On May 18, 2020 Flatiron Health, Foundation Medicine, and Genentech, a member of the Roche Group, in partnership with community and academic oncology practices, reported tha they have launched the Prospective Clinico-Genomic (PCG) Study, NCT04180176 (Press release, Flatiron Health, MAY 18, 2020, View Source [SID1234558251]). PCG is a novel, low-interventional study that will pilot the use of a technology-enabled prospective data collection platform to facilitate, streamline and simplify the execution of clinical trials for patients living with advanced lung cancer.

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The PCG Study, funded and sponsored by Genentech, is a feasibility study with secondary aims to better understand how genomic changes in a patient’s tumor may predict response or impact resistance to treatment in people diagnosed with metastatic non-small cell lung cancer or extensive stage small cell lung cancer by building a linked data- and bio-repository. Flatiron’s prospective real-world data collection technology will be leveraged for this study, which will enroll approximately 1,000 patients. These patients will undergo serial liquid biopsies using Foundation Medicine’s liquid biopsy assay to assess genomic changes in their cancer over the course of treatment. Leveraging technology developed following years of collaboration between Flatiron and Foundation Medicine, the clinical, genomic, imaging and outcomes data will be a part of a comprehensive data platform that is designed to accelerate research, a central part of Roche’s vision for personalized healthcare.

"Through technology-driven innovation, we have realized our vision of building a platform that enables meaningful clinical research while also minimizing the burden on clinicians and research teams. This includes features such as centralized and remote study monitoring, streamlined patient identification, and technology-assisted abstraction to eliminate duplicate data entry and the need to use a separate electronic data capture system," said Dr. Bobby Green, chief medical officer at Flatiron Health. "Our goal is to bring vital clinical research to patients where their care is already being delivered, and to do so efficiently and seamlessly."

Since launching the study in December 2019, 14 practices from Flatiron’s network have been activated: Alabama Oncology, Cancer & Hematology Centers of Western Michigan, Clearview Cancer Institute, Fort Wayne Medical Oncology and Hematology, Hematology Oncology Associates of Central New York, Hematology Oncology Associates of Fredericksburg, Highlands Oncology Group, Jackson Oncology Associates in Mississippi, New York Cancer & Blood Specialists, Oklahoma Cancer Specialists and Research Institute, RCCA-Central Jersey, Southeast Nebraska Cancer Center, Virginia Cancer Institute, and West Cancer Center. Additional research sites are planned over time.

"Clinical trials are critically important to advancing cancer research, but the way trials are run has in many ways not changed in decades, and continues to be burdensome and time-consuming," said Dr. Lee Schwartzberg, chief medical officer at OneOncology, and physician at West Cancer Center. "The PCG Study has the potential to help transform how clinical trials are conducted, ultimately making research more feasible for all sites and increasing the number of trial opportunities for patients. We hope that the study design and technology deployed in PCG will ultimately become standard practice and used across a wide swath of trials."

"We’ve been a part of this study since December, and it is an exciting opportunity to be a part of building this research platform. While this study is expected to help patients in the future, it also provides important information for our enrolled patients invaluable to their current management," shared Dr. Eric Santos, physician at Cancer & Hematology Centers of Western Michigan.

"Using new platforms to accelerate the development and delivery of the best possible medicines for every type of patient is central to our vision for personalized healthcare," said Mark Lee, global head of personalized healthcare, product development, at Genentech. "The PCG Study represents an important step toward the next iteration of the clinical research ecosystem, opening up opportunities to extend clinical trials into the real world setting to more investigators and more patients than ever before."

At this year’s ASCO (Free ASCO Whitepaper) Virtual Scientific Program, Genentech, Flatiron, Foundation Medicine and co-authors will present the study design and objectives in a Trials-In-Progress abstract titled, "A multi-stakeholder platform to prospectively link longitudinal real-world clinico-genomic, imaging, and outcomes data for patients with metastatic lung cancer."

To learn more about the PCG Study, contact [email protected].

On May 18, 2020 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism based therapies (CMBTs), reported the results of a health economic outcomes study demonstrating that the therapeutic benefit of increasing the use of novel medicines is so great that it is driving a decrease in the actual total cost of healthcare (Press release, TYME, MAY 18, 2020, View Source [SID1234558250]). The supporting data from the study are being presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Virtual Meeting held from May 18 to May 20 and published in the Society’s peer-reviewed journal Value in Health.

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Health technology assessment programs are increasingly using real-world, longitudinal patient data to assess the effect of new medicines on total cost of care. This study analyzed such data to measure the impact of new pancreatic cancer therapies on other, non-drug medical expenditures.

"Our study looked at treatment inflation-adjusted expenses per patient for pancreatic cancer care between 2009 and 2016 and found that for every additional $1 spent on medicines for pancreatic cancer in 2016, there was a reduction in non-drug spending of $8 – $9," said Robert Goldberg, Ph.D., Vice President and Co-Founder of the Center for Medicine in the Public Interest. "The value of advancing and accessing next-generation novel therapies is apparent from our total cost of care analysis looking at both medical and pharmacotherapy costs."

The study showed that between 2009 and 2016, average inflation-adjusted per patient spending on pancreatic cancer care declined from $37,000 to $10,000. Prescription drug spending increased during the same time period from $2,200 to $6,100 per person (inflation adjusted). In effect, for every additional dollar spent on disease-altering therapies for pancreatic cancer between 2009 and 2016, there was a reduction in non-drug spending of $8 – $9.

Furthermore, there was a decline in the length of stay in hospital settings and a decrease in hospital deaths for this cohort of patients with pancreatic cancer. From 2009 to 2016, the mean length of stay decreased by 1 day. The proportion of deaths in hospitals during that time period also decreased by 2.8%.

The analyses also evaluated hemorrhage complicating a procedure, including Whipple surgeries. Hemorrhages are estimated to occur in 7.2 to 8.5% of those patients who have undergone a pancreatectomy and are associated with longer and more expensive hospital stays. Patients who were discharged from inpatient settings after being diagnosed with a complicating hemorrhage appeared to be routed to less intensive settings of care. In particular, the proportion of those discharged into home health care, as opposed to short term hospital care or another institution, increased by 1.2% between 2009 and 2016.

The study analyzed longitudinal patient-level data from the Medical Expenditure Panel Survey (MEPS, 1996 – 2017). The study evaluated 80 patients who had a diagnosis of pancreatic cancer and available prescription data. Individual age and employment status were accounted for as covariates. Notably, the data revealed that while prescription medicine expenses have increased as part of the total cost of treating patients with pancreatic cancer over the last ten years, the overall healthcare cost of treating pancreatic cancer patients has gone down.

All analyses were performed using R version 3.6.1 on Ubuntu 19.04. Means and standard deviations were computed for the raw and inflation-adjusted total health care costs excluding drug spending. Study averages were computed for the total health care costs, including prescription medicine costs for the period between 2009-2016 which included approval and/or use of novel treatment approaches such as Abraxane (nab-paclitaxel), FOLFIRINOX and erlotinib. The prescription medicines expenses, and proportion of healthcare spending were also plotted along with a LOESS curve using the same parameters. All expenditures are adjusted for inflation using 2012 U.S. Dollars.

As a result of this health economic outcomes study, further analysis of a larger, longitudinal set of patient-level data is needed to more fully explore the relationship between spending on medical innovation, and reduction in total cost of patient care, as well as improvements in quality of life.

Details of this study are being presented at the ISPOR Virtual Meeting held from May 18 to May 20. For more information on ISPOR’s virtual program please visit the conference website at: View Source

The health economic outcomes poster on pancreatic cancer presented at the ISPOR virtual conference is as follows:

Title: Using longitudinal patient level data to assess the value of new pancreatic cancer treatments on total health spending.

Authors: Robert Goldberg1, Michele Korfin2, Giuseppe Del Priore2, Semmie Kim2, Vincent J. Picozzi3, M Mandelson3, Victoria G. Manax4

Institutions: Center for Medicine in the Public Interest, NY, NY1, Tyme Technologies, Inc., NY, NY2, Virginia Mason Medical Center, Seattle, WA3, Pancreatic Cancer Action Network, Manhattan Beach, CA4

Virtual ISPOR 2020/Abstract Information:
View Source

Abstract Number: PCN259

About Advanced Pancreatic Cancer
Advanced pancreatic cancer is a difficult-to-treat cancer with the lowest survival rates among all cancer types. Across all patients with pancreatic cancer, relative 5-year survival is 8% and is less than 3% for those with advanced disease.1 The median survival for patients in end-stage of the disease is approximately 3 months. There are two main types of pancreatic cancer – adenocarcinomas, which accounts for approximately 90% of all pancreatic cancer, and neuroendocrine tumors. Pancreatic cancer is relatively uncommon with new cases accounting for only 2.1% of all newly diagnosed cancers. However, pancreatic cancer is the fourth most common cause of cancer death for men and women in the United States.

About SM-88
SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events.

On May 18, 2020 Agilent Technologies Inc. (NYSE: A) reported that the U.S. Food and Drug Administration has approved the company’s PD-L1 IHC 28-8 pharmDx for expanded use in non-small cell lung cancer (NSCLC) (Press release, Agilent, MAY 18, 2020, View Source [SID1234558249]).

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"The expanded use of PD-L1 IHC 28-8 pharmDx will give physicians in the USA critical information to inform first-line treatment decisions for patients with metastatic non-small cell lung cancer"

Now, physicians will be able to use the PD-L1 IHC 28-8 pharmDx assay as an aid in identifying patients with metastatic NSCLC for treatment with the dual immunotherapy combination of Opdivo (nivolumab) and Yervoy (ipilimumab), manufactured by Bristol Myers Squibb. Based on the results of the Phase 3 CheckMate -227 clinical trial, Opdivo in combination with Yervoy was approved as first-line treatment for patients with metastatic NSCLC whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test.

"The expanded use of PD-L1 IHC 28-8 pharmDx will give physicians in the USA critical information to inform first-line treatment decisions for patients with metastatic non-small cell lung cancer," said Sam Raha, president of Agilent’s Diagnostics and Genomics Group.

Agilent developed PD-L1 IHC 28-8 pharmDx in 2016 through a collaboration with Bristol Myers Squibb, and it has been previously approved as a complementary in vitro diagnostic for non-squamous non-small cell lung cancer, as well as other forms of cancer, including, squamous cell carcinoma of the head and neck, and urothelial carcinoma.

Lung cancer is the most commonly diagnosed cancer worldwide across both sexes, causing 18.4% of all cancer deaths, with an estimated two million new cases reported in 2018. NSCLC accounts for 80%–90% of lung cancers, and 75% of NSCLC patients are diagnosed in the advanced stage.

Agilent is a worldwide leader in the development and commercialization of precision medicine diagnostics in collaboration with biopharmaceutical companies.

Opdivo and Yervoy are registered trademarks of Bristol-Myers Squibb Company.

On May 18, 2020 The Janssen Pharmaceutical Companies of Johnson & Johnson reported results from the Phase 1 CHRYSALIS study evaluating amivantamab (JNJ-6372) in the treatment of patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations (Press release, Janssen Pharmaceuticals, MAY 18, 2020, View Source [SID1234558248]).1 Amivantamab is an EGFR and MET-targeted bispecific antibody, which targets activating and resistance EGFR mutations, and MET pathway activation.2,3 Investigators assessed efficacy using overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), duration of response, as well as the safety profile of amivantamab,1 which were the basis of the U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation granted earlier this year.4

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The Phase 1 CHRYSALIS study is a first-in-human, open-label, multi-cohort, multicentre study evaluating the safety, pharmacokinetics and efficacy of amivantamab as a monotherapy and in combination with lazertinibi, a novel third-generation EGFR tyrosine kinase inhibitor (TKI), in adult patients with advanced NSCLC.5 Fifty patients with EGFR Exon 20 insertion-mutated NSCLC received the recommended Phase 2 dose (RP2D) of amivantamab.1 Among these 50 patients, 39 were evaluable for response with 13 distinct EGFR Exon 20 insertion mutations identified.1 Detailed results will be presented as a poster presentation and discussion at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Programme (Abstract #9512) beginning Friday 29th May.

Patients with NSCLC and EGFR Exon 20 insertion mutations have a form of disease that is generally insensitive to approved EGFR TKI treatments and as a result carries a worse prognosis compared to patients with more common EGFR mutations (Exon 19 deletions/L858R substitution).6 Currently, there are no targeted therapies approved specifically for patients with lung cancer who have EGFR Exon 20 insertion mutations.7 Estimated median overall survival for patients with NSCLC and Exon 20 insertion mutations is 16 months.8

"Lung cancer is the leading cause of cancer deaths worldwide, and genetic factors such as EGFR mutations can have a significant impact on the development and progression of non-small cell lung cancer," said Keunchil Park, M.D., Ph.D., Professor, Division of Haematology-Oncology, Department of Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine in Seoul, South Korea, and lead study investigator. "We look forward to sharing these data that provide initial insights into the potential of amivantamab as a treatment option for patients with non-small cell lung cancer and EGFR Exon 20 insertion mutations who have a high unmet need and often do not respond to the current standard of care."

Findings from the study showed an ORR of 36 percent (95 percent CI, 21–53) in all evaluable patients and 41 percent (95 percent CI, 24–61) in the 29 evaluable patients previously treated with platinum-based chemotherapy.1 Additionally, the median duration of response for all evaluable patients was 10 months and seven months for patients previously treated with platinum-based chemotherapy.1 The median progression-free survival was 8.3 months (95 percent CI, 3.0–14.8) for all evaluable patients and 8.6 months (95 percent CI, 3.7–14.8) for patients previously treated with platinum-based chemotherapy.1 The clinical benefit rate (partial response or better or stable disease of at least 12 weeks [two disease assessments]) was 67 percent (95 percent CI, 50–81) for all evaluable patients and 72 percent (95 percent CI, 53–87) for patients previously treated with platinum-based chemotherapy.1 Responses were observed in both treatment-naive patients and those previously treated with platinum-based chemotherapy.1 Tumour responses were most frequently observed at the first disease assessment after starting therapy.1

The most common all-grade adverse events (AE) were rash, infusion-related reaction (IRR), and paronychia.1 IRRs occurred predominantly on the first infusion and did not prevent subsequent treatments.1 No grade ≥3 rash was reported, and one patient reported grade 3 diarrhoea and six percent had diarrhoea of any grade.1 Six percent had treatment-related grade ≥3 AEs of hyperamylasaemia, hypokalaemia, increased lipase and shoulder/chest pain.1 Treatment-related serious AEs of cellulitis, interstitial lung disease and shoulder/chest pain were reported in six percent of patients.1 Additional EGFR-related AEs included stomatitis (sixteen percent), pruritus (fourteen percent), and diarrhoea (six percent).1

"Despite years of research and the availability of more treatment options, lung cancer remains Europe’s biggest cancer death threat," said Dr Joaquín Casariego, M.D., Janssen Therapeutic Area Lead Oncology for Europe, Middle East & Africa, Janssen-Cilag S.A. "It is vital that we develop new, innovative, targeted treatments to improve outcomes for patients with this aggressive cancer. The initial data presented today provides encouraging insights on the potential of amivantamab in non-small cell lung cancer bearing Exon 20 insertion mutations, and we are committed to exploring further the role this innovation may have in addressing the unmet needs for many more patients, their families and the medical community."

#ENDS#

About Amivantamab
Amivantamab (JNJ-6372) is an investigational EGFR-MET bispecific antibody with immune cell-directing activity, which targets activating and resistance EGFR mutations, and MET pathway activation.2,3 The production and development of the antibody followed Janssen Biotech, Inc.’s licensing agreement with Genmab for use of its DuoBody technology platform.9

About Non-Small Cell Lung Cancer (NSCLC)
In Europe, it is estimated that over 470,000 patients were diagnosed with lung cancer in 2018, with around 85 percent diagnosed with NSCLC.10,11 Lung cancer is Europe’s biggest cancer killer, with more deaths than breast cancer and prostate cancer combined.10 The five-year survival rate for patients with metastatic NSCLC is currently 24 percent.12

The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.13 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase that helps cells grow and divide.13 EGFR mutations are present in 10 to 15 percent of Caucasian patients with NSCLC and occur in 40 to 50 percent of Asian patients who have NSCLC adenocarcinoma.12,14,15 EGFR Exon 20 insertion mutations identify a distinct subset of lung adenocarcinomas, accounting for four to nine percent of all EGFR mutations.16

On May 18, 2020 The Janssen Pharmaceutical Companies of Johnson & Johnson reported results for the first time from a Phase 1 first-in-human dose escalation study (NCT03145181) of teclistamab (JNJ-7957), an investigational bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3 receptors on T-cells, in the treatment of patients with relapsed or refractory multiple myeloma (Press release, Janssen Pharmaceuticals, MAY 18, 2020, View Source [SID1234558247]). Initial results suggest a manageable safety profile across all teclistamab doses evaluated.1,2 Investigators reported that patients achieved deep responses which persisted, including some minimal residual disease (MRD)-negative complete responses (CR) at 10-6, with one durable beyond 12 months.1 The data will be featured during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Programme as an oral presentation on Saturday, May 30 at 1:00 p.m. ET/6:00 p.m. BST (Abstract #100).

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The study enrolled patients with multiple myeloma who had relapsed or were refractory to established therapies and had previously been treated with a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD).1,2 Patients had received a median of six prior lines of treatment (range, 2-14) before starting the study; 92 percent were triple-class exposed, 86 percent were refractory to the last line of therapy, 80 percent were triple-class refractory, and 41 percent were penta-drug refractory, meaning their cancer did not respond to treatment or had relapsed within 60 days with two or more immunomodulatory agents, two or more PIs, and an anti-CD38 therapy.1 Patients with triple-class refractory and penta-drug refractory multiple myeloma face poorer survival outcomes as treatment options are limited.3

"While the treatment of multiple myeloma has significantly advanced over recent years, finding additional treatment options for patients who relapse and become resistant to existing therapies remains critical," said Saad Usmani, M.D., FACP, Department of Hematologic Oncology and Blood Disorders, Levine Cancer Institute/Carolinas HealthCare System, and lead study investigator. "Initial findings for teclistamab in this heavily pre-treated population support further study of this investigational dual-targeting immunotherapeutic."

The study will be conducted in two parts: dose escalation (part 1) and dose expansion (part 2).1,2 Results from the Phase 1 portion of the study showed deep responses among patients (n=78) who were treated with teclistamab across dose groups, ranging from 0.3 µg/kg-720 µg/kg. At the 270 µg/kg dose (n=12), the overall response rate (ORR) was 67 percent (8/12); 50 percent (6/12) of patients achieved a very good partial response (VGPR) or better, and three patients achieved CR.1 Responses were deep and persisted. At the time of data cut-off, 76 percent (16/21) of patients who achieved a response across all doses remained in the study with an ongoing response, and 80 percent (4/5) who were evaluable for MRD analysis were MRD-negative, with two patients having a MRD-negative CR. Maintained MRD-negativity was confirmed for both patients who could be evaluated.1 Additional dose escalation and expansion of the study is ongoing.1

"We are continuing to pursue scientific advances in cancer types that we know best, like multiple myeloma, where we can achieve the optimal impact," said Patrick Laroche, M.D., Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag. "With teclistamab we aim to make a difference to the lives of the most vulnerable patients."

"We are committed to a multiplatform approach in our scientific strategy to address patients’ needs and provide treatment options for all patients with multiple myeloma," said Yusri Elsayed, M.D., M.H.Sc., Ph.D. Vice President, Global Head, Hematologic Malignancies, Janssen Research & Development, LLC. "Teclistamab is an example of one of our bispecific antibodies where we look to harness our immunotherapy expertise to advance potentially new options for patients whose disease has sadly progressed."

In the Phase 1 study, the most common adverse events (AEs) (all grade) were anaemia (58 percent); cytokine release syndrome (CRS) (56 percent); neutropenia (45 percent); thrombocytopenia (40 percent); and pyrexia (31 percent). In patients who experienced Grade 3 and above AEs (≥20 percent), the most common were neutropenia (38 percent); anaemia (36 percent); and thrombocytopenia (24 percent).1 One Grade 5 AE, respiratory failure in the setting of pneumonia, was reported but deemed by the investigator to be unrelated to the treatment.1 CRS events were all mild or moderate (Grade 1–2) and generally confined to first step-up and full doses, which may support the use of step-up dosing to mitigate CRS.1

About Teclistamab

Teclistamab (JNJ-7957) is an investigational bispecific antibody targeting both BCMA and CD3.1 CD3 is involved in activating the immune system’s response to fight infection, and BCMA is expressed at significantly higher levels in people with multiple myeloma.4,5,6 Teclistamab redirects CD3 T-cells to BCMA-expressing myeloma cells to induce cytotoxicity of the targeted cells.4,5 Results from preclinical studies demonstrate that teclistamab kills myeloma cell lines and myeloma bone marrow cells from heavily pre-treated patients.4

Teclistamab is currently being evaluated in a Phase 1 clinical study for the treatment of relapsed or refractory multiple myeloma and is also being explored in combination studies. The production and development of the antibody followed Janssen Biotech, Inc.’s licensing agreement with Genmab for use of its DuoBody technology platform.*

About Multiple Myeloma

Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells.7 In Europe, more than 48,200 people were diagnosed with MM in 2018, and more than 30,800 patients died.8 Around 50 percent of newly diagnosed patients do not reach five-year survival,7,9 and almost 29 percent of patients with multiple myeloma will die within one year of diagnosis.10

Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.11 Relapsed and refractory myeloma is defined as disease that is nonresponsive while on salvage therapy, or progresses within 60 days of last therapy in patients who have achieved minimal response (MR) or better at some point previously before then progressing in their disease course.12 While some patients with MM have no symptoms at all, others are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.13 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and require new therapies for continued disease control.14