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Onco-this-Week (EHA 2018)

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Summary: Onco-this-Week showcases a comprehensive coverage by Richa Tewari from the 23rd Congress of the European Hematological Association. Highlights include clinical updates from DUO, IMerge, ELOQUENT-3, iNNOVATE, Zella 201 QuANTUM-R, JULIET, CLL11, COSMOS, STOMP, MURANO and several other studies from Bristol-Myers Squibb, Roche, Pfizer and Abbvie. In the OTW Trivia, find out the about the FDA approved indications that has made Opdivo a successful immunotherapy candidate in several cancers. Stay tuned for next week’s edition where we will discuss regular and accelerated approvals with a special focus on comparison between Keytruda vs Opdivo indications.

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

 

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NEWS

CD22-targeting CAR-T shows encouraging responses in R/R B-ALL patients who failed on CD19-targeting CAR-Ts

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“22-CAR-T-cell immunotherapy brings hope for the patients with r/r B-ALL who failed on CD19-CAR T therapy,” said first author Jing Pan, MD, associate director of the  Department of Hematology at Beijing Boren Hospital, China, in presenting the research here at the European Hematology Association (EHA) 2018 Congress.

Pan and her team had previously reported on efficacy of low-dose CD19 CAR T cell therapy in r/r B-ALL in research published last year in the journal Leukemia. However, as that study showed, disease progression within 1 year is common, and once they relapse, patients are resistant to a secondary CD19 CAR T-cell therapy because of the loss or mutation of CD19.

“We think CAR T-cell therapy induces remission, and bridging to allo-HCT is the key point for this excellent long-term outcome.”

Pan noted that CD19 CAR T-cell therapy is nevertheless still the primary option for r/r B-ALL.

“The complete remission rate of CD19-CAR T-cell therapy in our hospital is up to 95%, so this is still the first choice,” Pan said.

 

Verastem Oncology Presents Duvelisib Data at EHA 2018 Annual Meeting

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“Dr. Matthew Davids gave an oral presentation of new clinical data from the ongoing Phase Ib/II study evaluating duvelisib in combination with FCR (chemo-immunotherapy) in younger, fit CLL patients,” said Diep Le, MD, PhD, Chief Medical Officer of Verastem Oncology. “The combination regimen achieved an overall response rate (ORR) of 94%, including 26% of patients experiencing a complete response or complete response with incomplete blood count recovery (CR/CRi), and 68% achieving a partial response. In addition, patients also experienced a high rate of bone marrow MRD negativity of 76%, which is significantly higher than historical data with FCR. Importantly, the results from this study demonstrated that duvelisib can be combined with a triple chemo-immunotherapy in the front-line setting with an acceptable safety profile”.

Dr. Le added, “In addition, the DUO crossover extension data presented build upon the previously reported positive Phase 3 DUO study results and further support duvelisib’s potential as an oral treatment option for patients with relapsed or refractory CLL/SLL. Post-crossover, oral duvelisib monotherapy demonstrated robust clinical activity with a 73% overall response rate (ORR) and a 15-month median PFS in the 89 patients that had previously received ofatumumab on DUO and subsequently progressed. Duvelisib monotherapy also demonstrated a manageable safety profile, with results from this study consistent with the well-characterized safety profile of duvelisib monotherapy in previous studies. It is encouraging to see such a robust response to duvelisib monotherapy, similar to response observed in the parent DUO study, in patients that had failed an additional line of therapy and needed a new treatment option. Collectively, the data presented at EHA this year continue to provide important insights to guide the future clinical development of duvelisib across a wide range of hematologic malignancies, both as a monotherapy and in combination with other agents.”

 

TG Therapeutics, Inc. Presents Phase 2 Data Evaluating Umbralisib in CLL Patients Intolerant to Prior BTK or PI3K Delta Inhibitor Therapy at the 23rd Congress of the European Hematology Association (EHA)

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, “We are pleased to present data evaluating umbralisib in patients intolerant to currently approved BTK or PI3K therapies during the EHA annual congress. While there have been great advancements in recent years in the treatment of CLL, this study confirms that there are many patients still in need of an alternative treatment option and that umbralisib can be used safely and effectively in those patients who were not able to tolerate a prior BTK or PI3K therapy.  The rate of patients withdrawing from kinase treatment for CLL in real world settings has been estimated to reach upwards of 40%, representing a significant unmet medical need.” Mr. Weiss continued, “We are extremely pleased with the data presented at ASCO and EHA this month and we look forward to presenting the topline response rate data from the UNITY- CLL Phase 3 trial by the end of summer 2018.”

 

Geron Reports Imetelstat Oral Presentation at European Hematology Association Congress

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“This encore presentation of data from the first 32 patients in Part 1 of IMerge reiterates the encouraging results that prompted the expansion of enrollment of Part 1 to a refined population of lower risk MDS patients who are naïve to lenalidomide and HMAs and who lacked del(5q). We are pleased that there are multiple patients that have been on treatment for over two years,” said John A. Scarlett, M.D., Geron’s President and Chief Executive Officer. “We look forward to data from the additional patients enrolled earlier this year in the expanded Part 1 of IMerge, as well as Janssen’s decision related to the continued development of imetelstat, which is expected by the end of the third quarter.”

Cellerant Therapeutics, Inc. Presents Phase 2 Results Showing CLT-008 Significantly Reduces Risk of Infections in AML Patients Undergoing Standard Induction Chemotherapy

“Infection is one of the main reasons for morbidity and mortality in AML patients receiving induction chemotherapy. The exciting results from this study show that this innovative approach to treatment of infections could allow more patients to safely survive optimal induction chemotherapy treatment and survive longer, particularly many elderly patients who are not offered induction chemotherapy due to the risk of infection,” said Dr. Pinkal Desai, Assistant Professor of Medicine, Weill Cornell Medicine and one of the Phase 2 study’s principal investigators.

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“CLT-008 is designed to provide innate immunity until the patient’s own immune system recovers. Prolonged neutropenia commonly occurs with most myelosuppressive treatments such as AML induction therapy, and these results demonstrate the potential of CLT-008 to mitigate the effects of neutropenia by bridging patients to neutrophil recovery, resulting in improved outcomes,” added Ram Mandalam, President and CEO of Cellerant.

 

Primary endpoint of PFS met in Ph II ELOQUENT-3 trial of elotuzumab + Pomalidomide + Low-Dose Dexamethasone in R/R MM

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“The ELOQUENT-3 trial is the first randomized trial comparing the standard of care, pomalidomide and low dose dexamethasone, with and without the addition of a monoclonal antibody. These data support the hypothesis that the addition of elotuzumab to pomalidomide and dexamethasone elicits a synergistic effect and prolongs, significantly, the progression-free survival of heavily pretreated patients with myeloma, regardless of the number of prior therapies,” said Meletios A. Dimopoulos, M.D., professor and chairman of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens, School of Medicine. “We believe that EPd, if approved by regulatory authorities, could become an important potential treatment option for patients with relapsed/refractory multiple myeloma whose disease has progressed after treatment with lenalidomide and a proteasome inhibitor.”

 

100% ORR observed in Ph Ib/II trial of APR-246 + Azacitidine in TP53 Mutant MDS patients

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David Sallman, M.D., lead principal investigator of the clinical study from the Moffitt Cancer Center, said, “The emerging data from this study continue to be very encouraging. Responses have been achieved in all patients, including an 89% complete response rate, and have been accompanied by deep molecular remission as assessed by serial TP53 analysis. Furthermore, the available data indicate that the combination of APR-246 and azacitidine is safe and well-tolerated in these patients. Comparison of the current data set to historical AZA clinical experience suggests that combination of APR-246 with AZA may offer these patients a better potential treatment option than AZA alone.”

 

European Hematology Association: iNNOVATE Study: Ibrutinib Plus Rituximab for Patients With Waldenström’s Macroglobulinemia

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In this double blind study, 150 patients with WM were randomly assigned to receive treatment with either ibrutinib/placebo + rituximab. More patients had a better response (major response rate) to treatment with ibrutinib + rituximab (72%) than with placebo + rituximab (32%). At 30 months after starting treatment, an estimated 82% of patients treated with ibrutinib + rituximab were alive and did not have disease progression versus 28% of patients treated with placebo + rituximab.

 

MEI Pharma Presents Clinical Data on ME-401 at the European Hematology Association Congress

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“The data demonstrates that ME-401 achieved a 90% response rate across all patient groups treated and was generally well tolerated with no dose-limiting toxicities identified at any dose level,” said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. “The full data from our ME-401 study is very encouraging and we expect to initiate a registration study for ME-401 this year for the treatment of adults with relapsed or refractory FL.”

 

Tolero Pharmaceuticals Presents Clinical Data for Investigational Agent Alvocidib in Patients with Relapsed Refractory MCL-1-Dependent AML at EHA 2018

“Our understanding of acute myeloid leukemia is evolving as we deepen our knowledge about the different mechanisms that play a role in the disease,” said Joshua F. Zeidner, MD, lead investigator of the Zella 201 study and assistant professor, Lineberger Comprehensive Cancer Center at the University of North Carolina at Chapel Hill. “These preliminary results are encouraging as they indicate alvocidib in combination with cytarabine and mitoxantrone may have activity in patients with relapsed and refractory MCL-1-dependent AML.”

 

Updated QuANTUM-R study results published

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“FLT3-ITD mutated AML represents a high unmet need entity as patients with this aggressive form of the disease have an overall dismal prognosis as evidenced by low response rates to current available therapies, high risk of relapse and a shorter overall survival than those without this mutation,” said Jorge E. Cortes, MD, Deputy Chair of the Department of Leukemia in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. “In relapsed/refractory AML with FLT3-ITD mutations, these findings represent the first reported clinical data demonstrating that a single agent can significantly improve overall survival, suggesting that quizartinib could potentially help these patients live longer. Additionally, in the study, a higher proportion of patients received a stem cell transplant in the quizartinib arm compared to the chemotherapy arm.”

 

Tisagenlecleucel shows 52% ORR at mFUP of 14 months in updated data from Ph II JULIET trial in R/R DLBCL patients

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“Advanced aggressive lymphoma patients who once faced a poor prognosis now have the possibility of sustained remission after a single course of therapy – a previously unimaginable and revolutionary breakthrough,” said the lead author of the updated JULIET analysis Peter Borchmann, MD, Department of Internal Medicine, University Hospital of Cologne, Germany. “With 14 months of data from JULIET, we are seeing that Kymriah may continue to redefine outcomes for patients with relapsed or refractory DLBCL.”

 

Ph II data of ex vivo expanded hematopoietic stem and progenitor cell investigational product Dilanubicel (NLA101) presented

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“Evaluation of allogeneic hematopoietic cell transplant success is commonly assessed as incidence of individual complications and treatment failures,” said Colleen Delaney, MD, MSc, Chief Medical Officer and Co-founder of Nohla Therapeutics. “The GRFS endpoint provides a more complete measurement of transplant success and long-term recovery that, along with survival, also accounts for complications such as GVHD and disease relapse. When evaluating dilanubicel data using this composite benchmark, we observed a compelling improvement for patients receiving dilanubicel compared to the concurrent control group. Our ongoing randomized phase 2b study will also evaluate this important endpoint, and we look forward to these results later this year.”

 

New pan-FLT3/pan-BTKi CG-806 data in patient-derived B cells presented

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“A safe and potent agent that inhibits all forms of BTK and other key rescue pathways (including AKT/PI3K, ERK and NFƙB) is needed for patients intolerant, refractory and resistant to ibrutinib,” said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. “These data strongly support the clinical development of CG-806 to address the limitations and challenges of ibrutinib. CG-806 is being readied for the clinic and we look forward to reporting on its development.”

 

Updated data of AFM13 + Pembro presented in R/R Hodgkin Lymphoma patients

“The high response rates in this study, in terms of both partial and complete responses, continue to compare favorably to the historical data of anti-PD-1 monotherapy, and would be expected to translate into meaningful progression free and overall survival over time,” said Dr. Stephen Ansell, Principal Investigator of the study. “Importantly, these data have shown that AFM13 can be safely administered in combination with Keytruda® and has the potential to improve patient outcomes.”

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“We are very excited about the potential opportunities for AFM13 to benefit patients with CD30positive malignancies,” said Dr. Leila Alland, Affimed’s Chief Medical Officer.  “We are planning additional studies of AFM13 in patients with CD30-positive malignancies and are actively seeking guidance from experts on our development plans including potential accelerated approval paths.”

 

Long-term obinutuzumab data from Ph III CLL11 study in 1L CLL patients presented

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“We are very pleased that the majority of patients treated with Gazyva/Gazyvaro are still alive after nearly five years of follow-up in the CLL11 study,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “This meaningful survival benefit compared to MabThera/Rituxan-based therapy reinforces that Gazyva/Gazyvaro-based therapy is an important option for people with previously untreated CLL.”

 

Beigene presented results on BTKi zanubrutinib

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“We continue to be encouraged by the quality and durability of response with zanubrutinib in the treatment of patients with Waldenström macroglobulinemia (WM), particularly with the observation that 43 percent of the evaluable patients achieved a very good partial response (VGPR). Additionally, the safety results from the combined experience in four ongoing monotherapy trials demonstrate that zanubrutinib was generally well-tolerated,” commented Jane Huang, M.D., Chief Medical Officer, Hematology, at BeiGene. “As these results mature, and as we near completion of enrollment in our Phase 3 trial comparing zanubrutinib with ibrutinib in patients with WM, we are hopeful that zanubrutinib, if approved, may represent a valuable treatment option for patients with this disease.”

 

ERYTECH Pharma to present results of its Ph IIb clinical trial evaluating eryaspase for the treatment of AML

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ERYTECH Pharma, a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, announced that it would present preclinical data on the enzymatic activity of eryaspase (GRASPA) for the treatment of relapsed acute lymphoblastic leukemia (ALL) and results of its Phase 2b clinical trial evaluating eryaspase (GRASPA) for the treatment of acute myeloid leukemia (AML) at the European Hematology Association (EHA) Congress, being held June 14-17, 2018 in Stockholm, Sweden.

 

Preliminary safety and efficacy data of CD19 inh MOR208 from cohort A of Ph II COSMOS trial in CLL patients presented

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“Patients with CLL after failure of ibrutinib therapy are in need of more therapeutic options. We are encouraged by the initial and, for the most part, still ongoing responses observed in this heavily pretreated patient population in our exploratory trial with MOR208 plus idelalisib,” commented Dr. Malte Peters, Chief Development Officer of MorphoSys AG. “Overall, this shows the potential medical application of MOR208 in additional B cell malignancies. The data shows that MOR208 may be combined with other cancer drugs used in hematological malignancies, including PI3K inhibitors. We look forward to the upcoming results from the second cohort of MOR208 plus venetoclax of our ongoing COSMOS study which we expect later this year.”

 

Updated Selinexor data from Ph Ib/II STOMP trial presented

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“The Phase 1b/2 STOMP study continues to generate important efficacy and safety data from the multiple ongoing arms evaluating selinexor and dexamethasone (dex) in combination with the standard approved therapies Velcade, Pomalyst and Darzalex in patients with multiple myeloma following at least one prior therapy,” said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm.  “Based on the positive STOMP results reported to date, we have initiated a new all-oral STOMP arm to investigate selinexor plus Revlimid® and dex in the front-line setting.  Given the observed synergistic activity of selinexor with standard approved myeloma therapies, we believe oral selinexor has the potential to be a future backbone therapy in myeloma, and we look forward to elucidating its activity as part of a front-line treatment regimen.”

 

New Undetectable MRD data from Phase 3 Relapsed/Refractory Chronic Lymphocytic Leukemia MURANO Trial of Venetoclax in Combination with Rituximab

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“In this analysis of MRD data in patients with chronic lymphocytic leukemia given venetoclax in combination with rituximab, high and durable undetectable MRD rates were achieved in peripheral blood at the end of combination treatment assessment regardless of the risk features,” said Peter Hillmen, Ph.D., Professor of Experimental Hematology, Leeds Teaching Hospital in the UK, and lead investigator of the MURANO study. “These undetectable MRD results, along with data regarding the nearly 14-month progression-free findings in patients who maintained undetectable MRD, are an encouraging finding from the MURANO study.”

 

RWE data concludes Ruxolitinib is associated with a reduction in risk of death and dangerous blood clots for PV patients

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“When you can complement clinical trial data with real-world experiences, it can provide valuable insight into how treatments affect patients in their day-to-day lives,” said lead study investigator, Alberto Alvarez-Larran, MD, Hematology Department, Hospital Clinic, Barcelona, Spain. “This latest research supports the use of Jakavi to help people with polycythemia vera gain better control of their disease when hydroxyurea is not an option.”

 

90% response rate obtained with next-gen PI3Ki ME-401 in Ph Ib trial of R/R FL, CLL and SLL patients

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“The data demonstrates that ME-401 achieved a 90% response rate across all patient groups treated and was generally well tolerated with no dose-limiting toxicities identified at any dose level,” said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. “The full data from our ME-401 study is very encouraging and we expect to initiate a registration study for ME-401 this year for the treatment of adults with relapsed or refractory FL.”

 

DARPin® therapy, MP0250, shows encouraging responses in RRMM patients in Ph II trial

“We are very encouraged by the initial activity and the safety profile of MP0250 in combination with bortezomib and dexamethasone, even at the low dose of MP0250. We have started the treatment of the first two patients with the higher dose of 12 mg/kg which may be even more effective,” said Andreas Harstrick, Chief Medical Officer of Molecular Partners.

Patrick Amstutz, CEO of Molecular Partners added: “These results further substantiate our development plans in multiple myeloma as well as the launch of our additional phase 1b/2 study of MP0250 in combination with osimertinib in EGFR-mutated NSCLC.”

 

Interim data from Ph II study of EZH2i Tazemetostat in R/R EZH2-mutated FL presented

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“I am impressed by the sustained clinical activity and the good tolerability of tazemetostat in this heavily pre-treated patient population. This is important for patients with relapsed or refractory follicular lymphoma, as both the response rates and durations of response usually tend to decrease with each successive line of treatment,” said Gilles Salles, M.D., Ph.D., at the University Hospital of Lyon France, and president of the Lymphoma Study Association (LYSA) cooperative group. “I believe tazemetostat has the potential to fill a significant unmet need for these patients and continued investigation of tazemetostat as single agent or in combination with other agents is warranted.”

 

Results from three trials of CD123-targeting therapy SL-401 in BPDCN, R/R MF, and R/R CMML patients to be presented

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Stemline Therapeutics, Inc. a clinical-stage biopharmaceutical company developing novel oncology therapeutics, announced that ELZONRISTM (tagraxofusp; SL-401) was the subject of three clinical presentations, including an oral presentation on the pivotal BPDCN program. Updated data from the ongoing Phase 2 trial in chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF) were also presented. Presentations were delivered on Friday, June 15th at the 23rdCongress of the European Hematology Association (EHA) in Stockholm, Sweden.

 

AbbVie to present data from several Venetoclax studies

“The breadth of venetoclax studies being presented at the European Hematology Association Annual Congress, across four blood cancers, is an indicator of the utility, versatility and potential to advance care for patients living with blood cancer around the world,”3 said Neil Gallagher, M.D., Ph.D., head of oncology clinical development, AbbVie. “As a company, we are committed to exploring additional therapeutic applications for venetoclax in our efforts to address major unmet medical needs, and develop novel treatments that work against key pathways of disease progression.”

 

BioLineRx to Present Overall Survival Data at EHA from Phase 2a Study of BL-8040 in r/r AML Patients

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“We are extremely encouraged with the overall survival data continuing to flow from this proof-of-concept study. The study included a very difficult-to-treat patient population, in which 81% were either refractory to one or two inductions, or experienced progression-free survival of less than 12 months after first-line therapy. These data continue to give us confidence in the AML space, where we have two important studies ongoing – a large, randomized controlled Phase 2b study in consolidation AML, and a Phase 1b/2 study in maintenance AML under our collaboration with Genentech,” said Philip A. Serlin, Chief Executive Officer of BioLineRx.

 

Cover image: (Wikimedia Commons) By BioTek Instruments, Inc. (BioTek Instruments, Inc.) [CC BY-SA 3.0 (https://creativecommons.org/licenses/by-sa/3.0)], via Wikimedia Commons. Final z-projected image of chondrocyte differentiated human mesenchymal stem cell 3D spheroid taken using Cytation 5 Cell Imaging Multi-Mode Reader. DAPI: Hoechst 33342 stained nuclei, GFP: Alexa Fluor 488 phalloidin stained actin filaments, CY5: Collagen II expression.

 

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.

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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).

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