Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

Posts by MaverickNY

ASH 2012 update on ARRY-520 in multiple myeloma

By on March 1, 2013

After highlighting the interesting biomarker program associated with AVEO’s tivozanib in renal cell and triple negative breast cancers in the last post, several people wrote in asking about other biomarker programs that have piqued my interest. Regular PSB readers will know that I’m not a fan of catch-all trials at all because the population being studied is too heterogeneous – use of biomarkers can help select which patients are more likely to respond to a particular drug and thus produce greater efficacy.

Another small biotech doing some interesting and compelling biomarker work is Array BioPharma, based in Boulder, Colorado.

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Will biomarkers revolutionalise treatment with tivozanib?

By on February 25, 2013

Following last weeks post on the phase III clinical data for tivozanib in advanced renal cell cancer (RCC), I thought it would be useful to provide an update on AVEO’s biomarker program.

I’m very excited about the work they are doing in this area and have been following them keenly since they first presented their initial work on myeloid cells in RCC at the AACR diagnostic conference back in 2010.  Since then, other companies have also published work in this field, including Regeneron, who also noticed the presence of myeloid cells in their work with aflibercept in glioblastoma.

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ASCO GU update on tivozanib in advanced clear cell renal cancer

By on February 21, 2013

AVEO presented the phase 3 clinical trial data for tivozanib in renal cancer at the American Society of Clinical Oncology Genitourinary Cancer Symposium (ASCO GU) in Orlando last week.

The TIVO-1 data (PDF download), presented by Dr Robert Motzer (New York), showed a significant improvement in progression free survival (PFS) of 11.9 vs 9.1 months (P=0.042), but not median overall survival (MOS) i.e. 28.8 vs 29.3 months (P=0.105, HR 1.25).  The lack of a significant MOS difference between the sorafenib and tivozanib treatment arms has received a lot of commentary recently, especially in light of the crossover clinical trial design.

This is a preview of ASCO GU update on tivozanib in advanced clear cell renal cancer. Read the full post

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Tumor Lysis Syndrome – what is it and why is it important in cancer research?

By on February 18, 2013

After the hullabaloo on Friday regarding AbbVie’s suspension of the ABT-199 trials following not one, but two, unexpected deaths from tumor lysis syndrome (TLS), a few people asked what is this condition and what causes it?

In simple terms, lysis is a medical word used to describe the break up or breakdown of cells – whether through decomposition, destruction, or dissolving. Thus, we have hemolysis, which is the destruction of red blood cells with the release of hemoglobin.

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Making a difference in Advanced Prostate Cancer – an interview with Bertrand Tombal

By on February 15, 2013

Since 2010, we have seen several technological advances in therapies for metastatic castration resistant prostate cancer (CRPC), leading Professor Bertrand Tombal (an Academic urologist in Brussels, Belgium) to describe 2011 as a Grand Cru year for CRPC at the European Society of Medical Oncology. One of the most promising therapies in this category was enzalutamide (Xtandi) from Medivation.

Enzalutamide is an anti-androgen receptor antagonist similar to bicalutamide, but differs in that it is a more potent inhibitor and has no agonist properties. Initially, it was approved by the FDA post chemotherapy but trials are currently ongoing in the pre-chemotherapy setting.

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Making a difference in pancreatic cancer – an interview with Dr Hedy Lee Kindler

By on February 12, 2013

Pancreatic cancer is one of those conditions I never hope to get. Why? Well, for starters, it’s one of the most difficult to treat tumour types, largely because so many patients are detected late, that is with stage IV metastatic disease. The annual incidence and prevalence are pretty much equal, suggesting that the for many with advanced disease, the lifespan is approximately one year or less. In fact, to put things even more succinctly, despite surgical resection, radiation and chemotherapy, more than 90% of people with pancreatic cancer do not survive beyond 5 years.

This is a preview of Making a difference in pancreatic cancer – an interview with Dr Hedy Lee Kindler. Read the full post

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Will ASCO GI herald a new era for pancreatic cancer?

By on January 24, 2013

Today I’m heading off to attend the ASCO GI meeting in San Fransciso, and in particular, the pancreatic cancer sessions on Friday.

Will ASCO GI herald a new era for pancreatic cancer?

Source: ASCO

The event promises to be an interesting day with a keynote from Margaret Tempero (UCSF), as well as Daniel van Hoff (TGEN) presenting the much awaited nab-paclitaxel (Abraxane) data in advanced pancreatic ductal carcinoma and a poster on masitinib from the French researchers.

Many of you will recall the excitement expressed at ESMO in this data, although the topline data in the Celgene press release on the MPACT study this week suggests the overall responses were good rather than great.

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Effectively targeting KRAS in lung cancer with a MEK inhibitor

By on November 29, 2012

Today is the 1000th blog post here on PSB, a milestone I never imagined actually reaching while writing the inaugural and rather boring post way back in 2006. At that time, 10 posts seemed a lot, never mind 100 or 1000! Anyway here we are, thus the facing the new dilemma of what to write about to celebrate the event.

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Time to rethink cancer clinical trials strategy?

By on November 27, 2012

Recently, I’ve been pondering clinical trial design and wondering whether there is better way to do things, since much of the current concepts were based on cytotoxics that often had a very narrow therapeutic window.  With the advent of oral tyrosine kinase inhibitors (TKIs), the model seems, well, a bit old and tired and doesn’t always help us develop the optimum outcome.

In phase I oncology clinical trials, for example, we seek to find the MTD, as explained by Drs Rubenstein and Simon (PDF download) at the NCI:

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Zaltrap – a simple dosing error or not?

By on November 9, 2012

The recent approval of Sanofi/Regeneron’s VEGF targeted monoclonal antibody, ziv-aflibercept (Zaltrap) in combination with FOLFIRI, for the treatment colorectal cancer (CRC) after failure of prior therapy with the FOLFOX regimen has proven to generate quite a controversy.

The efficacy benefit, although modest at 1.4 months extra survival, is similar to that seen with bevacizumab (Avastin) in the same setting.  The pricing, however, was clearly set at a premium at approximately $11,000 a month compared to less than half that for bevacizumab.  I never thought I would be blogging about the price of Avastin actually looking very reasonable!

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