Biotech Strategy Blog

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

Posts tagged ‘cabozantinib’

A dozen early stage clinical trials to watch out for at AACR24

Who’s packing a punch this year?

In 2011 we did an annual ASCO highlight video reel of what to watch out for. Three phase 1 antibodies were included as a potentially exciting new theme to watch out for. Oh, the brickbats and insults I received in my inbox!

Immunotherapy was not de rigeur back then by any stretch of the imagination and people were absolutely furious because it was so way out and bucked the prevailing trend of the day.

Those drugs now generate billions in revenue every quarter between them. Phooey to the naysayers 😉

In our latest AACR 2024 Preview we highlight a dozen early stage clinical developments to watch out for… will some of them pack an unexpected punch?

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Exploring novel targets and modalities in advanced cancer

New waves or on the rocks

It’s not that long ago when a certain tumour type saw several waves of promising new agents emerge, quite a few of which made it past the finish line and commercial approval.

These included novel drugs, fast follow-ons, and even me-toos.

The next batch in new development pipelines were not so lucky with a series of disappointing phase 3 misses.

Then radio silence ensued.

As we take another look at this niche, there are a number of early stage agents being put through their paces – small molecule inhibitors, protein degraders, bispecifics, immunotherapies – they’re all there.

Are we going to see some new waves or will they crash and flounder on the rocks?

To find out, we delved into the latest data to determine the current status…

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Reflections on ESMO22

Vive La France! 

Despite the raft of negative trials presented in Paris this year, it wasn’t all bad news, although for a while it certainly seemed this way with quite a few phase 3 trials missing their primary endpoints.

It’s time for our ESMO review where we highlight no less than 10 trials offering positive vibes and encouraging signals, particularly in early stage development.

So what were the standouts and why do they matter?

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A contrarian view of key cancer trial results

One thing I really miss from attending live conferences – aside from catching up with people in person – is “the living like a local” experience. Last time I was in Madrid, for example, there was this fishmonger (pescaderia) just a block down from the rented apartment. They were only open in the mornings, so you could dash down the hill, quickly nab some fresh produce, refrigerate it and have something nice to look forward to for dinner with a glass of wine at the end of a tiring day while writing up the highlights…

The image also offers another analogy – do some data presented at a meeting end up, well, a bit fishy on closer examination or reflection despite much of the hype enthused or extolled by others?

At the ESMO20 virtual Congress, we covered a tremendous amount of details from the data during both the daily highlights as well as the previews exploring what to watch out in the run-up to the event.  You can find all those reviews here.

There are always some surprises in store, however, both good and bad.  There’s also layers of obfuscation going on to consider in the form of cheerleading from companies, investigators, or stock holders, which may add positive spin on what is essentially so-so data, cases where great data goes largely ignored for whatever reason, or important lessons to be learned from failure.

In this wrap-up post, we take a sharp look at the ESMO20 winners, losers, and risers from a contrarian’s perspective…

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ESMO18 Preview 5 – A look at the evolving Renal Cell Carcinoma landscape

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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ASCO GI18 Preview

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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A look at CheckMate-214 in 1L metastatic RCC

There’s been another disturbance in the force – as luck would have it, after mentioning renal cell carcinoma (RCC) in yesterday’s post, BMS subsequently put out a press release on the CheckMate–214 study exploring the combination of nivolumab plus ipilimumab in the previously untreated metastatic setting.

The results to date were mixed, so what does this mean and what’s impacted by the findings?

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ECC Day 1 Highlights – the battle for Advanced Renal Cell Carcinoma

After an entertaining morning yesterday – two interviews completed and wrong conference centre visited (yes really, there’s always a first for everything!) by lunchtime, things thankfully settled down.

Friday, for the uninitiated, is company symposia day – the equivalent of ASCO’s Super Friday. I rarely attend these in Europe, as they are more about corporate messages than what I call “proper CME”, meaning scientific or clinical fair balance and independence. This is one area where Europe still has a-ways to catch up the US on.

Before anyone gives me a hard time on this, I’ll never forget a vendor telling me a couple of years ago that I would love a particular symposia as he had personally ‘supervised and written’ the slides for the event, thus ‘ensuring’ it would be excellent while persuading me to attend against my better judgment. Naturally, I hated it – too many company messages or perspectives, and not ones I agreed with either – and left early, sadly disappointed.

We did attend the first ECC Press Briefing Friday afternoon with Drs Sant, Chouieri and Sharma. The last two authors presented on the metastatic renal cell carcinoma (mRCC) data after initial therapy, which is being presented in the Presidential Symposium on Saturday morning. It was quite an eye opener in many ways, with some subtleties well worth exploring in additional analysis and discussion.

Beyond the obvious highlights of the day for Saturday (nivolumab and cabozantinib data in mRCC), the first official day here is pretty jam packed with lots of other data to ruminate over.  Throughout the day, we’ll be adding additional notes, commentary and insights as the data emerges – and wifi permits.

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ECC Vienna Preview 1 Late Breaking Abstracts

A decade or so ago, the annual conferences for the European Congress of Clinical Oncologists (ECCO) and European Society of Medical Oncologists (ESMO) were considered convenient dumping grounds for negative or failed trials. This was largely because they received much less attention than their big brother, the American Society of Clinical Oncology (ASCO).

In the last few years, this trend has shifted with excellent clincial and scientific data being presented at both meetings – they alternate as hosts each year – under the European Cancer Congress (ECC) umbrella.

Just to confuse a global audience long used to referring to the meetings as ESMO and ECCO, while the logical Twitter hashtag might appear to be #ESMO14 and #ECCO15, respectively, based on the standard nomenclature of conference acronym followed by the year, the vagaries of European politics mean we end up with… #ECC2015.

It will be interesting to see how they compete for attention because this hashtag signal will be dirty (more than one usage) and noisy (many disparate voices) with the European Curling Championship, a European Cheerleader Convention and another on e-cigarettes and vaping, all seemingly using the same moniker!

ECCO 2015 Vienna

Still, what many readers are really eager to learn though, is this a great, middling, or poor year for exciting new data in the field of cancer research and what can we expect to hear about in Vienna later this month?

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BMS and Exelixis announce new renal cell cancer data

New developments in renal cell carcinoma

Continuing our focus on genitourinary (GU) cancers this week, today we turn our focus from prostate cancer to renal cell carcinoma (RCC).

There were two important announcments on Monday this week relating to renal carcinoma.

Firstly, Exelixis announced positive top line data from a phase 3 pivotal trial of cabozantinib versus everolimus in relapsed metastatic renal cell carcinoma (METEOR).  The study met the primary endpoint (i.e. significantly improved progression free survival) and the company revealed the following data:

  • Cabozantinib reduced the risk of disease progression or death by 42%; Hazard Ratio = 0.58, (p < 0.0001) compared to everolimus
  • Interim Analysis of OS demonstrated a trend in favour of cabozantinib; Hazard Ratio = 0.67, (p = 0.005) compared to everolimus
  • Exelixis to complete US and EU regulatory filings in early 2016

Secondly, a press release from BMS highlighted the phase 3 CHECKMATE–025 trial comparing nivolumab to everolimus, also in relapsed metastatic RCC, where the independent Data Monitoring Committee recommended early stoppage on the basis of the primary endpoint (OS) being met. The company likely be seeking discussions with Health Authorities with a view to filing the data with the FDA and EMA.

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