Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts tagged ‘Oncology Strategy’

One of the most interesting sessions I attended at this year’s American Society of Clinical Oncology (ASCO) annual meeting in Chicago was the Clinical Science Symposium (CSS) on the next generation of EGFR inhibitors.

We’ve previously written on the blog about the data for AZD9291 and CO-1686 presented at ASCO, but the CSS also featured an informative discussion by Larry Schwartz, MD, Professor of Radiology at Columbia University Medical Center which raised questions about how we should evaluate new lung cancer drugs.

In a presentation entitled, “Getting the Right Drug to the Right Patient Faster,” Schwartz who is a diagnostic radiologist, discussed and critiqued abstract 8012 by Gideon Michael Blumenthal and colleagues at the U.S. Food and Drug Administration (FDA).

Larry Schwartz ASCO 2014

A meta-analysis of fifteen trials involving 12,534 patients (median N = 698) from nine experimental agents (tyrosine kinase inhibitor = 5, chemotherapy = 2, monoclonal antibody = 2) submitted to the FDA for treatment of metastatic non-small cell lung cancer (NSCLC) cancer in initial or supplemental New Drug or Biologics License Applications since 2003 was performed by Blumenthal and colleagues.

Their analysis showed a strong correlation (R² of 0.89) between overall response rate (ORR) and progression-free-survival (PFS) but only a weak or no correlation between ORR and overall survival (OS) (R² of 0.07) or between PFS and OS (R² of 0.09).

Dr Blumenthal noted in his conclusion that further work is ongoing to corroborate these findings given the lack of correlation between OS and ORR could have been due to high cross-over, under-power and long post-progression survival.

He went on to note that what the findings do show is that “a drug with a large effect on ORR is likely to have a large effect on PFS, conversely a drug with a small ORR may have a small effect on PFS.

The debate around objective response and outcomes is a very interesting one, as is the drive to find better biomarkers of response to improve chances of clinical trial success.

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The fourteenth annual BIO CEO & Investor Conference takes place next week (February 13-14, 2012) in New York at the Waldorf-Astoria hotel. I will be commuting from New Jersey so will not be experiencing at first hand the charm of staying at this iconic hotel.

BIO-Investor-CEO-Conference-New-York-2012-Waldof-AstoriaThe focus of the meeting is on publicly-traded biotechnology companies, and provides an opportunity for investors, analysts and industry executives to hear company presentations, undertaken one-on-one partnering discussions and listen to pharmaceutical industry leaders present their vision of the future.

Wifi permitting I will be live tweeting from the sessions I attend (@3NT).  I expect others at the conference such as @adamfeurestein to be sharing news and insights.  You can follow the twitter conversation using the (rather long) hashtag #BIOCEO2012.

My focus at the meeting will be on some of the workshops, rather than the company presentations which typically are shared on investor relations websites of publicly traded companies,.  A few that caught my attention include:

Secrets of Oncology Success – Lessons and Trends in Phase II Clinical Trial Outomes

In my opinion, too many companies rush phase II drug development, particularly in oncology.  I recently saw a company go to phase III on the basis of a 14 patient trial.   I will be interested to see what insights the panel offer on what trial designs they liked and which they didn’t and what lessons others can learn from this for new product development.

Speakers in this session include Mohammad Azab, CMO of Astex Pharmaceuticals and Michael Morrissey, CEO of Exelixis.

Neurology: “Alz” Well that Ends Well – Settling the Beta-Amyloid Debate

I doubt very much that this program will settle the debate over the amyloid hypothesis of Alzheimer’s disease, and whether this presents a “real” drug development target.  The challenge in this area is that by the time amyloid deposits can be imaged in the brain, the damage has already been done.

The amyloid load seen in the brain is also only loosely related to cognitive decline, suggesting that even if a therapeutic were able to remove plaque from the brain, it might not alleviate the symptoms of cognitive decline.

Drugs may need to target earlier stages of the disease such as synaptic decline, before beta-amyloid buildup is suggested.  Synaptic proteins have been suggested as a target.

I look forward to hearing the panels views on the current state of Alzheimer’s drug development and what the emerging targets may be.

The 2012 BIO CEO & Investor conference looks to be an interesting meeting in New York next week. If you are attending do let me know as it would be good to meet up if the opportunity presents.

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