Oncology Highlights - April 2016
Reading our newsletter will only take a few minutes and allows you to keep up to date with last month’s news items on oncology drug development.
Kind regards, the SMS-oncology team
Being married might be beneficial for prolonged cancer survival
Findings of two linked studies recently published in the journal Cancer show that cancer patients may live longer if they are married. Researchers of the Cancer Prevention Institute of California reported in the first study a 27% higher rate of death for unmarried male cancer patients than for married cancer patients, and a 19% difference between married and unmarried women. The association of marriage to prolonged survival of cancer patients has already been described by earlier studies, but there is limited data on the mechanisms that drive this association. For this very reason, co-lead researcher Dr. Scarlett Lin Gomez from the Cancer Prevention Institute of Californiam lays emphasis on the results of their recent study. Here he claims that for the first time a study is able to prove that instead of the assumed differences in economic resources, social support seems to be the key driver for the protective effects of marriage. In this study 783.167 cancer patients that were diagnosed between the years 2000-2009 were observed and followed up until 2012. Aspects they considered for each patient were the marital status, age, sex, address, race/ethnicity, economic status, year of cancer diagnosis and date of treatment initiation. The researchers will now investigate these correlations further in order to help unmarried cancer patients in the future to improve their survival chances. Read more (1) >, Read more (2) >
High rate of cancer recurrence found in certain hepatitis C patients
There were hints that Hepatitis C virus (HCV) patients convalesced from hepatocellular carcinoma (HCC) had a higher chance of a relapse if they were taking direct-acting antiviral treatments (DAAs). DAAs are medications targeted at specific steps within the HCV life cycle and results in disruption of the viral replication and infection. Study author Dr. Federica Buonfiglioli from the University of Bologna in Italy recently presented a retrospective study at the International Liver Congress in Barcelona wherein the researchers found that 29% of all recovered HCC patients eventually relapsed in case they were using DAAs. EASL Secretary General Professor Laurent Castera states that “these initial findings provide important insight to how Hepatitis C management strategies could be developed to detect HCC early in patients who are most at risk”. In consequence, scientists call for close monitoring of hepatitis C virus patients prescribed DAAs, particularly for those with a history of liver cancer.Read more >
Exciting but early results from a trial of engineered immune cells
The CD19-CAR T cell approach - engineering autologous T cells with CD19 specific artificial chimeric antigen receptors (CAR) - is currently one of the most promising techniques in the treatment options of B cell acute lymphoblastic leukemia (B-ALL). There are high medical needs for B-ALL patients making novel treatment options urgent. In a small phase I clinical trial an innovative technique was used with distinct CD4+ and CD8+ T cell subsets, which were harvested from the patients’ blood, engineered with the CD19 specific CAR and re-administered to the patient after lympho-depletion chemotherapy. Encouraging results were shown in patients treated with this adoptive transfer of autologous CAR T cells; 27 of 29 (93%) B-ALL patients achieved a bone marrow remission. Although in particular the short-term data is really exciting and encouraging, senior author Dr. David Maloney of Fred Hutch and Dr. Cameron Turtle carefully express their concerns that these are only initial conclusions and the long-term outcomes of the patients who went into remission has to be awaited. The study was first of all designed to evaluate the cell therapy’s safety. The enrollment of further patients and a longer follow-up are required to draw meaningful final conclusions. Read more >
Swiss Bank raised €412M for their UBS Oncology Impact Fund
In October 2015, the Swiss Bank showed great initiative in its goal to invest in early-stage cancer treatments with the launch of their UBS Oncology Impact fund. Recently it was announced that the largest amount ever for this type of fund - an investment of €412 million - could be raised, with nearly half of it coming from Asian investors. Due to the immense growing need for novel treatment options against cancer, the UBS would like to support some of the highly promising early-stage developments in oncology treatments thereby narrowing the gap until future Pharma investment. MPM Capital, an established venture capital from Boston, is the collaborating partner for the identification of the most promising 10 to 20 early-stage oncology drugs, which will receive an initial investment of about €9M each. Some of the royalties received from successful drugs shall be returned into academic grants for further cancer research as well as to provide cancer care access in developing countries. The aim is to hereby create a positive social impact referred to as “impact investing”. Read more >
Head and neck cancer drug from BMS wins breakthrough status
The PD-1 inhibitor Nivolumab (Opdivo) from Bristol-Myers Squibb (BMS) has been granted a breakthrough therapy status by the Food and Drug Administration (FDA). It will be used in previously treated patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) and will be followed by a platinum-based therapy. The designation was granted based on positive Phase III trial results, where Opdivo-treated patients achieved higher one-year overall survival rates and longer median overall survival, compared with those who received investigator's choice of therapy. Dr. Jean Viallet, Global Clinical Research Lead Oncology at Bristol-Myers Squibb, underlines the need for new treatment options in this cancer indication and therefore highlights the doubled numbers of patients in this trial that survived for a year thanks to Nivolumab. The breakthrough designation now shall accelerate the development of this promising therapy which seems to offer substantial benefits over the existing treatments.Read more >
EMA / FDA
EMA oncology drug recommendations for approval April 2016:
The Committee for Medicinal Products for Human Use (CHMP) adopted an extension or adaptation of indication for:
- Everolimus (Afinitor®, Novartis) for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease. In terms of its approval for neuroendocrine tumours, everoliums (inhibitor of the mammalian target of rapamycin; mTOR) was previously indicated for neuroendocrine tumours of only pancreatic origin.
- Bevacizumab (Avastin®, Roche) in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) activating mutations. Hence in the non-squamous NSCLC setting, the angiogenesis inhibitor bevacizumab can now be used in combination with either erlotinib or platinum-based chemotherapy.
- Obinutuzumab (Gazyvaro®, Roche) in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with follicular lymphoma (FL) who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen. Gazyvaro, an anti-CD20 monoclonal antibody targeting B lymphocytes, was first authorised in the European Union (EU) in July 2014 for use in combination with chlorambucil in patients with previously untreated chronic lymphocytic leukaemia.
- Ibrutinib (Imbruvica®, Janssen-Cilag) as a single agent for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). The indication of the small molecule Bruton's tyrosine kinase (BTK) inhibitor in CLL has also been changed to include all patients who have received at least one prior therapy, irrespective of particular genetic abnormalities (17p deletion or TP53 mutation), as was previously the case.
- Cabozantinib (Cabometyx, Exelixis) for the treatment of advanced renal cell carcinoma (RCC) in patients who have received prior anti-angiogenic therapy. RCC is the most common form of kidney cancer in adults. CABOMETYX, which was granted Fast Track and Breakthrough Therapy Designation by the FDA, targets multiple tyrosine kinases involved in the development of RCC, including MET, AXL and three VEGF receptors.
- Venetoclax (Venclexta, AbbVie and Genentech) for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy. Venetoclax is the first approved BCL-2 Inhibitor. It received Orphan drug status for the treatment of CLL and was granted Breakthrough Therapy Designation for the 17p deletion CLL development program.
FDA issues labeling guidelines for the evaluation of proprietary names
In 2006 the Institute of Medicine reported that 7000 deaths annually are attributable to medication errors and its “Preventing Medication Errors” report cited drug labeling and packaging as the cause of 33% of all medication errors, 30% of which are fatal. Physicians and other healthcare providers rely on the proprietary name to distinguish between product names that often look and/or sound alike. Therefore, the FDA has finally released a guidance for the review of proprietary drug names in premarket applications. Recommendations are made that will help reduce errors arising from such similar proprietary names as well as unclear label abbreviations, acronyms, dose designations, and overall error-prone label and packaging designs. They are intended to assist industry in the submission of a complete package of information to the FDA which in turn will use the assessment of “(1) the safety aspects of a proposed proprietary name to reduce medication errors, and (2) the promotional implications of a proposed proprietary name, to ensure compliance with other requirements for labeling and promotion using our traditional review methods.” Read more