On December 6, 2016 AstraZeneca reported data from the AURA3 trial that data is supportive of Tagrisso (osimertinib) potentially becoming the new standard of care for 2nd-line treatment of patients with epidermal growth factor receptor (EGFR) T790M mutation-positive locally-advanced or metastatic non-small cell lung cancer (NSCLC)(Press release, AstraZeneca, DEC 6, 2016, View Source [SID1234516948]). The first randomised Phase III data showed that Tagrisso 2nd-line therapy improved progression-free survival (PFS) by 5.7 months compared with standard platinum-based doublet chemotherapy (Hazard Ratio [HR]=0.3). The results were presented at the 17th World Conference on Lung Cancer (WCLC) in Vienna, Austria, hosted by the International Association for the Study of Lung Cancer, and published simultaneously online in The New England Journal of Medicine. Schedule your 30 min Free 1stOncology Demo! AURA3
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Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "The confirmatory Phase III data suggest the potential for Tagrisso to replace chemotherapy as the standard of care for patients who have progressed following EGFR tyrosine kinase inhibitor treatment. As lung cancer is the most common type of cancer to spread to the brain, it is also encouraging to see the activity of Tagrisso in patients with central nervous system metastases whose prognosis is often particularly poor."
AURA3 data showed Tagrisso offered a statistically-significant improvement in PFS versus standard platinum-based doublet chemotherapy (10.1 months vs 4.4 months, hazard ratio [HR] 0.30; 95% confidence interval (CI):0.23, 0.41; p<0.001). In the 34% of patients with central nervous system (CNS) metastases at baseline, PFS was also significantly greater with Tagrisso than with platinum-based doublet chemotherapy (8.5 months vs 4.2 months, HR 0.32; 95% CI: 0.21, 0.49).
Dr. Vassiliki A Papadimitrakopoulou, from the University of Texas MD Anderson Cancer Center, Houston, Texas, USA, said: "The results of AURA3 are not only statistically significant, but clinically meaningful because it is the first time a targeted medicine like Tagrisso has shown improvement in progression-free survival over standard platinum-pemetrexed chemotherapy. It’s very rewarding to be able to give this type of news to patients, as it highlights the major advances we are making in targeted lung cancer treatments."
Professor Tony Mok, from the Chinese University of Hong Kong, Hong Kong said: "The superiority of Tagrisso in progression free survival and response rate over platinum-pemetrexed chemotherapy suggests we may be moving towards a new standard of care for patients with resistance to EGFR TKI. With the publication of the AURA3 data, clinicians should perform T790M mutation testing to ensure Tagrisso be given to patients who are most likely to benefit."
The AURA3 safety data for Tagrisso were in line with previous experience. Grade ≥3 drug-related adverse events (AEs) were reported in 6% of patients (n=16) treated with Tagrisso and 34% (n=46) treated with platinum-based doublet chemotherapy. The most common drug-related AEs in the Tagrisso group, were diarrhoea (29% overall; 1% Grade ≥3) and rash (28% overall; <1% Grade ≥3) and, in the chemotherapy group, they were nausea (47% overall; 3% Grade ≥3) and decreased appetite (32% overall; 3% Grade ≥3).
The data for AURA3 are consistent with those previously presented in the Phase II trials, AURA2 and AURA extension. This consistency extends to testing of tissue and plasma samples for the detection of the EGFR T790M resistance mutation. In AURA3, approximately half of patients with T790M in tumour tissue also had the T790M mutation detected in plasma. Clinical benefits were reported with Tagrisso compared to platinum-based doublet chemotherapy, irrespective of whether the T790M mutation was identified by plasma ctDNA or tissue testing. When feasible, tissue testing is recommended for patients with a negative plasma T790M test.
Tagrisso was granted accelerated approval by the US Food and Drug Administration (FDA) in November 2015 for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, who have progressed on or after EGFR TKI therapy. In the EU, Tagrisso was granted conditional marketing authorisation for adult patients with locally advanced or metastatic EGFR T790M NSCLC, irrespective of previous EGFR-TKI treatment by the European Medicines Agency (EMA) in February 2016.
In addition, Tagrisso received approval in Japan in March 2016 for the treatment of patients with EGFR T790M mutation-positive inoperable or recurrent NSCLC that is resistant to EGFR TKI therapy, and it is currently under fast track review in China, where nearly half of lung cancer patients are thought to have the EGFR mutation.
NOTES TO EDITORS
To view and download additional supporting materials including backgrounders, infographics and images, please visit: View Source where they are available throughout WCLC 2016.
About AURA3
AURA3 compared the efficacy and safety of Tagrisso<> 80mg once daily and platinum-based doublet chemotherapy (platinum-pemetrexed) in 419 patients with EGFR T790M mutation-positive, locally-advanced or metastatic NSCLC whose disease had progressed on or after treatment with a previous EGFR tyrosine kinase inhibitor (TKI). The trial was carried out in more than 130 locations worldwide, including the USA, Canada, Europe, China, Japan, Korea, Taiwan and Australia.
The primary endpoint of the trial was PFS, and secondary endpoints included overall survival (OS), overall response rate (ORR), duration of response (DoR), disease control rate (DCR), safety and measures of health-related quality of life (HRQoL).
About Non-Small Cell Lung Cancer (NSCLC)
Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-third of all cancer deaths and more than breast, prostate and colorectal cancers combined. Among patients with lung cancer, 25% to 40% have brain metastases at some time in the course of their disease. Patients who have the EGFRm form of NSCLC, which occurs in 10-15% of NSCLC patients in the US and Europe and 30-40% of NSCLC patients in Asia, are particularly sensitive to treatment with currently-available EGFR-TKIs, which block the cell signalling pathways that drive the growth of tumour cells. However, tumours almost always develop resistance to treatment, leading to disease progression. Approximately two-thirds of patients develop resistance to approved EGFR-TKIs such as gefitinib and erlotinib due to the secondary mutation, T790M.
About Tagrisso
Tagrisso (osimertinib, AZD9291) 80mg once daily tablet is approved in the US, EU, Japan, Canada, Switzerland, Israel, Mexico, Australia and a number of other countries as the first treatment for patients with locally-advanced or metastatic EGFR T790M mutation-positive NSCLC. Tagrisso is also approved in South Korea in the same indication. Eligibility for treatment with Tagrisso is dependent on confirmation that the EGFR T790M mutation is present in the tumour.
Tagrisso has one of the fastest development programmes, from start of clinical trials to approval in just over two and a half years. Tagrisso is as an irreversible EGFR inhibitor, born out of scientific exploration and engineered to combat the mechanism of resistance by targeting the T790M resistance mutation. Tagrisso is also investigated in the adjuvant and metastatic first-line settings, including in patients with and without brain metastases, in leptomeningeal disease, and in combination with other treatments.
Author: [email protected]
Apogenix Reports Final Phase I MDS Data at this Year´s American Society of Hematology (ASH) Meeting
On December 5, 2016 Apogenix, a biopharmaceutical company developing next-generation immuno-oncology therapeutics, reported that the final data from the Phase I clinical trial evaluating the safety and efficacy of asunercept (APG101) in lower (low and intermediate) risk patients with MDS were presented in an oral presentation at this year´s ASH (Free ASH Whitepaper) meeting on December 3, 2016 in San Diego, CA, USA (Press release, Apogenix, DEC 5, 2016, View Source [SID1234524575]).
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Asunercept is a fusion protein consisting of the extracellular domain of human CD95-receptor and the Fc domain of a human IgG1 antibody. Asunercept binds to the CD95-ligand on cells as well as to the soluble ligand, thus blocking the interaction between CD95-receptor and its cognate ligand. CD95-receptor is overexpressed on erythroid progenitor cells in the majority of patients with lower-risk MDS. Activation of CD95-receptor blocks erythrocyte production in the bone marrow. Its overexpression is a predictive factor of resistance to erythropoiesis stimulating agents (ESAs). In this Phase I study, all 20 patients enrolled were eligible for inclusion if they suffered from anemia resulting in a high transfusion burden, had hemoglobin levels of less than 10 g/dL, and were refractory to ESAs. Patients received once-weekly asunercept infusions for 12 weeks. Eight of the 20 patients (40%) showed a marked reduction of transfusion frequency for 6 months (end of observation period). Asunercept was generally well tolerated with no reported grade 3 or higher related adverse events. The most common treatment-emergent adverse events included peripheral edema (6 patients), urinary tract infection (4 patients), and oral herpes (3 patients).
"MDS patients display inappropriately increased CD95-receptor mediated signaling in the bone marrow, resulting in ineffective erythropoiesis," Prof W.K. Hofmann, head of the Department of Oncology & Hematology at the University Mannheim Heidelberg and study investigator, explained. "Asunercept inhibits this signaling pathway and promotes early-and late-stage erythroid differentiation, thereby correcting the ineffective erythropoiesis."
"Even though the study was only designed as a safety and pharmacodynamic Phase I trial, the results of short-term asunercept treatment in lower-risk MDS patients are very exciting," Harald Fricke, MD, Chief Medical Officer of Apogenix, said. "There is a substantial unmet medical need for patients who are refractory to treatment with ESAs and we look forward to continuing development of asunercept for this important indication."
Based on the effect of asunercept on early-and late-stage erythroid differentiation and the encouraging clinical activity in these patients, additional clinical Phase II studies are in preparation to test asunercept in lower-risk MDS patients with resistance to ESA treatment.
About Asunercept (APG101)
Apogenix’s lead immuno-oncology candidate asunercept is a fully human fusion protein that consists of the extracellular domain of the CD95-receptor and the Fc domain of an IgG1 antibody. Asunercept is being developed for the treatment of solid tumors and malignant hematological diseases. The World Health Organization (WHO) has recently assigned the international nonproprietary name (INN) "asunercept" for APG101.
CytomX Announces Fourth Target Selection by Bristol-Myers Squibb Under Strategic Oncology Collaboration
On December 5, 2016 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, reported the selection of the fourth target by Bristol-Myers Squibb under the companies’ current strategic oncology collaboration established in 2014 (Press release, CytomX Therapeutics, DEC 5, 2016, View Source;p=RssLanding&cat=news&id=2227453 [SID1234517019]). As a result, Bristol-Myers Squibb will pay CytomX $15 million. This constitutes the final target selection under this agreement.
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"We are thrilled with the continued progress in our alliance with Bristol-Myers Squibb that has included two new target selections this year and the recent presentations of strong preclinical proof-of-concept data for our anti-CTLA-4 Probody therapeutic program at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Symposium on Immuno-Oncology and the Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) Annual Meeting," said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics. "We look forward to continued progress in each of these collaboration programs as we pursue our vision of transforming lives with safer, more effective therapies."
Investigational therapeutics developed with CytomX’s Probody platform are designed to be active in the tumor while sparing healthy tissue. By restricting activity to the tumor microenvironment, investigational Probody therapeutics directed against both validated and novel targets have been shown preclinically to enable anti-tumor efficacy with an enhanced safety window, relative to traditional antibody-based therapies.
About the Collaboration Agreement
Under the terms of the agreement, which was entered into in May of 2014, CytomX granted Bristol-Myers Squibb exclusive worldwide rights to develop and commercialize Probody therapeutics for up to four oncology targets. Bristol-Myers Squibb made an upfront payment of $50 million to CytomX in 2014, and provides research funding over the course of the research term. Upon the selection of the third and fourth targets, Bristol-Myers Squibb pays CytomX selection payments. CytomX is also eligible to receive additional preclinical payments and up to $298 million in future development, regulatory and sales milestone payments for each collaboration target, as well as tiered royalties rising from mid-single digit to low double digits on net sales of each product commercialized by Bristol-Myers Squibb.
Verastem Presents Phase 2 DYNAMO® Clinical Data at ASH 2016 Annual Meeting
On December 5, 2016 Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to treat cancer, reported the presentation of results from the DYNAMO study, a Phase 2 clinical trial evaluating the safety and efficacy of duvelisib in patients with indolent non-Hodgkin lymphoma (iNHL) that is double refractory to both rituximab and chemotherapy, at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2016 Annual Meeting held December 3-6, 2016 in San Diego (Press release, Verastem, DEC 5, 2016, View Source;p=RssLanding&cat=news&id=2227733 [SID1234516975]). Duvelisib is an investigational, oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma that has demonstrated clinical activity as a monotherapy in multiple hematologic cancers, including chronic lymphocytic leukemia (CLL), iNHL and T cell lymphomas.
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Results from the study were presented by Dr. Ian Flinn in an oral presentation, "DYNAMO: A phase 2 study demonstrating the clinical activity of duvelisib in patients with refractory indolent non-Hodgkin lymphoma." (Abstract number: 1218) Ian Flinn, M.D., Ph.D., Director of the Blood Cancer Research Program at Sarah Cannon Research Institute and the principal investigator on the DYNAMO study, described the results demonstrating duvelisib’s clinical activity in patients with double refractory iNHL, which included robust and durable responses, and a manageable safety profile.
The DYNAMO study included 129 evaluable patients with double refractory iNHL (median 3 prior anticancer regimens, range 1-18). The overall response rate (ORR) was 46% as determined by independent review committee (IRC; p=0.0001; 95% CI 0.37-0.55). Among disease subgroups, the ORR was 41% in follicular lymphoma (n=83), 68% in small lymphocytic lymphoma (n=28), and 33% in marginal zone lymphoma (n=18). Median duration of response (DOR) among all patients was 9.9 months. Notably, 83% of patients had reductions in the size of their target lymph nodes per IRC.
Duvelisib was generally well tolerated, with an expected and manageable safety profile with appropriate risk mitigation. The most common Grade ≥3 adverse events (occurring in ≥10% of patients) included neutropenia (28%), infection (18%), diarrhea (15%), thrombocytopenia (13%) and anemia (12%).
Dr. Flinn commented, "These results from the DYNAMO study presented at ASH (Free ASH Whitepaper) this year clearly show that duvelisib is clinically active with benefit observed across a variety of disease subtypes. It is important to recognize how heavily pre-treated the DYNAMO patients were, being refractory to both rituximab and chemotherapy. This patient population needs more treatment options."
"We are very encouraged by these results," said Gregory I. Berk, M.D., Chief Medical Officer of Verastem. "The activity and safety of duvelisib observed in the DYNAMO trial are just more evidence of the potential of this drug. We are committed to continuing duvelisib’s development with the belief that it may represent a valuable treatment for patients with very few treatment options."
A copy of the DYNAMO oral presentation is available here.
The following is a summary of other presentations at ASH (Free ASH Whitepaper) 2016:
Poster Presentations
Title: Preliminary results in first-line treatment of follicular lymphoma with the oral dual PI3K-delta,gamma inhibitor, duvelisib, in combination with rituximab or obinutuzumab
Lead Author: Carla Casulo, M.D., Assistant Professor, Wilmot Cancer Institute, University of Rochester
Abstract Number: 2979
Date and Time: Sunday, December 4, 2016, 6:00 – 8:00 pm PT
The poster can be viewed here.
Title: Inhibition of FAK Exerts Anti-Leukemic Activity and Potentiates ABT-199-Induced Apoptosis in AML
Lead Author: Bing Carter, Ph.D., Associate Professor, Department of Leukemia – Research, Division of Cancer Medicine, The University of Texas M.D. Anderson Cancer Center
Abstract Number: 1574
Date and Time: Saturday, December 3, 2016, 5:30 – 7:30 pm PT
The poster can be viewed here.
More About the Phase 2 DYNAMO Study
The DYNAMO study is a Phase 2, single-arm study which evaluated the efficacy and safety of duvelisib (25 mg twice daily) as a monotherapy in 129 patients with follicular lymphoma (n=83), small lymphocytic lymphoma (n=28) or marginal zone lymphoma (n=18) whose disease has progressed and who are refractory to rituximab and to either chemotherapy or radioimmunotherapy. The primary endpoint of the study was overall response rate as assessed by an independent review committee.
About the Tumor Microenvironment
The tumor microenvironment encompasses various cellular populations and extracellular matrices within the tumor or cancer niche that support cancer cell survival. This includes immunosuppressive cell populations such as regulatory T cells, myeloid-derived suppressor cells, M2 tumor-associated macrophages, as well as tumor-associated fibroblasts and extracellular matrix proteins which can hamper the entry and therapeutic benefit of cytotoxic immune cells and anti-cancer drugs. In addition to targeting the proliferative and survival signaling of cancer cells, Verastem’s compounds duvelisib and defactinib target the tumor microenvironment as a mechanism of action to potentially improve a patient’s response to therapy.
About Duvelisib
Duvelisib is an investigational, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes that are known to help support the growth and survival of malignant B cells and T cells. PI3K signaling may lead to the proliferation of malignant B cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib is currently being evaluated in late- and mid-stage clinical trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed/refractory chronic lymphocytic leukemia (CLL)4, and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL) that achieved its primary endpoint of overall response rate upon topline analysis of efficacy data5. Duvelisib is also being evaluated for the treatment of hematologic malignancies through investigator-sponsored studies, including T cell lymphoma.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.
About Defactinib
Defactinib (VS-6063) is an investigational inhibitor of Focal Adhesion Kinase (FAK), a non-receptor tyrosine kinase encoded by the PTK-2 gene that mediates oncogenic signaling in response to cellular adhesion and growth factors.7 Based on the multi-faceted roles of FAK, defactinib is used to treat cancer through modulation of the tumor microenvironment, enhancement of anti-tumor immunity, and reduction of cancer stem cells.8,9 Defactinib is currently being evaluated in three separate clinical collaborations in combination with immunotherapeutic agents for the treatment of several different cancer types including pancreatic, ovarian, non-small cell lung cancer, and mesothelioma. These studies are combination clinical trials with pembrolizumab and avelumab from Merck & Co. and Pfizer/Merck KGaA, respectively.10,11,12 Information about these and additional clinical trials evaluating the safety and efficacy of defactinib can be found on www.clinicaltrials.gov.
Novartis survey uncovers real-world burden of myeloproliferative neoplasms (rare blood cancers) on daily activity and ability to work
On December 5, 2016 Novartis reported results from the first-ever international survey of patients with myeloproliferative neoplasms (MPNs), specifically myelofibrosis (MF), polycythemia vera (PV) or essential thrombocythemia (ET), which indicate that the majority of patients living with these MPNs experience a reduced quality of life (Press release, Novartis, DEC 5, 2016, View Source [SID1234516970]). The findings also reveal that many patients struggle with emotional distress and experience a negative impact on their ability to work. These data were presented for the first time at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, CA (abstract #4267, 12/5/16 6:00 PM PDT)[1].
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MPNs are a group of rare and life-threatening blood cancers. People living with an MPN can have a poor quality of life and shortened survival rate[2]. Two of the most debilitating MPNs are MF and PV, as compared to ET[3]. MF and PV are associated with a range of symptoms and complications, including fatigue, night sweats, itchy skin, enlarged spleen and cardiovascular events[2-5]. The international MPN LANDMARK Survey included 699 patients with representation across six countries and four continents and was conducted to gain a better understanding of how MPNs impact a patient’s quality of life, activities of daily living, work productivity and emotional well-being[1].
"Rare blood cancers like MPNs are often not well-recognized, yet these diseases can have a significant impact on even the simplest tasks in a patient’s daily life," said Bruno Strigini, CEO of Novartis Oncology. "We hope the survey results illuminate the awareness of these debilitating blood cancers, emphasizing the need to help optimize patient care."
In the international survey, patients reported that their disease negatively impacted their ability to complete daily activities by 40%. Patients also noted a 35% impairment on their capacity to work. Furthermore, employed patients who missed work over the last seven days due to their disease reported missing an average of 3.1 hours due to their disease and/or symptom burden[1].
"These results help quantify the daily difficulty of living with an MPN, which can help patients explain disease burden to family, friends, colleagues and physicians who may be unfamiliar with these conditions," said Dr. Claire Harrison, Guy’s and St. Thomas’ NHS Foundation Trust, London, United Kingdom. "The survey results also help paint the full picture of the impact of the disease, which will enable physicians to manage the total patient in hopes of increasing quality of life."
Results also demonstrated that more than 75% of patients who experienced symptoms suffered a significant reduction in quality of life due to their symptoms (83% of MF patients, 72% of PV patients, 74% of ET patients); these numbers are consistent with previously-reported literature[2],[6]. The most commonly-reported symptom across disease areas in the last 12 months was fatigue (54% of MF patients, 45% of PV patients, 64% of ET patients), which was also the symptom patients cited they most wanted to resolve. In addition to physical symptoms, approximately one-third of patients in the study felt anxious or worried about their disease, with the greatest impact seen on those with MF and PV (34% of MF patients, 29% of PV patients, 26% of ET patients)[1].
About the International MPN LANDMARK Survey
The international MPN LANDMARK survey is a cross-sectional survey of patients with MPNs (myelofibrosis (MF), polycythemia vera (PV), essential thrombocythemia (ET)) and physicians who treat these conditions across Germany, Italy, United Kingdom, Japan, Canada and Australia. Patients (174 MF, 223 PV, 302 ET) who partook in the survey completed an online questionnaire to measure MPN-related symptoms experienced over the past year and the impact of their condition on their quality of life and ability to work. Additional survey results will be presented next year.
Findings from the international survey complement results from the Incyte-funded MPN LANDMARK survey conducted in the US[1].
About Myeloproliferative Neoplasms (MPNs)
Myeloproliferative neoplasms (MPNs) are a group of related and rare blood cancers in which bone marrow cells responsible for the body’s blood cells develop and function abnormally. Specific MPN conditions include myelofibrosis (MF), polycythemia vera (PV) and essential thrombocythemia (ET)[4],[5],[7].
In patients with MF, their bone marrow can no longer produce enough normal blood cells, causing the spleen to enlarge[8]. MF affects approximately one in every 100,000 people and has similar survival rates as other malignancies, such as breast cancer and colon cancer[2],[9-12].
PV is associated with an overproduction of blood cells that can cause serious cardiovascular complications if left inadequately controlled, such as blood clots, stroke and heart attack[5],[13]. PV affects up to three per 100,000 people globally each year[2],[5].
ET is characterized by an overproduction of platelets and complications which commonly include blood clotting and/or bleeding[7].