On April 20, 2016 Kuros Biosciences Ltd. ("Kuros" or the "Company"), reported that Checkmate Pharmaceuticals Inc., Cambridge, MA, USA ("Checkmate") has dosed its first first melanoma patient in a Phase 1b clinical trial with CMP-001, formerly known as CYT003 (Press release, Kuros Biosciences, APR 20, 2016, View Source [SID1234516801]). The trial is designed as a multi-center, open-label study of CMP-001 in combination with pembrolizumab for patients with advanced melanoma who have either progressed on anti-PD1 therapy or have failed to respond to at least 12 weeks of therapy.

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In August 2015, Checkmate acquired exclusive access to Cytos’ clinically validated product candidate CYT003 as well as its VLP platform and to technology related to oligonucleotide synthesis for multiple products in the field of oncology. As a result of the first dosing of a patient with this licensed product candidate, Kuros will receive a milestone payment of USD 1 million from Checkmate. In this collaboration Kuros may receive up to USD 90 million in development milestones and may receive up to double-digit royalties on net sales from successfully developed products.

Didier Cowling, Chief Executive Officer of Kuros, commented: "We are very pleased that Checkmate has already advanced CMP-001 into a phase 1b clinical trial. Reaching this milestone only 10 months after signing the license agreement is a significant achievement. We wish to congratulate Checkmate on its progress and are eager to see how intra-tumoral therapy with CPM-001 will perform in combination with pembrolizumab in patients with advanced melanoma. "

For further information, please contact:

Kuros Biosciences Ltd

Harry Welten, MBA

Chief Financial Officer

Tel: +41 44 733 46 46

[email protected]

In this proof-of-concept, open-label, phase 2 study, patients with relapsed/refractory multiple myeloma (RRMM) received elotuzumab with bortezomib and dexamethasone (EBd) or bortezomib and dexamethasone (Bd) until disease progression/unacceptable toxicity. Primary endpoint was progression-free survival (PFS); secondary/exploratory endpoints included overall response rate (ORR) and overall survival (OS). Two-sided 0.30 significance level was specified (80% power, 103 events) to detect hazard ratio (HR) of 0.69. Efficacy and safety analyses were performed on all randomized patients and all treated patients, respectively. Of 152 randomized patients (77 EBd, 75 Bd), 150 were treated (75 EBd, 75 Bd). PFS was greater with EBd versus Bd (HR, 0.72; 70% confidence interval [CI], 0.59-0.88; stratified log-rank P=.09); median PFS was longer with EBd (9.7 months) versus Bd (6.9 months). In an updated analysis, EBd-treated patients homozygous for the high-affinity FcγRIIIa allele had median PFS of 22.3 months versus 9.8 in EBd-treated patients homozygous for the low-affinity allele. ORR was 66% (EBd) versus 63% (Bd). Very good partial response or better occurred in 36% of patients (EBd) versus 27% (Bd). Early OS results, based on 40 deaths, revealed an HR of 0.61 (70% CI, 0.43-0.85). To date, 60 deaths have occurred (28 EBd, 32 Bd). No additional clinically significant adverse events occurred with EBd versus Bd. Grade 1/2 infusion reaction rate was low (5% EBd) and mitigated with premedication. In patients with RRMM, elotuzumab, an immunostimulatory antibody, appears to provide clinical benefit without added clinically significant toxicity when combined with Bd versus Bd alone. ClinicalTrials.govNCT01478048 .
Copyright © 2016 American Society of Hematology (ASH) (Free ASH Whitepaper).

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Infantile fibrosarcoma (IFS) is a rare pediatric cancer typically presenting in the first 2 years of life. Surgical resection is usually curative and chemotherapy is active against gross residual disease. However, when recurrences occur, therapeutic options are limited. We report a case of refractory IFS with constitutive activation of the tropomyosin-related kinase (TRK) signaling pathway from an ETS variant gene 6-neurotrophin 3 receptor gene (ETV6-NTRK3) gene fusion. The patient enrolled in a pediatric Phase 1 trial of LOXO-101, an experimental, highly selective inhibitor of TRK. The patient experienced a rapid, radiographic response, demonstrating the potential for LOXO-101 to provide benefit for IFS harboring NTRK gene fusions.
© 2016 The Authors. Pediatric Blood & Cancer, published by Wiley Periodicals, Inc.

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Follicular lymphoma (FL) is the second most common type of lymphoid cancer in Western Europe.
The aim of this study was to evaluate the cost utility of rituximab-bendamustine treatment compared with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) treatment as a first-line therapy for patients with advanced FL in Spain.
A Markov model was developed to estimate the cost effectiveness of rituximab-bendamustine compared with R-CHOP as first-line treatment for patients with advanced FL in the Spanish National Health System (NHS). Transitions between health states (progression-free, including induction and maintenance; first relapse; second relapse; and death) were allowed for the patient cohort in 4-week-long cycles. Clinical data for the extrapolation of progression-free survival curves were obtained from randomized trials. Mortality rates and utilities were obtained from the literature. Outcomes were measured as quality-adjusted life-years (QALYs). The total costs (€, 2013) included drug costs (ex-factory prices with mandatory deductions), disease management costs and adverse event-associated costs. Costs and outcomes were discounted at a 3 % annual rate. Probabilistic sensitivity analysis was performed using 10,000 Monte Carlo simulations to assess the model robustness.
Treatment and administration costs during the induction phase were higher for rituximab-bendamustine (€17,671) than for R-CHOP (€11,850). At the end of the 25-year period, the rituximab-bendamustine first-line strategy had a total cost of €68,357 compared with €69,528 for R-CHOP. Health benefits were higher for rituximab-bendamustine treatment (10.31 QALYs) than for R-CHOP treatment (9.82 QALYs). In the probabilistic analysis, rituximab-bendamustine was the dominant strategy over treatment with R-CHOP in 53.4 % of the simulations.
First-line therapy with rituximab-bendamustine in FL patients was the dominant strategy over treatment with R-CHOP; it showed cost savings and higher health benefits for the Spanish NHS.

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Formation of new blood vessels in tumors, a process termed tumor angiogenesis, is a crucial step during oncogenic progression. Blocking tumor angiogenesis is therefore expected to have a profound impact on tumor growth. It took several decades of collective efforts to translate this intriguing idea into tangible clinical benefit. Today, anti-angiogenesis agents represent standard-of-care therapies for multiple types of cancers, and the clinical experience has taught us many lessons about the concept and application of anti-angiogenesis. This Perspective is an attempt to summarize these lessons and how they can be leveraged to improve anti-angiogenesis therapy.
Copyright © 2016 Elsevier Inc. All rights reserved.

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