On May 16, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that 15 industry sponsored abstracts regarding Genmab programs were accepted for presentation at the 24th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress 2019 in Amsterdam, the Netherlands, taking place June 13-16, 2019 (Press release, Genmab, MAY 16, 2019, View Source [SID1234536411]). A list of accepted Industry-sponsored abstracts featured at the congress includes 14 daratumumab abstracts, four of which were accepted for oral presentations, including a presentation of the Phase III CASSIOPEIA data, which the Scientific Program Committee of the EHA (Free EHA Whitepaper) selected for presentation during the Presidential Symposium, which showcases abstracts that represent innovative research in hematology. In addition, one abstract features Genmab’s proprietary DuoBody-CD3xCD20 product. The abstracts have been published on the EHA (Free EHA Whitepaper) website and may be accessed via www.ehaweb.org.

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"The presentation of impressive pre-clinical data on our DuoBody-CD3xCD20 program exemplifies how Genmab is advancing its proprietary product pipeline using our strong expertise in antibody drug development to create truly differentiated products to help patients with hematologic malignancies. We are also very pleased that the EHA (Free EHA Whitepaper) has selected the CASSIOPEIA data for presentation during the prestigious Presidential Symposium as it reinforces Genmab’s impactful contribution to multiple myeloma treatment," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Industry-Sponsored Abstracts are as follows:

DuoBody-CD3xCD20:
Potent Anti-tumor Activity of DuoBody-CD3xCD20 in Pre-clinical Models In Vitro and In Vivo – Poster presentation, Saturday, June 15, 5:30 PM – 7:00 PM CEST

Daratumumab (Submitted by Janssen Biotech, Inc.):
Phase 3 Randomized Study of Daratumumab, Bortezomib, Thalidomide, and Dexamethasone (VTd) Versus VTd in Transplant-eligible Newly Diagnosed Multiple Myeloma: Part 1 CASSIOPEIA Results – Oral presentation, Friday, June 14, 3:45 PM – 4:00 PM CEST

Efficacy of Daratumumab, Bortezomib, Thalidomide, and Dexamethasone in Transplant-eligible Newly Diagnosed Multiple Myeloma Based Minimal Residual Disease Status: Analysis of CASSIOPEIA – Oral presentation, Saturday, June 15, 4:45 PM – 5:00 PM CEST

Randomized, Open-label, Non-inferiority, Phase 3 Study of Subcutaneous Versus Intravenous Daratumumab Administration in Patients with Relapsed or Refractory Multiple Myeloma: COLUMBA – Oral presentation, Saturday, June 15, 11:30 AM – 11:45 AM CEST

Subcutaneous Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone in Patients with Newly Diagnosed Amyloid Light Chain Amyloidosis: Updated Safety Run-in Results of ANDROMEDA – Oral presentation, Saturday, June 15, 5:00 PM – 5:15 PM CEST

Stem Cell Yield and Transplantation in Transplant-eligible Newly Diagnosed Multiple Myeloma Patients Receiving Daratumumab, Bortezomib, Thalidomide, and Dexamethasone: Phase 3 CASSIOPEIA Study – Poster presentation, Friday, June 14, 5:30 PM – 7:00 PM CEST

Impact of Age on Efficacy and Safety of Daratumumab in Combination with Lenalidomide and Dexamethasone in Patients with Transplant-ineligible Newly Diagnosed Multiple Myeloma: MAIA – Poster presentation, Friday, June 14, 5:30 PM – 7:00 PM CEST

Faster and Sustained Improvement in Health-related Quality of Life in Transplant-ineligible Newly Diagnosed Multiple Myeloma Patients Treated with Daratumumab, Lenalidomide, and Dexamethasone (D-Rd) Versus Rd: MAIA – Poster presentation, Friday, June 14, 5:30 PM – 7:00 PM CEST

Efficacy and Safety of Daratumumab, Lenalidomide, and Dexamethasone in Relapsed or Refractory Multiple Myeloma: Updated Subgroup Analysis of POLLUX Based on Cytogenetic Risk – Poster presentation, Friday, June 14, 5:30 PM – 7:00 PM CEST

Efficacy and Safety of Daratumumab, Bortezomib, and Dexamethasone in Relapsed or Refractory Multiple Myeloma: Updated Subgroup Analysis of CASTOR Based on Cytogenetic Risk – Poster presentation, Friday, June 14, 5:30 PM – 7:00 PM CEST

Characterization of Treatments and Real-life Outcomes in Patients with Newly Diagnosed Multiple Myeloma Who Received Frontline Autologous Stem Cell Transplantation in Sweden – Poster presentation, Friday, June 14, 5:30 PM – 7:00 PM CEST

Characterization of Frontline Treatment Patterns and the Proportion of Patients Reaching Subsequent Lines of Therapy in Transplant-eligible Patients with Newly Diagnosed Multiple Myeloma – Poster presentation, Friday, June 14, 5:30 PM – 7:00 PM CEST

Improvement in Health-related Quality of Life for Newly Diagnosed Multiple Myeloma Transplant-eligible Patients Treated with Daratumumab, Bortezomib, Thalidomide, and Dexamethasone: CASSIOPEIA – Poster presentation, Saturday, June 15, 5:30 PM – 7:00 PM CEST

Results of the Daratumumab Monotherapy Early Access Treatment Protocol in Patients from Europe and Russia with Relapsed or Refractory Multiple Myeloma – Poster presentation, Saturday, June 15, 5:30 PM – 7:00 PM CEST

Comparative Effectiveness of Frontline Treatments for Patients with Newly Diagnosed Multiple Myeloma Who are Transplant-ineligible – Poster presentation, Saturday, June 15, 5:30 PM – 7:00 PM CEST

On May 16, 2019 Fusion Pharmaceuticals, a clinical-stage biopharmaceutical company developing targeted alpha-particle radiotherapeutics for treating cancer, reported that it will present a poster at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting, which is being held from May 31 to June 4, 2019, at the McCormick Place Convention Center in Chicago, Illinois (Press release, Fusion Pharmaceuticals, MAY 16, 2019, View Source [SID1234536410]). The abstract is available on the ASCO (Free ASCO Whitepaper) meeting website at View Source

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The Company will present a poster highlighting a Phase 1 study evaluating its lead candidate [225Ac]-FPI-1434, a radioimmunoconjugate consisting of a humanized monoclonal antibody that binds to the external domain of IGF-1R, a bifunctional chelate, proprietary linker, and the alpha-emitting radionuclide actinium-225 (Ac-225). The indium-111 analog, [111In]-FPI-1547, which contains the identical antibody and bifunctional chelate is used for patient selection and quantification of IGF-1R expressing targets prior to therapy.

The Phase 1 study has a primary objective of evaluating the safety and tolerability of [111In]-FPI-1547 Injection and [225Ac]-FPI-1434 Injection in patients with advanced refractory solid tumors and to determine the maximum tolerated dose of a single [225Ac]-FPI-1434 Injection. The study is currently enrolling patients in Canada.

Details of the poster presentation are below:

Abstract Title: A Phase I study of [225Ac]-FPI-1434 radioimmunotherapy in patients with IGF-1R expressing solid tumors.

Abstract Number for Publication: TPS3152

Session Title: Developmental Therapeutics and Tumor Biology (Nonimmuno)

Date: Saturday, June 1, 2019, 8:00 AM-11:00 AM CDT

Location: McCormick Place, Hall A

On May 16, 2019 Foundation Medicine, Inc. reported that new data informed by the use of its portfolio of comprehensive genomic profiling (CGP) tests will be presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from May 31 to June 4 in Chicago (Press release, Foundation Medicine, MAY 16, 2019, View Source [SID1234536409]). The company and its collaborators will present a total of 18 studies, including two poster discussions.

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Highlights of these presentations include:

New data that provides additional insights into the utility of tumor mutational burden (TMB) as a pan-tumor genomic biomarker across a variety of cancers, including metastatic breast cancer and non-small cell lung cancer (NSCLC), and how it impacts response to immunotherapy;
Studies demonstrating the utility of known and novel biomarkers, including results in cancers that have not traditionally been treated with targeted therapies, such as urothelial cancer and cholangiocarcinoma; and
Results from analysis of data within Foundation Medicine and Flatiron Health’s clinico-genomic database demonstrating that combining measures of TMB and PD-L1 can better predict response to immunotherapy in advanced NSCLC patients than either biomarker alone.
Data to be presented support the clinical use of tissue and liquid CGP tests and demonstrate the importance of genomic biomarkers to help inform selection of targeted therapies, including immunotherapies, across a variety of advanced tumor types.

"We are excited to share new data derived from the use of comprehensive genomic profiling to further characterize the molecular underpinnings of cancer and provide additional evidence of the role of biomarkers in optimizing precision medicine approaches," said Brian Alexander, M.D., M.P.H., chief medical officer at Foundation Medicine. "Given the continued pace of innovation for targeted and immunotherapies, the clinically relevant insights derived from comprehensive genomic profiling, including those from Foundation Medicine and Flatiron Health’s unique database of clinico-genomic information, are a vital source of information to support the development of such therapies and can help improve clinical decision-making and patient care."

Tumor Mutational Burden (TMB) as Predictor of Response to Immunotherapy

In one study, more than 3,800 metastatic breast cancer samples were classified as HER2 negative (ER+/HER2-), HER2 amplified and triple negative breast cancer. The study showed that TMB can help predict responsiveness to immunotherapy, which has been difficult to show in metastatic breast cancer patients, across all three subtypes.

[Immunotherapy predictive biomarkers in metastatic breast cancer (MBC). Poster discussion. Abstract 1023, Poster #104. June 2, 8:00am – 11:00am, Hall A. Poster Discussion – June 2, 11:15am – 12:45pm, Hall D2.]

Another study to be presented by Friends of Cancer Research found it is feasible to standardize the measurement of TMB across different CGP testing platforms, including FoundationOneCDx. These data were drawn from the findings of the organization’s TMB Harmonization Project, which aims to establish best practices to improve consistency and reliability of TMB estimation across platforms in the interest of optimizing the clinical utility of TMB in cancer care through engaging a coalition of research and industry organizations, including Foundation Medicine.

[TMB standardization by alignment to reference standards: Phase II of the Friends of Cancer Research TMB Harmonization Project. Abstract 2624, Poster #268. June 1, 8:00am – 11:00am, Hall A. Presented by Friends of Cancer Research.]

Utility of Comprehensive Genomic Profiling

In a retrospective analysis, more than 200,000 relapsed or refractory cancers were evaluated to determine how pan-tumor FGFR2 genomic alterations co-occur with other genomic alterations including TMB, microsatellite instability (MSI), and PD-L1 expression. Cancers with an FGFR2 receptor tyrosine kinase (RTK) alteration were shown to have higher frequency of elevated TMB than cancers with other RTK alterations, suggesting potential immunotherapy responsiveness.

[FGFR2: A pan-genomic target. Abstract 3099, Poster #91. June 1, 8:00am – 11:00am, Hall A.]

In another retrospective analysis, researchers evaluated more than 2,000 primary and metastatic urothelial cancer cases, the largest analysis of its kind. All classes of genomic alterations were evaluated in two subtypes of the cancer: upper tract and bladder tumors. FGFR3 was found more frequently in upper tract tumors (26 percent of cases) than in bladder tumors (19 percent of cases). Overall, 48 percent of all tumors harbored genomic alterations that could benefit from approved or investigational targeted therapies, suggesting CGP should be incorporated into routine evaluation of metastatic urothelial cancer before initiating treatment.

[Comprehensive genomic profiling (CGP) of upper-tract (UTUC) and bladder (BUC) urothelial carcinoma reveals opportunities for therapeutic and biomarker development. Abstract 4581, Poster #346. June 3, 1:15pm – 4:15pm, Hall A. Poster Discussion – June 3, 4:30pm – 6:00pm, Hall D2.]

A study characterizing NSCLC cases found HER2 exon 20 insertion mutations in 1.5 percent (n=648) of NSCLC cases analyzed and noted that these are generally mutually exclusive of other known drivers. Detection of these alterations using tissue or liquid CGP may be critical to identify matched targeted therapy options, which have recently shown efficacy in the clinic, for this subset of patients.

[Characterization of 648 non-small cell lung cancer (NSCLC) cases with 28 unique HER2 exon 20 insertions. Abstract 9063. Poster #386. June 2, 8:00am – 11:00am, Hall A.]

Using Data to Advance Precision Medicine

Another ASCO (Free ASCO Whitepaper) presentation will share data from a clinico-genomic database, which includes more than 50,000 de-identified matched profiles linking comprehensive genomic profiling results from Foundation Medicine with patient outcomes data from Flatiron Health’s electronic health records database. The study evaluated more than 400 advanced NSCLC patients and showed that combining the biomarkers TMB and PD-L1 expression can predict response to immunotherapy better than either of these markers alone, reinforcing the importance of testing patients for both biomarkers to inform treatment strategies.

[Tumor mutational burden (TMB) and PD-L1 expression as predictors of response to immunotherapy (IO) in NSCLC. Abstract 2630, Poster #274. June 1, 8:00am – 11:00am, Hall A. Presented by Flatiron Health.]

The following is a list of select abstracts that will be presented at the meeting. For a full list of the data being presented by Foundation Medicine and its collaborators, please visit: View Source

Abstract #

Title

Collaborator

Day/Time

Location

Foundation Medicine Poster Discussions

1023

Immunotherapy predictive biomarkers in metastatic breast cancer (MBC).

June 2: Poster Display –8:00 – 11:00am

Poster Discussion – 11:15am –12:45pm

Hall A

Hall D2

4581

Comprehensive genomic profiling (CGP) of upper-tract (UTUC) and bladder (BUC) urothelial carcinoma reveals opportunities for therapeutic and biomarker development.

June 3:

Poster Display – 1:15pm –4:15pm

Poster Discussion – 4:30pm –6:00pm

Hall A

Hall D2

Foundation Medicine Posters

3099

FGFR2: A pan-genomic target.

June 1, 8:00am – 11:00am

Hall A

6557

Accelerating advanced precision medicine through a harmonized data exchange platform and research consortium (PMEC).

June 1, 1:15pm – 4:15pm

Hall A

9063

Characterization of 648 non-small cell lung cancer (NSCLC) cases with 28 unique HER2 exon 20 insertions.

June 2, 8:00am – 11:00am

Hall A

3533

RAS-amplified colorectal cancers: Microsatellite stability status, RAS/BRAF mutations, and prediction of anti-EGFR resistance.

June 3, 8:00am – 11:00am

Hall A

4545

Analysis of EGFR mutant urothelial carcinoma (UC) reveals distinct mutational landscape.

June 3, 1:15pm – 4:15pm

Hall A

9566

Anal melanoma: A comparative comprehensive genomic profiling study.

June 3, 1:15pm – 4:15pm

Hall A

9591

Extra-mammary Paget’s disease (EMPD) of the skin: A comprehensive genomic profiling (CGP) study.

June 3, 1:15pm – 4:15pm

Hall A

Foundation Medicine and Collaborator Presentations

2630

Tumor mutational burden (TMB) and PD-L1 expression as predictors of response to immunotherapy (IO) in NSCLC.

Flatiron Health

June 1, 8:00am – 11:00am

Hall A

2624

TMB standardization by alignment to reference standards: Phase II of the Friends of Cancer Research TMB Harmonization Project.

Friends of Cancer Research

June 1, 8:00am – 11:00am

Hall A

4080

Comprehensive genomic profiling in FIGHT-202 reveals the landscape of actionable alterations in advanced cholangiocarcinoma.

Incyte

June 3, 8:00am – 11:00am

Hall A

4087

Profiling of 3,634 cholangiocarcinomas (CCA) to identify genomic alterations (GA), tumor mutational burden (TMB) and genomic loss of heterozygosity (gLOH).

MD Anderson

June 3, 8:00am – 11:00am

Hall A

4535

Squamous-cell carcinoma variant histology (SCC-VH) in muscle-invasive bladder cancer (MIBC): A comprehensive clinical, genomic, and therapeutic assessment from multiple dataset.

Fondazione IRCCS Istituto Nazionale dei Tumori

June 3, 1:15pm – 4:15pm

Hall A

On May 16, 2019 Eli Lilly and Company (NYSE:LLY) reported that it will attend the UBS Global Healthcare Conference on Tuesday, May 21, 2019 (Press release, Eli Lilly, MAY 16, 2019, View Source [SID1234536408]). Christi Shaw, president of Lilly Bio-Medicines, will participate in a fireside chat at 9:30 a.m., Eastern Time.

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

On May 16, 2019 Constellation Pharmaceuticals, Inc. (Nasdaq: CNST) reported that two abstracts relating to the MANIFEST clinical trial of CPI-0610 for myelofibrosis – one in association with the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting and the other in association with the European Hematology Association (EHA) (Free EHA Whitepaper) annual meeting – published online (Press release, Constellation Pharmaceuticals, MAY 16, 2019, View Source [SID1234536407]). The abstracts include an analysis based on a data cutoff of January 17, 2019, from 18 enrolled patients. Upcoming presentations at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) will reflect an analysis of a larger patient population based on a data cutoff of April 17, 2019.

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MANIFEST is an open-label Phase 2 clinical trial of CPI-0610 in patients with myelofibrosis (MF), a rare cancer of the bone marrow that disrupts the body’s normal production of blood cells. Constellation is evaluating CPI-0610, either as a monotherapy or in combination with ruxolitinib, in a second-line setting in patients with MF who are refractory to or intolerant of or have relapsed or lost response to ruxolitinib. Patients in the two second-line arms are being stratified based on transfusion dependent status. The primary endpoint for the cohorts with transfusion-dependent patients is conversion to transfusion independence for 12 consecutive weeks. The primary endpoint for the patients who were non-transfusion dependent at baseline is spleen volume reduction. In addition, the Company added a third arm designed to evaluate treatment with CPI-0610 in combination with ruxolitinib as a first-line therapy in JAK 1/2-inhibitor-naïve MF patients.

Data Highlights From Abstracts

Below are highlights of data on second-line patients in the ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) abstracts, which published on May 15 and May 16, respectively.

Spleen volume reductions as measured by MRI occurred in all ten evaluable patients and ranged from 6% to 44%.

Symptom improvements were observed.

Out of the four patients who received bone marrow assessments, three had a one-grade improvement in bone marrow fibrosis and had hemoglobin increases of ≥1.5 g/dL for ≥12 weeks without transfusions. The fourth patient had a one-grade improvement in the bone marrow reticulin score. All of these score improvements were based on a scale of 0-3.

Two of the four patients with bone marrow assessments were transfusion dependent at baseline, and both of these patients became transfusion independent.

Hemoglobin increases of ≥1.5 g/dL occurred in both of two evaluable patients on monotherapy and three of nine patients on the combination with ruxolitinib.

CPI-0610, both as monotherapy and in combination with ruxolitinib, was generally well tolerated. The most common side effects were Grade 1 / 2 diarrhea, nausea / vomiting, and reversible and non-cumulative thrombocytopenia.
"Interim data from the MANIFEST trial indicate that CPI-0610 has been generally well-tolerated, with promising therapeutic activity for the treatment of myelofibrosis," said Adrian Senderowicz, Chief Medical Officer at Constellation Pharmaceuticals. "In addition to spleen and symptom improvement in these refractory patients, we are pleased to see an array of clinical data suggesting the potential for disease-modifying effects, such as improved hematopoietic function, conversion to transfusion independence, and improvement in bone marrow fibrosis. We look forward to providing further updates of the MANIFEST trial at both ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper)."

ASCO Poster Presentation

TITLE: A Phase 2 Study of CPI-0610, a Bromodomain and Extraterminal Protein Inhibitor (BETi) alone or with Ruxolitinib (RUX), in Patients with Myelofibrosis (MF)

Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Date and Time: Monday, June 3, 2019, 8:00 AM CDT (9:00 AM EDT)

Dr. Marina Kremyanskaya of the Mount Sinai School of Medicine, an investigator in the MANIFEST clinical trial, will present a poster with updated details of interim data at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. The data to be presented in the poster were gathered from 44 patients enrolled as of April 17, 2019. Twelve patients received 24-week assessments and 16 patients received 12-week assessments. Among the parameters being assessed were spleen volume reduction, total symptom scores, transfusion dependence, bone marrow fibrosis, and safety.

EHA Oral Presentation

TITLE: CPI-0610, A Bromodomain and Extraterminal Domain (BET) Inhibitor, Reduces Proinflammatory Cytokines, Bone Marrow Fibrosis and the Number of Transfusions in Myelofibrosis Patients

Session: New Agents in MPN

Date and Time: June 15, 12:15 PM CEST (6:15 AM EDT)

Dr. Ronald Hoffman of Mt. Sinai Health System, an investigator in MANIFEST, will make an oral presentation on these updated interim data at the European Hematology Association (EHA) (Free EHA Whitepaper) annual meeting on June 15 at 12:15 PM CEST.

Investor Event. Constellation will also host an investor meeting and conference call to discuss these interim data on June 4 at 7:00 AM CDT. This event will include participation by Dr. Srdan Verstovsek, a medical oncologist at the University of Texas MD Anderson Cancer Center who is an investigator in the MANIFEST trial, and Dr. Raajit Rampal, hematologic oncologist at Memorial Sloan Kettering Cancer Center. Details will be announced later.