Biotech Strategy Blog

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

Posts tagged ‘ASCO20’

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…

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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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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It’s time for another landscape review of a particular class of drugs in early development.

Here we take an in-depth look at the emerging SERD landscape in ER+ metastatic breast cancer. There’s a lot going on the ER+HER2- niche these days after a bit of a lull once we saw the CDK4/6 inhibitors approved so it’s a good opportunity for some extended colour commentary on what could become a hot area in oncology over the next couple of years.

Overcoming or delaying the onset of therapeutic resistance is going to be important, but how do we go about achieving this?

Historically we have seen some success in inhibiting the activity of the estrogen receptor (ER) as a driver of oncogenic activity, but what if we could degrade the aberrant protein instead? Would this approach yield some further benefits for people with advanced breast cancer?

There are quite a few companies, big and small, involved in this space so there’s still much to play for, especially in terms of figuring out what the ideal drug should look like and which combinations might be most useful. We also highlight key upcoming conference presentations to watch out for – hint: there’s quite a lot of them!

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

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Time for some additional colour commentary!

There has been some incredibly intense interest surrounding TIGIT as a new therapeutic target in oncology of late, to the point where some observers have been wildly claiming this is the new universal checkpoint everyone has been waiting for.

But is it?

It’s early days yet with little data presented from people with cancer, so at this point it could well be a bit of a stretch to find another anti-PD–1/PD-L1 equivalent, but this doesn’t mean there isn’t utility in seeing clinical activity in some tumour types, far from it.

In our latest post, we take a look at what’s coming up in the TIGIT niche, along with an interview from a company active in this niche.

What do the company have to say and how do they see this panning out?

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

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