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AstraZeneca and Kyowa Hakko Kirin partner on immuno-oncology clinical study

On July 30, 2014 AstraZeneca reported that it has entered into a clinical study collaboration with Kyowa Hakko Kirin for a Phase I/Ib immuno-oncology study that will evaluate the safety and efficacy of two separate combinations of three investigational compounds in multiple solid tumours (Press release AstraZeneca, JUL 29, 2014, View Source;astrazeneca-and-kyowa-hakko-kirin-partner-on-immuno-oncology-clinical-study [SID:1234500667]).

The study will evaluate AstraZeneca’s anti-PD-L1 antibody, MEDI4736, in combination with Kyowa Hakko Kirin’s anti-CCR4 antibody, mogamulizumab, and AstraZeneca’s anti-CTLA-4 antibody tremelimumab, in combination with mogamulizumab.

MEDI4736, tremelimumab, and mogamulizumab are part of a new class of cancer treatments known as immunotherapies, which use the body’s own immune system to help fight cancer. MEDI4736 and tremelimumab block the signals that help tumours avoid detection by the immune system, while mogamulizumab suppresses some of the immune cells that shield the tumour from the immune system.

Under the terms of the agreement, AstraZeneca and Kyowa Hakko Kirin will co-fund the study, which will be conducted by Kyowa Hakko Kirin. The Phase I part of the study is expected to establish a recommended dose regimen and Phase Ib will assess the safety and efficacy of the two combinations. Results from these studies will determine the future clinical development of the combinations.

Briggs Morrison, Executive Vice President, Global Medicines Development & Chief Medical Officer, AstraZeneca, said: “We believe that combination therapy in immuno-oncology has the potential to be one of the most effective ways of treating cancer. Our partnership with Kyowa Hakko Kirin provides the opportunity to explore two novel and exciting combinations.”

“With recent progress in the field of cancer immunotherapy, we have the potential to bring significant benefits to patients,” said Yoichi Sato, Managing Executive Officer, Vice President, Head of Research and Development Division of Kyowa Hakko Kirin. “Given the potential synergistic activity of our anti-CCR4 antibody when combined with immune checkpoint inhibitors, we look forward to collaborating with AstraZeneca to explore these combinations in multiple types of cancer.”

AstraZeneca and MedImmune have a broad programme of immuno-oncology combination trials underway, including MEDI4736 with Incyte’s oral indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360 and MEDI4736 with Advaxis’ immunotherapy vaccine, ADXS-HPV.

AstraZeneca and QIAGEN enter collaboration to develop diagnostic test for lung cancer patients suitable for treatment with IRESSA

On July 28, 2014 AstraZeneca reported that it has entered into a collaboration with Netherlands-based QIAGEN to develop a non-invasive diagnostic test to identify non-small cell lung cancer (NSCLC) patients who are suitable for treatment with IRESSA (Press release AstraZeneca, JUL 28, 2014, View Source;diagnostic-collaboration-cbrs-layout-1 [SID:1234501057]).

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IRESSA is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor that blocks the signals from the EGFR, which leads to tumour growth. EGFR is a protein found in abnormally high levels on the surface of many types of cancer cells, particularly non-small cell lung cancer (NSCLC) cells. Using QIAGEN’s diagnostic test, doctors will be able to identify patients with the EGFR mutation, and therefore who might benefit most from treatment with IRESSA, through a blood test. Currently the main method of assessing EGFR mutation status involves the collection of tumour tissue by needle biopsy or during resection.

QIAGEN’s test uses a highly sensitive assay to detect EGFR mutations in the small fragments of circulating tumour DNA (ctDNA) in plasma taken from patients’ blood samples. The test has demonstrated robust and reliable identification of EGFR mutation status using samples from the Phase IV IRESSA Follow Up Measure (IFUM) study.

This collaboration is part of a long standing relationship between AstraZeneca and QIAGEN. The two companies are seeking approval from the European Medicines Agency for the ctDNA test, as a companion diagnostic for IRESSA.

Mondher Mahjoubi, Senior Vice President, Global Product Strategy for Oncology at AstraZeneca, said: "By combining AstraZeneca’s expertise in lung cancer with QIAGEN’s diagnostic capabilities, we have the potential to transform the way specific tumour types are identified and treated. The use of circulating tumour DNA testing will allow doctors to target the individual needs of each patient quickly and accurately."

"We are excited about this new partnership with AstraZeneca", said Peer M. Schatz, CEO of QIAGEN. "Liquid biopsies are an exciting new field in sample technology and an area of core leadership for QIAGEN. We are rapidly expanding our portfolio in this field and are seeing a broad uptake of our new standards. Our novel solutions for processing tumor DNA and RNA from body fluids are being widely validated for clinical use with existing and new assays and have the potential to improve outcomes for patients for whom invasive surgery is not an option."

Stemline Therapeutics Announces Opening of SL-401 Corporate IND and Start of Clinical Trials in BPDCN and AML

On July 28, 2014 Stemline Therapeutics reported the opening of its SL-401 Investigational New Drug (IND) and initiation of a broad clinical development program including trials in blastic plasmacytoid dendritic cell neoplasm (BPDCN) and acute myeloid leukemia (AML) (Press release Stemline Therapeutics, JUL 28, 2014, View Source [SID:1234500657]). SL-401 is a targeted therapy directed to the interleukin-3 receptor (IL-3R) present on cancer stem cells (CSCs) and tumor bulk of many hematologic cancers. SL-401 has completed a physician-sponsored Phase 1/2 trial and demonstrated a tolerable safety profile and clinical activity in multiple indications, including durable complete responses (CRs), in BPDCN and relapsed/refractory AML. Seven of nine evaluable BPDCN patients had objective responses, including 5 CRs. Stemline has now initiated a corporate-sponsored multicenter, open-label trial in patients with BPDCN and relapsed/refractory AML. This study is designed to accrue at least 60 patients, including a brief lead-in that transitions into a larger expansion stage in these indications. Additional trials in other IL-3R expressing malignancies will follow this year and into early next year.

Eric K. Rowinsky, M.D., Chief Medical Officer and Head of Research and Development, commented, "We’re extremely excited to officially kick off our broad clinical development program for SL-401. We’ve already witnessed significant single-agent clinical activity and a wealth of safety data in over 80 patients in a previous physician-sponsored Phase 1/2 trial. We’ve designed our initial corporate-sponsored SL-401 trial to serve as the basis for potential accelerated approval in BPDCN." Dr. Rowinsky continued, "We also expect to initiate other open-label trials this year in additional rare IL-3R+ cancers of unmet medical need including mastocytosis, hypereosinophilic syndrome, myelofibrosis, and chronic myelomonocytic leukemia, which are myeloproliferative disorders that derive from a common IL-3R+ progenitor cell. Here, too, we’ve designed these studies to form the basis of potential accelerated approval in any one, or more, of these indications. We also intend to initiate other studies over the coming months in AML first line (in 1st CR with minimal residual disease positivity), relapsed/refractory myeloma, relapsed/refractory hairy cell leukemia, and other hematologic cancers known to express high levels of IL-3R. We expect to provide specifics around these programs and potential clinical updates on our ongoing open-label trials as the year progresses."

MorphoSys Provides Update on the Company’s Proprietary Drug Portfolio

MorphoSys has prioritized presenting first clinical data from the NHL trial at a major conference later this year, earlier than previously anticipated (Press release MorphoSys, JUL 28, 2014, View Source [SID:1234500655]).. In the trial, four different subtypes of NHL, namely follicular lymphoma (FL), mantle cell lymphoma (MCL), diffuse large B cell lymphoma (DLBCL) and other indolent NHL types are investigated. Recruitment in B-ALL has recently been slower than originally anticipated, but enrollment is nevertheless planned to be completed by the end of 2014. For this reason, MorphoSys does not expect to present clinical data for B-ALL in 2014.

Roche's Gazyvaro approved in Europe for patients with the most common type of leukemia

On July 29, 2014 Roche reported that the European Commission has approved Gazyvaro (obinutuzumab) in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia who have comorbidities making them unsuitable for an intensive therapy (full-dose fludarabine based therapy) (Press release Hoffmann-La Roche, JUL 28, 2014, View Source [SID:1234500665]). Outside of the EU and Switzerland, Gazyvaro is marketed as Gazyva.

“We are proud to make Gazyvaro available for CLL patients in Europe,” said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head, Global Product Development. “Gazyvaro is a new option that helps patients achieve deep responses to treatment that translate to longer lasting remissions.”

The European approval was based on the outcomes of the CLL11 study which was conducted in close collaboration with the German CLL Study Group. The study showed that Gazyvaro plus chlorambucil met its primary endpoint by significantly reducing the risk of disease worsening or death by 61% compared to MabThera/Rituxan plus chlorambucil (progression free survival; PFS). For patients in the Gazyvaro arm, median PFS was 26.7 months compared with 15.2 months for those in the MabThera/Rituxan arm (HR 0.39, CI 0.31-0.49, p<0.001). Additional Gazyvaro data from the CLL11 study showed higher complete response rates (21% compared with 7%) and a ten-fold increase in the percentage of people achieving minimal residual disease (MRD) negativity* (37.7% compared with 3.3%) compared to the MabThera/Rituxan arm of the study. Gazyvaro plus chlorambucil also increased the time people with previously untreated CLL lived (overall survival, OS) compared to those who received treatment with chlorambucil alone. The most common serious adverse events (AEs) for Gazyvaro were infusion-related reactions (IRRs), infections and low cell count of certain white blood cells (neutropenia). The incidence and severity of IRRs decreased dramatically after the first infusion and no serious IRRs have been reported beyond the first infusion. These data from the CLL11 study were published in the New England Journal of Medicine (N Engl J Med. 2014 Mar 20;370(12):1101-10. doi: 10.1056/NEJMoa1313984. Epub 2014 Jan 8. View Source). For CLL patients in Europe, Roche expects to begin launching Gazyvaro in a number of European countries in 2014. Roche is also studying Gazyvaro in other cancers of the blood where anti-CD20 antibodies have been shown to be effective, and where future combination therapies may reduce or eliminate the need for chemotherapy.