Zebrafish larvae have evolved into a very attractive model for drug discovery
Zebrafish larvae have evolved into a very attractive model for drug discovery. Watch Roche video published on 3 June 2013, part of Drawn to Science serie.
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Recently published methods facilitate genetical engineering of zebrafish, allowing the study of targets of interest in an easily accessible vertebrate system: a multiorgan culture model. Zebrafish is being used in Roche pRED for both safety and efficacy studies.
Roche acquires GeneWEAVE to strengthen offerings in microbiology diagnostics
Roche has signed a definitive agreement under which it will acquire GeneWEAVE BioSciences, Inc. Roche has been buying the company focused on innovative, clinical microbiology diagnostics solutions, for up to $425 million. With the deal, Roche has further strengthened its commitment to fight superbugs.
Sources and more information
Roche acquires GeneWEAVE to strengthen offerings in microbiology diagnostics, geneweave news, August 13, 2015.
Roche buys ‘superbug’ diagnostics firm for up to $425 million, Reuters, Aug 13, 2015.
Clinical studies are designed to answer specific scientific questions
Clinical trials are essential to providing the scientific data to determine whether new drugs, diagnostics or procedures are both safe and effective when used to diagnose and treat people. Roche video, published on 28 May 2014, part of Drawn to Science series.
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Carefully conducted clinical trials are performed in human volunteers to provide answers to important questions. Every new treatment is usually tested in three phases of clinical trials before regulatory agencies consider it safe and effective. Depending on product type and development stage, investigators initially enroll volunteers and/or patients into small pilot studies and subsequently conduct progressively larger scale comparative studies. As positive safety and efficacy data are gathered, the number of patients typically increases. Clinical trials can vary in size, and can involve a single research entity in one country or multiple entities in multiple countries.
As our understanding of disease advances, traditional clinical trial designs are becoming less and less viable. Two innovations in this area – the Umbrella trial and the Bucket (or Basket) trial – allow researchers to assess the safety and efficacy of new targeted drugs more efficiently. In addition, adaptive trial design offers the possibility to amend the clinical study protocol to reflect new insights or research data while the study is still ongoing. These innovations, which are all being used by Roche, allow us to bring new medicines to patients as fast and as efficiently as possible.
Roche: lower the cost of your breast cancer drug so public health services can afford it!
Text by Margaret Connolly
” Thirteen years ago, a five-year old boy told me all he wanted for Christmas was, “Just one thing, Auntie Margaret: Five minutes with my mummy.”
It broke my heart – his wonderful mummy, Helen Mulhearn, had suffered an awful death 16 months before due to late-diagnosed breast cancer. At that time there were not many drugs that could have helped her. Then four and a half years ago, I was found to have breast cancer too. I was lucky – I was diagnosed early, and with standard breast cancer suitable for a drug that cost just pennies, thank God.
Does Pertuzumab add 16 months survival benefit to Trastuzumab and chemotherapy treatment for HER2-Positive metastatic breast cancer?
A drug used to treat advanced breast cancer has had what appears to be unprecedented success in prolonging lives in a clinical trial, researchers reported on Sunday.
Patients who received the drug — Perjeta, from the Swiss drug maker Roche — had a median survival time nearly 16 months longer than those in the control group.
The Swiss drugmaker also has another related drug called Kadcyla, which is also being tested in combination with Perjeta.
Aim In CLEOPATRA, 808 pts with HER2-positive MBC were randomized to receive 1L placebo (Pla) + T + D or Ptz + T + D. At primary analysis, pertuzumab was shown to increase progression-free survival significantly, with a strong trend to OS benefit. At a second interim analysis (May 2012), OS was improved to a degree which was both statistically significant and clinically meaningful (HR = 0.66, 95% CI 0.52–0.84; P = 0.0008) but the median OS in pts who received Ptz was not reached. Here we report results of a subsequent prespecified OS analysis.
Methods This OS analysis was planned when ≥385 deaths were reported. The log-rank test, stratified by prior treatment status and geographic region, was used to compare OS between arms, applying the Lan-DeMets α-spending function with an O’Brien-Fleming threshold of p ≤ 0.0456. The Kaplan–Meier approach was used to estimate median OS in both arms; a stratified Cox proportional hazard model was used to estimate HR and 95% CIs. Subgroup analyses of OS were performed for stratification factors and other key baseline characteristics.
Results Median follow-up time was 50 months (mos) and the statistically significant improvement in OS in favor of Ptz + T + D was maintained (HR = 0.68, 95% CI 0.56–0.84; p = 0.0002). Median OS was 40.8 mos in the Pla arm and 56.5 mos in the Ptz arm, the difference at the medians being 15.7 mos. The OS benefit in predefined subgroups was consistent with previous observations. It is to be noted that following the previous report of OS benefit, cross-over therapy was allowed and 48 pts in the Pla arm crossed over to the Ptz arm. The safety profile of Ptz + T + D in the overall population and in pts who crossed over to the Ptz arm was consistent with the known safety profile of Ptz and the long-term cardiac safety profile was maintained.
Conclusions 1L treatment with Ptz + T + D significantly improved OS for pts with HER2-positive MBC compared with Pla + T + D, providing a 15.7 mo increase in the median values. The 56.5 mo median OS is unprecedented in 1L MBC and this substantial improvement confirms the Ptz regimen as 1L standard of care for pts with HER2-positive MBC.
Sources and Press Releases:
Pertuzumab Adds 16 Months Survival Benefit to Trastuzumab and Chemotherapy Treatment for HER2-Positive Metastatic Breast Cancer, ESMO 2014 Press Release, 28 Sep 2014.
Final overall survival (OS) analysis from the CLEOPATRA study of first-line (1L) pertuzumab (Ptz), trastuzumab (T), and docetaxel (D) in patients (pts) with HER2-positive metastatic breast cancer (MBC), ESMO 2014, 28.09.2014.
Roche Breast Cancer Drug Appears to Greatly Extend Patients’ Lives, NYTimes, SEPT. 28, 2014.
Roche breast cancer drug shows ‘unprecedented’ survival benefit, Reuters, 28.09.2014.