Sanofi names ex-Roche cancer guru Dietmar Berger as development lead

Roche alumnus Dietmar Berger has joined Sanofi as head of development following a short stint in biotech.

In his new role Berger will oversee the company’s clinical portfolio across all therapeutic areas to help bring new medicines to patients.

Last year Berger became one of several Big Pharma names to make the jump to biotech, taking a role as global head of research and development at T-cell immunotherapy biotech Atara Biotherapeutics.

He held this position for a relatively short time, having started in May 2018 and resigning last week when Atara got a new CEO in the form of Pascal Touchon, formerly of Novartis.

Prior to joining Atara, Berger was senior vice president and global head, product development, clinical science hematology and oncology at Roche/Genentech – and before that was vice president of global clinical development for the company’s HER2 breast cancer franchise.

Berger leant his expertise to filings of some of Roche’s most important new drugs – such as the cancer immunotherapy Tecentriq and the potential blockbuster in haemophilia, Hemlibra.

But it seemed that Roche’s decision not to develop any T-cell therapies of its own –  choosing instead to combine Tecentriq (atezolizumab) with cell therapies from Kite/Gilead under a deal announced in 2016 – eventually led Berger to be tempted away to a more specialist company focusing on this promising area.

The new job will see him reunited with John Reed, formerly head of the Pharma Research and Early Development (pRED) unit at Roche and now Sanofi’s global head of R&D.

Previously Berger led oncology clinical development at Bayer and held positions of increasing responsibility at Amgen.

He has also led research groups focusing on preclinical drug development, tumor models, angiogenesis, and immunotherapy as head of the Clinical Research Center at the University Medical Hospital, Freiburg, Germany, and at The Scripps Research Institute, La Jolla, California. He received the Cancer Award of the German Cancer Society for his research on angiogenesis and earned his M.D. and Ph.D. degrees from the University of Freiburg.

Sanofi names ex-Roche cancer guru Dietmar Berger as development lead

Mitsubishi Tanabe pulls ALS drug from European assessment

Mitsubishi Tanabe Pharma has withdrawn its EU application for ALS drug Radicava (edaravone), citing ‘unwarranted’ additional data requirements from the EMA.

The drug has been approved in the US, Japan, South Korea, Canada and Switzerland based on results from a a six month trial in Japan involving 137 people that showed those taking Radicava declined less on a clinical assessment compared with those receiving placebo.

However, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has said than an additional study of survival, lasting at least 12 months, would be required to obtain the data necessary for regulatory approval in the EU.

In a statement Mitsubishi Tanabe said it believes “that the efficacy and safety of edaravone has been demonstrated and an additional long-term study is unwarranted”.

Therefore, the company said it “has made the difficult decision to withdraw the marketing authorisation application for edaravone” and “will now carefully consider the future options for edaravone in the EU”.

The company added that it will “continue to make every effort to deliver edaravone to patients suffering from ALS worldwide by increasing, as far as possible, the number of countries with regulator approvals based on current data”.

Radicava is an intravenous infusion given by a healthcare professional. It is administered with a first treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period.

Subsequent cycles consist of dosing on 10 of 14 days, followed by 14 days drug-free.

Mitsubishi Tanabe is also developing an oral formulation of the drug as an option to supplement the existing IV formulation.

Radicava was the first ALS treatment approved by the FDA in more than 20 years. The Association asked the manufacturer to file its drug upon learning about its use to treat ALS in Japan.

The drug does, however, come with a raised risk of serious side effects such as hives, swelling, or shortness of breath, and potentially life-threatening allergic reactions to sodium bisulfite.

And as ever there is the issue of cost – the annual cost before any discount is more than $145,500.

Mitsubishi Tanabe pulls ALS drug from EMA assessment

ASCO, Partners Aim to Create Core Cancer Model, EHR Data Elements

Almost 40% of Americans will be diagnosed with cancer at some point in their lifetime. But only 3% of adult cancer patients participate in clinical trials, which gather most of the high-quality data used for cancer research. That’s not enough data to quickly lead to better treatments and results.

What if we could learn from the experiences of the other 97% of patients representing all demographics? What if we could explore the data from millions of patients and study the myriad combinations and comparisons of treatment parameters to provide substantial insights on the best treatment for each patient?

Data from most of the nearly 15 million individuals living with cancer in the U.S. is contained in electronic health records (EHRs) of some kind. But many EHR systems in use prioritize the collection of different types of data, use different terms to describe the same type of data, or collect data in different formats, making them incompatible with one another. This incompatibility dramatically limits the ability of cancer researchers and doctors to learn from patient records, hinders care coordination, and adds to the administrative burdens and costs for all users, but especially practices and patients.

That’s why we need mCODE.

We See the Possibilities

Every interaction between a clinician and a cancer patient provides high-quality data that could lead to safer care, improved outcomes, and lower costs. But first we need data that is:

• Standardized and collected in a computable manner so it can be aggregated with data from many other patients and analyzed for best practices
• Exchanged through EHR systems that are interoperable
• Collected in a streamlined way that doesn’t burden the clinicians
• Secure and protects patient privacy

We Can Make This Happen

The American Society of Clinical Oncology (ASCO) and its nonprofit subsidiary, CancerLinQ LLC, and The MITRE Corporation are collaborating to develop and launch mCODE. We have identified those minimal cancer data elements that are essential for analyzing patient characteristics, treatments, and outcomes across patients and practices to improve treatment and care coordination.

mCODE provides both a common data language and an open source, nonproprietary data model for interconnectivity across systems. Once adopted across the oncology community, mCODE can facilitate the ability of clinicians and researchers to provide better treatments for cancer patients by using the invaluable information contained in the EHRs.

Every Patient’s Journey Can Improve All Future Care

Interested in joining the mCODE Council? Submit your application online.

Downloadable Information on mCODE

The mCODE data specification is made available on an open source basis. We ask requesters to provide their contact information to better understand the potential user base, which will help us tailor use cases and features for future development. Also, we will notify you of updates and other relevant information on mCODE. (This is optional, and you can opt out of our email list at any time.)

https://mcodeinitiative.org/

ASCO 2019 day 3

Exclusive live coverage from day three of the American Society of Clinical Oncology’s annual meeting in Chicago.

• To view all of our coverage from the preeminent cancer event, produced in association with Kantar Health, as well as additional content, visit the Spotlight on ASCO 2019 and the future of oncology

Key highlights for Sunday include:

• AstraZeneca/Merck & Co will provide one of the highlights of Sunday at ASCO, with data from the phase 3 POLO trial as a maintenance treatment in metastatic pancreatic cancer with germline BRCA mutation. This will flesh out a top-line positive result announced earlier this year.
• Novartis also has data from alpelisib, a PIK3CA class drug in patients with breast cancer. With this drug Novartis is hoping to succeed where its Swiss rival Roche has failed. Last year Roche ditched its PIK3CA drug taselisib after deciding trial data showed unpleasant side-effects would outweigh its very limited benefits in eligible patients with breast cancer. Novartis will also have further data from its breast cancer drug Kisqali.
• Also on Sunday, Roche will present early data from its “tumour agnostic” drug entrectinib in children with recurrent or refractory solid tumours, including central nervous system tumours.

ASCO 2019 day three

Kite Winds Up Phase 1 of Leukemia Med Trial

— Data Show High Rates of Response to Single Infusion of KTE-X19 —

— Phase 2 Portion of ZUMA-3 is Ongoing and Includes Dosing and Revised Safety Management Protocol Studied in Phase 1 —

Kite, a Gilead Company (Nasdaq: GILD), today announced results from the completed Phase 1 of the ZUMA-3 study evaluating KTE-X19, an investigational CD19 chimeric antigen receptor T (CAR T) cell therapy. ZUMA-3 is a single-arm Phase 1/2 study in adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL). The results provide guidance on dosing and safety management for KTE-X19 to inform the ongoing Phase 2 study. The data were presented during an oral session at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, May 31 – June 4 (Abstract #7006).

https://www.marketscreener.com/GILEAD-SCIENCES-4876/news/Gilead-Sciences-Kite-Announces-End-of-Phase-1-ZUMA-3-Results-for-KTE-X19-in-Adult-Patients-with-Re-28692908/

J&J reps said to have blanketed Okla. docs with promos later called false, misleading

Promotional materials that the U.S. Food and Drug Administration would later label “false or misleading” were repeatedly used by Johnson & Johnson sales representatives to promote the company’s opioid Duragesic patch to Oklahoma doctors in the early 2000s.

That troubling fact was made clear Friday morning as an attorney for the state quizzed a Johnson & Johnson corporate representative for nearly three hours about the contents of call notes made by the sales representatives following more than 60 sales visits to physicians in offices scattered throughout Oklahoma.

The testimony came on Day 4 in a Cleveland County District Court trial in a case where Oklahoma Attorney General Mike Hunter has accused Johnson & Johnson and its subsidiaries of creating a public nuisance through false marketing that downplayed the risks of their opioid painkillers while overstating their benefits. The state has accused the companies of helping cause an opioid epidemic that has led to thousands of Oklahoma deaths and addictions.

A multitude of sales call notes from 2001 to early 2004 showed that in calls on Oklahoma doctors, Johnson & Johnson sales representatives repeatedly cited studies that their own company had funded.

Those later discredited studies purported to show Duragesic improved physical and social functioning, had demonstrated effectiveness in treating lower back pain and was less likely to be abused than many other forms of opioids.

The sales representatives also repeatedly cited emergency room admission data provided by the Drug Abuse Warning Network as showing that Duragesic had a lower addiction rate than other opioid drugs.

The FDA issued a stern warning to Johnson & Johnson in 2004 that criticized the studies and said there was a lack of evidence to back the claims.

Corporate Representative Kimberly Deem-Eshleman said her company didn’t agree with the FDA’s assessment of the studies, but agreed to pull the promotional materials it was using.

The call notes reveal that during the same sales calls where sales representatives were telling doctors that Duragesic was less subject to abuse, some doctors were telling the representatives about incidents in which the opioid patch was abused.

For example, following a September 23, 2003, sales call, Johnson & Johnson sales representative Holly Abraham reported that a Stillwater doctor had told her that “nurses were taking the old patches.”

Another doctor told a sales representative about a patient who was using more than one patch.

https://www.marketscreener.com/JOHNSON-JOHNSON-4832/news/Johnson-Johnson-Drug-company-reps-blanketed-Oklahoma-doctors-with-promotional-materials-later-de-28692313/

Epizyme files tazemetostat, seeking first okay in rare cancer

Epizyme has filed for accelerated FDA approval of tazemetostat for advanced epithelioid sarcoma (ES), a rare form of cancer with no approved drugs in the US.

The Massachusetts biotech is seeking a green light for the first-in-class EZH2 inhibitor in patients with metastatic or locally advanced ES not suitable for surgery, which can be curative in this rare type of slow-growing tumour if caught early enough.

The cancer typically starts as a single painless lump, but can quickly spread to form multiple growths and be quite aggressive by the time a patient seeks medical advice. Treatment options at the moment are surgery, radiotherapy and chemotherapy, and if approved tazemetostat would be the first targeted therapy for ES.

“We believe that tazemetostat could dramatically change the care of people with ES who have limited treatment options, which are also associated with challenging side effects,” said the biotech’s CEO Rob Bazemore earlier this year.

Analysts at Jefferies have suggested that the accelerated application based on a phase 2 trial in 62 patients – due to be reported at ASCO on 3 June – looks “approvable” given that tazemetostat’s objective response rates and duration of response seem to be better than data for other drugs used to treat sarcomas.

According to the ASCO abstract, the drug achieved an ORR of 15%, with an average duration of response of more than 12 months, and what looks like a benign side-effect profile. If the FDA concurs with that view, tazemetostat could be on the market next year, and Epizyme has committed to carrying out a global, confirmatory phase 3 trial in the latter half of the year.

ES is the first of two submissions planned for tazemetostat this year as Epizyme attempts to position its orally-active drug in a range of solid tumours and blood cancers.

Next up is a filing in the fourth quarter for third-line or later treatment of follicular lymphoma (FL), a cancer that is a much bigger opportunity than ES, particularly if Epizyme can follow through on its plan to move tazemetostat into earlier lines of treatment.

While ES is a relatively small indication – representing around $100 million in potential annual sales according to some analysts –  last year Morgan Stanley suggested that approval in additional cancers could propel tazemetostat towards blockbuster sales levels.

Epizyme has trials planned for the drug in combination with Roche’s Rituxan (rituximab) for the treatment of patients with relapsed refractory FL, as well as part of a triple therapy with Rituxan and Celgene’s Revlimid (lenalidomide) – a regimen known as R2 that has just been approved as a second-line treatment for FL and other forms of indolent non-Hodgkin’s lymphoma (NHL).

Epizyme files tazemetostat, seeking first okay in rare cancer