Biotech Strategy Blog

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

Posts from the ‘Cancer’ category

Not in San Diego: We took a close look at the potential for targeting gamma delta (𝞬𝝳) T cells early last year in an extended mini-series looking at the landscape including some of the early companies leading the way in this niche.

Since then there’s been a raft of company related announcements and collaborations in recent months, highlighting the ongoing interest in this field.

In this post, it’s time to revisit the original landscape (link), as well as explore how well some of the biotech companies who are active in this space are navigating the R&D roller coaster.

We will also be discussing recent data presented at the AACR20 virtual meetings.

So what did we learn about gamma delta T Cell therapies at AACR20 – who stands out from the increasingly crowded pack?

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Not in San Diego – What we wanted to explore in this post was some nice examples of either creative thinking outside the box or where researchers have challenged existing dogma and revealed some intriguing or unexpected findings. These are all examples from talks or posters showcased yesterday during the second AACR virtual meeting…

We take a look at several quite different approaches, which may either turn out to be useful new agents in clinical development, new targets, or even some unexpected tweaks in clinical trial design based on emerging evidence on the biology side that may lead to a new understanding in an area where previous attempts failed to yield a positive result…

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Not in San Diego – In normal times of past years, the AACR annual meeting generally takes place once a year in April before we haed onto oter events such as ASGCT, ASCO, and EHA. In these abnormal times in the middle of the COVID–19 pandemic, however, the virtual event was split into two, with the first online event in April covering mainly early clinical data, and now we get to learn from the meaty scientific presentations, which are being highlighted this week.

A network of mutations, tumour suppresses, metabolic and immune processes, as well as other hidden factors can unexpectedly impact therapy outcomes in NSCLC

We have a lot of translational researchers reading BSB, so I wanted to kick off the first of the AACR Virtual Meeting series with a scientific focus, which is likely of interest to many for a number of obvious reasons.

The good news is this a topic we have covered before and so there’s already a body of work to build on for reference since this latest round of information not only adds to what we know, but also highlights some additional unknown unknowns yet to be elucidated.

The dichotomy is an essential part of the very essence and fun of science – the more we think we know, the less we really know in practice, especially as the various layers of the onion get gradually peeled off over time.

This latest review mixes up translational research with clinical research…

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Stormy waters – Oncology R&D is a fine line between success and over the edge sometimes!

BSB Reader Mailbag – With the FDA approval of lurbinectedin on Monday and two very different recent announcements regarding adjuvant therapy readouts for CDK4/6 inhibitors, we received a bunch of BSB reader questions on both topics.

It’s been a while since we dived into the mailbag in a busy conference season, so this is a great time to reflect on some broader thoughts in oncology R&D for context.

Here, we look at two key aspects…

  • Am I enthused about the lurbinectedin data or not?
  • What half dozen factors could we be thinking about when considering CDK4/6 inhibitors in adjuvant HR+/HER2- breast cancer in order to decide if one is better than the other or does luck play a part?

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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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Do any of the early trials in advanced cancers aspire to be great?

Not in Chicago – Of relevance to the ongoing ASCO20 coverage, in the Preview series this year, two of the companies we highlighted going into the meeting (Innovent and Alphamab) both announced deals this week with Roche and Sanofi, respectively – talk about highlighting hot topics ahead of time 😉

After last week’s look at winners and losers in hematologic malignancies, this time around we now turn our attention to explore what’s happening on the new product development front regarding solid tumours.  In this review, we critique some of the trials presented and put them in broader context.

As always, there are both some important learnings we can glean as well as some, well, head/desk moments to contemplate…

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Sadly not the #blisterwalk this year

Not in Chicago – Breast cancer has been a hot topic again on several fronts after a bit of a lull on the R&D front.

Writing about such trials across ESMO Breast, ASCO and the second AACR meeting is all very well, but what about some KOL commentary and reactions to some of the data we get to see?

If this has been a burning question for you, this is a handy article to catch up on. Of course, to be clear – not all the trials will be positive or biomarker analysis helpful, so here we tackle the issue and look at what’s what though the lens of a specialist…

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Not in Chicago: We continue our ASCO coverage with a look at the evolving TIGIT landscape and the initial tiragolumab data in lung cancer.

With all the breathless hype of late one wonders if some observers believe (accompanied by loud trumpeting of horns) this is the next big checkpoint target after CTLA-4 and PD(L)1, but is it?  The field has barely got started with a raft of new trials opening to evaluate several molecules in different combinations across solid tumours, and yet we have something of a fanfare already.

Will TIGIT roar and fire up the immune system in some people with cancer or will it fizzle out?

To those of us familiar with new product development and early stage development the ‘hot’ status is likely leaving us somewhat bemused at the noise around the emerging targets, after all it’s going to be a long while before we see those all important phase 3 readouts with appropriate head-to-head comparisons.

In this latest article, we take a look at the Genentech antibody, tiragolumab, and also discuss the development with a company executive to gain their perspectives, insights and rationale on what was behind the recent trial expansions beyond the phase 1 study in advanced solid cancers.

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Not in Chicago: A hallmark of the annual meeting of the American Society of Clinical Oncology (ASCO) is “practice changing” clinical trial data often featured in the plenary session.

This year one of the noteworthy phase 3 trials presented at the meeting (link to ASCO20 Abstract LBA5), was the AstraZeneca sponsored “ADAURA” trial for osimertinib as adjuvant therapy in patients with stage 1B-IIIA EGFR mutation-positive NSCLC after complete tumor resection.

We’ve been following the clinical development of osimertinib since the initial presentation of the phase 1 data in 2013 (link).

Source: ASCO20 Press Briefing by Dr Roy Herbst

At first glance it’s hard not to be wowed by the separation of the disease-free survival (DFS) curves in ADAURA, which show a benefit for patients who received the EGFR inhibitor osimertinib compared to those who received placebo. A 0.17 hazard ratio is certainly not something we see every day.

Indeed, if you were in the media and listened to Dr Herbst on the #ASCO20 press briefing last week – to use a “Britishism” – you would have thought this trial was “the best thing since sliced bread.”  The data monitoring committee recommended unblinding the study early.

Dr Ross Camidge Colorado

D Ross Camidge, MD PhD

Anyone leaving the story there and doing a superficial report about this data is, however, doing a disservice to their readers. The US academic lung cancer community are not all singing Handel’s Hallelujah chorus for the ADAURA trial and in this post, we take a critical look at why this might be the case.

For good measure, we interviewed a global thought leader who was prepared to offer some candid expert commentary.

Dr Ross Camidge is Professor of Medicine/Oncology and holds the Joyce Zeff Chair in Lung Cancer Research at the University of Colorado school of medicine. He kindly spoke to BSB and shared his perspective on adjuvant therapy in EGFR mutant lung cancer.

Dr Camidge characterized the disease-free survival in the ADAURA trial as a potential false dawn and told BSB:

“I do not believe the data should be practice changing or at least not yet. I think when you show there is an overall survival benefit then it will be practice changing…

So far there is no reason to suggest that disease free survival is going to translate into an overall survival advantage as it has not in any other comparable targeted therapy trial in EGFR mutant lung cancer. If this trial is the exception though, it will certainly not be of the same magnitude as the DFS benefit. However, the real unanswered questions are who needs this drug in this setting and if they need it, who can stop it safely and when.”

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Time for some reflections from ASCO

Many eyes at ASCO this weekend will be eagerly turned towards the plenary session on Sunday and the stunning osimertinib data in the ADAURA (adjuvant osimertinib therapy for EGFR positive disease) where 69% were stage II/IIIA and for those patients, DFS HR was 0.17 with a 2 year DFS rate of 90% (only 44% with placebo).

There is no doubt this is the data of the meeting for me – when was the last time we saw a hazard ratio of 0.17?! More on this development after the data has been presented.

Beyond the plenary there are plenty of interesting studies to discuss and ponder at various stages of development. Over the next couple of days a number of other stories and interviews will be also posted.

Here, we provide an update on one of the early drug development stories we’ve been following longitudinally over the last five years from preclinical through to the clinic and offer some reflections on progress to date.

A KOL interview and commentary are included as well…

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

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