Biotech Strategy Blog

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

Posts tagged ‘CHECKMATE-214’

Looping across different types of analyses can yield intriguing and unexpected results

Not in Chicago It still feels surreal not to have been to windy city and back for the annual meeting at ASCO this year, such was the ongoing effect of the pandemic in the oncology world.

That said, the virtual meeting has produced some gems this year, including some very important findings many may have missed.

In our latest post meeting report we focus on both biomarkers and clinical findings.

We look at how there are various elements may interplay in unexpected ways, whether signatures from one trial are helpful in another, are there likely to be changes in treatment patterns as a result of data presented and where some emerging early signals might be useful.

One other aspect which crossed my mind was how a deep scientific approach used in one particular cancer might have potential applications in other tumour types with few somatic mutations present such as TNBC, prostate cancer or soft tissue sarcomas.

The results might produce quite different results, yet the process itself might be rather useful to consider…

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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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For what seems the longest time, we have seen the battle in metastatic clear cell renal cell carcinoma (ccRCC) being focused on various anti-VEGF TKIs, whether against interferon, mTOR inhibitors, and even each other.

Lately, anti-PD(L)1 antibodies have also come on the scene – both as monotherapy and in different combinations – so are things set to change?

Will it be plaining sailing or are there hidden dangers ahead for the unwary?

Here, we take a look at the ever evolving landscape in RCC and explore the issues and challenges surrounding some of the novel combination readouts, including a look at the role immuno-oncology might play going forward.

Not surprisingly, there’s a lot to consider, discuss and think about…

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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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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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