On March 2, 2017 Mersana Therapeutics, Inc., a biotechnology company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) based on its Fleximer platform technology, reported that it will present data on its lead preclinical immunoconjugate, XMT-1522, at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2017 in Washington, D.C (Press release, Mersana Therapeutics, MAR 2, 2017, View Source [SID1234517971]). The two poster presentations will highlight results from ongoing non-clinical studies where the compound was evaluated as a potential combination partner with immunomodulatory cancer therapies and it was also characterized for its pharmacokinetics, metabolism and biodistribution in tumor-bearing mice. Schedule your 30 min Free 1stOncology Demo!
The accepted abstracts are listed below and are now available online on the AACR (Free AACR Whitepaper) 2017 conference website: www.aacr.org
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Abstract Control Number: 6879
Title: Combination of anti-HER2 ADC XMT-1522 and checkpoint inhibitor pembrolizumab for treatment of NSCLC in preclinical models
Authors: Natasha Bodyak, Marina Protopopova, Qingxiu Zhang, Alex Yurkovetskiy, Mao Yin, LiuLiang Qin, Laura L Poling, Rebecca Mosher, Donald A. Bergstrom, Timothy B. Lowinger
Session Category: Immunology
Session Title: Immune Response to Hematopoietic Tumors: New Developments in Tumor Immunology
Session Date and Time: Monday Apr 3, 2017 1:00 PM – 5:00 PM
Location: Convention Center, Halls A-C, Poster Section 26
Poster Board Number: 29
Abstract control number: 6716
Title: Non-clinical pharmacokinetics of XMT-1522, a HER2 targeting auristatin-based antibody drug conjugate.
Authors: Donald A. Bergstrom, Natalya Bodyak, Alex Yurkovetskiy, Michael DeVit, Mao Yin, Laura L. Poling, Joshua D. Thomas, Dmitry Gumerov, Dongmei Xiao, Elena Ter-Ovanesyan, Charlie Bu, LiuLiang Qin, Alex Uttard, Alex Johnson, Timothy B. Lowinger
Session Category: Experimental and Molecular Therapeutics
Session Date and Time: Sunday Apr 2, 2017 1:00 PM – 5:00 PM
Location: Convention Center, Halls A-C, Poster Section 26
Poster Board Number: 29
About XMT-1522
XMT-1522 incorporates a novel, proprietary HER2 antibody, which is conjugated with Mersana’s Dolaflexin platform which includes its Fleximer technology and proprietary auristatin payload. XMT-1522 provides a drug load of approximately 12-15 molecules per antibody, specifically designed to improve potency while simultaneously increasing tolerability. XMT-1522 has the potential to extend HER2-targeted therapy beyond the current "HER2-positive" populations into patients with lower levels of HER2 expression.
Author: [email protected]
BeiGene Announces Initiation of First Pivotal Study in China with BTK Inhibitor BGB-3111
On March 2, 2017 BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical company developing molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported the dosing of the first patient in a pivotal clinical trial of BGB-3111, an investigational Bruton’s Tyrosine Kinase (BTK) inhibitor, in Chinese patients with relapsed or refractory mantle cell lymphoma (MCL) (Press release, BeiGene, MAR 2, 2017, View Source [SID1234517970]). BGB-3111 is also currently being evaluated in a global Phase III study in comparison with ibrutinib for the treatment of patients with Waldenström’s Macroglobulinemia. Schedule your 30 min Free 1stOncology Demo! "We are pleased to announce the beginning of the first pivotal clinical trial of BGB-3111 in China. BGB-3111 has been under clinical investigation since August 2014, and over 300 patients with various B-cell malignancies have been treated with BGB-3111 in Australia, New Zealand, the United States, Korea, and China," commented John V. Oyler, Founder, Chief Executive Officer, and Chairman.
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"The initiation of the first pivotal trial in China with one of our portfolio compounds is an important step towards our goal of advancing innovative cancer treatments for patients in China," commented Lai Wang, Ph.D., Head of China Development.
The Phase II single-arm, open-label, multi-center study is designed to investigate the efficacy and safety of BGB-3111 in patients with relapsed or refractory MCL. The study’s primary endpoint is the objective response rate, defined as achievement of either a partial response or complete response at any time on study drug. Secondary endpoints include progression free survival, duration of response, time to response, safety, and tolerability. Professor Jun Zhu of the Beijing Cancer Hospital is the lead principal investigator of the trial.
About BGB-3111
BGB-3111 is a potent and highly selective investigational small molecule inhibitor of BTK. BGB-3111 has demonstrated higher selectivity against BTK than ibrutinib (the only BTK inhibitor currently approved by the U.S. Food and Drug Administration and the European Medicines Agency) based on biochemical assays, higher exposure than ibrutinib based on their respective Phase I experience, and sustained 24-hour BTK occupancy in both the blood and the lymph node.
Karyopharm Announces Results from Interim Analysis of Phase 2 SOPRA Study Evaluating Selinexor in Relapsed/Refractory Acute Myeloid Leukemia
On March 2, 2017Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported the results of a planned interim analysis of the Phase 2 SOPRA study evaluating single agent selinexor in relapsed/refractory acute myeloid leukemia (AML) (Press release, Karyopharm, MAR 2, 2017, View Source [SID1234517968]).
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The Company determined in concert with the study’s independent Data Safety Monitoring Board (DSMB) that SOPRA will not reach statistical significance for overall survival (OS), the study’s primary endpoint. However, since selinexor-treated patients that achieved a complete response (CR) showed a substantial OS benefit as compared with the physician’s choice (PC) arm, Karyopharm and the DSMB agreed that patients would be permitted to continue on the selinexor arm or the PC arm, as applicable, following discussion between the patient and their treating physician. The Company plans to continue clinical development of selinexor in AML through investigator sponsored trials in multiple combination regimens, including with chemotherapy, given encouraging data to date across these settings.
SOPRA is a Phase 2 randomized study of patients 60 years of age or older with relapsed or refractory AML who were ineligible for intensive chemotherapy and/or transplantation. Patients were randomized to either receive single-agent oral selinexor 60mg twice weekly or PC. PC included best supportive care (BSC) alone, or BSC plus either azacitidine (Vidaza), decitabine (Dacogen), or low dose cytosine arabinoside (LD-AraC). Based on unaudited site data, SOPRA enrolled 176 patients (median of two prior regimens) in the U.S., Canada, Europe and Israel. Among patients on the selinexor arm, 13% demonstrated a CR with or without full hematologic recovery (CRi) compared to 3% of patients on the PC control arm. Some patients remained on selinexor for over one year, but this did not result in a statistically superior OS compared to the PC arm. The DSMB found no new clinically significant adverse events in the patients receiving selinexor. Importantly, rates of sepsis and febrile neutropenia (FN) were lower on the selinexor arm (sepsis 4.9%, FN 14.7%) compared to the PC arm (sepsis 6.1%, FN 36.4%). As expected, the most common selinexor-related adverse events were nausea, anorexia, fatigue, vomiting, and thrombocytopenia. Patients who have benefited from selinexor treatment on the SOPRA study have the option to continue therapy.
"SOPRA is a robust, well-conducted trial and the response rates achieved with single-agent selinexor in this heavily pretreated older population have been encouraging," said Hagop Kantarjian, MD, Chair of the Department of Leukemia, The University of Texas MD Anderson Cancer Center. "Importantly, the safety profile was as expected and the recommended Phase 2 dose was generally well-tolerated. Unfortunately, as is common in AML, the higher response rates observed with single-agent selinexor versus physician’s choice did not translate into extended survival in the overall population of these frail and heavily pretreated patients."
"After performing an in-depth analysis, we and the DSMB agree that, despite the higher complete response rates observed with selinexor, the phase 2 SOPRA study evaluating single-agent selinexor in relapsed or refractory AML has not reached statistical significance for overall survival, the primary endpoint of the study," said Michael G. Kauffman, MD, PhD, Chief Executive Officer of Karyopharm. "While we are disappointed with the overall outcome, we are pleased that 60mg of single-agent selinexor dosed twice per week was well-tolerated and carried no increased risk of sepsis or febrile neutropenia. At Karyopharm, our primary focus remains the advancement of selinexor in relapsed or refractory multiple myeloma, where we believe we have a clear path to regulatory approval."
Dr. Kauffman continued, "Beyond myeloma, we see diffuse large B-cell lymphoma (DLBCL) and liposarcoma as high unmet need indications where selinexor has a meaningful opportunity for clinical success and where we are expecting key data readouts during 2017. We look forward to reporting top-line data from our randomized Phase 2b SADAL study evaluating single-agent selinexor in patients with relapsed or refractory DLBCL in early 2017 and top-line data from the Phase 2 portion of the randomized Phase 2/3 SEAL study evaluating single-agent selinexor in patients with advanced liposarcoma in mid-2017."
Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm, commented, "We continue to believe selinexor has potential in AML, most likely in combination with other agents in front line and later settings. We continue to explore the use of selinexor in combination with novel and standard agents through investigator-sponsored AML studies. Clinical data recently reported at the 2016 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting demonstrated that selinexor in combination with certain standard therapies, including intensive chemotherapy as well as hypomethylating agents, demonstrated encouraging activity in AML in adults, both as an initial therapy and in the relapsed setting. The benefit of selinexor in combination with intensive chemotherapy will be assessed in randomized investigator sponsored trials that we expect will begin in 2017. Furthermore, selinexor in combination with intensive chemotherapy has shown very promising responses in pediatric patients with heavily pretreated AML."
"We are deeply grateful for the support and commitment of the AML investigators and the patients and families who have taken part in or contributed to the SOPRA study," Dr. Shacham concluded.
More About the Phase 2 SOPRA Study
The Phase 2 SOPRA (Selinexor in Older Patients with Relapsed/Refractory AML) study is a randomized trial evaluating single-agent selinexor (KPT-330), Karyopharm’s lead, novel, oral Selective Inhibitor of Nuclear Export / SINE compound, versus physician’s choice in patients 60 years of age or older with relapsed or refractory AML who were ineligible for intensive chemotherapy and/or transplantation. In the SOPRA study, 176 patients with AML whose disease had relapsed after, or was refractory to, first line therapy were randomized 2:1 to receive either oral selinexor (60 mg twice per week) or one of four physician’s choice (PC) therapies. Physician’s choice included best supportive care (BSC) alone, or BSC plus either azacytidine (Vidaza), decitabine (Dacogen), or low dose cytosine arabinoside (LD-AraC). The primary endpoint of the SOPRA study was overall survival (OS), with a target of a 75% improvement in OS from 3.0 months in the PC arm to 5.2 months in the selinexor arm. SOPRA was conducted at approximately 94 sites worldwide, including sites in the U.S., Canada, Europe and Israel.
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 1,900 patients have been treated with selinexor and it is currently being evaluated in several mid- and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in combination with low-dose dexamethasone (STORM) and backbone therapies (STOMP), and in diffuse large B-cell lymphoma (SADAL), and liposarcoma (SEAL), among others. Karyopharm plans to initiate a pivotal randomized Phase 3 study of selinexor in combination with bortezomib (Velcade) and low-dose dexamethasone (BOSTON) in patients with multiple myeloma in early 2017. 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 the Company’s clinical development priorities for selinexor. The latest clinical trial information for selinexor is available at www.clinicaltrials.gov.
Aduro Biotech Announces Upcoming Data Presentations at the Keystone Symposia on Cancer Immunology and Immunotherapy Conference
On March 2, 2017 Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, reported data presentations relating to its technology platforms to be given at the Keystone Symposia on Cancer Immunology and Immunotherapy Conference: Taking a Place in Mainstream taking place in Whistler, B.C., Canada, March 19 through 23, 2017 (Press release, Aduro Biotech, MAR 2, 2017, View Source [SID1234517967]). Schedule your 30 min Free 1stOncology Demo!
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Poster 1061: Administration of the synthetic STING agonist ADU-S100 leads to durable anti-tumor immunity via promoting T-cell responses
Poster Session: 1
Date/Time: Monday, March 20, 7:30 p.m. to 10:00 p.m. PT
Poster 2038: Efficacy of pLADD, a personalized immunotherapy strategy targeting tumor-specific neoantigens using live attenuated Listeria monocytogenes
Poster Session: 2
Date/Time: Tuesday, March 21, 2017, 7:30 p.m. to 10:00 p.m. PT
Foundation Medicine Receives Medicare Payment in Non-Small Cell Lung Cancer under a Local Coverage Determination for FoundationOne®, the Company’s Comprehensive Genomic Profiling Assay
On March 2, 2017 Foundation Medicine, Inc. (NASDAQ:FMI) reported that it has received payment from Palmetto GBA, the Company’s Medicare Administrative Contractor (MAC) in North Carolina, for its FoundationOne comprehensive genomic profiling assay when used in the clinical course of care for individuals in the United States with Stage IIIB/IV non-small cell lung cancer (NSCLC) who meet the eligibility requirements under Palmetto GBA’s Local Coverage Determination L36143 (LCD) (Press release, Foundation Medicine, MAR 2, 2017, View Source [SID1234517962]). The LCD was most recently updated on December 22, 2016. Foundation Medicine began submitting an initial set of claims to Palmetto GBA in January 2017 for FoundationOne, and received its first payments for claims under this LCD on March 1, 2017. Schedule your 30 min Free 1stOncology Demo! "Coverage and payment for FoundationOne under Palmetto GBA’s LCD is a positive step toward advancing access to precision medicines for individuals living with non-small cell lung cancer," said Troy Cox, chief executive officer for Foundation Medicine. "We look forward to continuing to work with Palmetto GBA as we gain additional payment experience under this LCD for non-small cell lung cancer. We will continue to work with FDA and CMS as they review our universal companion diagnostic test through the Parallel Review process with the goal of being the first pan-cancer, universal companion diagnostic test to receive FDA approval and a National Coverage Determination from CMS."
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