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Onco-this-Week

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HIGHLIGHTS

  1. EU approval of Atezolizumab + bevacizumab in non-sq mNSCLC. The Ph III IMpower150 trial showed prolonged survival, reduction in the risk of disease worsening or death and tumor shrinkage with Atezolizumab + Bevacizumab + chemotherapy in NSCLC patients. Whereas FDA had approved the combination in 1L EGFR/ALK WT patients; today’s EU approval is granted in 1L all comers and 2L EGFR/ALK+ mNSCLC patients! Though this approval based on pretty robust data helps Atezolizumab fight Pembrolizumab in these patients, the success is slightly dampened with failure of IMpower132 trial last year.
  2. Priority review to Fedratinib in Myelofibrosis. With Ruxolitinib being the only FDA-approved drug in Myelofibrosis, it is not surprising to witness a high unmet need of therapy options in Ruxolitinib-ineligible or -refractory patients. Ph III JAKARTA and Ph II JAKARTA2 trials data helped Fedratinib secure a priority review in Ruxolitinib-treated myelofibrosis patients, and the physicians may welcome an additional therapeutic option; however there may be concerns around safety of this JAK2 inhibitor stemming from 2013 when Fedratinib program was put under clinical hold (removed almost four years later).
  3. Positive CHMP opinion to Pembrolizumab’s six-week dosing schedule. In all monotherapy indications (five to be precise), Pembrolizumab is currently given as 200 mg every three weeks – the new dosing schedule might just get more patient-friendly with 400 mg to be given every six weeks. CHMP’s nod comes on the heel of a study where the two dosing regimens were found to have a similar benefit-risk profile; thus a 400 mg Q6W schedule is expected to offer more flexibility to the patients.

 

 

This edition of Onco-this-Week is Sponsored by

North America Immigration Law Group & Nano-Tag Biotechnologies

 

DRUG APPROVALS

Atezolizumab + bevacizumab with chemotherapy combination approved by EU in 1L non-sq and 2L EGFR/ALK+ mNSCLC based on Ph III IMpower150 trial results

“Today’s announcement makes the combination of Tecentriq, Avastin and chemotherapy available to people in Europe with advanced, non-squamous non-small cell lung cancer.” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “This approval includes EGFR mutant or ALK-positive non-small cell lung cancer after failure of a targeted therapy marking a first for this subgroup of patients, in which there is a significant need for alternative treatment options.”

REGULATORY NEWS

Pre-EMA-submission request filed for NDA of Doxorubicin Hydrochloride Cytori in breast cancer, ovarian cancer, multiple myeloma, and Kaposi’s sarcoma

“Liposomal doxorubicin is a commonly prescribed chemotherapeutic drug for patients with advanced breast and ovarian cancer as well as other indications,” said Dr. Marc Hedrick MD, President/CEO of Cytori Therapeutics.  “Bringing Doxorubicin Hydrochloride Cytori to market in Europe as an alternative to the branded drug is an important near-term corporate goal.”


Priority review granted to JAK2 inhibitor Fedratinib in Ruxolitinib-treated Myelofibrosis patients based on Ph III JAKARTA and Ph II JAKARTA2 trials data; PDUFA: Sep 2019

“The acceptance of the NDA and granting of Priority Review for fedratinib represent the first potential new treatment option after many years for patients affected by myelofibrosis.” said Jay Backstrom, M.D., Chief Medical Officer for Celgene. “Patients with myelofibrosis, including the number who are ineligible for or failed existing therapy continues to increase, representing a well-defined unmet medical need. We believe fedratinib can play an important role in the treatment of myelofibrosis and we look forward to working with the FDA as the review process advances.”


IND approved for Ph I trial of autologous NK cell adoptive immunotherapy SNK01 in patients with cancer refractory to conventional therapy

“We are very pleased to receive our first US IND approval to begin clinical trials in refractory cancer patients,” said Paul Song, MD, CMO and CCO of NKMax America.  “While we collect our initial toxicity data, we are also preparing to submit additional IND applications for combination therapy in cancer as well as for several other non-cancerous diseases.”


sNDA submitted for Venetoclax + Obinutuzumab in 1L CLL patients with co-existing medical conditions based on Ph III CLL14 study results


“More than 20,000 people will be diagnosed with untreated chronic lymphocytic leukaemia in the US this year, and many are ineligible for intensive chemotherapy-based options,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We are encouraged that this chemotherapy-free, fixed-duration combination is being reviewed under the FDA’s Real-Time Oncology Review pilot programme, and we are working closely with the agency to bring this new option to people with previously untreated chronic lymphocytic leukaemia as quickly as possible.”

 

Interim data from Ph II trial of Grb2-targeting antisense RNAi nanoparticle prexigebersen (BP1001) and amended registrational plan announced in AML/high risk MDS patients


“These updated interim data from Stage 1 of our Ph 2 study of prexigebersen in de novo AML patients give strong evidence of the safety and efficacy profile of our lead compound and underscore its potential to provide meaningful treatment improvement in this difficult-to-treat patient population,” said Peter Nielsen, President and Chief Executive Officer of Bio-Path. “We were particularly pleased with these results, especially when you consider that the large percentage of these patients are secondary AML patients. The CR/CRp/CRi rate for LDAC treatment alone for the class of patients in this study was benchmarked at 7-13%1, whereas prexigebersen treatment with LDAC is currently showing a 29% CR/CRi/MLFS rate, with a highly favorable safety profile.”

 

French and Belgian agencies authorize initiation of Ph I trial of selective SIRPα antagonist BI765063 +/- PD-1 inh BI754091 in advanced solid tumor patients


Alexis Peyroles, CEO of OSE Immunotherapeutics, said: “Clinical trial authorization for this Ph 1 trial of BI 765063 (OSE-172) as a monotherapy and in combination marks a major step of investigation into the potential of the anti-SIRPα checkpoint inhibitor with PD-1 blockade. We are very pleased by the rapid progression of this innovative program. These two significant green lights allow us to finalize the clinical entry in premier oncology Ph 1 European cancer centers.”

 

Marketing authorization application filed for ARi Darolutamide to MHLW in Japan in nmCRPC patients based on Ph III ARAMIS trial data


“In the early stage of prostate cancer, patients are typically asymptomatic. Thus, it is critically important for men to have treatment options that significantly delay the development of metastases while limiting burdensome side effects of therapy, which allow them to continue their day-to-day lives,” said Scott Z. Fields, M.D., senior vice president and head of Oncology Development at Bayer’s Pharmaceutical Division. “With this submission, we are one step closer to providing patients and physicians in Japan with a potential new treatment option for CRPC.”

 

FDA clears INDA for Ph I trial of menin-MLL protein-protein interaction inhibitor, KO-539, in R/R AML patients


“Despite recent advances in the treatment of AML, genetically defined subsets of acute leukemias such as MLL-rearrangements and NPM1 mutations remain areas of high unmet need,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “Our data suggest that KO-539 drives robust and persistent responses in these preclinical models by induction of differentiation in AML blasts, a mechanism that is distinct from and potentially complementary to existing therapies. We are very encouraged by these preliminary results, and we look forward to beginning clinical testing of KO-539 next quarter.”

 

CHMP gives positive opinion to Pembrolizumab’s six-week dosing schedule in all monotherapy indications


“Merck remains committed to improving the lives of people living with cancer, which includes the pursuit of innovative options for administering KEYTRUDA to address the unique needs of patients and healthcare providers,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “Importantly, the positive CHMP opinion supports the approval of a six-week dosing option across all eight approved KEYTRUDA monotherapy indications in Europe, spanning five cancer types. If approved by the European Commission, the KEYTRUDA 400 mg every six weeks dose will provide both physicians and patients with greater flexibility in their treatment plans.”

 

Positive CHMP opinion to Lorlatinib in 2L-3L ALK+ NSCLC patients based on Ph II B7461001 trial


“Addressing drug resistance and relapse remains a challenge in the treatment of ALK-positive non-small cell lung cancer,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “This CHMP opinion represents a step forward in bringing LORVIQUA to patients in Europe living with advanced ALK-positive non-small cell lung cancer who have limited treatment options.”

 

CARsgen Therapeutics receives IND clearance for BCMA-CAR-T cells in RRMM from the NMPA


“At the American Society of Hematology meeting in December 2018, our collaborator, Dr. Songfu Jiang presented encouraging safety and efficacy data in patients with rrMM who received CT053 BCMA-CAR-T cells. The IND clearance of BCMA-CAR-T cells by China’s NMPA is of great significance to CARsgen,” said Dr. Zonghai Li, founder, CEO and CSO of CARsgen. ”

 

 

TRIAL RESULTS

ASCO SITC 2019: Final data analysis from Ph IIb trial of Nelipepimut-S + Trastuzumab in HER2 low-expressing breast cancer and TNBC patients presented


“This final analysis of the study database establishes a clinically meaningful and statistically significant prolongation in DFS, a validated surrogate marker of overall survival for TNBC – by both hazard ratios and 24-month event rates – and a meaningful decrease in the frequency of relapses identified by standard clinical follow-up in favor of NPS plus trastuzumab given in the adjuvant setting in TNBC patients,” commented Elizabeth A. Mittendorf, MD, PhD, Rob and Karen Hale Distinguished Chair in Surgical Oncology, Director of Research, Breast Surgical Oncology Brigham and Women’s Hospital, Director, Breast Immuno-Oncology Program Dana-Farber/Brigham and Women’s Cancer Center, and the Principal Investigator of the Ph 2b study.

 

ASCO SITC 2019: IL-12 immunotherapy GEN-1 data from Ph Ib OVATION I trial in 1L Stage III/IV ovarian cancer patients presented

“In this Ph IB dose-escalation study, the 14 patients who were evaluable for response, 100% of patients administered NAC plus the two higher doses of GEN-1 experienced an objective tumor response (defined as a partial or complete response) compared to only 60% of patients given the two lower doses,” said Dr. Thaker. “Patients in the higher dose cohorts also had a high surgery success rate, with 88% of these patients achieving the optimal outcome of a complete (R0) resection. Pre- and post-treatment levels of key ovarian cancer biomarkers were also measured as part of this study and showed marked reduction in immunosuppressive response across multiple biomarkers post-treatment, including FOXP3 and IDO-1 – an outcome not previously observed with NAC treatment alone. Together, these findings indicate that GEN-1 may alter the tumor microenvironment and may improve ovarian cancer outcomes in combination with NAC. As a clinician, these observations are very encouraging, and I look forward to further data from the GEN-1 development program to more fully characterize GEN-1’s potential to treat patients with this deadly disease.”

 

ASCO-SITC 2019: Updates on Ph I trial of B7/CD28-like immune checkpoint PVRIG inhibitor, COM701, presented

“We continue to see significant interest in the study from investigators as they recognize the potential and differentiation of COM701 relative to other checkpoint inhibitors in development,” said Henry Adewoye, M.D., Chief Medical Officer at Compugen. “After recently adding Massachusetts General Hospital and the University of Chicago, two additional leading medical centers with significant experience in immuno-oncology, we now have five sites recruiting patients for this Ph 1 study. Patient enrollment is also on track and we expect to complete enrollment of both the monotherapy and dual combination dose escalation arms of the study this year.”

 

ASCO-SITC 2019: Preliminary data from Ph Ib REVEAL trial of TLR7/8 agonist NKTR-262 + CD122-preferential IL-2 pathway agonist bempegaldesleukin (NKTR-214) in solid tumors presented


“We’re excited by the preliminary data from the REVEAL study which demonstrate desirable changes in the tumor micro-environment consistent with the activation of both the innate and adaptive immune responses induced by NKTR-262 and bempeg,” said Dr. Jonathan Zalevsky, Chief Scientific Officer at Nektar. “The early data from REVEAL demonstrate that a comprehensive approach to activating the body’s immune system can drive abscopal anti-tumor responses even in the absence of a checkpoint inhibitor. We are looking forward to the ongoing dose-escalation and planned expansion of the study.”

 

Ph III DUO trial results of Duvelisib in 3L+ CLL/SLL patients announced


“Although the treatment landscape in CLL/SLL has advanced in recent years, there remains an unmet need with many patients progressing or relapsing,” commented Ian Flinn, MD, PhD, Director, Lymphoma/CLL Program at Sarah Cannon Research Institute and lead investigator of the DUO study. “These data from the randomized Ph 3 DUO study, which were calculated from patients who had previously received at least two prior therapies, demonstrate that COPIKTRA achieved a 78% overall response rate and progression-free survival of 16.4 months, compared to 9.1 months for ofatumumab, in patients with relapsed or refractory CLL/SLL, including in high risk patients with the 17p deletion. With convenient oral administration COPIKTRA has been a valuable addition to the treatment landscape for CLL/SLL patients and for the physicians who treat them.”

 

 

TRIAL STATUSES

Patient enrollment completed in Part 3 of Ph I trial of first in human nanomedicine drug, BXQ-350, in rare cancers and GIST


“The safety profile of our drug illustrated in Ph I Part 1 and 2 of our trial has created enthusiasm about BXQ-350 among our Principal Investigators (PIs),” stated Dr. Ray Takigiku, Founder and CEO of Bexion. “The objective of Part 3 is to build and expand on the impressive results observed in our prior Ph 1 studies.  The rapid enrollment is a reflection of the strong safety profile demonstrated for BXQ-350 and underscores the unmet medical need for new and novel treatment options in these patient populations.”

 

First patient dosed in Ph Ib/IIa trial of IL-7 fusion protein TJ107 in advanced solid tumors in China


“With the initiation of this Ph 1b study of TJ107 to treat cancer patients, we now have seven clinical stage programs, which demonstrated our clinical development capabilities,” said Dr. Joan Shen, M.D., Head of R&D at I-Mab. “By leveraging Genexine’s ongoing clinical efforts in TJ107, we expect to rapidly advance the development of TJ107 for Greater China markets.”

 

First patient dosed in Ph I trial of bispecific CTLA4/OX40 dual inhibitor ATOR-1015 in advanced solid tumors


“I state with satisfaction that ATOR-1015 is the first investigational tumor-localizing bispecific CTLA-4 antibody ever being tested in the clinic. With this, Alligator takes the lead in a very hot area of research. While immune activation through CTLA-4 has shown impressive efficacy in multiple cancers, it is coupled with severe toxicity. We believe that ATOR-1015 will be at least as effective as the approved monospecific CTLA-4 antibody Yervoy®, and with less side effects,” said Per Norlén, CEO of Alligator. “As the study progresses we look forward to learning more about the potential of this investigational medicine to improve the treatment of multiple cancers”.

 

First patient dosed in TACTI-002 Ph II trial of LAG-3 fusion protein Efti + Pembrolizumab in 2L SCCHN or 1L-2L NSCLC patients


Immutep CSO and CMO, Dr Frederic Triebel, said: “Dosing the first patient of our TACTI-002 Ph II clinical study is an important milestone. The interim data reported so far from our TACTI-mel Ph I study in melanoma has shown that the combination of efti with pembrolizumab, a PD-1 blocking antibody, is delivering long lasting and durable responses. Given that the TACTI-002 study leverages the same combination therapy, we are hopeful that it will be beneficial for patients with head and neck squamous cell carcinoma or non-small cell lung cancer.”

 

First patient enrolled in Ph I/II expansion trial of alkylating deacetylase inhibitor (AK-DACi), Tinostamustine, in R/R MM, HL, PTCL, CTCL and TCPL patients


“The initiation of the expansion arms of this Ph 1/2 trial is a significant step for our work in oncology as we pursue important treatment options for people living with these types of devastating cancers,” said Paul Medeiros, president of Imbrium Therapeutics. “We look forward to continue building on the foundation of safety data generated in the dose-escalation portion of the trial as we advance the development of tinostamustine as a potential therapy for people with limited treatment options.”

 

Ph II CONTESSA 2 trial of Tesetaxel initiated in taxane-naive locally advanced or metastatic HER2neg HR+ breast cancer patients


“There is a significant unmet need for new therapies that offer quality-of-life advantages for patients with advanced breast cancer,” said Lee Schwartzberg, M.D., Executive Director, West Cancer Center, and Professor of Medicine, University of Tennessee Health Science Center. “While patients with advanced disease often recur after having previously received a taxane with their breast cancer surgery, many have no prior taxane exposure because they are diagnosed when their disease is already advanced and inoperable or they did not receive chemotherapy with their breast cancer surgery. CONTESSA 2 is designed to complement CONTESSA, a Ph 3 study in taxane-experienced patients, by investigating the same tesetaxel-containing regimen in patients who have not previously received a taxane.”

 

Target enrolment reached in Ph IIa trial of RX-3117 + nab-paclitaxel in 1L mPancreatic cancer pts


“We are on track to complete this study as planned in the second half of this year,” said Ely Benaim, M.D., chief medical officer of Rexahn. “Since many patients are still being treated in the trial, it is too early to estimate progression free survival, however we expect to report additional safety and efficacy data later this year.”

 

COLLABORATIONS

Triple combination of DPP8/9 inhibitor BXCL701, CD122-biased agonist NKTR-214 and PD-L1 inhibitor avelumab to be tested in pancreatic cancer

“We are excited to welcome Merck KGaA, Darmstadt, Germany and Pfizer as partners for the development of this novel triple combination regimen with Nektar,” said Vimal Mehta, Chief Executive Officer of BTI. “We believe that the expansion of this clinical collaboration provides clear evidence of industry enthusiasm toward BXCL701. We look forward to working closely with Merck KGaA, Darmstadt, Germany and Pfizer as well as Nektar to leverage their clinical and regulatory expertise as we establish the development plan for the triple combination in pancreatic cancer.”

 

 

RESULTS ALERT // AACR 2019

  1. Updates from Ph II study of NLG207 to be presented
  2. Updates from Ph I/II trial of ION-1301 Targeting APRIL, a Proliferation-Inducing Ligand, in RRMM patients to be presented
  3. Clinical updates from Sapcitabine program and AUTO1 program to be presented
  4. Syndax Pharmaceuticals present clinical updates from Entinostat program
  5. Oncopeptides AB to present clinical updates from HORIZON and ANCHOR trials
  6. Updates from Ph II study of NLG207 to be presented
  7. Data from lead clinical programs of Onvansertib in AML and mCRPC to be presented
  8. First clinical results of placental-derived natural killer (PNK) cells PNK-007 to be presented
  9. Positive outcome from Ph IIb UNITY-NHL trial of Umbralisib in CD20 inhibitor-treated R/R MZL to be presented; primary endpoint of ORR met
  10. Next gen CAR-T platform and CART-mesothelin clinical results to be presented by Atara Biotherapeutics
  11. Updates from STING agonist ADU-S100, and anti-APRIL antibody BION-1301 to be presented

 

FINANCIAL NEWS // Fourth quarter and year-end 2018 financial results

  1. Zai Labs Ltd.
  2. Merrimack Pharmaceuticals
  3. Trovagene
  4. Ziopharma Oncology
  5. Fate Therapeutics, Inc.
  6. Karyopharm Therapeutics Inc.
  7. Iovance Biotherapeutics
  8. NewLink Genetics
  9. Nektar Therapeutics
  10. Nordic Nanovector ASA
  11. Tocagen
  12. Sierra Oncology
  13. Mirati Therapeutics
  14. Genmab
  15. Halozyme
  16. Mersana Therapeutics
  17. BioXcel Therapeutics
  18. Celldex Therapeutics, Inc.
  19. Fate Therapeutics, Inc.
  20. Aravive, Inc.
  21. Radius Health, Inc.
  22. TRACON Pharmaceuticals, Inc.
  23. G1 Therapeutics
  24. Jounce Therapeutics
  25. Aeglea BioTherapeutics
  26. Sunesis Pharmaceuticals
  27. Sierra Oncology

 

 

 

 

Q: What are grades of recommendations in ESMO guidelines?

 A: Grades of recommendation are divided in five categories, from A-E as follows:

A Strong proof for expected substantial clinical benefit, strongly recommended
B Strong or moderate proof but with expected limited clinical benefit, generally recommended
C Insufficient proof for efficacy or low benefit to risk ratio (adverse events, costs, …), recommendation depending on unmet needs
D Moderate proof against efficacy or for adverse outcome, generally not recommended
E Strong proof against efficacy or for adverse outcome, never recommended

 

The levels of evidence are defined as:

I Evidence from at least one large controlled, randomised study with low potential for bias or meta-analyses of well conducted randomised trials without heterogeneity
II Small randomised trials or large randomised studies with probable bias (lower methodological quality) or meta-analyses of such studies or of studies with established heterogeneity
III Prospective cohort trials
IV Case–control trials or retrospective cohort trials
V Experts opinions, case reports, or trials without control group

 

Source: https://www.esmo.org/content/download/77789/1426712/file/ESMO-Clinical-Practice-Guidelines-Standard-Operating-Procedures.pdf

 

 

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. Currently, he is a Lead Scientist at MicroCures Inc. Previously, he served as 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 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: “Multiphoton image of microglia (GFP, green) and cerebral blood vessels (Texas-red dextran, red) in living, anesthetized transgenic mouse. Microglia are glial cells that are the resident macrophages. Honorable Mention, 2009 Olympus BioScapes Digital Imaging Competition®.” Source

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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 (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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