Biotech Strategy Blog

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

Posts tagged ‘Merck’

Flying high in the DDR oncology niche

Recently, PARP inhibitors have been back in the news for several reasons, including the publication of the olaparib (AstraZenca/Merck) advanced mCRPC data in the New England Journal of Medicine from the phase 3 PROfound trial and the announcement regarding achievement of the key secondary endpoint of overall survival. As Dr José Baselga quite rightly noted, this is very good news indeed because:

“Overall survival in metastatic castration-resistant prostate cancer has remained extremely challenging to achieve.”

We’ve rather more trial misses in this disease setting than successes from various therapies over the last few years including ipilimumab, PROSTVAC, alisertib, and atezolizumab, to name a few off the top of my head.

Related to mCRPC, let’s also not forget the upcoming PDUFA date later this month for Clovis’s rucaparib in the very same indication.

Not to be outdone on the PARP front, just a few days GSK received FDA approval for niraparib as first-line monotherapy maintenance therapy for women with platinum-responsive advanced ovarian cancer – regardless of biomarker status – based on the phase 3 PRIMA study presented at ESMO last year and simultaneously published in the NEJM. Recall that the majority of women (51%) had homologous-recombination deficiency (HRD) and this subset saw the greatest benefit.

Flying high in the DDR space?

We have now seen clinical benefit in the PARP inhibitors in four tumour types driven by DNA damage repair (DDR) deficiencies, namely ovarian, breast, pancreatic, and prostate cancers.

How do we go about extending the concept of DDR in terms of the biology of other tumour types?

A number of related pathway targets have been investigated, including ATM/ATR, Chk1, Wee–1 and others, with mixed success.

It’s not the nature of oncology R&D to stand still, however; what if we could turn things on their head and think creatively about the problems still to be addressed?

One particular new company to the PARP space is doing just that… so what are they doing and what’s different about their approach?

To learn more from our oncology analysis and get a heads up on new insights and commentary subscribers can log-in or you can click to gain access to BSB Premium Content.

This content is restricted to subscribers

Under the Radar

We get to chat with many leading oncologists and cancer researchers on Biotech Strategy Blog – it’s truly one of the perks of the job to meet experts and hear them discuss their early research.

Like a tutorial, we have the opportunity to ask questions and improve our own understanding, but where it becomes really interesting is when they talk about promising translational opportunities, because this is what we are about.

How do you translate basic research into oncology new products and figure out where are the viable opportunities?

In this post, we spoke with one of the world’s leading immunologists – someone we’ve never spoken to before – who a few weeks ago spun-out a company to commercialize one of their early research areas and while we were doing the interview told us about another commercial opportunity they had in mind. This was very much “under the radar” and in a relatively earlier stage of commercialization. Both targets have potential for synergy in our view, particularly in combination strategies and cancer immunotherapy regimens.

With one company in stealth mode and the other only incorporated a matter of weeks ago (at time of writing they don’t yet have a website), it’s exciting to see science translation in action.

This is one of the reasons why one of the many tribes that read BSB are those in business development and licensing (BD&L) or investment roles.

In this post we interviewed the delightful Prof. Akiko Iwasaki from Yale. We’ve also put together commentary on the opportunities and the science behind them, as well as some recent anecdotes gleaned from another expert in one of the fields discussed.

If you are part of a BD&L team then do consider purchasing a group or team license. We’d be happy to have our group sales department discuss this further with you.

To learn more from our oncology coverage and get a heads up on our latest analysis, commentary, and an expert interview with a leading immunologist, subscribers can log-in or you can click to gain access to BSB Premium Content.

This content is restricted to subscribers

PARP inhibition in metastatic prostate cancer

Who’s King of the PARP castle?

After yesterday’s review and expert commentary on the phase 3 PROfound trial presented in the Presidential Session at ESMO 2019, we’re continuing our look at PARP inhibitors in advanced prostate cancer.

Perhaps surprisingly, there were a lot of insights to be found in the posters that were presented and discussed at the meeting for other PARPs in clinical development.

How do these stack up against olaparib? We’re not fans of cross-trial comparisons as they always come with a mandatory health warning, but if you want to consider the emerging landscape, it is important to be aware of the different patient populations, lines of therapy, and details of the trial designs.

For additional perspective at ESMO19, we spoke to a European prostate cancer expert who kindly talked about his clinical practice and also offered insights into a PARP clinical trial he and colleagues presented in Barcelona.

Who will be King of the PARP castle in advanced prostate cancer?

To learn more from our latest oncology conference insights and get a heads up on our latest post ESMO Coverage and reflections, including a specialist thought leader interview, subscribers can log-in or you can click to gain access to BSB Premium Content.

This content is restricted to subscribers

Where’s the next exciting IO target coming from?

Following the success of anti-CTLA4 and PD(L)1 therapies over the last five years or so, there is much time and attention being focused on addressing a key question, namely – what’s the next viable checkpoint target?

There are quite a few possibilities emerging, although to be fair, some of them will no doubt go by the wayside over the next year or two.  There has already been quite a bit of attrition since 2015/16.  Figuring out which ones will be a target versus being a useful marker is also an important aspect of new product development.

Competition is a fine thing – as long as they’re going in the direction you want to go.

For most of our ASCO coverage over the last few years we have tended to include a variety of approaches in the pre-conference Preview series that can run from a tumour type, a up and coming modality, an emerging target, and various other ways of looking at or making sense of the sea of data.

Here, we take a look at an IO target that is receiving much interest and explore what we know and where this might be headed… and ask whether the early promise is living up to the billing in practice?

To learn more from our latest conference coverage and oncology insights, subscribers can log-in or you can click to gain access to BSB Premium Content.

This content is restricted to subscribers

Targeting neutrophils for cancer immunotherapy

If we want to help more patients respond to initial immune checkpoint blockade then we not only need to figure out why some people respond initially but stop responding, but also look at why the majority do not respond upfront.

The reasons might take on many forms depending on the defects in their immune system that the cancer might have hijacked to its advantage.

One obvious way is increased immunosuppression and a more hostile tumour microenvironment. In the past, we have looked at the adenosine fog, as well as the cytokine, TGF-beta, as two quite different ways where the tumours might be impacted in terms of their responsiveness to therapeutic intervention.

In our latest mini-series this week, we are going to explore additional ways that cause non-response to cancer immunotherapy due to immunosuppression and how companies – big and small – are investigating novel therapeutic approaches in this niche based on the underlying biology of the disease.

We begin our journey with a look at neutrophils from the eyes of a researcher who is an expert in this field and how an understanding of the science has led to new novel targets with even some early stage compounds in the clinic already…

To learn more and get a heads up on our latest oncology insights and though leader interviews, subscribers can log-in or you can click to gain access to BSB Premium Content.

This content is restricted to subscribers

How will the RCC landscape change – who dares, wins?!

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…

To learn more and get a heads up on our latest conference and oncology insights, subscribers can log-in or you can click to gain access to BSB Premium Content.

This content is restricted to subscribers

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.

To learn more about our insights and predictions in 1L NSCLC, subscribers can log-in or you can purchase access to BSB Premium Content. 

This content is restricted to subscribers

New IO developments in breast cancer

#ASCO17 Poster Hall aka rugby scrum

There were a lot of gems in the poster halls at ASCO this year, a fact that is partly a reflection of the wealth of new data with various IO combos and also the early cutoff date.

Now I jested before the meeting that these sessions were akin to a rugby scrum and lo and behold (see photo right) they were even more jam packed than usual!

If you wanted to best the eager and energetic Wall St analysts then remembering your ruck and maul skills were not a bad thing to have in muscle memory… It was not something I attempted in the Go-Cart this year for fear of bowling people over in the stampede to nab the QR codes 🙂

Much of the previous readouts have been with monotherapy in immunogenic tumours such as melanoma, lung, bladder, gastric, renal cell carcinoma etc. Objective response rates in metastatic triple negative breast cancer (TNBC) have generally been under 20%, however.

Lately, the focus has turned to the deepening of responses in these tumours with various combination approaches and also moving earlier in the disease setting, where immunotherapies might be expected to be more effective with a lower tumour burden.

While in Chicago, we spoke to a breast cancer specialist about where IO combos are going and his thoughts on future opportunities in our third post in a series on various aspects of new developments in breast cancer.

To learn more insights, subscribers can log-in or you can purchase access to BSB Premium Content. 

This content is restricted to subscribers

ESMO16 What’s Hot in Head and Neck Cancer?

Iron Men of CrosbyThis is the third in our mini-series previewing the forthcoming European Society for Medical Oncology 2016 Congress in Copenhagen (Twitter #ESMO16).

In this post we’re taking a look at what’s hot in head and neck cancer.

It’s not a cancer type we typically hear a lot about, but there’s an unmet medical need for effective new treatments.

To learn more about our insights on this intriguing topic, subscribers can log-in…

This content is restricted to subscribers

ESMO16 Preview on Late Breaking Abstracts in Lung Cancer

The 2016 Congress of the European Society for Medical Oncology (ESMO) is fast approaching. It takes place next month from October 7th to 11th and we will be on site covering the meeting for Biotech Strategy Blog. We’re looking forward to a great meeting!

ESMO 2016 CongressIf you are sitting on the fence as to whether you should go to Copenhagen, then hopefully our series of Previews will help you decide.

Be warned that accommodation is in already in short supply and ESMO are now putting people up across the Oresund bridge in Malmo, Sweden.

The Congress App has a lot of useful information and is well worth downloading, if you haven’t done so already.

Last week many of the late breaking abstract (LBA) titles were announced, although there are still some placeholders. While we won’t know the actual late-breaking data until the meeting, the LBA titles offer insights into what will be presented in Copenhagen.

In the second in our ESMO 2016 Preview series, we’re highlighting the lung cancer late breakers that we’re looking forward to hearing, providing some background on why they may be of interest, and a look at how some of subset landscapes may be a-changing in the future.

Subscribers can login to learn more insights or you can purchase access…

This content is restricted to subscribers

error: Content is protected !!