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Onco-this-Week

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Editor’s Note- In Onco-this-Week, Richa Tewari updates us about the FDA approval of Blinatumomab for Minimal Residual Disease-positive Acute Lymphoblastic Leukemia. In addition, find out which drug/combinations received FDA’s Breakthrough Therapy designations and which compound caused tumor shrinkage in ovarian cancer patients. Also in this edition, we have updates about the story of a drug-candidate that is inspiring others to develop drugs for both adult and pediatric patients on the basis of tumor genetics rather than tumor site of origin. But that is not the end, we have several other updates on clinical trails in  NSCLC, Endometrial Cancer, Ovarian Cancer. And if you are still trying to make sense of this avalanche of information, check out the YouTube videos that talk about the basics of the FDA approval process and the overview of the Clinical Trials process. – Abhi Dey 

(For detailed info, click on the headline of each story to get directed to the original news source)

FDA APPROVALS

This hand drawn white board video illustrates the 5 important stages of drug approval by the FDA. Discovery and Screening, IND Application Submission, Clinical Trials, Application Review and Inspections, and Safety Monitoring.

 

FDA Approves Blinatumomab for MRD+ ALL

“This is the first FDA-approved treatment for patients with MRD-positive ALL,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Because patients who have MRD are more likely to relapse, having a treatment option that eliminates even very low amounts of residual leukemia cells may help keep the cancer in remission longer. We look forward to furthering our understanding about the reduction in MRD after treatment with Blincyto. Studies are being conducted to assess how Blincyto affects long-term survival outcomes in patients with MRD.”

RESULTS

Before we begin, lets watch this YouTube video to understand clinical trials. This animation explains what clinical trials are, how they are conducted, and why they are important for patients with diseases like pancreatic cancer. The animation also provides an overview of study design, eligibility criteria, informed consent, safeguards, different phases of clinical trials, and the potential benefits and potential risks of participation. You can find out more about clinical trials and pancreatic cancer at: http://www.AnimatedPancreasPatient.com

 

 

Phase III IMpower150 study meets primary endpoint of OS improvement with Atezolizumab + Bevacizumab + Chemotherapy vs. Bevacizumab + Chemotherapy in advanced NSCLC patients

“We are pleased that the IMpower150 study demonstrated a clinically meaningful survival benefit for people receiving their initial treatment for this type of advanced lung cancer,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “These results add to the growing body of evidence supporting the role of combining TECENTRIQ with Avastin. We will submit these additional data to global health authorities and hope to bring this potential treatment option to patients as soon as possible.”

Recurrent Endometrial Cancer responds to everolimus + letrozole: Responses in half of patients with no prior chemotherapy

EL is an active regimen in 24% of patients with recurrent EC. Responses in the NPC stratum suggest that EL is active in patients with chemo-naive recurrent EC. Further study of its activity in chemo-naive patients is warranted. While not statistically significant, more patients with PT had thromboembolic events.

SGO 2018: 63% ORR observed with Mirvetuximab – Pembrolizumab combo in Ovarian Cancer patients with medium or high FRα expression levels

“We are encouraged by the early evidence of anti-tumor activity with durable responses and the tolerability profile of mirvetuximab in combination with pembrolizumab, particularly among the subset of patients with medium or high folate receptor alpha expression where we saw the greatest benefit,” said Anna Berkenblit, M.D., Vice President and Chief Medical Officer of ImmunoGen. “Across multiple combinations, we’ve demonstrated that our Phase 3 single agent dose level for mirvetuximab combines readily with other therapies. The consistency of these findings further underscore the potential of mirvetuximab for ovarian cancer – both as monotherapy, and in combination with other therapies in earlier lines of treatment.”

SGO 2018: Encouraging trends observed with Niraparib + Pembrolizumab in platinum resistant/refractory Ovarian Cancer patients

“Patients with platinum-resistant or platinum-refractory ovarian cancer have limited treatment options available to them. Approximately 10,000 women in each of the US and EU begin treatment for platinum-resistant or refractory ovarian cancer each year,” said Mary Lynne Hedley, Ph.D., President and COO of TESARO. “Preliminary results from TOPACIO suggest the combination of niraparib and an anti-PD-1 antibody could provide meaningful clinical benefit to these patients, regardless of biomarker status. Planning of a registration study is underway to support approval of ZEJULA and TSR-042 combination therapy for these patients. TSR-042 is TESARO’s anti-PD-1 antibody, which is currently in a registration study for MSI-H tumors.”

“These data provide a compelling initial step in our ovarian cancer development strategy which is progressing from monotherapy ZEJULA utilized in PRIMA, NOVA and QUADRA to  doublet and triplet combination approaches with anti-PD-1 antibodies and bevacizumab,” said Marty Huber, M.D., Senior Vice President and Chief Medical Officer of TESARO. “Our ultimate goal is to maximize the benefit to women across the full spectrum of ovarian cancer”

SGO 2018: Phase III SOLO2 trial shows significant PFS improvement with Olaparib in platinum-sensitive relapsed ovarian cancer (PSROC) patients in 3L maintenance settings

Olaparib tablet maintenance treatment in SOLO2 led to a clinically meaningful, statistically significant PFS benefit in pts with PSROC and a BRCAm. Key endpoints of PFS by BICR and PFS2 substantiated the efficacy benefit. Maintenance treatment with the tablet formulation of olaparib was well tolerated, with a low incidence of discontinuation due to toxicity.

 

SGO 2018: Phase II MEDIOLA study shows 70% ORR in relapsed Ovarian Cancer patients with Olaparib/Durvalumab combination

“The combination of olaparib and durvalumab was well tolerated, with a low incidence of grade 3 or higher adverse events or all-grade immune-related adverse events,” Yvette Drew, MD, of Newcastle University in Newcastle-Upon-Tyne, England, reported at the 2018 Society of Gynecologic Oncology Annual Meeting.

“Preliminary efficacy results suggest strong activity in relapsed platinum-sensitive ovarian cancer, particularly in early-line patients…Baseline PD-L1 expression and tumor-infiltrating lymphocytes (TILs) did not appear to correlate with clinical outcomes,” added Drew.

PFS improvement observed in Phase III trial of Sorafenib in rare sarcomas

“Sorafenib is a novel way of treating this rare cancer,” said lead investigator and study chair Mrinal M. Gounder, M.D., sarcoma medical oncologist at Memorial Sloan Kettering Cancer Center in New York City. “The promising results of this phase 3 trial represent a paradigm shift in the approach to treatment of patients with desmoid tumors.”

IKS 2018: Stable disease with tumor shrinkage reported with NK100 in Ovarian Cancer patients

“We are very encouraged by our initial clinical observations of FATE-NK100 in heavily pre-treated patients with recurrent ovarian cancer,” said Melissa Geller M.D., Associate Professor of Gynecologic Oncology, Department of Obstetrics, Gynecology and Women’s Health at the University of Minnesota and Principal Investigator of the APOLLO clinical trial at the Masonic Cancer Center. “Currently approved single-agent therapies for platinum-resistant ovarian cancer typically have low response rates and short median progression-free survival. The administration of NK100 directly within the peritoneal cavity is a novel therapeutic strategy to potentially improve these dismal outcomes.”

SPECIAL STATUSES

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Astellas and Seattle Genetics Receive FDA Breakthrough Therapy Designation for Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Cancer

“The FDA Breakthrough Therapy Designation underscores the potential of enfortumab vedotin as a meaningful treatment for patients with locally advanced or metastatic urothelial cancer. Further, it supports our rapid development plans for this ADC, including the ongoing pivotal study in this patient population,” said Robert Lechleider, M.D., Vice President, Clinical Development at Seattle Genetics. “Seattle Genetics is an emerging multi-product oncology company, advancing a robust pipeline with the goal of improving outcomes for cancer patients. Enfortumab vedotin is at the forefront of our late-stage clinical pipeline, and we are working closely with our partner and the FDA to bring this potential new treatment to patients as quickly as possible.”

“Achieving Breakthrough Therapy Designation for enfortumab vedotin is another step forward in our goal to bring an additional treatment option to patients who need it most,” said Steven Benner, M.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development at Astellas. “With the enfortumab vedotin registrational phase 2 trial and CPI-combination trial actively underway, Astellas looks forward to expanding development of enfortumab vedotin and its oncology pipeline, including treatments that would target some of the hardest-to-treat cancers.”

Priority review and Breakthrough Therapy designation to Nivolumab + Ipilimumab in MSI-H or dMMR mCRC patients; FDA action date: Jul 2018

“The FDA acceptance of this application with priority review reinforces our belief in the potential of the Opdivo plus Yervoy combination to treat patients with previously treated metastatic colorectal cancer defined by MSI-H or dMMR biomarkers, and is a result of our longstanding commitment to the exploration of I-O/I-O combinations for patient populations with high unmet need,” said Ian M. Waxman, M.D., development lead, Gastrointestinal Cancers, Bristol-Myers Squibb. “We look forward to working with the FDA with the goal of bringing this combination to these colorectal cancer patients.”

DS-8201 receives SAKIGAKE designation for advanced HER2+ve gastric or GEJ cancer

“There are no HER2-targeting treatment options currently available for patients with HER2-positive gastric cancer whose tumors are no longer controlled by trastuzumab,” said Koichi Akahane, PhD, MBA, Executive Officer, Head of Oncology Function, R&D Division, Daiichi Sankyo. “We look forward to working closely with the Japan Ministry of Health, Labour and Welfare under the terms of the SAKIGAKE program to accelerate the development of DS-8201 particularly since Japan has one of the highest incidence rates of gastric cancer worldwide.”

REGULATORY NEWS

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PDUFA extension for radiotherapeutic norepinephrine reuptake transporter substrate, iobenguane I 131, in rare NETs

“We remain confident in our NDA submission and are committed to bringing AZEDRA forward as an option for patients with malignant pheo and para,” said Mark Baker, Chief Executive Officer of Progenics. “We look forward to continuing our dialogue with the Agency as we prepare for a potential approval of AZEDRA.”

Loxo completes rolling NDA submission for Larotectinib in NTRK+ve solid tumors

“We are grateful to the many patients who participated in our clinical trials in the spirit of helping others with advanced cancer,” said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. “We hope that the larotrectinib development program inspires others to develop drugs for both adult and pediatric patients on the basis of tumor genetics rather than tumor site of origin.”

Phase III SEQUOIA study to continue as per DMC recommendation without modification

“Clearing the first interim analysis with feedback from the DMC to continue the SEQUOIA study without modifications is a key corporate milestone for ARMO in 2018,” said Joseph Leveque, MD, Chief Medical Officer of ARMO Biosciences.  “The DMC’s recommendation supports the safety profile we have seen with pegilodecakin when combined with 5-fluorouracyl and platinum based chemotherapy which is the basis for a number of difficult to treat cancers.  As such, we believe that pegilodecakin in combination with FOLFOX could provide a safe and efficacious therapeutic option for second-line PDAC patients.  The SEQUOIA study continues to enroll well and had 178 patients randomized as of March 15th of this year, which keeps us on track to deliver both the second interim analysis and the final data analysis on this pivotal study in 2020.”

Nivolumab receives positive CHMP opinion for Q4W Dosing in advanced Melanoma and previously treated RCC patients

“BMS is committed to improving cancer care by, among other things, addressing scheduling and convenience concerns of patients with a range of dosing options for an Immuno-Oncology agent that allows for enhanced flexibility,” said Fouad Namouni, M.D., head of development, Oncology, Bristol-Myers Squibb. “This positive CHMP opinion reinforces our commitment and we look forward to hearing from the European Commission. Once approved, the Opdivo four-week dosing infused over 60 minutes would enable BMS to deliver on our promise to explore potentially more flexible and convenient dosing options for patients, caregivers and healthcare providers alike.”

CHMP OPINION: Positive vote to Rucaparib’s application in Ovarian Cancer

“The recommendation to approve Rubraca as monotherapy is welcome news, as once approved it will offer a new treatment option for women with advanced, recurrent ovarian cancer who have BRCA mutant platinum sensitive disease and are unsuitable for platinum based chemotherapy. In this analysis, we observed many women benefiting from extended progression-free survival with acceptable tolerability,” said Dr. Rebecca Kristeleit, Clinical Senior Lecturer and Consultant Medical Oncologist, University College London/University College London Hospitals UK. “These are really important data demonstrating meaningful efficacy and a new non-chemotherapy treatment option for this group of patients who have already been exposed to a number of chemotherapy regimens.”

NICE OPINION: Cabozantinib gets a green light in medullary thyroid cancer

Ipsen’s Cometriq can now be routinely funded by the NHS to treat patients with medullary thyroid cancer (MTC) in England and Wales.

The National Institute for Health and Care Excellence has issued guidelines recommending the drug as an option for treating progressive MTC in adults with unresectable, locally advanced or metastatic disease.

This is a rare cancer, accounting for 3-12 percent of all thyroid cancers, and can spread to the lungs or bone. Approximately 25 percent of MTCs are the result of an inherited faulty gene that runs in the family.

TRIAL STATUSES

via GIPHY

 

Phase II trial of PI3K / AKT / mTOR pathway inhibitor, GDC-0084, commences in GBM patients

Kazia CEO, Dr James Garner, commented, “the entire team has been working hard to design and implement the GDC-0084 clinical study. We are very pleased to now have the trial underway, and look forward to working with the participating clinicians. The need for new therapies in this disease remains immense, and we believe that GDC-0084 may have a valuable role to play in improving outcomes for patients with glioblastoma.”

First patient enrolled in the Phase IIb CYPRESS 2 trial evaluating AM0010 + Nivolumab in 2L, PD-L1 low/neg NSCLC patients

“We are pleased to have dosed the first patient in our CYPRESS development program, which will guide our registrational strategy for pegilodecakin in NSCLC,” said Joseph Leveque, MD, Chief Medical Officer of ARMO Biosciences.  “In our Phase 1 b trial, pegilodecakin showed very encouraging disease control (DCR), overall response (ORR), progression-free survival (PFS) and overall survival (OS) when combined with pembrolizumab or nivolumab, regardless of the PD-L1 expression, tumor mutational burden (TMB) or disseminated disease in NSCLC patients.   We expect that the CYPRESS studies could provide confirmatory translational data to our Phase 1b experience and will allow us to define targeted registrational studies with pegilodecakin in these tough to treat patient populations, which could potentially commence as early as 2019.”

COLLABORATIONS

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Bluebird bio and Celgene to co-develop and co-rromote Anti-BCMA CAR T Cell Therapy bb2121 in the United States

“Entering into this co-development and co-promotion partnership with Celgene is a significant step forward in building a fully integrated oncology franchise for bluebird and together, we are committed to rapidly advancing development of bb2121 for patients,” said Joanne Smith-Farrell, Ph.D., oncology franchise leader and senior vice president, corporate development and strategy, bluebird bio. “The collaboration builds upon our extensive research and development capabilities in oncology and is a testament to the strong partnership that exists between our two companies.”

NCCN GUIDELINES

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Management of immune-related adverse events in patients treated with Immune Checkpoint Inhibitor (ICPi) therapy

The systematic review identified 204 eligible publications. Much of the evidence consisted of systematic reviews of observational data, consensus guidelines, case series, and case reports. Due to the paucity of high-quality evidence on management of immune-related adverse events, recommendations are based on expert consensus.

 

And now, time for some humor before we sign-off….

Source: Mooselakecartoons.com

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: Pixabay, Giphy, Wikipedia and Twitter

Cover image:Artist’s rendering of small chemical ornaments (cones) slow the release of anti-cancer antibodies (blue) from this functionalized mesoporous silica (orange) By ENERGY.GOV (https://flic.kr/p/fuajMn) [Public domain], via Wikimedia Commons

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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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