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Onco-this-Week

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In the current issue of Onco-this-Week, Richa Tewari updates you about the FDA approvals in treating patients with stage III or IV classical Hodgkin Lymphoma, chronic myelogenous leukemia (CML) and hepatocellular carcinoma (HCC). Check out the hits/misses of immunotherapy/chemotherapy in advanced stage liver cancer, lung cancer, multiple myeloma, paraganglioma and chronic lymphocytic leukemia clinical trials. Also find out who received an FDA priority review for prostate cancer and an orphan drug designation for T-cell Lymphoma. And the information doesn’t stop at drug-candidates, because we have more news about path-breaking diagnostics in solid tumors, favorable recommendations, novel collaborations, licensing deals and publications that will keep you filled-in with progressive efforts of our cancer researchers, oncologists, surgeons and, above all, the cancer patients, whose courage to fight makes all these efforts worthwhile.

But before we begin, here is something for comic relief

Source: Mooselakecartoons.com

And just FYI (For Your Infographic)

 

What Is Cancer Immunotherapy

by Nakanishi.

From Visually.

APPROVALS

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CD30-targeting ADC Brentuximab vedotin + chemotherapy approved by FDA in 1L stage III or IV classical Hodgkin Lymphoma

“The standard of care for treating newly diagnosed advanced Hodgkin lymphoma has not changed in more than four decades. For years, the physician community has been conducting clinical trials to identify improved regimens that are both less toxic and more effective to no avail,” said Joseph M. Connors, M.D., FRCPC, Clinical Director, Center for Lymphoid Cancer at BC Cancer in Vancouver, Canada. “The ECHELON-1 study results demonstrated superior efficacy of the ADCETRIS plus chemotherapy regimen when compared to the standard of care while removing bleomycin, an agent that can cause unpredictable and sometimes fatal lung toxicity, completely from the regimen. This represents a meaningful advance for this often younger patient population.”

Nilotinib gets FDA approval in pediatric patients with Ph+ CML-CP

“Novartis’ commitment to people living with CML is reinforced by today’s FDA approval of Tasigna in children,” said Liz Barrett, CEO, Novartis Oncology. “This expanded use, along with the other recent global regulatory Tasigna milestones, underscores our dedication to reimagining medicine and addressing the needs for people with CML, including children with this cancer.”

Lenvatinib approved in unresectable 1L HCC in Japan based on Ph III REFLECT trial data

“With the approval of this additional indication of unresectable HCC for LENVIMA, we are proud to be able to deliver the first new front-line systemic therapy treatment option for HCC in Japan in approximately 10 years, and expect this will contribute to HCC treatment,” said Dr. Takashi Owa, Eisai Oncology Business Group Chief Medicine Creation Officer. “Eisai will continue with its efforts in oncology research and development in order to deliver hopes for a potential cure for cancer to patients and their families.”

“Today’s approval is an important first for LENVIMA and a significant first regulatory event under our collaboration with Eisai,” said Dr. Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, Merck Research Laboratories. “We congratulate Eisai on the approval of this new indication and look forward to working together to bring this important treatment option to patients.”

 

RESULTS

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SIR 2018: Early safety results from Ph I trial shows talimogene laherparepvec (T-VEC) tolerable and able to stimulate the immune system to destroy cancer cells

“Advanced stage liver tumors, including ones that have spread from other locations, have limited treatment options because the patients can be in poor health; further, the complex structure of the organ can make it difficult to target with standard approaches,” said Steven S. Raman, M.D., professor of radiology, surgery and urology at the David Geffen School of Medicine, University of California, Los Angeles, and lead author of the study. “This minimally invasive treatment offers patients a novel way to directly and indirectly attack the cancer cells.”

Ph III IMpower131 study showed reduced risk of disease worsening or death with Atezolizumab + Chemotherapy in sqNSCLC patients

“Squamous non-small cell lung cancer is difficult to treat and there have been limited new treatment options over the last few decades,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We will share the IMpower131 results with global health authorities and we look forward to seeing more mature overall survival data.”

 

Ph II data of Rova-T in 3L DLL3-expressing R/R SCLC patients out; AbbVie not to seek accelerated approval

“We continue to believe Rova-T has potential for patients with small cell lung cancer and other DLL3-expressing cancers,” said Mike Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. “Although the results from the study were not what we hoped for, we look forward to receiving data from the ongoing Phase 3 studies in the first- and second-line settings and remain committed to developing Rova-T for the treatment of patients with small cell lung cancer.”

 

EBMT 2018: Ph 2 GPS study shows clinical benefit with galinpepimut-S in high risk multiple myeloma patients

“These results are encouraging particularly given the patients’ poor prognosis due to their high-risk cytogenetic profile at disease presentation and their still harboring minimal residual disease prior to GPS treatment”, said Angelos M. Stergiou, M.D., Sc.D. h.c., President and CEO of Sellas in a press release.  “The improved PFS at 23.6 months in this setting instills further confidence in our advancing GPS development as an important immuno-therapeutic treatment option for aggressive multiple myeloma.”

Ph II results of Iobenguane I 131 show significant response in pheochromocytoma and paraganglioma patients

“In this pivotal study of AZEDRA in pheo and para patients, the overall tumor biomarker response correlated significantly with responder status with both the primary and secondary endpoints,” said Dr. Camilo Jimenez, Associate Professor, Department of Endocrine Neoplasia and Hormonal Disorders at the University of Texas M. D. Anderson Cancer Center. “AZEDRA has already been shown to have a significant positive impact on the cardiovascular symptoms associated with pheochromocytoma and paraganglioma. It has also demonstrated objective antitumor effects as measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria. The biochemical tumor marker data presented today provides further evidence of AZEDRA’s potential to offer a meaningful treatment option for patients with these life-threatening tumors.”

PFS rate improvement there, but no OS rate improvement with Venetoclax + Rituximab in Ph III MURANO trial in R/R CLL patients

The PFS benefit extended across patients subgroups, including high- and low-risk groups. The 2-year PFS rate among patients with chromosome 17p deletion was 81.5% in the venetoclax arm versus 27.8% with BR (HR, 0.13; 95% CI, 0.05-0.29). For patients without chromosome 17p deletion, the 2-year PFS rate was 85.9% versus 41.0% in favor of the venetoclax arm (HR, 0.19; 95% CI, 0.12-0.32).

Two-year event-free survival also favored the venetoclax group (84.9% vs 34.8%; HR, 0.17; 95% CI, 0.11-0.25). The rate of overall survival (OS) favored the venetoclax arm at 24 months (91.9% vs 86.6%). However, the difference was not statistically significant and neither arm reached median OS (HR, 0.48; 95% CI, 0.25-0.90). 

REGULATORY NEWS

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EMA accepts Type II variation application for Enzalutamide in nmCRPC based on Ph III PROSPER trial data

“In many cases, men see their prostate cancer progress after initial androgen deprivation therapy. Until recently, no treatments have been proven efficacious for men with unproven metastatic disease castration-resistant prostate cancer,” said Dr Cora N. Sternberg, a key investigator in the trial and Chief of Medical Oncology at San Camillo Forlanini Hospital, Italy. “The PROSPER data may help us better understand this challenging stage of the disease.”

SPECIAL STATUSES

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Priority review to sNDA for Enzalutamide in nmCRPC based on Ph III PROSPER trial data; PDUFA: Jul 2018

“Once cancer spreads and metastasizes, men with castration-resistant prostate cancer face a daunting prognosis and challenging odds,” said Steven Benner, M.D., senior vice president and global therapeutic area head, Oncology Development, Astellas. “We’re pleased to see the FDA’s Priority Review designation as we work to potentially bring XTANDI to men living with non-metastatic CRPC.”

“Treatment options have been limited for men with non-metastatic CRPC, in whom the only evidence of progressive disease is a rapidly rising PSA,” said Mace Rothenberg, M.D., chief development officer, Oncology, Pfizer Global Product Development. “XTANDI is already established as a standard of care for men with metastatic CRPC. This milestone marks an important step toward our ability to bring XTANDI to CRPC patients in an earlier setting.”

SIRPaFc fusion protein TTI-621 gets Orphan drug designation in CTCL

“The FDA’s decision to designate TTI-621 as an orphan drug underscores the urgent need to develop additional therapeutics for patients with cutaneous T-cell lymphoma,” said Dr. Niclas Stiernholm, President and CEO of Trillium Therapeutics. “We believe that our investigational drug holds promise as a potential new treatment and will continue advancing the compound through clinical development in both of our trials.”

NCCN RECOMMENDATIONS

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Optune + Temozolomide gets category 1 recommendation in 1L Glioblastoma

“Many physicians look to the NCCN Guidelines as the standard resource when determining the best course of treatment for patients,” said Asaf Danziger, Novocure’s Chief Executive Officer. “The introduction of Optune with temozolomide gives newly diagnosed GBM patients the potential for long-term survival. We believe the updated NCCN guidelines will increase physician awareness, particularly in the radiation oncology and medical oncology communities, helping us to reach patients earlier in the course of this aggressive disease.”

Regorafenib Dose Escalation in mCRC, based on Ph II ReDOS results

“The most important aspect of this study is that now we have another option, and I think it is a preferred option, of how to administer regorafenib,” said Bekaii-Saab. “As we get more confirmatory studies, [we might want] to consider regorafenib a little earlier if we want to get the full benefit of the agent rather than wait until the end when the patient is literally about to go to hospice. A dose-escalation strategy would make more sense now than the standard 160 mg. We have to become more proactive about how we place our drugs and how to optimize the dose-escalation strategy for regorafenib.”

Colon cancer patients with low-risk stage III to be treated with a shorter schedule of adjuvant chemotherapy

“I believe we will have the first…important changes [in adjuvant chemotherapy] since 2004,” commented Axel Grothey, MD, of the Mayo Clinic Cancer Center in Rochester, Minnesota.

TRIAL STATUSES

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Enrolment completed for Ph I study of TriMix mRNA-based Cancer Specific Immunotherapy (ECI-006) in Melanoma

The ongoing clinical study is a multicenter open-label Phase 1b study evaluating the safety and tolerability of intranodal administration of two different doses (600 µg or 1800 µg) of ECI-006 in stage IIc/III/IV melanoma patients after surgical removal of their tumor lesions and is being conducted across Belgium and Spain. The study will also assess immune response following the five intranodal administrations of ECI-006 administered over a period of 14 weeks.

Initial immunological data from the low dose cohort are expected in the second half of 2018.

Marina Cools, Clinical Lead at eTheRNA, said: “We are pleased to have achieved this important milestone in the Phase 1b study with ECI-006, with initial data indicating that the study’s low dose is safe and well tolerated by patients. We will begin enrolment for the high dose cohort of this study during the second quarter of this year.”

Surface Oncology Announces First Patient Dosed in Ph I Clinical Trial of SRF231- An antibody targeting CD47

“The initiation of this clinical trial is a milestone for Surface and demonstrates the outstanding progress we’ve made in advancing our innovative oncology pipeline,” said Rob Ross, M.D., chief medical officer of Surface Oncology. “SRF231 is the first of what we expect will be multiple novel agents that we bring into clinical development to help patients suffering from cancer.”

Dx TEST

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Foundation Medicine gets final NCD from CMS, including coverage for FoundationOne CDx™ across all solid tumors

“We applaud CMS for issuing this final National Coverage Determination that significantly expands coverage beyond the preliminary draft policy. Most notably, the NCD, as it applies to FoundationOne CDx, will provide coverage for eligible patients across all solid tumors,” said Troy Cox, chief executive officer at Foundation Medicine. “The final NCD will significantly improve access and coverage for Medicare beneficiaries to comprehensive genomic profiling and biomarker-driven treatments. We look forward to commercializing FoundationOne CDx by the end of March, providing the oncology community with the only FDA-approved broad assay for all solid tumors.”

Chugai to commercialize FoundationOne CDx assay in Japan; seeking MHLW regulatory approval

“Seeking approval for FoundationOne CDx in Japan is an important step for the integration of comprehensive genomic profiling into oncology clinical care,” said Melanie Nallicheri, chief business officer and head, biopharma for Foundation Medicine. “Importantly, an MHLW-approved assay could enable the same accelerated pathway for companion diagnostic development and approval that Foundation Medicine has pioneered in the United States with FDA approval, meeting a critical need today for our biopharma partners’ global development and commercial efforts. We look forward to partnering with Chugai, and our biopharma partners, to expand MHLW-approved companion diagnostics claims on FoundationOne CDx ensuring patient access to personalized cancer care.”

COLLABORATIONS

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AbbVie and the International Myeloma Foundation Announce Partnership to Study the Role of a Genetic Mutation in Outcomes of Patients with Multiple Myeloma

“There are significant knowledge gaps about multiple myeloma, and among these gaps is the role of genetic mutations in response to treatment, and the related outcomes for patients,” said Brian G.M. Durie, M.D., IMF chairman. “This study has the potential to provide valuable real-world evidence that can help advance care for patients, and we are proud to join forces with AbbVie to further advance efforts in research and education in multiple myeloma.”

LICENSING DEALS

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Helsinn Group to acquire worldwide rights to alkylating agent, Valchlor®/Ledaga®, for MF-CTCL

Riccardo Braglia, Helsinn Group Vice Chairman and CEO, commented: “Helsinn is delighted to announce the acquisition of Valchlor®/Ledaga®, for the treatment of mycosis fungoides-type cutaneous T‐cell lymphoma in patients who have received prior skin‐directed therapy. This is a discomforting disease which has a significant impact on patients’ quality of life. Helsinn is committed to developing and marketing products designed to help people with cancer get the most out of every day and benefit from Valchlor®, which is approved and marketed in the U.S. where limited treatment choices are available.We are excited to be adding this drug to our portfolio of products designed to offer appropriate cancer therapeutic and supportive care treatment options to patients. We are looking forward to bringing the drug to more patients worldwide”.

CHMP OPINIONS

 

ABP 980 (Biosimilar Herceptin®) receives positive CHMP opinion for the treatment of three types of cancer

“The positive opinion issued by the CHMP for ABP 980 marks an important step for our biosimilar portfolio, as it’s our second oncology biosimilar to reach this important milestone, and further underscores our commitment to providing the oncology community access to high-quality cancer therapies,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “We look forward to continuing our work with Allergan and European regulatory authorities to bring additional options to patients with cancer.”

PUBLICATIONS

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Detailed data from Ph III COLUMBUS trial of Encorafenib + Binimetinib published in The Lancet Oncology

“A median progression-free survival of nearly 15 months with the combination of encorafenib and binimetinib is clinically meaningful for patients with advanced BRAF-mutant metastatic melanoma,” said Keith T. Flaherty, M.D., Director of the Termeer Center for Targeted Therapy, Massachusetts General Hospital Cancer Center and Professor of Medicine, Harvard Medical School. “Further, a median overall survival of 33.6 months, compared to 16.9 months with vemurafenib monotherapy (HR of 0.61, 95% CI 0.47-0.79, p<0.001), a secondary endpoint not included in this publication, was recently announced. This further supplements the published data and shows that the combination of encorafenib and binimetinib may become a promising new therapy for patients with advanced BRAF-mutant metastatic melanoma.”

Ponatinib pivotal Ph II PACE trial data published in Blood

“The PACE trial is among the longest and largest studies of patients with CP-CML who have received two or three prior TKIs, and the findings provide treating physicians with important updated information about the clinical benefits and safety profile of ICLUSIG,” said Jorge Eduardo Cortes, M.D., Deputy Chair and Professor of Medicine, Department of Leukemia, MD Anderson Cancer Center. “These final PACE results demonstrate that ICLUSIG provides lasting clinically meaningful responses, irrespective of dose reductions, in this population.”

“The publication of these data is an important milestone for the ICLUSIG clinical program as it shows that ICLUSIG continues to be an effective treatment option for appropriate patients whose prior TKIs have failed, including patients with the T315I mutation, for whom no other TKI is indicated,” said Frank Neumann, M.D., Ph.D., Senior Medical Director, Global Clinical Lead, ICLUSIG, Takeda. “While the PACE study analysis did not evaluate the impact of initiating therapy with a lower dose on adverse events and response rates, this important question is being addressed by the ongoing prospective dose-ranging OPTIC (Optimizing Ponatinib Treatment in CML) trial (NCT02467270).”

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: Life of a Cancer Cell from Wikimedia Commons (By Bruce Blaus – Own work, CC BY-SA 4.0, https://commons.wikimedia.org/w/index.php?curid=51617454)

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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