Biotech Strategy Blog

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

Posts tagged ‘pembrolizumab’

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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After writing about the 1L NSCLC landscape every quarter last year, I was thinking the other day that we were due another update and discussion on this riveting topic again soon and added it to the editorial calendar of topics to write about on BSB.

It was therefore no surprise to hear Merck’s announcement this morning that their phase 3 trial KEYNOTE-189 exploring pembrolizumab plus chemotherapy hit its co-primary endpoints and is now the second study to do so after Genentech/Roche’s announcement for atezolizumab plus chemo plus the VEGF inhibitor, bevacizumab was a success.

Are we at a crossroad for lung cancer?  With many more readouts yet to come competition in this space is certainly heating up dramatically!

Meanwhile, there are a few important implications to consider here, so we sat down and penned an update based on the emerging data and highlight some key insights to consider…

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Happy New Year!

Immunotherapy treatment for multiple myeloma has been around for several decades, first in the form of stem cell transplantation, then augmented by the addition of IMiD immune modulation drugs such as thalidomide, lenalidomide or pomalidomide. In due course, along came immune checkpoint blockade in solid tumours and it was only a matter of time before they would be evaluated in hematologic malignancies, albeit with mixed results.

The proteasome inhibitors and IMiDs are unlikely to go away any time soon, but other targets have also emerged including CD38, SLAMF7/CS1, BCMA/APRIL, PD–1/L1 and a few others that are being currently investigated in the clinic.

Where does this leave us and what looks really promising?

In our latest thought leader interview undertaken at the recent American Society of Hematology (ASH) meeting in Atlanta, we asked a global expert for his candid views and were not surprised at some of the hard hitting comments that emerged from the in-depth discussion of several key issues…

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It’s one of those truly crazy busy times of the year with no less than three cancer conferences going on this week alone in different cities and time zones. I’ve also been busy scheduling and conducting phone interviews for these events.  More than once have I dialled the wrong number or access code or got briefly confused by time zone changes (CT and CEST?!) and misread the interview at the wrong time… and was that 4.30pm ET or CT?

River Walk, San Antonio, Texas

One of those… If it’s Tuesday it must be Belgium moments to be sure.

Thankfully, everyone has been very thoughtful and helpful and I haven’t managed to get the expert names incorrect (yet)!

Today, I want to take a break from the ASH17 coverage and switch horses from hematologic malignancies to breast cancer and from Atlanta to San Antonio, as there is some important new data emerging from the Lone Star state.

In particular, one of the top posts of 2016 on BSB was on CDK4/6 inhibitors so it’s time for an update on this and some other key studies!

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SITC 2017

Treatment with checkpoint blockade has undoubtedly improved the lives of some people with advanced cancers such as melanoma and lung cancer, however the number who do achieve complete remission with single agent therapy is low (typically <20%).

In addition, not all people will respond up front while others achieve an objective response then relapse as acquired resistance or immune escape hits.

One challenge facing the field is identifying these mechanisms of resistance and finding the optimal combination approaches that lead to improved outcomes.

This weekend at the Society for Immunotherapy of Cancer (SITC) annual meeting, there were quite a few interesting new combination developments with early data.

Here, we take a look at one such combination to explore the data, the biomarker research that is ongoing and also some of the challenges associated with finding needles in the proverbial haystack…

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With so much data to cover recently, we haven’t have time for a perennial favourite, the monthly mailbag to answer BSB reader Q&A on hot oncology topics.

October has brought out quite a lot of controversy to consider, most of it happening in the last week!

Here, we consider questions on Immune Design’s phase 3 trial with their NY-ESO-1 vaccine, CMB305, which attracted both a lot of market attention and also questions from readers.

We also review a bunch of questions relating to 1L NSCLC and the upcoming readouts.  This niche is probably potentially one of the most competitive spaces in oncology R&D at present and readers seem almost insatiable for information on this topic.

It is quite a turnaround considering the last decade of numerous failed trials or even non-inferiority studies that were being conducted.

Like many readers, I can well remember sitting in freezing cold, half empty halls wondering if the latest chemo or targeted therapy doublet was going to offer a mere 2-3 months improvement in PFS and no OS benefit or not.  It was that binary and also depressing.

With the possibilities offered by immune checkpoint blockade, in a short space of time 1L NSCLC has gone from graveyard to uber intense with several companies vying to demonstrate improvements in overall survival by 6 months or more.

There’s a lot more to come here and not all of the lung trials will be positive – that’s expecting too much against the game of chance.  Here, we look at numerous factors that could make a difference, both positive and negative.

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As we demonstrated in the recent Novel Targets podcast that opened Season 3, one topic that is a key focus for many in the IO space is addressing mechanisms of immune escape and acquired resistance to single agent treatment with immunotherapy.

We’ve seen several oncogenic escape mechanisms reported, included activation of the JAK/STAT pathways in some patients and loss of existing immunity when the tumour suddenly becomes cold or an immune dessert.

The good news is that there are a number of ideas that can be pursued, including activating the innate immune system in various combinations.

As we see more companies invest in the innate immunity space in order to have a rational partner with which to combine with their checkpoint inhibitor, it will be important to maintain focus on trial designs and synergistic mechanism of actions to improve efficacy while reducing the potential for overlapping or severe toxicities.

Here’s one intriguing and promising new approach that caught our eye this month that is worthy of researching and following over time…

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It really doesn’t feel like a year since we were at ESMO in Copenhagen, in what was probably the most exciting meeting of the year in many ways.

Packed audience!

With the ASCO abstract deadline being in Jan/Feb, ESMO offers a great opportunity for companies to have another major slot in the calendar to present ground breaking data. In some ways, having positive data at a European meeting can actually amplify positive studies that might otherwise get lost in the noise at ASCO, which is almost becoming too big.

So what’s in store now that the meeting is upon us?

There are some large and small trials with important data on the first two days that bear thinking about and further discussion.

Here’s our take on the first batch of readouts, including some surprises…

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Madrid city center

Greetings from Vienna, Austria!  Fresh off a red eye… we’re en route to one European cancer conference in Germany, while writing about another one in Madrid.

This latest preview looks at some of the key IO studies that are either intriguing or have potentially interesting results that BSB readers have written in asking us about.

There are some targeted therapies thrown in too for good measure too, as there are some IO-targeted combos to look at, as well as IO-IO approaches.

What I want to accomplish in this latest preview is point out some elements of what we call ‘interestingness’ where people should be watch or wary of either jumping to conclusions or making comparisons across trials and arriving at assumptions that may not turn out to be valid. My best advice here is to always be sceptical and assume there’s no concordance and that way you won’t be caught unawares.  It’s easier said than done, though.

Indeed there were so many questions about ESMO that we needed two preview posts to cover many of the questions we received.

Part 2 should roll out tomorrow, wifi on the road permitting – stay tuned for more on ESMO17.

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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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