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Onco-this-Week

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Summary: This week’s most exciting pieces of news are back-to-back FDA’s approvals of Pembrolizumab (in PD-L1+ R/R metastatic Cervical Cancer and R/R PMBCL), in addition to Venetoclax (in 2L+ CLL or SLL), Bevacizumab + chemotherapy (in adjuvant setting in advanced ovarian cancer), EU approval of Osimertinib (EGFR-mutated frontline NSCLC) and China’s first-ever IO approval of Nivolumab (previously treated NSCLC regardless of PD-L1 expression and tumor histology). We also have an educational video that summarizes the basics of Biosimilars and an infographic on Cancer Health Disparities-their driving factors and NIH’s efforts to address them. Stay tuned for next week’s edition that will have the coverage of European Hematology Association 2018 conference. 

Special Feature in this edition is Onco-this-Week Trivia on Pembrolizumab. Read on to know more!

 

Educational Video: (Source: FDA) What are biosimilar products, and why are they important to the health care and patient communities? Learn more with Leah Christl, Ph.D., Associate Director for Therapeutic Biologics and lead of the Office of New Drugs (OND) Therapeutic Biologics and Biosimilars staff at FDA CDER. For more information, visit https://www.FDA.gov/biosimilars .

This edition of Onco-this-Week is Sponsored by Nano-Tag Biotechnologies

 

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DRUG APPROVALS

FDA Approves Pembrolizumab for PD-L1+ R/R metastatic Cervical Cancer

“Even with the many advances observed across gynecologic cancers, new treatment options have been lacking for previously treated patients with advanced cervical cancer,” Bradley Monk, oncologist with Arizona Oncology, medical director of US Oncology Research Gynecology Program and professor of obstetrics and gynecology at University of Arizona’s College of Medicine and Creighton University School of Medicine, said in a statement.

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“The approval of Keytruda in this indication is important news—and as an oncologist, it is exciting to see a much needed option made available to these patients,” added Monk.

 

Pembrolizumab approved in USA for treatment of R/R PMBCL based on Ph II KEYNOTE-170 trial results

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“Relapsed or refractory PMBCL is often a challenging disease to treat, and many affected patients are young adults,” said Philippe Armand, M.D., Ph.D., medical oncologist in the Hematologic Oncology Treatment Center at Dana-Farber Cancer Institute. “In the clinical trial that supported this approval, treatment with KEYTRUDA resulted in meaningful responses, including complete disease remission in some patients. This approval therefore provides another therapeutic option for patients with PMBCL who have progressed on or after prior therapies.”

“The approval of our anti-PD-1 therapy, KEYTRUDA, for the treatment of refractory or relapsed PMBCL provides an important therapeutic option for patients who have this rare disease,” said Jonathan Cheng, M.D., vice president, oncology clinical research, Merck Research Laboratories. “This approval reinforces Merck’s commitment to helping patients diagnosed with hematologic cancers and marks the second indication for KEYTRUDA in a hematologic malignancy.”

 

FDA approves Venetoclax for 2L+ CLL or SLL, with or without 17p deletion based on Ph III MURANO study data

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“We are pleased that this approval makes Venclexta, a first-of-its-kind targeted therapy, available for more people with chronic lymphocytic leukaemia whose disease has returned after previous treatment,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Venclexta plus Rituxan provides a new chemotherapy-free option shown to help people live longer without their disease progressing compared to a standard-of-care therapy.”

 

CNDA approves China’s First IO agent, Nivolumab, for previously treated NSCLC regardless of PD-L1 expression and tumor histology based on data from Ph III CheckMate-078 trial

“Lung cancer is a major public health issue in China, representing the highest incidence and mortality among all cancers in the country,” said Professor Yi-Long Wu, a tenured director of Guangdong General Hospital and the chair of the Chinese Thoracic Oncology Group. “With most lung cancer patients already at an advanced stage when diagnosed, prolonging survival is an important goal. The approval of Opdivo as the first I-O agent in China is a significant therapeutic advance and is great news for patients and clinicians alike, offering for the first time an I-O treatment option that is proven to extend survival in predominantly Chinese patients with previously treated NSCLC.”

Murdo Gordon, executive vice president and chief commercial officer, Bristol-Myers Squibb, commented, “With approvals in more than 60 countries, Opdivo is a global standard of care for previously treated NSCLC, and we are proud to bring this foundational I-O treatment option to patients and physicians in China. We look forward to continuing to work together with the CNDA to usher in additional healthcare innovations in China, with our shared commitment to moving quickly to help patients.”

FDA approves Bevacizumab + chemotherapy as an adjuvant treatment for women with advanced ovarian cancer based on Ph III GOG-0218 study results

“Today’s approval is an important advance for women newly diagnosed with this type of ovarian cancer,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We’re committed to advancing medicines in areas of unmet need and this FDA approval of Avastin plus chemotherapy gives women with advanced ovarian cancer a new treatment option that has been shown to significantly delay disease progression or death.”

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Osimertinib gets EU approval in EGFR-mutated 1L NSCLC patients

Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca, said: “Today’s approval is an exciting advance in bringing a potential new standard of care to patients with EGFR-mutated NSCLC in the EU. This milestone is also a step forward for our Company, marking another regional approval for Tagrisso in the 1st-line setting.”

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Dr. David Planchard, Associate Professor of Medicine, Head of Thoracic Group, Gustave Roussy cancer center, France said: “The FLAURA trial is changing medical practice in the 1st-line treatment of EGFR-mutated NSCLC. The progression-free survival benefit seen in the trial is unprecedented for patients with an EGFR mutation, and this benefit was consistent across all subgroups including in patients with or without central nervous system metastases. Further, the preliminary overall survival data, while not statistically significant at the time of the interim analysis, is promising, with a 37 percent reduction in the risk of death.”

 

RESULTS

QoL data of Ph III NETTER-1 trial of 177Lu-Dotatate published; in addition to improving PFS, it provides a significant QoL benefit in midgut NET patients compared with high-dose octreotide

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“Treatment options have been limited for patients with neuroendocrine tumors and toxicities of treatment can often outweigh the benefit. Our studies have shown Lutathera is an effective option to treat tumor progression and also provide patients with a better quality of life,” said Jonathan R. Strosberg, M.D., head of the Neuroendocrine Tumor Program at Moffitt Cancer Center.

 

Clinical benefit observed in more than 50% of patients treated with anti-CD19 x anti-CD22 bispecific ADC OXS-1550 in Ph I/II trial

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GT Biopharma’s President and Chief Medical Officer (CMO) Dr. Raymond Urbanski said: “In light of these data and discussions with the Bi-Specific ADC Advisory Board, I am increasingly encouraged by OXS-1550 and its potential to have a significant role in an oncologist’s armamentarium. I also remain convinced that the bi-specific ADC platform has the potential to generate additional attractive product candidates. I look forward to continuing to work closely with the University of Minnesota team and other members of the Bi-Specific ADC Advisory Board with the goal of optimizing next steps for this program and the broader bi-specific ADC platform.”

 

REGULATORY NEWS

Betalutin (177Lu-lilotomab satetraxetan) granted Fast Track designation in the US for pre-treated Follicular Lymphoma

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Lisa Rojkjaer MD, Nordic Nanovector CMO, commented: “We are pleased to have been granted Fast Track designation for Betalutin®. This designation is based on the promising safety and preliminary efficacy data in patients with relapsed/refractory indolent non-Hodgkin’s lymphoma from the first part of the LYMRIT 37-01 study, and highlights the potential of Betalutin® to be a new therapeutic option for these patients. We are now focusing the PARADIGME trial on 3L CD20-refractory FL patients, a population in urgent need of new therapies, and look forward to working with the FDA to advance the development of Betalutin®”.

FDA approves addition of updated OS data to Carfilzomib label

“Amgen is focused on advancing treatment options that have the potential to transform outcomes for patients,” said David M. Reese, M.D., senior vice president of Translational Sciences and Oncology at Amgen. “The ASPIRE trial showed significant improvement in survival in patients with relapsed or refractory multiple myeloma who received KYPROLIS as part of a triplet regimen. With this approval, the U.S. Prescribing Information for KYPROLIS now includes positive overall survival data from two Phase 3 trials, underscoring the important role of proteasome inhibition in the treatment of multiple myeloma.”

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Priority review granted to Talazoparib in gBRCA+ HER2neg breast cancer based on EMBRACA results; PDUFA: Dec 2018

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“Women with a hereditary BRCA mutation are typically diagnosed with breast cancer at a younger age than the overall breast cancer population and have limited treatment options when they develop advanced disease,” said Mace Rothenberg, M.D., chief development officer, Oncology, Pfizer Global Product Development. “Today’s filing acceptances are just the latest example of the success of Pfizer’s precision medicine approach to drug development, in this case targeting the faulty DNA damage repair process associated with BRCA mutations. We are now one step closer to offering a potential alternative to chemotherapy for these patients.”

 

TRIAL STATUS

First patient dosed in Ph I trial of CD47i TTI-622 (SIRPaFc-IgG4) in R/R lymphoma or myeloma patients

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“This is an exciting time for Trillium as we initiate clinical development with our second CD47 blocking agent,” commented Dr. Yaping Shou, Trillium’s Chief Medical Officer. “TTI-622 deepens our presence in the CD47 space, and its minimal binding to human erythrocytes could confer best-in-class status among IgG4-based blocking agents currently in development.”

First patient dosed in Ph I trial of Actimab-A + CLAG-M in R/R AML patients

Dr. Mark Berger, Actinium’s Chief Medical Officer said, “We are grateful for all of the hard work that the team at MCW has put in to get to this important milestone.  Actimab-A has demonstrated promising activity as a single agent in difficult to treat patient populations that we attribute to its targeting ability, potency and tolerability.  We are excited to be leveraging these strengths of Actimab in a combination regimen to bring this potentially important therapy to a greater number of patients in indications that need improved outcomes.  We are confident that the addition of Actimab to a salvage chemotherapy regimen has the potential to improve outcomes through improved response rates and by increasing the number of patients that can receive a bone marrow transplant.”

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First patient dosed in Ph Ia/Ib study of SBP-101 + gemcitabine + nab-paclitaxel in 1L mPDAC patients

Dr. Kotasek, the Principal Investigator for this study at the Adelaide Cancer Centre commented, “Pancreatic cancer is a challenging disease with few significant options available with a meaningful impact on response rates and progression free survival.  We are excited to participate in this clinical study, and to continue our evaluation of SBP-101 as front-line combination treatment for previously untreated patients with metastatic PDA.”

Dr. George is a medical oncologist having graduated with honors from the University of Florida College of Medicine.  He is the Director of the GI Oncology Program at the University of Florida and Associate Director of Clincial Investigation at the UF Health Cancer Center.  He is the Principal Investigator for this study at the University of Florida Health Cancer Center and he commented, “We are extremely honored to be participating in this important study that was born from the discoveries made by Dr. Raymond Bergeron here at the University of Florida.  Pancreatic cancer requires us to think outside the box which is exactly what this treatment has the potential to offer our patients with PDA.”

First patient dosed in Ph II trial of TF-targeting MMAE ADC, Tisotumab vedotin, for women with recurrent or metastatic cervical cancer

“While significant advances have been made in the treatment and prevention of cervical cancer, there remains a need for targeted agents that are effective for patients who progress or relapse after standard treatments,” said Robert Coleman, M.D., FACOG, FACS, Professor of Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX and principal investigator of the innovaTV 204 trial. “In a prior study, tisotumab vedotin demonstrated encouraging results in previously treated recurrent and/or metastatic cervical cancer, an area of unmet need where there is no established standard of care and response rates are limited.”

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“With the initiation of this phase 2 study of tisotumab vedotin for women with previously treated recurrent and/or metastatic cervical cancer, we now have four late-stage development programs on registrational pathways to achieve our goal of becoming a global, multi-product oncology company,” said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. “In addition, we plan to evaluate tisotumab vedotin in collaboration with Genmab in other solid tumors where there remains an unmet medical need for new treatment options.”

First patient dosed in Ph I trial of dendritic cells-based immunotherapy AST-VAC2 in NSCLC patients

“We are excited to have launched this clinical trial using AST-VAC2 for NSCLC,” said the trial’s chief investigator Professor Christian Ottensmeier MD, PhD, FRCP, Professor of Experimental Medicine within Medicine at the University of Southampton. “The study will allow us to demonstrate the safety and immunogenicity of what I believe is a groundbreaking dendritic cell technology. The approach has the potential to redefine the way we use dendritic cell vaccines in the clinic and may be applicable to many cancer indications.”

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“We are thankful for Cancer Research UK’s sponsoring the clinical trial and look forward to advancing our immunotherapy strategy around this trial and the earlier Phase 2 trial of AST-VAC1 in Acute Myeloid Leukemia (AML),” said Michael Mulroy, President and Chief Executive Officer of Asterias. “AST-VAC2 is an allogeneic approach that has the potential to avoid many of the issues that autologous therapies face today.  We are evaluating further development of AST-VAC2 as a monotherapy or in combination with other therapies in various cancer indications that may benefit from this therapy.”

Ph I trial of CD73-targeting mAb SRF373 initiated in multiple tumors including TNBC, MSS CRC, Pancreatic cancer, NSCLC, RCC and ovarian cancer

“We are very excited that Novartis has advanced our second product program into clinical development” said Rob Ross, M.D., chief medical officer of Surface Oncology. “We believe the profile of NZV930 is compelling and targeting adenosine reduction could play an important role in the treatment of patients suffering with a variety of types of cancer.”

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OncoMed doses first patient in Ph Ib part of anti-TIGIT trial with OMP-313M32 + nivolumab enrolling solid tumor patients who progressed on PD-(L)1 inhibitors

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“The dosing of the first patient in the Phase 1b portion of the anti-TIGIT trial marks an important milestone in the advancement of this therapeutic candidate through the clinic, where we will be evaluating the potential synergy of our anti-TIGIT monoclonal antibody with anti-PD1,” said John Lewicki, Ph.D., president and chief executive officer of OncoMed. “We look forward to continuing our exploration of the potential anti-tumor activity of anti-TIGIT and its ability to combine safely with anti-PD1 in key clinical oncology settings. Simultaneously, dose escalation in the Phase 1a portion of the trial is nearing completion and dose expansion in select tumor types is planned.”

 

First patient dosed in Ph I ADXS-NEO trial in NSCLC, MSS CRC and SCCHN patients

“We are extremely pleased to advance ADXS-NEO into the clinic. This program brings our clinically-validated Lm Technology to the cutting-edge area of neoantigen immuno-oncology,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. “We are committed to realizing the potential of ADXS-NEO to mobilize patients’ immune systems against mutations that accumulate within and contribute to the development of their cancer, and to bring the potential benefits of our technology to more patients and their families.”

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FDA clears INDs for AB928 and AB122 – Ph Ib/II program initiated to evaluate A2A/B receptor antagonist AB928 combinations

“We are thrilled to receive our first IND clearances to permit dosing in patients for AB928, our dual adenosine receptor antagonist, in combination with other anti-cancer agents,” said Terry Rosen, Ph.D., Chief Executive Officer at Arcus. “For our initial Phase 1/1b combination trials for AB928, we have selected tumor types that we believe will be most responsive to adenosine 2 receptor antagonism and combination partners that we expect to be synergistic with this mechanism, specifically immunogenic cell death (ICD) inducing chemotherapy and anti-PD-1 therapy. We have designed our Phase 1/1b program for AB928 to provide us with significant flexibility to open new arms to evaluate promising combinations and to expand or close existing arms based on the emerging data. We are extremely pleased to begin testing in patients the first adenosine 2 receptor antagonist that was specifically designed to be a therapeutic for cancer.”

 

Merck provides update on Tepotinib Ph II results in both 1L and 2L advanced HCC – both studies met primary endpoint

“These results, together with the interim data seen in patients with advanced non-small cell lung cancer harboring MET exon 14 skipping mutations presented at ASCO, provide further evidence of the potential of tepotinib as an innovative precision medicine,” said Luciano Rossetti, Global Head of Research & Development at the Biopharma business of Merck. “While this is a positive result, given the evolving standard of care in HCC, we will assess the possibility of pursuing tepotinib in this indication as a combination therapy versus a single-agent treatment.”

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COLLABORATIONS

Apexigen and Yale Cancer Center to evaluate APX005M +Cabiralizumab + Nivolumab in PD-(L)1 progressors mNSCLC, metastatic melanoma and RCC patients

“There is an urgent need to find effective therapies for the growing number of patients who have not responded to checkpoint inhibitors,” said Xiaodong Yang, M.D., Ph.D., President and Chief Executive Officer of Apexigen. “CD40 has a fundamental role in the activation of both innate and adaptive immunity, and we believe that CD40 activation by APX005M will become a key component of a number of promising new I-O therapeutic regimens for treating cancer patients.”

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“This most exciting collaboration between Apexigen and Yale is a result of studies with tumor bearing mice that are poorly responsive to inhibitors of PD-1/PD-L1. Based on these studies, we believe that activation of the innate immune system by APX005M in combination with cabiralizumab will enhance the activity of nivolumab, leading to a novel therapeutic approach for the increasing population of cancer patients who progress on currently approved immune checkpoint inhibitors. This is the first time this combination of drugs has been given to patients and we are eager to initiate this new clinical trial,” said Harriet Kluger, M.D., Professor of Medicine at Yale Cancer Center and Principal Investigator of the trial.

 

DIAGNOSTIC ASSAY

PD-L1 IHC 22C3 pharmDx approved by FDA to identify cervical cancer patients for treatment with Pembrolizumab

“PD-L1 is a critical biomarker for identifying patients who are likely to derive benefit from anti-PD-1 immunotherapy, and with an increasingly complex marketplace, pathologists look to Agilent as the clear leader to provide accurate and reliable PD-L1 testing,” said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. “This expansion of use for the Dako PD-L1 IHC 22C3 pharmDx assay gives patients with cervical cancer the possibility of having their tumor sample tested for PD-L1 expression, and determining eligibility for treatment with KEYTRUDA.”

Infographically Speaking….

Cover image: (Wikimedia Commons) This scanning electron micrograph (SEM) depicted a number of red blood cells found enmeshed in a fibrinous matrix on the luminal surface of an indwelling vascular catheter; Magnified 2858x. Note the biconcave cytomorphologic shape of each erythrocyte, which increases the surface area of these hemoglobin-filled cells, thereby, promoting a greater degree of gas exchange, which is their primary function in an in vivo setting. In their adult phase, these cells possess no nucleus. What appears to be irregularly-shaped chunks of debris, are actually fibrin clumps, which when inside the living organism, functions as a key component in the process of blood clot formation, acting to entrap the red blood cells in a mesh-like latticework of proteinaceous strands, thereby, stabilizing and strengthening the clot, in much the same way as rebar acts to strengthen, and reinforce cement. 

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

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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.

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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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