On May 18, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson, reported 21 company-sponsored abstracts will be presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL on June 1-5 (Press release, Johnson & Johnson, MAY 18, 2018, View Source [SID1234526805]). New data analyses in support of a portfolio of products, including the investigational treatments erdafitinib and apalutamide, as well as approved treatments Imbruvica (ibrutinib), Darzalex (daratumumab), and Zytiga (abiraterone acetate) will be highlighted across urothelial, haematologic and prostate cancers.

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Notably, Phase 2 trial results for the investigational compound erdafitinib, which received U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation, will be presented during an oral presentation on Sunday, June 3 (Abstract #4503).1,2 For haematologic cancers, Phase 3 data from the iNNOVATE study will provide the first look at ibrutinib plus rituximab versus placebo plus rituximab in patients with newly diagnosed and relapsed/refractory Waldenström’s macroglobulinemia (WM) (Abstract #8003).3 In addition, Phase 2 data from the CAPTIVATE study will be presented evaluating ibrutinib plus venetoclax in first-line chronic lymphocytic leukaemia (CLL) (Abstract #7502).4 Oral presentations for erdafitinib and ibrutinib have been selected to be featured at the Best of ASCO (Free ASCO Whitepaper) 2018 Meetings, which highlight cutting-edge science and reflect the leading research in oncology.

"The breadth of new data from our portfolio shows our commitment to finding solutions for patients living with cancer according to their specific treatment needs," said Dr Ivo Winiger-Candolfi, Oncology Therapeutic Area Lead, Janssen Europe, Middle East and Africa. "It reinforces our dedication to work with our partners and move a step closer to making cancer a preventable, chronic or curable disease."

Selected data presentations include:

Erdafitinib: Results from the primary analysis of the Phase 2 study of erdafitinib (ERDA; JNJ-42756493) in patients with metastatic or unresectable urothelial carcinoma (mUC) and Fibroblast Growth Factor Receptor alterations (FGFRalt).
These data will be featured in an oral presentation from 9:00 – 9:12 a.m. CDT on Sunday, June 3 (Abstract #4503)1 and have been selected for the Best of ASCO (Free ASCO Whitepaper) 2018 Meetings.
Ibrutinib: Findings from the Phase 3 placebo-controlled iNNOVATE study will be presented, assessing ibrutinib plus rituximab versus placebo plus rituximab in patients with newly diagnosed and relapsed/refractory WM.*
These data will be featured in an oral presentation from 3:45 – 3:57 p.m. CDT on Friday, June 1 (Abstract #8003)3 and have been selected for the Best of ASCO (Free ASCO Whitepaper) 2018 Meetings.
Ibrutinib: Early results from the Phase 2 CAPTIVATE study will be presented, evaluating ibrutinib in combination with venetoclax in first-line CLL.*
These data will be featured in an oral presentation from 10:09 – 10:21 a.m. CDT on Sunday, June 3 (Abstract #7502) and have been selected for the Best of ASCO (Free ASCO Whitepaper) 2018 Meetings.4
Daratumumab: Phase 1 data from the MMY1001 study will report on the efficacy and safety of daratumumab in combination with carfilzomib and dexamethasone in lenalidomide-refractory patients with relapsed multiple myeloma.
These data will be presented in an oral presentation from 3:09 – 3:21 p.m. CDT on Friday, June 1 (Abstract #8002).5
Daratumumab: Follow-up efficacy and safety data from the pivotal Phase 3 ALCYONE study will be presented for daratumumab in combination with bortezomib, melphalan and prednisone in patients with newly diagnosed multiple myeloma who are transplant ineligible.
These data will be presented in a poster presentation from 8:00 – 11:30 a.m. CDT on Monday, June 4 (Abstract #8031).6
Daratumumab: Safety run-in results from the Phase 3 ANDROMEDA study will be presented evaluating the subcutaneous use of daratumumab in combination with cyclophosphamide, bortezomib, and dexamethasone in patients with newly diagnosed amyloid light chain (AL) amyloidosis.7 Amyloidosis is an incurable disease in which cells that normally produce antibodies make an abnormal protein that deposits in and causes damage to organs such as the heart and kidneys.8
These data will be presented in a poster discussion presentation from 3:00 – 4:15 p.m. CDT on Monday, June 4 (Abstract #8011).
Apalutamide: New analyses from the pivotal Phase 3 SPARTAN clinical trial will be presented examining the relationship between time to metastasis (TTM) and site of metastases in patients with non-metastatic castration-resistant prostate cancer (nmCRPC).
These data will be presented in a poster presentation from 1:15 – 4:45 p.m. CDT on Saturday, June 2 (Abstract #5033).9
Abiraterone acetate: New findings from the pivotal Phase 3 LATITUDE clinical trial in patients with metastatic high-risk castration-sensitive prostate cancer (CSPC) will be presented.
These data will be presented in a poster presentation from 1:15 – 4:45 p.m. CDT on Saturday, June 2 (Abstract #5028).10
Prostate Cancer: New analysis exploring the association between metastasis-free survival (MFS) and overall survival (OS) will be presented in nmCRPC for the first time.
These data will be presented in a poster presentation from 1:15 – 4:45 p.m. CDT on Saturday, June 2 (Abstract #5032).11
For more information on the abstracts presented by Janssen, please click here.

*Abstracts were submitted by ibrutinib co-developer partner, Pharmacyclics, an AbbVie company.

#ENDS#

About erdafitinib

Erdafitinib is an investigational, once-daily pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor being evaluated by Janssen Research and Development in Phase 2 and 3 clinical trials in patients with advanced urothelial cancer and other solid tumours. FGFRs are a family of receptor tyrosine kinases which may be upregulated in various tumour cell types and may be involved in tumour cell differentiation and proliferation, tumour angiogenesis, and tumour cell survival.12 In 2008, Janssen entered into an exclusive worldwide license and collaboration agreement with Astex Therapeutics Ltd. to develop and commercialise erdafitinib.

About ibrutinib

Ibrutinib is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, which works by forming a strong covalent bond with BTK to block the transmission of cell survival signals within the malignant B-cells.13 By blocking this BTK protein, ibrutinib helps kill and reduce the number of cancer cells, thereby delaying progression of the cancer.14

Ibrutinib is currently approved in Europe for the following uses:15

Chronic lymphocytic leukaemia (CLL): As a single agent for the treatment of adult patients with previously untreated CLL, and as a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy.
Mantle cell lymphoma (MCL): Adult patients with relapsed or refractory mantle cell MCL.
Waldenström’s macroglobulinemia (WM): Adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemo-immunotherapy.
The most common adverse reactions seen with ibrutinib include diarrhoea, neutropenia, haemorrhage (e.g., bruising), musculoskeletal pain, nausea, rash, and pyrexia.15

For a full list of side effects and for further information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.15

About daratumumab

Daratumumab is a first-in-class biologic targeting CD38, a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.16,17,18 Daratumumab is believed to induce tumour cell death through multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as well as through apoptosis, in which a series of molecular steps in a cell lead to its death.19 A subset of myeloid derived suppressor cells (MDSCs), CD38+ regulatory T cells (Tregs) and CD38+ B cells (Bregs) were decreased by daratumumab.19 Daratumumab is being evaluated in a comprehensive clinical development program across a range of treatment settings in multiple myeloma, such as in frontline and relapsed settings.20,21,22,23,24,25,26,27,28 Additional studies are ongoing or planned to assess its potential for a solid tumour indication and in other malignant and pre-malignant diseases in which CD38 is expressed, such as smouldering myeloma.29,30,31,32 For more information, please see www.clinicaltrials.gov.

Daratumumab is currently approved in Europe for the following uses:19

As monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.
In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
The most common adverse reactions seen with daratumumab include infusion reactions, fatigue, nausea, diarrhoea, muscle spasms, pyrexia, cough, dyspnoea, neutropenia, thrombocytopenia and upper respiratory tract infection. In addition, in combination with bortezomib, peripheral oedema and peripheral sensory neuropathy were frequently reported.19

For a full list of side effects and for further information on dosage and administration, contraindications and other precautions when using daratumumab please refer to the Summary of Product Characteristics.19

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialise daratumumab.33

About apalutamide

Apalutamide is an investigational, next-generation oral androgen receptor (AR) inhibitor that blocks the androgen signalling pathway in prostate cancer cells.34 Apalutamide inhibits the growth of cancer cells in three ways: by preventing the binding of androgen to the AR; by stopping the AR from entering the cancer cells; and by preventing the AR from binding to the DNA of the cancer cell.34 Apalutamide received US FDA approval on February 14, 2018 for the treatment of non-metastatic CRPC.35 On February 9, 2018 Janssen submitted a Marketing Authorisation Application to the European Medicines Agency (EMA).36

About abiraterone acetate

Abiraterone acetate plus prednisone / prednisolone is the only approved therapy in mCRPC that inhibits production of androgens (which fuel prostate cancer growth) at all three sources that are important in prostate cancer – the testes, adrenals and the tumour itself.37,38

Abiraterone acetate with prednisone / prednisolone is currently approved in Europe for the following uses:37

The treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT).
The treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.
The treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
The most common adverse reactions seen with abiraterone acetate plus prednisone / prednisolone include urinary tract infection, hypokalemia, hypertension, and peripheral oedema.37

For a full list of side effects and for further information on dosage and administration, contraindications and other precautions when using abiraterone acetate plus prednisone / prednisolone please refer to the Summary of Product Characteristics.37

On May 18, 2018 Dendreon Pharmaceuticals LLC, a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy, reported it will conduct a large-scale, placebo-controlled clinical trial evaluating the effectiveness of PROVENGE (sipuleucel-T) in reducing disease progression in men with prostate cancer on active surveillance (AS) (Press release, Dendreon, MAY 18, 2018, View Source [SID1234526806]). PROVENGE was the first U.S. Food and Drug Administration (FDA)-approved immunotherapy made from a patient’s own immune cells and remains the only immunotherapy treatment for prostate cancer. More than 30,000 men have been prescribed PROVENGE, and it has been clinically proven to extend life for men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (mCRPC).

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"Dendreon led the way with PROVENGE, the first active cellular immunotherapy approved by the FDA," said Jim Caggiano, chief executive officer of Dendreon. "We have already established that PROVENGE helps mCRPC patients live longer, and physicians have prescribed it to over 30,000 men. With this trial, Dendreon is taking another leadership position in the treatment of prostate cancer; if successful, it could again revolutionize the way the disease is treated."

Nearly 165,000 men are diagnosed with prostate cancer every year.1 Approximately 30 to 40 percent opt for AS2 – which includes regular monitoring to ensure the cancer is not growing or spreading – instead of choosing more aggressive treatment options. AS can allow men to delay – or even avoid – surgery and radiation, which often result in life-altering side effects.3 To date, no anti-cancer drug has been proven to prevent the disease from progressing during AS.

"The large body of data collected on PROVENGE has proven it has a significant impact on increasing overall survival in men with mCRPC," said Bruce A. Brown, M.D., senior vice president, medical, at Dendreon. "With the ProVent trial, our aim is to determine if PROVENGE can reduce prostate cancer disease progression in men on AS and potentially provide an alternative to choosing a treatment that can negatively impact quality of life."3

The ProVent clinical trial will assess the efficacy of PROVENGE in reducing histopathologic disease progression in men on AS, with a targeted enrollment of 450 participants. Men age 18 or older who have histologically-proven adenocarcinoma of the prostate diagnosed within 12 months of randomization are eligible to enroll. Study enrollment is expected to begin in late 2018, with topline results expected in 2023.

About the ProVent Trial

The randomized, double-blind, placebo-controlled, multicenter ProVent trial will be conducted at approximately 50 sites across the United States. Study participants will be randomized 2:1 to receive PROVENGE or placebo. The primary objective of the trial is to assess the efficacy of PROVENGE in reducing histopathologic disease progression in men on AS.

The primary endpoint is histological upgrade from ISUP Grade Group 1 to Grade Group 2 or higher, or Grade Group 2 upgraded to Grade Group 3 or higher. Secondary endpoints include the number of study participants with subsequent prostate cancer treatment (e.g., surgery, radiation, hormone therapy), the percentage of participants with a negative biopsy, and safety. Exploratory objectives will evaluate the association of immunologic responses with efficacy and patient quality of life outcomes.

About Active Surveillance (AS)

During AS, prostate tumors are not treated, but are regularly monitored via biopsies (every 1-2 years) and regular prostate-specific antigen (PSA) testing to determine disease progression. AS reduces the risk of overtreatment of clinically-insignificant prostate cancer, while retaining the option of definitive therapy.

AS is increasingly accepted as a treatment option for certain categories of prostate cancer.4 It is included in treatment guidelines from organizations including the American Urological Association, American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and National Comprehensive Cancer Network.

About PROVENGE (sipuleucel-T)

PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

IMPORTANT SAFETY INFORMATION

Acute Infusion Reactions: Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.

Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.

Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.

Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.

Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.

Adverse Reactions: The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

On May 16, 2018 Sensei Biotherapeutics, Inc., a privately-held biopharmaceutical company developing immuno-oncology therapies that teach the immune system to recognize and attack cancer, reported the appointment of John Celebi, M.B.A., as President and Chief Executive Officer (Press release, Sensei Biotherapeutics, MAY 16, 2018, View Source [SID1234526734]). He also joins the company’s board of directors. Mr. Celebi brings more than two decades of leadership experience with innovative and growing biotechnology companies, most recently in the field of cancer immunotherapies.

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The appointment of Mr. Celebi as President and Chief Executive Officer occurs at a time when Sensei is emerging with a focused immuno-oncology strategy, promising clinical data from the Phase I trial of its lead drug candidate SNS-301, and the proprietary SPIRIT drug development platform that is generating a pipeline of innovative immuno-oncology therapies. SNS-301 and the SPIRIT platform originated at Panacea Pharmaceuticals which has become Sensei Biotherapeutics. Sensei’s growing team of 14 employees is focused on its growth strategy in
immuno-oncology, operating out of its new 30,000 square foot laboratory and office space.

"I am delighted to join Sensei at this exciting time when we have the opportunity to apply our SPIRIT platform to develop immuno-oncology therapies with an innovative mechanism for detecting and eliminating cancer. We are encouraged by the clinical data that is emerging for our lead drug candidate, SNS-301, which we are advancing to lead the way in our strategy to build a precision pipeline of immuno-oncology therapies through companion diagnostics," said Mr. Celebi. "Sensei is well positioned to leverage our unique technology to develop novel
therapies with the potential to achieve our mission to have a positive and profound impact for
cancer patients."

"We welcome John’s strong experience and strategic business acumen to help build our vision and future for Sensei," said Hossein Ghanbari, PhD, Chief Scientific Officer and Board Chair of Sensei Biotherapeutics, and the company’s original co-founder and Chief Executive Officer.

"John’s oncology background and accomplished track record in biotech will serve Sensei exceptionally well as we move forward with our innovative immuno-oncology platform and advance new medicines for patients." Mr. Celebi has a distinguished track record for growing innovative entrepreneurial biotechnology companies, including in the field of oncology. Previously, Mr. Celebi served as the Chief Operating Officer of X4 Pharmaceuticals where he established and oversaw the company’s oncology business strategy. He also served as Chief Business Officer of Igenica Biotherapeutics, Inc., an immunotherapy company formed by The Column Group, 5AM Ventures, Orbimed and Third Rock Ventures, where he established key academic and industry relationships, including with MedImmune. He has extensive transactional and alliance management experience. Previously, he served as Vice President of Business Development, New Product Planning and Alliance Management at ArQule, Inc., where he played a central role
in the formation of alliances with Roche, Daiichi-Sankyo, and Kyowa Hakko Kirin. Mr. Celebi was one of the early employees at Tularik, Inc., where he conducted drug discovery and basic research for an anti-viral drug program. Mr. Celebi received an M.B.A. from Carnegie Mellon University and a B.S. in Biophysics from the University of California, San Diego.

On May 17, 2018 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported a poster presentation of additional prostate cancer data (Abstract #229675) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting to be held in Chicago, June 1-5, 2018 (Press release, Inovio, MAY 17, 2018, View Source [SID1234526752]). Previously reported data from a Phase 1b clinical trial demonstrated that Inovio’s cancer immunotherapy (INO-5150) slowed PSA rise in patients with biochemically recurrent prostate cancer. Additional analyses show clinically meaningful PSA stabilization post-administration of Inovio’s immunotherapy in patients with no documented disease progression during the study. Of note, this effect was also observed in the patients with the fastest PSA doubling at the time of study entry.

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The multi-center Phase 1b study enrolled 62 patients with biochemically relapsed prostate cancer following definitive local therapy. Under the trial design, eligible patients received INO-5150 (DNA plasmids encoding prostate specific antigen (PSA) and prostate specific membrane antigen (PSMA)) alone or co-administered with INO-9012 (IL-12 plasmid) delivered intramuscularly followed by EP using the CELLECTRA-5P device. Of the 61 evaluable patients, 77% (47/61) demonstrated T cell immunogenicity, and 38% (19/50) exhibited CD38+, Perforin+CD8+ T cell responses. Additional analyses are underway to elucidate the correlation between immunologic efficacy and clinical benefit. For more information, please visit ClinicalTrials.gov (Identifier: NCT02514213).

Dr. J. Joseph Kim, Inovio’s President & CEO, said, "The additional results from our Phase 1b INO-5150 study continue to support our rationale that Inovio’s T cell generating INO-5150 could be an important agent as an immunotherapy as it provides strong and durable immune responses in a particularly difficult-to-treat prostate cancer patient population. We remain diligent on establishing an outside partnership to further advance INO-5150 and I look forward to sharing additional observations from our prostate cancer development program later this year."

INO-5150 was generated using Inovio’s proprietary ASPIRE technology process to enable significant production of engineered PSA and PSMA antigens with genetic sequences differentiated from native human PSA and PSMA sequences. This patented approach is designed to help the body’s immune system overcome its "self-tolerance" to prostate cancer cells and mount a strong targeted CD8+ killer T cell response to eliminate the cancerous cells displaying these antigens. PSMA is also one of 3 antigens comprising INO-5401, which is being tested in two separate Phase 1/2 trials as an immunotherapy to treat glioblastoma and metastatic bladder cancer in combination with Regeneron and Genentech/Roche’s checkpoint inhibitors, respectively.

Independently, as part of the active, ongoing collaboration, two additional posters are being presented at the ASCO (Free ASCO Whitepaper) meeting that provide details on the ongoing trials of AstraZeneca/MedImmune’s MEDI0457 (formerly called INO-3112 which MedImmune in-licensed from Inovio) in abstract #TPS6093 and #5525.

On May 17, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that three posters highlighting clinical data from the ongoing Phase 1b/2 STOMP study will be presented at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) 2018 Annual Meeting taking place June 14-17, 2018 in Stockholm, Sweden (Press release, Karyopharm, MAY 17, 2018, View Source [SID1234526769]). These three poster presentations will feature updated data from the STOMP arms evaluating selinexor, the Company’s lead, novel, oral SINE compound, and dexamethasone in combination with standard approved therapies, Velcade, Pomalyst or Darzalex in patients with heavily pretreated multiple myeloma.

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"Following our positive results for selinexor in the STORM study in patients with penta-refractory multiple myeloma, we are pleased to be presenting updated results of selinexor combinations in earlier lines of myeloma treatment," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. "In the previously reported Phase 1b/2 STOMP study results, selinexor has shown robust anti-myeloma activity and a manageable safety profile in patients with relapsed or refractory myeloma after at least one prior therapy. The STOMP results not only provide the underlying clinical rationale for the ongoing pivotal Phase 3 BOSTON study evaluating selinexor in combination with once weekly Velcade, but also provide supportive data for selinexor as a potential new backbone therapy in combination with approved myeloma therapies, often with synergistic activity. We look forward to sharing these updated STOMP results from the Velcade, Pomalyst and Darzalex arms with the medical community at EHA (Free EHA Whitepaper) this year."

Details for the EHA (Free EHA Whitepaper) 2018 presentations are as follows:

Title: Selinexor combined with pomalidomide and low dose dexamethasone (SPd) in a relapsed/refractory multiple myeloma patient population
Presenter:Christine Chen, University of Toronto, Princess Margaret Cancer Center
Final Abstract Code: PF586
Topic/Session Title: Myeloma and other monoclonal gammopathies – Clinical
Date and Time:Friday, June 15, 2018; 17:30 – 19:00 CEST
Location: Poster area

Title: Selinexor combined with low dose bortezomib and dexamethasone (SVd) induces a high response rate in patients with relapsed or refractory multiple myeloma (MM)
Lead author: Nizar Bahlis, Southern Alberta Cancer Research Institute
Final Abstract Code: PS1322
Topic/Session Title: Myeloma and other monoclonal gammopathies – Clinical
Date and Time: Saturday, June 16, 2018; 17:30 – 19:00 CEST
Location: Poster area

Title: A Phase 1b study using the combination of selinexor, daratumumab, and dexamethasone in multiple myeloma patients previously exposed to proteasome inhibitors and immunomodulatory drugs
Lead author:Cristina Gasparetto, Duke University
Final Abstract Code: PS1329
Topic/Session Title: Myeloma and other monoclonal gammopathies – Clinical
Date and Time: Saturday, June 16, 2018; 17:30 – 19:00 CEST
Location: Poster area

About Selinexor

Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. To date, over 2,400 patients have been treated with selinexor. In April 2018, Karyopharm reported positive top-line data from the Phase 2b STORM study evaluating selinexor in combination with low-dose dexamethasone in patients with penta-refractory multiple myeloma. Selinexor has been granted Orphan Drug Designation in multiple myeloma and Fast Track designation for the patient population evaluated in the STORM study. Karyopharm plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) during the second half of 2018, with a request for accelerated approval for oral selinexor as a new treatment for patients with penta-refractory multiple myeloma. The Company also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in early 2019 with a request for conditional approval. Selinexor is also being evaluated in several other mid- and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a pivotal, randomized Phase 3 study in combination with Velcade (bortezomib) and low-dose dexamethasone (BOSTON) and as a potential backbone therapy in combination with approved therapies (STOMP), and in diffuse large B-cell lymphoma (SADAL), liposarcoma (SEAL), and an investigator-sponsored study in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with one or more approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.