Biotech Strategy Blog

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

Posts tagged ‘Pancreatic Cancer’

SITC17 – Final Look at what to watch out for

With the annual meeting of Society for Immunotherapy of Cancer (SITC) fast approaching this week, it’s time for a look at some of the final highlights to watch out for.

National Harbor from Gaylord HotelIn this latest conference preview, we have chosen a dozen key topics of interest that readers may find worth checking out plus an honourable mention for early compounds in development that we may well hear more about going forward.

Some of the early warning signs were offered up in the earlier Previews and with the abstracts now available, things are getting very interesting indeed…

How are things panning out so far with the abstract drop and are the new products in development living up to the hype and expectations?

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TARGETS17 Gems from the Poster Halls

Before we move on to the Society for Immunotherapy of Cancer (SITC) meeting later this week, it’s time to wrap up the exciting AACR-NCI-EORTC molecular targets conference, which along with the CRI-CIMT-EATI-AACR international cancer immunotherapy conference in Mainz, have been my two favourite oncology meetings of the year so far.

Who would have predicted that back in January?

A scoot around the narrow #Targets17 poster hall…

It would be hard not to close out coverage without a popular Gems from the Poster Halls post.

Typically, we have focused this theme from cancer conferences around the following:

  • A new target
  • An interesting molecule
  • Intriguing basic or translational science of note
  • A particular tumour type
  • Insightful sentiments from thought leaders

In this latest version, we have examples of each.  We also have my favourite quote and discussion from the meeting, which perhaps not surprisingly, comes from a CAR T cell therapy discussion.

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Some simply stunning cancer research for Journal Club

Over the last four or five weeks we have seen some truly remarkable research published by numerous cancer researchers around the globe… which means that it’s time for another Journal Club review of key research to feature some cool science.

Here, we have selected half a dozen key papers of interest in both solid tumours and hematological malignancies that are well worth reading and digesting.  The impact from many of these may well lead to new molecules being explored.  We also include at least one review paper for BSB readers to peruse.

While much of the focus is inevitably on lung cancer and melanoma of late, we also highlight important research in pancreatic cancer, aggressive lymphomas and AML.

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How do we get cancer immunotherapy to work in Prostate Cancer?

Dr James Gulley is Chief of the Genito-Urinary malignancies branch and Director of the Medical Oncology service at the National Cancer Institute (NCI) in the National Institutes of Health. He’s a world-leading GU cancer expert and at the forefront of pioneering research to make cancer immunotherapy work in prostate cancer.

We last spoke to him at ASCO 2015 (See post: The future of prostate cancer immunotherapy).

Almost two years on, and new research by Dr Gulley and colleagues from the NCI shows that the STING pathway may have an important role to play in prostate cancer immunotherapy. Activation of this pathway through a novel mechanism could turn a cold non-inflamed tumor into a more inflamed or hotter one in men with advanced prostate cancer. How cool is that?!

At the 2017 annual meeting of the American Association for Cancer Research (AACR) that was recently held in Washington DC, Dr Gulley graciously spoke to BSB about some of the novel trials that are underway at the NCI, with the aim of making cancer immunotherapy work in men with advanced prostate cancer.

Dr Jim Gulley, NCI at AACR17

This is the seventh expert interviews in our series from AACR17 where we explore the conundrum:

How does Dr Gulley plan to light the immune camp fire in prostate cancer?

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Reflections on Saturday at AACR17

Waiting in line for the White House Tour

The 2017 annual meeting of the American Association for Cancer Research in Washington DC (Twitter #AACR17) officially starts tomorrow, but today was a day full of educational sessions and workshops.

After a day of rain yesterday, it was good to have a dry day for the start of the world’s leading cancer science meeting.

In this post we offer some top-line commentary on those educational sessions we attended; the choice reflects personal interests or current fetishes.

By definition, there is far more excellent research at AACR than we can possibly cover on the blog; so we encourage you to check out the AACR webcasts if you have a specific interest or want to check out a particular session.

We’d also like to congratulate AACR for moving with the times and allowing personal photography and the sharing of content on social media, except where a slide or presentation says “Do Not Post.”

The few slides that I saw today that had “Do Not Post” showed unpublished data. Our longstanding unwritten policy has been not to tweet or share on social media data that clearly states it is unpublished, so this was not an unreasonable request and one we heartily concur with in principle.

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Biotech Mailbag – Jounce & the CAR T Race to Market

The race to the be first to market in the United States with a CD19 directed CAR-T cell therapy is a bit like the America’s Cup Challenge Race Series – one boat/company is ahead and then another is ahead, it’s an ever changing and fluid situation…

Americas Cup Portsmouth

In this post, we’re looking at questions from subscribers – so what’s in the July BSB mailbag?

* CAR T Cell Therapy: Is the recent FDA hold – that came and went in record time, a setback to Juno? Who will win the CAR-T race to market in the United States? What is the market opportunity in Europe?
* Jounce/Celgene Deal: Celgene have a reputation for doing deals with innovative biotech companies, but then what? Is the Jounce deal a good one, or is it a value destroyer?

There are a few other questions in the mail bag, but the above gives you a flavour of some of the commentary in this post.

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ASCO 2016 Preview 1 – Novel Combination Approaches

For years we’ve followed the trials and tribulations of targeted therapies seeing many approved and quite a few disappear forlornly (and officially) off to dog drug heaven. Many more sit in no-man’s land as companies eagerly wait in a holding pattern for other trial readouts in different tumour types. Sadly, sometimes these studies don’t generate enough compelling data either. With so much competition about, there are no shortcuts or low-hanging fruit in biotech or cancer drug development any more.

ASCO16 Chicago 1

En route to Chicago and ASCO!

Then along came antibody drug conjugates (ADCs), with some encouraging results in a range of cancers in both solid tumours and hematologic malignancies that lead to the approval of several new therapies.

After that, the next big advance was immunotherapies, specifically checkpoint blockade, with encouraging single agent activity in melanoma, lung, and even urothelial bladder cancer. We’ve also seen the promise fo combining two different checkpoints such as nivolumab and ipilimumab together in metastatic melanoma, albeit with an increase in toxicities.

This is all very well and good, although the challenge remains that the majority of patients either respond to therapy and relapse, or do not respond at all, depending on the circumstances, the tumour type and the regimen. We still have a long way to go in moving the needle and creating a new paradigm shift on a broad scale.

So what happens when we start to combine modalities – such as targeted therapies with immunotherapies?

Uh-oh, I hear the distant cries of disagreement erupt…

  • Remember vemurafenib plus ipilimumab in metastatic melanoma was scuppered by severe hepatitis?
  • What about osimertinib plus durvalumab in NSCLC and the increased incidence of ILD?

Both of these statements are true, and yet… we should not assume that all mixed therapy combination approaches are doomed on the basis of a mere n of 2. What happens if some are synergistic or additive? What happens of there are hidden gems that teach us new ways of doing things rather than doing the same old thing just because it’s always been done that way?

With this in mind, I’d like to open the door on our first ASCO 2016 Preview series with a look at novel combination approaches in development that caught my eye.

What are the early hints and signals that we can learn from the data? Which companies are evaluating imaginative new ideas that may turn the tables on traditional thinking?  The ideas discussed here may well surprise a few people.

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Will pembrolizumab extend its activity in GI cancers?

Franciscan Crab Restaurant San FranciscoWe saw at ASCO last year that response to checkpoint immunotherapy is feasible in some patients with colorectal cancer, but what about other gastrointestinal tumours such as pancreatic, duodenal and biliary cancers?

Can their activity extend beyond the obvious hypermutated tumours such as melanoma, lung, renal and bladder cancers?

Many of you will know that most pancreatic cancers, for example, are detected late and prognosis in metastatic disease is generally poor. You also typically don’t see much coverage of the other GI non-CRC cancers from cancer conferences in the medical media outside of pancreatic cancer occasionally.

At the ASCO Gastrointestinal symposium (#GI16) this past weekend, there was some new data of note in these tumour types that is well worth highlighting and discussing because it may have a major impact on the GI landscape.

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CD40 as a Cancer Immunotherapy Target

There are now several CD40 agonist antibodies in early clinical development from several different companies, including:

  • Roche – RO7009789
  • Apexigen – APX005M
  • Seattle Genetics – SEA-CD40
  • Alligator Bioscience – ADC–1013

This post is the last in our cancer immunotherapy coverage from the European Cancer Congress in Vienna. It features excerpts from an interview with Dr Christian Rommel, head of oncology discovery at Roche in Basle, Switzerland in which he talks about the development of their CD40 monoclonal antibody. Readers may recall we wrote about this from SITC 2014 last year: “Targeting CD40 in Cancer Immunotherapy.”

This post is also a new primer on CD40 as we start our coverage of the Society for Immunotherapy of Cancer (SITC) 2015 annual meeting. We’re informed by SITC it’s a sell out conference with 600 more people than last year’s record breaking number. Cancer Immunotherapy is indeed the hottest topic in cancer drug development.

If you have plans to be at National Harbor this week, we hope to see you there!

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AB Science files for Pancreatic Cancer approval

AB Science confirms the filing for the Marketing Authorization Application to the European Medicines Agency of Masitinib in the treatment of Pancreatic Cancer.

AB Science LogoParis based biopharmaceutical company AB Science announced in an October 16 news release that the company has applied to the European Medicines Agency (EMA) for approval of masitinib in pancreatic cancer.

Masitinib is a tyrosine kinase inhibitor of PDGF, PDGFR, FGFR, FAK, c-KIT. A phase 3 clinical trial (NCT00789633) in pancreatic cancer is underway that compares masitinib with gemcitabine to placebo with gemcitabine.  The trial started in November 2008 with an estimated enrollment of 320 patients at 68 study locations. As far as I am aware no data has yet been presented for this trial.

The phase 2 trial results for mastinib in pancreatic cancer were, however, extremely promising.

Alain Moussy, CEO of AB Science in an interview on Pharma Strategy Blog, A leap of faith: AB Science & mastinib in pancreatic cancer, stated that masitinib “is unique its ability to resensitize the pancreatic cell that has become resistant to gemcitabine.”

Strangely, the AB Science news release today offers no top line results, and merely states the “communication of results was delayed to allow the filing for patent applications aimed at extending the period of marketing exclusivity.”

The presumption from the filing and today’s announcement is that the data for mastinib in pancreatic cancer is positive, which is good news for patients. I look forward to hearing more about the overall survival benefit for masitinib when more data becomes available.

This news also adds to the excitement building in pancreatic cancer, with the Celgene Abraxane data expected before year end.

Update November 1, 2012: Phase 3 Trial Results Announced

In an October 30, 2012 news release, AB Science finally shared the data for their Phase 3 clinical trial (NCT00789633): A Study to Compare Efficacy and Safety of Masitinib in Combination With Gemcitabine, to Placebo in Combination With Gemcitabine, in Treatment of Patients With Advanced/Metastatic Pancreatic Cancer.

I don’t plan to rehash the self-explanatory news release, but the results are mixed. The Principal Investigator, and leading pancreatic cancer experts I contacted (who were not involved with the trial) did not respond to requests for comment. This suggests that we will have to wait till the data is presented at the ASCO GI symposium in San Francisco next year to fully understand the implications for clinical practice.

Bad news: Study failed to meet it’s primary endpoint of showing that masitinib increased overall survival (patients lived longer) when used in combination with gemcitinabine versus gemcitabine alone.

  • Median OS was 7.7 months in the masitinib plus gemcitabine treatment arm versus 7.0 months in the placebo plus gemcitabine treatment arm (p=0.74; hazard ratio=0.90).

The company news release states:

“This finding of a non significant survival improvement in the overall population is explained by the fact that masitinib is not indicated when Gemzar® is highly efficient.”

However, there is some positive news for AB Science, and that is a subset of the 320 patients in the study did significantly live longer with masitinib.

Good news: a subset of pancreatic cancer patients with a novel genetic biomarker for tumor aggressiveness, identified using RNA expression from whole blood samples, lived significantly longer with masitinb.

  • Patients in the subset with this biomarker (65% of the study population) had a median overall survival (OS) of 5 months on gemcitabine alone, while those on masitinib and gemcitabine had an OS of 11.0 months (hazard ratio of 0.29, p=0.000038).

A survival advantage of 6 months with mastinib is a dramatic result!

If mastinib can be used in conjunction with a predictive biomarker that identifies those patients who may likely respond, it is hard not to imagine that some form of regulatory approval would be forthcoming, despite the failure of the trial to meet it’s primary endpoint. However, more clinical data and another clinical trial may be needed to validate the biomarker, if as it appears, the biomarker was identified retrospectively.

There are also many unanswered questions:

  • what is the technology needed to detect the biomarker?
  • is this a test that can be routinely performed?
  • is there a diagnostic kit available?
  • How might such a genetic biomarker be used in clinical practice by non-academic physicians?
  • What is the extent to which the biomarker has been shown to be valid and reproducible?

I look forward to hearing more about the masitinib data at the ASCO GI 2013 meeting.

Update November 6, 2012: Skuldtech identified as diagnostics partner

Another piece of the jigsaw has been provided in a November 3 news release from AB Science that french company, Skuldtech is the company they are working with on a companion diagnostic test for masitinib in pancreatic cancer. As usual, I found the news out first on Twitter:

The AB Science news release states that:

Skuldtech and AB Science plan to exploit these new markers for commercialization of a future companion test associated with masitinib, a molecule developed by AB science for treating pancreatic cancer.

It goes on to say:

“From a simple drop of blood, Skuldtech and AB Science were able to identify specific markers – transcriptomic markers – that can distinguish between the different populations treated during the phase III study and select the predictive markers for pancreatic cancer survival associated with masitinib treatment.”

We await further information on the cost, availability and validation of the companion diagnostic.

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