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Onco-this-Week

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Editor’s Note: This late edition of Onco-this-week covers the latest IO success, TKI failure, special statues, clinical hold removal and more from the week ending April 14th (2018). We have updates from Keytruda meeting primary endpoint of overall survival in Ph3 trials in PD-L1+ lung cancer patients and news about the fresh collaboration between Astra Zeneca and Molecular Partners on recently FDA approved Osimertinib. In our educational video section, learn about the different types of costs related to taking part in a clinical trial, and who is expected to pay for which costs. Also in this edition is a special infographic on the changing landscape of treatment for childhood cancers. Stay tuned for the latest from AACR 2018 in our next edition – Abhi Dey

 

Educational Video (Source: NCI, NIH)

Paying for Clinical Trials

RESULTS

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Pembrolizumab meets primary endpoint of OS improvement in Ph III KEYNOTE-042 trial in 1L PD-L1+ve NSCLC pts

“With KEYNOTE-042, KEYTRUDA has now shown a significant survival benefit compared with chemotherapy for patients with locally advanced or metastatic nonsquamous or squamous NSCLC expressing PD-L1 at 1 percent or higher by tumor proportion score,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “KEYTRUDA is a foundational treatment for NSCLC and has consistently demonstrated a survival benefit as monotherapy, or in combination with chemotherapy, in the treatment of metastatic lung cancer. We sincerely thank the patients and clinical investigators for their participation in this important study.”

“Improvement in overall survival is the ultimate objective in the treatment of advanced lung cancer. KEYNOTE-042 is the first randomized Phase 3 study of a single-agent immunotherapy using overall survival as the primary endpoint that has demonstrated significant benefit as first-line therapy in NSCLC patients who tested positive for PD-L1 at 1 percent or higher,” said Dr. Tony Mok, professor in the Department of Clinical Oncology at the Chinese University of Hong Kong.

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Ph III ATLAS trial of adjuvant Axitinib in high risk RCC patients fails

“We are disappointed by the outcome of this study as we had hoped the efficacy that INLYTA has demonstrated as a second-line treatment in patients with advanced renal cell carcinoma would carry over to patients with earlier stage disease, where it would delay or prevent disease relapse. That goal was not achieved. We will conduct additional analyses on the data that may provide insight into this result. Studies evaluating INLYTA in combination with immune checkpoint inhibitors for patients with a variety of advanced stage cancers, including RCC, will continue,” said Mace Rothenberg, M.D., Chief Development Officer, Oncology, Pfizer Global Product Development.

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Nivolumab + Ipilimumab induced an ICR of 46% in melanoma patients with asymptomatic, untreated brain metastases

Nivolumab combined with ipilimumab and nivolumab monotherapy are active in melanoma brain metastases. A high proportion of patients achieved an intracranial response with the combination. Thus, nivolumab combined with ipilimumab should be considered as a first-line therapy for patients with asymptomatic untreated brain metastases.

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IKZF1 Deletions Predict Poor Prognosis in Pediatric ALL

Childhood Cancer: Things Are Getting Better, There

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From Visually.

 

IKZF1plus describes a new MRD-dependent very-poor prognostic profile in BCP ALL. Because current AIEOP-BFM treatment is largely ineffective for MRD-positive IKZF1plus patients, new experimental treatment approaches will be evaluated in the upcoming trial AIEOP-BFM ALL 2017.

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Encouraging Poziotinib data observed on longer follow-up of Ph II trial in EGFR Exon 20 Mutant NSCLC patients

“The updated data from MD Anderson provides additional insight into just how meaningful poziotinib may be in this area of high unmet need,” said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. “At each turn, the possibility of this drug as an option for EGFR Exon 20 mutant NSCLC patients is becoming more clear.”

“Our study at MD Anderson has far exceeded our enrollment expectations,” said Xiuning Le, M.D., Assistant Professor, Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center. “At this point, the original cohort of 30 EGFR patients is fully enrolled and the expanded cohort of 20 patients is nearing the completion of enrollment. As enrollment in our study nears completion, we will soon begin enrolling patients in Spectrum’s ongoing multicenter Phase 2 study.”

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Crizotinib demonstrates durable activity in East Asian patients with ROS1+ NSCLC in Ph II trial

In the efficacy and safety analyses, 127 patients were included, with 49.6% still receiving treatment at data cutoff. ORR by IRR was 71.7% (95% CI, 63.0% to 79.3%), with 17 complete responses and 74 partial responses. ORRs were similar irrespective of the number of prior lines of therapy, and responses were durable (median duration of response, 19.7 months; 95% CI, 14.1 months to not reached). Median progression-free survival by IRR was 15.9 months (95% CI, 12.9 to 24.0 months). No new safety signals associated with crizotinib were reported.

This study demonstrated clinically meaningful benefit and durable responses with crizotinib in East Asian patients with ROS1-positive advanced NSCLC. Crizotinib was generally well tolerated, with a safety profile consistent with previous reports.

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Trastuzumab + standard chemotherapy improve survival in women with rare form of uterine cancer

Addition of trastuzumab to carboplatin-paclitaxel was well tolerated and increased progression-free survival. These encouraging results deserve further investigation to determine their impact on overall survival in patients with advanced or recurrent uterine serous carcinoma who overexpress HER2/neu.

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SPECIAL STATUSES

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FDA Grants Duvelisib Priority Review for CLL and Follicular Lymphoma

“Obtaining Priority Review in the U.S. for duvelisib marks another important milestone for Verastem and speaks to the unmet need in relapsed/refractory CLL/SLL and FL and the urgency to identify effective therapies to treat these patients,” said Robert Forrester, President and Chief Executive Officer of Verastem.

“As an orally administered therapy, we believe duvelisib will provide an important treatment option for patients with CLL/SLL and FL, and for the physicians who treat them. We look forward to working with the FDA during the review process. We are continuing our commercial preparations for duvelisib to execute the launch promptly in the U.S. if approved. In parallel, we are exploring ex-U.S. partnering opportunities for duvelisib and plan to file a European Marketing Application towards the end of the year.”

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Selinexor Receives Fast Track Designation from FDA for the Treatment of Penta-Refractory Multiple Myeloma patients

“The designation of Fast Track for selinexor represents important recognition by the FDA of the potential of this anti-cancer agent to address the significant unmet need in the treatment of patients with penta-refractory myeloma that has continued to progress despite available therapies,” said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm.  “We are fully committed to working closely with the FDA as we continue development of this potential new, orally-administered treatment for patients who currently have no other treatment options of proven benefit.”

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TRIAL STATUSES

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DMC recommends continuation of Ph III OPTIMA study of ThermoDox in HCC patients

“The DMC’s latest recommendation to continue the ongoing OPTIMA Study further supports our confidence in ThermoDox® and the OPTIMA Study’s design to demonstrate the safety and effectiveness of ThermoDox® plus standardized RFA therapy in the treatment of patients with primary liver cancer,” said Nicholas Borys, M.D., Celsion’s senior vice president and chief medical officer. “An important feature of the OPTIMA Study protocol is investigators’ adherence to RFA heating time of greater than 45 minutes for tumors greater than three centimeters – a key determination from the in-depth analyses of our previously completed HEAT Study. Based on the DMC’s review of the 411 patients enrolled in the OPTIMA Study as of February 5, 2018, it concluded that the integrity of the study is intact and that ThermoDox® is safe for continued enrollment of newly diagnosed, intermediate-stage patients. We note also that in the analysis of blinded data from the intent-to-treat population, consolidated for both arms, median progression free survival (PFS) was 20.8 months. This compares favorably to the HEAT Study median PFS of 13.8 months and is consistent with the hypothesis-generating estimates from the HEAT Study manuscript published in the October 2017 issue of the peer-reviewed medical journal, ‘Clinical Cancer Research.’”

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PD-1 inhibitor Tislelizumab’s Ph II trial starts in previously treated HCC

“We have made great progress in the development of tislelizumab with three global Phase 3 trials now enrolling patients. Along with our partner, Celgene, we are encouraged by this progress and excited for the development opportunity of tislelizumab globally,” commented John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene.

“This potentially registration-enabling trial of tislelizumab is expected to help us further understand its safety and efficacy with respect to the line of treatment in which it is administered to patients with advanced liver cancer. For these patients, as well as for patients in the concurrent front-line Phase 3 study of tislelizumab as compared to sorafenib, we are hopeful that tislelizumab will provide a new treatment option for a patient population with significant unmet needs,” commented Amy Peterson, M.D., Chief Medical Officer for Immuno-Oncology of BeiGene.

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Tractinostat’s Ph Ib/II clinical trial commences in EBV+ lymphomas

“The presence of EBV gene sequences in patient tumor samples is the primary biomarker to select patients likely to benefit from this treatment.” stated Marshelle Smith Warren, MD, Viracta’s VP R&D and Chief Medical Officer.

“Based on previous clinical experience with viral gene activation, using an epigenetic modifying drug, we are excited to explore how the unique properties of tractinostat may benefit this high-need patient population,” stated Viracta scientific founder, Douglas Faller, MD, PhD.

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COLLABORATIONS

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Molecular Partners and AstraZeneca to test MP0250 with Osimertinib in EGFR-mutated NSCLC

“We are delighted to welcome AstraZeneca as collaboration partner for our second phase 2 study of MP0250. This underlines the growing interest in MP0250 and nicely documents the potential value of MP0250 in EGFR-mutated NSCLC,” said Dr. Andreas Harstrick, Chief Medical Officer at Molecular Partners.

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NICE’s OPINIONS

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Positive recommendation to NHS use of Atezolizumab for NSCLC

“We are delighted that NICE has revised its decision, meaning that people living with this devastating form of cancer will now have access to a much needed treatment,” said Simon Eayrs, integrated franchise lead at Roche Products Ltd.

“This decision proves that patients are able to get access to new and innovative treatments when all parties work together to find a practical solution.”

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NICE rejects Alectinib for untreated ALK-positive advanced NSCLC patients

NICE commented that while Alecensa seemed to be more effective than crizotinib at delaying disease progression as per the current evidence, its contribution in prolonging survival was debated.

It also voiced concerns over some of the assumptions used in the cost-effectiveness modelling, including on drug waste, the types of treatments that people receive after disease progression, and the types of care used to manage disease progression in the central nervous system.

Based on the most plausible assumptions, cost-effectiveness estimates for Alecensa versus crizotinib came in above the range that the committee considered to be cost-effective for the NHS, NICE said.

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Finally, some humor before we sign off…

Source: Mooselake Cartoons

 

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: Getty Images, Wikipedia and Twitter

Cover image: Scanning electron micrograph of just-divided HeLa cells. Zeiss Merlin HR-SEM. (Source: NIH/Wikimedia Commons )

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).

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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.

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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