This post started out as a look a one of the Gems from the Poster Halls at ESMO, including an interview with a thought leader in biomarkers, then morphed into a broader Op Ed that includes a strategic analysis of where we are, where we are going, and how we could get there more effectively and efficiently.
It’s time to turn tables to start challenging the status quo and slow pace of development if we really want to make a difference in advanced ovarian cancer. I was recently challenged by a well respected GYN oncologist to delineate how we could do things differently so here are some ideas, along with the scientific rationale in my response to his gauntlet.
Is the ideal situation one where multiple companies randomly throw mud at the wall hoping something sticks the best approach? Or are there more effective ways to make a difference?
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After yesterdays post on Gems from the Poster Halls at the American Association for Cancer Research (AACR) in Philadelphia where we took a look at new developments in targeted therapies, several subscribers asked for a repeat, but with a focus on immuno-oncology.
There are a number of elements that many people are interested in, especially given the Merck and BMS clinical data at AACR, where we clearly saw that:
- Anti-PD–1 therapy with pembrolizumab is superior to anti-CTLA4 with ipilimumab in metastatic melanoma (expect nivolumab to show the same thing at ASCO)
- Combined PD–1 plus CTLA4 blockade (with nivolumab plus ipilimumab) was superior to anti-CTLA4 alone, but with higher grade 3/4 toxicities, also in advanced melanoma
Sadly though, we still see that 70-80% of patients don’t respond to these therapies.
- How can we improve on that?
- What happens when we explore other factors, tumour types and different aspects of the immune system?
- What can we learn about novel sequencing or combination approaches?
- Which ones look interesting?
Endless questions can be asked – to which we still have too few answers – although there were some encouraging signs and hints of possibilities at AACR.
The 2015 AACR program was particularly challenging this year with lots of really good symposia and general sessions, making it tough to whizz round the vast poster hall spread out around the exhibits as well. To give you an idea of scale, it was pretty typical to cover 17K to 18K steps a day, approximately 7 to 8 miles. For many people, fitting in a quick lunch and the posters was certainly a challenging feat, depending where you were in the complex. With a morning session ending at 12.30pm, the afternoon session starting at 1pm and 2,000 steps between the Grand and Terrace Ballrooms, you sure had to get your skates on, Beep Beep!
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Our ASCO 2014 conference coverage continues with more gems from the poster sessions; it’s where we believe you find the promising gems that offer hints of future promise (or not) as the case maybe.
Sometimes a failure with one agent can help another company design a more optimal trial for their own new product in development, thus moving the field on. Other times, a surprising result can emerge that teaches us something new about the science and increasing our body of knowledge about pathways or biomarkers.
The other thing to understand about phase I trials is that they are generally conducted in the salvage situation where patients are refractory to most current treatments. The disease burden is high and the patients much sicker than when they were newly diagnosed. What companies are looking for is to characterise the side effect and PK profiles while looking for possible hints of where the agent might be efficacious. Given that most cancer therapies are given in combination, it’s very rare to see a home run in phase I, especially in solid tumours.
Here are a triplet of interesting posters from small companies looking at moving the needle in solid tumours with early phase I studies:
Companies mentioned: Nucana, OncoMed, Celldex
Agents mentioned: Acelarin, OMP–59R5, varlilumab
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