Biotech Strategy Blog

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

Posts tagged ‘Pharma CI’

MYSTIC Interim Analysis July 2017 shows PFS Miss

There has been considerable focus on the impact of cancer immunotherapy and checkpoint blockade in particular in non-small cell lung cancer (NSCLC) of late, with approval of several agents in the 1L and 2L metastatic setting, as well as positive results reported in stage 3 unresectable disease earlier this year.

To date, the approvals have focused on monotherapies in second-line (nivolumab, pembrolizumab and atezolizumab) allcomers, as well as in 1L in two cases i.e. for people who are PD-L1 High expressers (≥ 50%) for pembrolizumab or allcomers in combination with chemotherapy (pembrolizumab).

Today as part of their 2Q earnings call details, AstraZeneca ($AZN) announced that the MYSTIC trial exploring the combination of the anti-PD-L1 antibody, durvalumab (Imfinzi), plus anti-CTLA–4 antibody, tremelimumab, unfortunately missed the interim endpoint of progression-free survival (PFS).

This is the first dual IO-IO combo readout in this setting and while disappointing, the results aren’t entirely surprising, as regular readers will no doubt realise.

We are now awaiting several other trial readouts in 1L NSCLC, including Merck’s phase 3 confirmatory trial for pembrolizumab plus chemo and Genentech/Roche’s IMpower150 trial, which explores atezolizumab in combination with chemotherapy, with and without the anti-VEGF inhibitor, bevacizumab (Avastin).

For historical reference, we originally wrote up our perspectives on the 1L NSCLC landscape in January this year then followed that up with a provocative post outlining out predictions on what to expect earlier this month, including the projected miss in PFS for AstraZeneca’s IO combo.

So what does this latest data mean for AZN?

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A look at why we get mixed results with phase 3 checkpoint trials

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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A look at Nektar Therapeutics immunotherapy pipeline

The latest company immunotherapy announcement is from Lilly and Nektar Therapeutics, for a strategic collaboration to co-develop NKTR–358, which targets the IL–2 receptor complex, thereby impacting regulatory T cells (Tregs). It is thought that this target may have particular relevance to autoimmune disorders and other chronic inflammatory conditions. This agreement involves an initial payment of $150 million, with the potential for up to $250 million in additional development and regulatory milestones.

Source: Nektar Therapeutics

Preclinical data on this novel compound was recently presented on July 10th at the World Congress of Inflammation.

We first spoke to Nektar at SITC in November, including an interview with one of their leading scientists (Dr Jonathan Zalevsky) together with the academic PI (Dr Adi Diab), and I’m delighted to say that the dynamic duo graciously agreed to a follow-up discussion at ASCO last month on the emerging IO pipeline.

In our current analysis and commentary on the IO pipeline, we also look briefly at the Lilly deal with NKTR–358 in autoimmune disease.

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Can we use immunotherapy to treat or delay Alzheimers Disease?

Berlin Wall Museum

Preserved section of the Berlin Wall

I have a personal interest in Alzheimers Disease, my mother Audrey died from it three years ago back in 2014.

Since then, I’ve watched with fascination and excitement the progress made in using the body’s own immune system against cancer. There’s still a long way to go, but a revolution in treating cancer is underway, as we’ve been documenting on this blog and the Novel Targets Podcast.

In recent years in the United States we’ve also seen grand initiatives targeting cancer such as Vice President Biden’s Moonshot, as well as large philanthropic support e.g. the creation of the Parker Institute for Cancer Immunotherapy.

Sadly, we’ve not seen the same level of interest in targeting dementia or funding research into new treatments for Alzheimers disease.

In the United States, the media doesn’t talk much about Alzheimers (compared to cancer), unlike for example, in the United Kingdom where any promising data is heralded with headlines that frequently deliver “hype over hope.”

Alzheimers is an insidious disease that removes the ability of the person to advocate and care for themselves, instead placing the burden on families and caregivers, often for extended periods of time. Ultimately many people end up in supported living or nursing homes.

As we debate healthcare insurance in the United States, who is going to pay for the cost of dementia care as the population grows older? Caring for dementia is arguably the greatest public health challenge that the western world faces.

Which is why I was excited to talk with a researcher who is thinking outside of the box and leading the way in how we could use our immune system against Alzheimers.

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Can epigenetic therapy boost cancer immunotherapy?

In our latest thought leader interview we explore the intersection between epigenetic therapy and immunotherapy.

Gems from the ASCO17 poster hall

Much of the IO focus to date has been on monotherapies rather than combos, although that situation is slowly changing.

What we can also expect to see are the emergence of regimens, long the bedrock of traditional cancer therapy approaches.

As we learn how to bucket more discrete populations based on the underlying biology of the tumour microenvironment, so we will see a more IFTTT (If this then that) approach evolve in order to fix or improve a situation before or after attempting the core therapy. It might require a focus on changing the immunosuppressive or inhibitory factors, for example, or addressing factors that induce primary resistance upfront. The possibilities are endless.

Obviously, there are a number of ways to do this from chemotherapy and radiotherapy to epigenetic agents to targeted therapies – these traditional treatments are not going to go away, but I can see a future where we see more integration based on a patient’s underlying immune status. It won’t be the zero sum game many analysts seem to think it might be.

In the past, we have covered chemotherapy, radiotherapy and targeted therapies and looked at how they might be employed with immunotherapies in various guises. In this latest thought leader interview, we look at a different approach, epigenetic therapy and other novel immunotherapies.

Here, we combine two popular types of posts – Gems from the Poster Halls with an Expert Interview  – for detailed look at one particular area of research that is beginning to look quite intriguing.

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Predictions in 1L NSCLC trials

Back in January this year, we posted an early look on what to expect from the evolving 1L NSCLC landscape following the controversial FDA submission of Merck’s pembrolizumab with chemotherapy. This lead to subsequent approval in May.

Checkpoint Charlie, Berlin July 2017

At that time, quite a few people were shocked and surprised that the phase 2 KEYNOTE–021 Cohort G data presented ESMO was neatly parlayed into accelerated approval in the US.

Since then, a lot has happened and now many readers are on tenterhooks as we await the next round of lung cancer trial results in the upfront setting.

First up is AstraZeneca’s MYSTIC trial exploring an IO-IO combination with durvalumab plus tremelimumab. Merck’s confirmatory trial for pembrolizumab plus chemo is also expected in the fall – will it support the accelarated approval – or not? Meanwhile, we also await Roche/Genentech’s IMpower150 study evaluating their checkpoint inhibitor, atezolizumab, in combination with chemotherapy by the year end.

These are quite different strategies with diverse endpoints so following them closely will be key to understanding what happens next.  Based on what we’ve seen in lung cancer to date, the roller coaster looks set to continue.  The C-suite shenanigans have only added to the intrigue and mystique – do they mean anything?  Who knows, but we’re focusing on the hard data i.e. science and the clinical clues that are available.

It’s all to play for and many readers wrote in asking for an update on the landscape and what to expect now that we’re much nearer to the shoes actually dropping.

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Paris Immuno-Oncology Summit 2017

Paris, France – Last week I had the pleasure of attending a two day Immuno-Oncology Summit, an industry sponsored CME event organized by the European Academy of Tumor Immunology (EATI) and Miltenyi Biotec.

The summit was held at the Centre de Recherche des Cordeliers (CRC) in the quartier Latin on the historic left bank of Paris, a short walk away from Notre Dame cathedral.

Paris Immuno-Oncology Summit 2017

Most of the attendees were French researchers so this opportunity afforded them a chance to hear from leading researchers at the forefront of cancer immunology, including several who travelled from the United States to speak at the event.

CRC Courtyard Statue

I have yet to attend a cancer immunotherapy meeting where I didn’t come away with new insights into what is a fast moving field, where it’s important to see “connections” beyond a tumor type or target.

This post offers top-line commentary highlights on five key presentations at the summit. There were two parallel tracks and a lot of interesting speakers at what was an enjoyable meeting, so think of this like a postcard from Paris.

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July Journal Club

La Tour Eiffel par nuit

Paris, France:  It’s the dog days of summer and my reading stack of interesting science and cancer research papers is particularly high at the moment despite reading voraciously over the last few weeks…

So much excellent research keeps on piling up as fast as one can get through it.

It’s beginning to feel like Ravel’s Bolero…

Still, there’s one particular batch of important papers that draws together some interesting findings in an area we have been following for a little while now and these data most certainly advance the field in more ways than one.

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When targeted and immunotherapy worlds collide

Traditionally we’ve seen the evolution of oncology companies with chemotherapies, then those with targeted therapies, whether TKIs or antibodies.

Increasingly, we’re seeing the rise of an entirely new empire – those with a raft of immunotherapies in their pipeline.

Gems from #ASCO17 Poster Halls

Then there are those with a more mixed portfolio approach of targeted compounds and novel immunotherapy agents… which leads to some interesting combination approaches that target the cancer immunity cycle and address issues that exert inhibitory factors dampening down the immune system responses.

Our latest fireside chat and expert interview focuses on an up and coming biotech company with a pipeline that combines protein targeted antibodies with novel approaches that can potentially reprogram various immune cells in the tumour microenvironment.

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EACR17 Cancer Genomics Day 3

Churchill College, Cambridge: Yesterday heralded the 4th and final day of the EACR Cancer Genomics conference with some invited speakers and proffered papers based on research from several groups and labs.

Churchill College, Cambridge

We got to see through the keyhole on several important areas of research that highlight both challenges and opportunities faced by the field.

The good news is that the opportunities provide insights into how we can learn from ongoing and optimise future clinical trials.

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