Biotech Strategy Blog

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

Posts tagged ‘IMvigor211’

What we wanted to accomplish in our latest thought leader interview was to peek under the hood with someone active in this field who is an experienced participant in phase 2 and 3 trials, as well as being a solid translational researcher capable of thinking outside the box critically.

Stacking up the evidence from IO trials

Today we cover a global KOL’s perspectives on cancers of the lung, renal, bladder, and even melanoma, in a wide ranging discussion about immunotherapy trials and some of the pitfalls and opportunities to watch out for.

It makes for an intriguing read as there are likely a few issues that many have not thought about in great depth.

This is an important discussion in the context of not just data that was recently presented at several conferences including AACR, but also with the upcoming monotherapy and chemo combination trials (including squamous and non-squamous lung cancer) expected at ASCO in a few weeks time.

We discuss quite a few of the key challenges and opportunities relating to the broader picture and highlight some of the important issues to watch out for…

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Berlin: Checkpoint Charlie

With a series of inconsistent results involving phase 3 trials involving checkpoint antibody therapy, even in similar indications, it’s time to get down and dirty and look at some of the factors that might be influencing the outcomes since three of the five approved anti-PD(L)1 products have now been similarly affected.

It’s an interesting and intriguing conundrum, to be sure…

Instead of obeying traffic rules, with immune checkpoints maybe we need to consider following immunology rules instead 🙂

The potential hidden answers, however, might be surprising to some readers.

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Florence, Italy: Today at the EACR-AACR-SIC Conference on “The Challenges of Optimizing Immuno and Targeted Therapies,Tom Powles MRCP MD, Clinical Professor of Geniturinary Oncology at Barts Cancer Institute in London, gave a special lecture on the IMvigor211 trial (NCT02302807).

EACR AACR SIC Conf Banner

This was a phase 3 study of the PD-L1 checkpoint inhibitor atezolizumab compared with chemotherapy in participants with locally advanced or metastatic urothelial bladder cancer.

Prof Tom Powles (Barts)

Prof Tom Powles (Barts Cancer Institute)

Readers may recall we interviewed Prof Powles back in August 2015 about the potential for the PD-L1 checkpoint inhibitor atezolizumab in urothelial bladder cancer? (See post: Atezolizumab PD-L1 Checkpoint Inhibitor will Change Bladder Cancer Treatment.)

We also featured the atezo data presented by Dr Jonathan Rosenberg (MSKCC) at ESMO 2015 on Episode 7 of the Novel Targets Podcast, where we also heard Prof Powles tell us about the long durable responses he had obtained in clinical practice in some of his patients.

Subsequently on May 18, 2016 the US Food and Drug administration (FDA) granted accelerated approval to atezolizumab (Tecentriq) for urothelial bladder cancer (link to news release).

Fast forward a year to May 9, 2017 and the surprise announcement that the confirmatory phase 3 trial (IMvigor211) failed to meet its primary endpoint (link to Genentech press release).

So what happened? Why did the atezo phase 3 trial end up being negative when we saw durable responses in the randomised phase 2 trial and other PD-1 checkpoint inhibitors have shown an overall survival benefit in the same indication?

Many in the media only want to write about positive data, but in science we often learn as much from our failures as we do from our successes, perhaps even more sometimes.

IMvigor211 was expected to be a positive trial especially after the recent Merck success gaining an overall survival benefit for pembrolizumab, so the negative result is noteworthy and one that anyone in the field of cancer immunotherapy drug development will want to understand.

Professor Powles kindly spoke to BSB and shared his perspective.

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