Biotech Strategy Blog

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

Posts tagged ‘Ipilimumab’

The annual ASCO-SITC meeting (#ImmunoOnc19) was held in San Francisco this year and has come a long way from the inaugural event we attended in Orlando.

Finding the signals amongst the noise

In the original 2017 event, I vividly recall as stirring presentation from Dr Limo Chen on targeting CD38 in solid tumours, last year we wrote an update on GU cancers including the STING pathway.

What’s in store from San Francisco and how do we go about finding key signals from the noise?

Over the next two posts I’m going to focus on new findings in various approaches that either look interesting and worth watching, or where there are lessons that can be learned for future developments.

This time around, some of the highlights surprised even me…

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In the third part of our ASCO GU coverage from San Francisco, which includes previews and post-match commentary, it’s time to turn our attention to renal cancer. This isn’t one disease, but a broad tumour type with multiple subtypes, some based on histology, with perhaps others to emerge down the road as we learn more about the disease and immune profiling.

There’s quite a bit to discuss this year, some of it quite complex and nuanced.

In the old days, much of the focus was on sequencing single agent TKIs in clear cell carcinoma, now it’s getting much more complex as scientists and researchers figure out combinations and regimen approaches, never mind what to do with the various histologies.

We walk readers through the latest information as we await the data presentations coming out tomorrow…

 

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SITC Phase 1 Review Part 1 – It’s time for a two-part mini-series on recent phase 1 clinical trials and how to interpret the findings.

Are we at a crosswords with IO combos?

As a former new products development professional, this is something that I’m particularly enthusiastic about.

While it is fascinating to see other people’s reactions to early oncology trials, these should often be taken with a very large pinch of salt, in my view.

In Part 1, it’s time to take a step back and understand not only what companies are doing, but also how they set the trials up and what they are looking for. We highlight some examples of data readouts to illustrate the points.

In Part 2 on Monday we take a rock around the clock at some of the other recent phase 1 readouts and explain what we can learn from what was presented. The devil is often in the small details that many observers miss at first glance.

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We’ll have “boots on the ground” for the 2018 Congress of the European Society for Medical Oncology (Twitter: #ESMO18) that starts out of the gate on Friday in Munich.

The Fall cancer conference season is in swing…

Our conference coverage is not only about what data we think matters, particularly in the fast-moving world of immuno-oncology, but more importantly, why it matters.

Next up in our ESMO18 Previews, we take a closer look at renal cancer, an area that received some attention in Madrid last year and is likely to receive renewed focus again.

We also include a look at the broader RCC landscape in terms of US physician prescribing habits (i.e. KOL and Community oncologists), including some trend data to explore the impact of the nivo/ipi combination and cabozantinib data, as well as excerpts from an expert interview we conducted with Dr Awny Farajallah, Head of U.S. Medical at Bristol Myers Squibb.

Finally, we also highlight some key abstracts to watch out for in renal cell carcinoma (RCC) that are expected to be presented at ESMO18 and explore their relevance.

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It is always a pleasure to talk with experts who have a clear vision of not just what the current treatment landscape looks like, but where the field is going.

Dr Stephen Liu at ASCO18

Dr Stephen Liu is a medical oncologist and assistant professor at Georgetown University Medical Center in Washington DC, where he specializes in thoracic oncology.  He’s also actively involved in clinical trials and developmental therapeutics.

We last interviewed him at ASCO 2016 – you can also hear him on Episode 13 of the Novel Targets Podcast – where he shared his thoughts on some of the early lung cancer immunotherapy combination trials underway.

As regular readers know, we like to follow stories over time and also catch up with thoughtful, intelligent people we’ve talked to in the past whose opinions we value.

Dr Liu kindly shared his highlights of ASCO 2018 in lung cancer, and in a wide ranging discussion, also offered some thoughts on what the future may hold and where we may be going next.

There was a lot to learn from Chicago this year, with plenty of nuances and subtleties to consider. If you read only one post on lung cancer from ASCO18, this interview tells you all you need to know!

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At AACR last week we had the long awaited initial readouts for three key phase 3 studies in lung cancer, namely CheckMate–227, IMpower150, and KEYNOTE–189 in the same session on the same day.

This had me thinking about how it might end up being, “a killer and a chiller and a thriller when I get the (PD–1) gorilla in Manila,” with sincere apologies to Muhammed Ali and Dr Jean-Charles Soria for (mis)appropriating their past themes 😉

Chicago River Bridge at #AACR18

For those attending the event, you might well be forgiven for thinking from the first two adjectives that I’m referring to the weather, as it was certainly cold enough (!), or even the results this week from AstraZeneca’s unfortunately named ARCTIC study exploring the IO-IO combo of durvalumab plus tremelimumab in the third line setting with a miss in both PFS and OS endpoints.

In reality, we should be warmed and heartened to see three positive immunotheraopy trials appear at once and presented in the same session at the same meeting.  It isn’t always the case as regular attendees at ASCO well know.

When all is said and done, what do thought leaders specialising in lung cancer really think about the data that was presented in Chicago, and what were the convergence and discord on the various key issues under consideration?  There is, after all, a lot of subtlety and nuance to consider in 1L NSCLC.

To find out more, we interviewed not one, but four, lung cancer specialists in Chicago for their personal perspectives.  What they had to say as a group was both candid and absolutely fascinating, so it made sense to curate their insights around various key topics together into one detailed post for easy reading… 

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Chicago!

One of the key topics arising out of probably the hottest session (lung cancer clinical trials plenary) at AACR last week was tumour mutation burden (TMB).

An important question to be addressed was whether or not the nivolumab plus ipilimumab combination from the CheckMate–227 study will be useful in previously untreated non-small cell lung cancer (NSCLC) patients with a high TMB?

There are a number of questions that occurred to us that need careful consideration:

  • Is TMB ready for prime time?
  • What are the challenges and issues involved?
  • How useful are the data from CheckMate–227 and CheckMate–568?
  • Where are we going next?

To find out more, we had some fascination discussions at AACR with two up and coming young researchers from industry (Dr David Fabrizio of Foundation Medicine) and academia (Dr Nicky McGranahan from UCL in London), who are both experts intimately involved in measuring TMB.

What did they had to say and what does it all mean?

Their candid answers may well surprise a few people…

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San Francisco

The first cancer conference of 2018 is now upon us and after enjoying last year’s event in San Francisco, I wanted to take some time to explore some key abstracts of interest at the ASCO GI meeting, which begins tomorrow.

This conference covers various updates on new developments in oesophageal, gastric, colon, pancreatic and colorectal cancers.

Are there any trials or new developments to get excited about at this year’s GI18 meeting?

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After writing about the 1L NSCLC landscape every quarter last year, I was thinking the other day that we were due another update and discussion on this riveting topic again soon and added it to the editorial calendar of topics to write about on BSB.

It was therefore no surprise to hear Merck’s announcement this morning that their phase 3 trial KEYNOTE-189 exploring pembrolizumab plus chemotherapy hit its co-primary endpoints and is now the second study to do so after Genentech/Roche’s announcement for atezolizumab plus chemo plus the VEGF inhibitor, bevacizumab was a success.

Are we at a crossroad for lung cancer?  With many more readouts yet to come competition in this space is certainly heating up dramatically!

Meanwhile, there are a few important implications to consider here, so we sat down and penned an update based on the emerging data and highlight some key insights to consider…

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With so much data to cover recently, we haven’t have time for a perennial favourite, the monthly mailbag to answer BSB reader Q&A on hot oncology topics.

October has brought out quite a lot of controversy to consider, most of it happening in the last week!

Here, we consider questions on Immune Design’s phase 3 trial with their NY-ESO-1 vaccine, CMB305, which attracted both a lot of market attention and also questions from readers.

We also review a bunch of questions relating to 1L NSCLC and the upcoming readouts.  This niche is probably potentially one of the most competitive spaces in oncology R&D at present and readers seem almost insatiable for information on this topic.

It is quite a turnaround considering the last decade of numerous failed trials or even non-inferiority studies that were being conducted.

Like many readers, I can well remember sitting in freezing cold, half empty halls wondering if the latest chemo or targeted therapy doublet was going to offer a mere 2-3 months improvement in PFS and no OS benefit or not.  It was that binary and also depressing.

With the possibilities offered by immune checkpoint blockade, in a short space of time 1L NSCLC has gone from graveyard to uber intense with several companies vying to demonstrate improvements in overall survival by 6 months or more.

There’s a lot more to come here and not all of the lung trials will be positive – that’s expecting too much against the game of chance.  Here, we look at numerous factors that could make a difference, both positive and negative.

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