On March 30, 2017 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported it has been informed by SWOG, an independent network of researchers that design and conduct cancer clinical trials, that the SWOG Phase 1b/2 trial evaluating PEGPH20 plus modified FOLFIRINOX chemotherapy versus modified FOLFIRINOX alone in patients with previously untreated metastatic pancreas cancer has been temporarily closed to enrollment (Press release, Halozyme, MAR 30, 2017, View Source [SID1234518336]). Schedule your 30 min Free 1stOncology Demo! During a planned early futility analysis, the independent Data Monitoring Committee found, based on preliminary data in an all comer population, that the addition of PEGPH20 given every two weeks to modified FOLFIRINOX would be unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall survival compared to modified FOLFIRINOX alone. Halozyme is working with SWOG to verify and analyze the initial data set, including a planned analysis by hyaluronan (HA) level, following completion of retrospective determination of tumor HA levels.
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"We see every clinical trial involving PEGPH20 as a possibility to advance the study and understanding of how to treat patients with some of the most difficult cancers," said Dr. Helen Torley, president and CEO. "We will work with SWOG to better understand these data and the patients who may best benefit from the addition of PEGPH20."
Halozyme and its collaboration partners have ongoing studies to evaluate PEGPH20 in combination with chemotherapies and immunotherapies in pancreatic, gastric, lung and breast cancers, with plans to initiate additional combination studies in pancreatic, gastric, gall bladder and bile duct cancers later this year.
Month: March 2017
After Much Anticipation, Cellectar Biosciences Initiates NCI-Supported Phase II Trial of CLR 131 in Multiple Myeloma and Other Blood Cancers
On March 30, 2017 Cellectar Biosciences, Inc. (Nasdaq: CLRB), an oncology-focused clinical stage biotechnology company, reported the initiation of a Phase II clinical study of its lead phospholipid drug conjugate (PDC) CLR 131 in patients with multiple myeloma and other hematologic malignancies (Press release, Cellectar Biosciences, MAR 30, 2017, View Source [SID1234518332]). Schedule your 30 min Free 1stOncology Demo!
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The study will be conducted in up to 15 centers in the United States for patients with a variety of orphan-designated relapse or refractory hematologic cancers. The study’s primary endpoint is objective response rate (ORR), with additional endpoints of progression free survival (PFS), median overall survival (OS) and other markers of efficacy following a single 25.0 mCi/m2 dose of CLR 131, with the option for a second 25.0 mCi/m2 dose approximately 75-180 days later. Cellectar will receive approximately $2 million in a non-dilutive grant to help fund the trial from the National Cancer Institute and initial efficacy data are expected as early as the second half of 2017.
"I would like to thank the entire team at Cellectar whose diligent efforts enabled the company to initiate the Phase II trial a full quarter ahead of our original guidance. The prospect of extending patient survival with a one or two-dose treatment continues to drive a high sense of urgency for all involved in this study as we continue to focus on providing clinical benefit to patients who suffer from these difficult to treat conditions," said Jim Caruso, president and CEO of Cellectar Biosciences. "Given the results from our Phase I trial of CLR 131 in multiple myeloma, we are enthusiastic about the potential outcomes of this Phase II trial, and look forward to reporting results as they become available."
The hematologic cancers to be studied include multiple myeloma (MM), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and potentially diffuse large B-cell lymphoma (DLBCL).
In addition to the CLR 131 infusion(s), MM patients will receive 40 mg oral dexamethasone weekly for up to 12 weeks. Efficacy responses will be determined by the latest International Multiple Myeloma Working Group criteria. Efficacy for all lymphoma patients will be determined according to Lugano criteria. More information about the trial, including eligibility requirements, can be found at www.clinicaltrials.gov, reference NCT02952508.
About CLR 131
CLR 131 is an investigational compound under development for a range of hematologic malignancies. It is currently being evaluated as a single-dose treatment in a Phase I clinical trial in patients with relapse or refractory (R/R) multiple myeloma as well as in a Phase II clinical trial for R/R MM and select R/R lymphomas with either a one- or two-dose treatment. Based upon preclinical and interim Phase I study data, treatment with CLR 131 provides a novel approach to treating hematological diseases and may provide patients with therapeutic benefits, including overall survival, an improvement in progression-free survival, surrogate efficacy marker response rate, and overall quality of life. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131, directly to tumor cells. The FDA has granted Cellectar an orphan drug designation for CLR 131 in the treatment of multiple myeloma.
About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). The company deliberately designed its phospholipid ether (PLE) carrier platform to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in more than 80 different xenograft models of cancer.
Bristol-Myers Squibb Enters Collaboration to Leverage Foundation Medicine’s Molecular Information Platform to Identify Predictive Biomarkers Across Multiple Tumor Types and Immunotherapy Agents
On March 30, 2017 Bristol-Myers Squibb Company (NYSE:BMY) and Foundation Medicine (NASDAQ:FMI) reported a collaboration that leverages Foundation Medicine’s comprehensive genomic profiling and molecular information solutions to identify predictive biomarkers such as Tumor Mutational Burden (TMB) and Microsatellite Instability (MSI) in patients enrolled across clinical trials investigating Bristol-Myers Squibb’s cancer immunotherapies (Press release, Bristol-Myers Squibb, MAR 30, 2017, View Source [SID1234518330]). Biomarkers can be used to characterize a tumor and the tumor microenvironment, which may reveal immune-related mechanisms predictive of how a patient may respond to immunotherapy. Schedule your 30 min Free 1stOncology Demo! Cancer immunotherapy works by helping the immune system mount an anti-cancer response, a process that depends in part on the recognition of cancer-specific proteins called neoantigens. Higher levels of tumor mutations have been shown to correlate to the number of neoantigens, and therefore may help identify patients more likely to respond to cancer immunotherapies. Foundation Medicine’s approach utilizing its FoundationOne assay combines comprehensive genomic profiling with its advanced and proprietary algorithms to measure biomarkers, including TMB and MSI, without the need for whole exome sequencing.
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"Translational medicine research is critical to further our understanding of cancer biology and to identify which patient populations are most likely to derive benefit from our Immuno-Oncology agents," said Fouad Namouni, M.D., head of Development, Oncology, Bristol-Myers Squibb. "We believe this collaboration with Foundation Medicine will help us better understand the relation of genomic approaches to immunotherapy efficacy across a number of different tumor types and immunotherapy agents."
"Cancer immuno-therapy is evolving rapidly, and biopharmaceutical companies and practicing oncologists alike may benefit from a reliable, validated, comprehensive view of mutational burden and genomic alterations to make the most informed care decisions," said Melanie Nallicheri, chief business officer and head, Biopharma for Foundation Medicine. "Our collaboration with Bristol-Myers Squibb highlights the potential value of our molecular information platform to the biopharma industry for its ability to inform, to reduce risk and to accelerate clinical development in this high growth and highly competitive oncology field."
Kite to Present Two Plenary Presentations from the ZUMA-1 Pivotal Trial of Axicabtagene Ciloleucel at the 2017 American Association of Cancer Research Annual Meeting
On March 20, 2017 Kite Pharma, Inc. (Nasdaq:KITE) reported new data presentations from multiple studies related to its lead investigational candidate, axicabtagene ciloleucel, at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Washington D.C., April 1-5, 2017 (Press release, Kite Pharma, MAR 30, 2017, View Source [SID1234518324]). Kite will also present pre-clinical data relating to KITE-585, the company’s fully human anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell product candidate. The full text for clinical trial abstracts will be available online March 31, 2017, at 4:30 p.m. Eastern Time, through the AACR (Free AACR Whitepaper) website at www.aacr.org. Schedule your 30 min Free 1stOncology Demo! "We are excited to present the primary analysis of ZUMA-1. The results demonstrate the promise of anti-CD19 CAR T-cell therapy to transform treatment of B-cell malignancies," said David Chang, M.D., Ph.D., Executive Vice President, Research and Development, and Chief Medical Officer. "We intend to apply the learnings from ZUMA-1, as well as our internal clinical development and manufacturing expertise, to accelerate the development of some of our most promising pipeline candidates such as KITE-585 into the clinic later this year."
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Oral Presentations
Primary results from ZUMA-1: a pivotal trial of axicabtagene ciloleucel (axicel; KTE-C19) in patients with refractory aggressive non-Hodgkin lymphoma (NHL)
Abstract # CT019
Presenter: Frederick L. Locke, M.D., Moffitt Cancer Center, Tampa, FL
Session: Immuno-oncology Biomarkers in Clinical Trials Plenary Session
Sunday, April 2, 2017: 4:05-4:14 PM EDT; Hall D-E, Level 2
Immune signatures of cytokine release syndrome and neurologic events in a multicenter registrational trial (ZUMA-1) in subjects with refractory diffuse large B cell lymphoma treated with axicabtagene ciloleucel (KTE-C19)
Abstract # CT020
Presenter: Frederick L. Locke, M.D., Moffitt Cancer Center, Tampa, FL
Session: Immuno-oncology Biomarkers in Clinical Trials Plenary Session
Sunday, April 2, 2017: 4:14-4:24 PM EDT; Hall D-E, Level 2
Polyfunctional anti-CD19 CAR T cells determined by single-cell multiplex proteomics associated with clinical activity in patients with advanced non-Hodgkin’s lymphoma
Abstract # 2990
Presenter: John M. Rossi, M.S., Kite Pharma
Session: Clinical Research, Clinical Biomarkers
Monday, April 3, 2017: 4:05-4:20 PM EDT; Room 151, Level 1
Development of KITE-585: A fully human BCMA CAR T-cell therapy for the treatment of multiple myeloma
Abstract # 4979
Presenter: Gregor B. Adams, Ph.D., Kite Pharma
Session: Immunology: Adoptive Cellular Therapy for Cancer
Tuesday, April 4, 2017: 3:35-3:50 PM EDT; Ballroom A-B, Level 3
Poster Presentations
Selectivity and specificity of engineered T cells expressing KITE-585, a chimeric antigen receptor targeting B-cell maturation antigen (BCMA)
Abstract # 2135
Presenter: Tassja Spindler, Kite Pharma
Session: Experimental and Molecular therapeutics: New Targets 2
Monday, April 3, 2017: 1:00-5:00 PM EDT; Halls A-C, Poster Section 6
About axicabtagene ciloleucel
Kite’s lead product candidate, axicabtagene ciloleucel, is an investigational therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells. Axicabtagene ciloleucel has been granted Breakthrough Therapy Designation status for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) regulatory support for DLBCL in the EU.
About KITE-585
KITE-585 is an investigational therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (CAR) to target the B cell maturation antigen (BCMA), a protein expressed on the cell surface of multiple myelomas (MM), and redirect the T cells to kill cancer cells. In 2016, there were an estimated 30,330 new cases of MM and 12,650 disease related deaths in the US1. Current treatments, including multi-therapy combinations, require chronic care and most patients will eventually relapse2. Kite expects to file an Investigational New Drug Application (IND) for KITE-585 in 2017.
Ignyta Announces Peer-Reviewed Publication of Activity of a TRK Inhibitor in a Primary Brain Tumor: Successful Treatment of Glioneuronal Tumor With Pan-TRK, CNS-Active Inhibitor Entrectinib Published in Precision Oncology
On March 30, 2017 Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, reported data demonstrating the successful treatment with entrectinib – Ignyta’s investigational, orally available, CNS-active tyrosine kinase inhibitor targeting tumors that harbor TRK, ROS1 or ALK fusions – of a patient with a primary brain tumor harboring an NTRK1 fusion (Press release, Ignyta, MAR 30, 2017, View Source [SID1234518323]). Schedule your 30 min Free 1stOncology Demo! The study, exploring genetic alterations associated with glioneuronal tumors, was led by researchers at Massachusetts General Hospital and was published in Precision Oncology. Researchers discovered novel oncogenic fusions involving members of the NTRK gene family in three out of 26 patients evaluated, and reported that in a patient with a BCAN-NTRK1 fusion, treatment with entrectinib resulted in a 60 percent regression in tumor size and the resolution of clinical symptoms that was maintained for 11 months on treatment. Entrectinib is currently being studied in a registration-enabling Phase 2 clinical trial known as STARTRK-2.
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"We are pleased to see the CNS activity of entrectinib demonstrated in this peer-reviewed publication in Precision Oncology, which highlights the need for CNS-active compounds to effectively treat CNS neoplasms, as well as other solid tumors with a propensity to metastasize to the brain," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "This robust activity of entrectinib in a patient with a primary brain tumor builds on the rapid and durable anti-tumor activity we’ve seen with this compound across other TRK, ROS1, or ALK solid tumors across multiple histologies and complements the 71% RECIST ORR (five out of seven patients) demonstrated in patients with extracranial tumors that had metastasized to the brain in our Phase 1 studies. Entrectinib is the only TRK inhibitor to have demonstrated RECIST responses in patients with CNS disease and the only TRK inhibitor to have a peer-reviewed publication on its activity in primary brain tumors."
Data presented in the study characterized a cohort of 26 glioneuronal tumors, which identified, through in-depth genomic analysis, BRAF mutations in 34 percent of tumors and oncogenic fusions in 30 percent of tumors. Further, researchers identified three tumors in the cohort that contained fusions involving members of the NTRK gene family, including one patient harboring a BCAN-NTRK1 fusion. Based on previous clinical results, therapeutic intervention for the patient harboring the NTRK1 fusion was pursued, and entrectinib was selected due to its CNS activity. Following subtotal surgical resection and confirmation of the tumor’s specific genetic alteration, the patient was enrolled in the Phase 1 dose-escalation trial of entrectinib (NCT02097810). The patient received entrectinib daily for 11 months and experienced lower extremity edema as the only documented side effect related to therapy. Analysis after nine months of treatment showed a 60 percent reduction in the size of the tumor, as well as improvement in vision-related symptoms. The patient was taken off of treatment after 11 months due to a gradual worsening of vision and tumor size. Based on the results of the study, we believe NTRK fusions should be considered an actionable target for glioneuronal tumor treatment.