 2018?

A: The following 2018 ESMO Clinical Practice Guidelines are available online:
  • Bone sarcomas
  • Hepatocellular carcinoma
  • Metastatic non-small cell lung cancer
  • Waldenstrom’s Macroglobulinaemia
  • Primary Cutaneous Lymphomas
  • Gastrointestinal Stromal Tumours
  • Soft Tissue and Visceral Sarcomas
  • Hodgkin Lymphoma
  • Non-epithelial Ovarian Cancer

Q: Which ESMO Clinical Practice Guidelines were updated in 2017?

A: Following six guidelines were updated in 2017:
  • Thyroid Cancer
  • Early and Locally Advanced NSCLC
  • Rectal Cancer
  • Chronic Myeloid Leukaemia
  • Multiple Myeloma
  • Newly Diagnosed and Relapsed Mantle Cell Lymphoma
  • Cervical Cancer

Source: https://oncologypro.esmo.org/Guidelines/Clinical-Practice-Guidelines

 

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.

Image Sources: Wikipedia and Twitter

Cover image: (CellImageLibrary)Colorized transmission electron micrograph (TEM) of rough endoplasmic reticulum (ER) from an acinar cell in the pancreas.– Source

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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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