Biotech Strategy Blog

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

Posts from the ‘Cancer’ category

One of the surprise controversies at ESMO16 was the fall-out between Myriad Genetics (NASDAQ: MYGN) and Tesaro (NASDAQ: TSRO) over whether the company’s PARP inhibitor, niraparib, should require a companion diagnostic for the treatment of women with platinum-sensitive ovarian cancer in the maintenance setting. We previously wrote about this from Copenhagen (Link).



Tesaro were so keen on controlling their message, in the run-up to ESMO, they even went to the trouble of taking out a legal injunction against Myriad Genetics in an attempt to prevent them publishing their own press release discussing the niraparib data.

We knew about this “off the record” at ESMO, but it’s now a matter of public knowledge and John Carroll admirably reported the story on Endpoints last week (Link).

It is a sad reflection on any biotech partnership or pharma alliance if you can’t reach an agreement in private, and have to resort to an injunction in US Federal Court. Doubly unfortunate when you lose the injunction too!

As many readers are already aware, back in June 2014 AstraZeneca failed to convince an FDA ODAC about the merits of olaparib in the same indication that Tesaro are seeking. This is why the data for Tesaro and their regulatory/commercial approach justifies careful scrutiny.

What’s more, data from Myriad Genetics was key to AstraZeneca obtaining a subsequent indication for olaparib in more advanced ovarian cancer, so their experience in this space cannot be dismissed.


Johnathan M. Lancaster MD PhD

At ESMO, the Myriad Genetics Laboratory Chief Medical Officer, Dr Johnathan Lancaster kindly spoke to BSB.

He shared his perspective on the niraparib data and why a companion diagnostic should be considered based on the NOVA trial data presented by Dr Mansoor Mirza. You can read more about the data in The NEJM paper that was published simultaneously (Link).

Dr Lancaster was formerly Director of the Center for Women’s Oncology, and Chair of the Department of Women’s Oncology at Moffitt Cancer Center in Tampa.

While he does bring a corporate bias based on his position at Myriad Genetics Laboratories – and Myriad clearly have a vested interest in selling diagnostic tests – his clinical perspective is worthy of consideration and it’s one that is shared by other GYN oncology thought leaders we have spoken to (see: earlier post, “what Tesaro aren’t telling you about niraparib”).

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Yesterday saw the FDA approval of atezolizumab (Tecentriq) for the second-line treatment of metastatic non-small cell lung cancer (NSCLC) (link to company press release).  According to Genentech:

“This approval is based on results from the randomized Phase III OAK and Phase II POPLAR studies. The largest study, OAK, showed that TECENTRIQ helped people in the overall study population live a median of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy (median overall survival [OS]: 13.8 vs. 9.6 months; HR = 0.74, 95% CI: 0.63, 0.87). The study enrolled people regardless of their PD-L1 status and included both squamous and non-squamous disease types.”

The FDA approval is largely a broad one in 2L and 3L across PD-L1 expression and histologies [Link]:

“TECENTRIQ is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving TECENTRIQ.”

The approval was widely expected in light of the Phase III OAK trial data presented in the Presidential Symposium at ESMO16 meeting in Copenhagen.

Sign adjacent to #ESMO16 in Copenhagen

Sign adjacent to #ESMO16 in Copenhagen

Imagine hearing live about positive first-line data with pembrolizumab, with and without chemotherapy, negative data from nivolumab in the same setting, the 2L data for atezolizumab and two discussants drilling into both the data and broader impact of these studies to a jam packed audience that even included thought leaders from other tumour types who were also eager to hear the news. To say the atmosphere was electric would be a rather British understatement here.

We previously covered our initial impressions from that session [Link], but we also had the pleasure and privilege of interviewing a leading US thought leader in the lung cancer space after the session to garner his impressions of the data and also some perspectives on the key issues that the field is facing.

The pembro plus chemo data is already providing some controversy amongst various protagonists given there are a number of similar combination trials expected to read out over the next year to 18 months, plus much anticipation from analysts regarding the ditching of chemo for IO combos such as anti-PD–1 plus anti-CTLA–4 (BMS and AstraZeneca have keen stakes here), but what do thought leaders really think of that concept? Is that the slam dunk that many analysts seem to think it is?

This, my friends, is where things start to get a lot more complicated, akin to 3D chess in Star Trek.

What is happening now in advanced NSCLC is not how the market will look in a year or two. In many ways, the rate of approvals are outstripping the pace of science right now, but once the low hanging fruit is gone, competition will need to evolve in much more sophisticated and elegant levels.

With these questions in mind, we have a double header for you today – you can read on to find out more details from our latest though leader interview, supported by some insightful perspectives from a medical oncologist who treats lung cancer patients in private practice. Today’s post therefore covers some wide ranging discussions across the key issues in advanced NSCLC and it’s future direction.

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Please note that subscription prices will increase on Monday 24th, so if you’ve been on the fence about our upcoming coverage of #SITC2016, #ENA2016 (EORTC/NCI/AACR Mol Targets), #ASH16, #SABCS16 and #JPM17 then now is a good time to lock in at the current rates!

Copenhagen – Day 3, Sunday at #ESMO16 was a day to remember on many levels. From being carried forward by a rush of people as a massive crowd was finally let into the Presidential Symposium…

Large crowd of delegates wait patiently to enter ESMO16 Presidential Symposium

Large crowd of delegates wait patiently to enter ESMO16 Presidential Symposium

…to hearing an outstanding discussion of data by one of Europe’s leading lung cancer experts, Professor Jean-Charles Soria (@jsoriamd). He was insightful, engaging, as well as funny in places and was a hard act to follow…

Prof. Soria discussing KEYNOTE-024 data at ESMO 2016

Prof. Soria discussing KEYNOTE-024 data at ESMO 2016

The end result was a day to remember, most significantly it was one where we heard data that will change the standard of care in front-line non-small cell lung cancer (NSCLC), with the expected approval of pembrolizumab (Keytruda) for patients whose tumors have a high expression of PD-L1 (50% or more).

We’re continuing our daily digest of highlights from sessions we attended at the 2016 European Society for Medical Oncology (ESMO) Congress here in Denmark.


The sun has not shone much here in Denmark during the Congress, the above photo of Nyhavn was taken just before the meeting started, but the data at ESMO16 has shone brightly with two more publications online in The New England Journal of Medicine to coincide with their presentation in Sunday’s Presidential Symposium:

Pembrolizumab versus Chemotherapy for PD-L1–Positive Non–Small-Cell Lung Cancer (NEJM link)

Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck (NEJM link).

This mini-series of daily digests over the 4 days of the Congress is intended to give subscribers a finger on the pulse on some of the buzz and conversation…. and occasionally an alternative perspective. We’ll be writing more detailed posts as part of a post-conference series.

In this post, @MaverickNY offers her topline impressions of the lung cancer data presented in the Presidential Symposium, how this will change how some patients are treated, and the resulting impact on the lung cancer landscape. Cancer Immunotherapy continues to drive changes in clinical practice, and is doing so at a very remarkable pace.

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Copenhagen – it’s the end of Day 2 of the European Society for Medical Oncology (ESMO), which this year had a record-breaking 20,239 attendees.


Three of the presentations in today’s plenary Presidential Symposium were simultaneously published in The New England Journal of Medicine – I haven’t seen that happen before.

All three were also featured in this morning’s media briefing in Copenhagen.

  • Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer (NEJM link)
  • Prolonged Survival in Stage III Melanoma with ipilimumab Adjuvant Therapy (NEJM link)
  • Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer (NEJM link)

In today’s daily digest there’s top-line commentary and insights from some of the sessions we attended. In a separate post, we have already discussed the niraparib data.

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Copenhagen – PARP inhibitors are creating quite a lot of controversy here at the 2016 ESMO Congress.

Yesterday, we heard the data for rucaparib (Clovis Oncology) as monotherapy treatment for the advanced ovarian cancer patients with BRCA mutations who have been treated with 2 or more chemotherapies.

In a totally different ovarian cancer indication, today at #ESMO16 we heard the results of the phase 3 trial for niraparib, the PARP inhibitor from Tesaro, that many thought was superior to the rucaparib data, ignoring the fact you can’t make comparisons for maintenance versus relapsed/refractory treatment.

The niraparib ENGOT trial was presented in today’s plenary Presidential Symposium by Dr Mansoor Mirza and simultaneously published in The New England Journal of Medicine (link). It was also featured in a media briefing earlier today in Copenhagen.


In this piece we’ve taken a critical look at the Tesaro (NASDAQ: TSRO) niraparib data and the controversial claim made by their principal investigator, Dr Mirza, that the data shows there is no need for a companion diagnostic to be associated with this drug.

In other words, the intent that regulatory approval will be sought for this drug as maintenance therapy for platinum-sensitive ovarian cancer patients, irrespective of whether they have a BRCA mutation or homologous recombination deficiency (HRD).

This post provides commentary on this and offers the perspective of a leading ovarian cancer expert with deep experience of companion diagnostics in this field.

Subscribers can login to read what Tesaro aren’t saying about the Niraparib data or you can purchase access below…

Copenhagen – today was day one (Day 1) of the 2016 Congress of the European Society for Medical Oncology (Twitter #ESMO16).


ESMO 2016 Registration

The meeting is a few weeks later than last year’s European Cancer Congress in Vienna, and it definitely feels as though autumn has arrived in Europe.


Cyclists in Central Copenhagen

This year we’re providing a daily digest at the end of each day at ESMO 2016 in Copenhagen.

The aim is to provide some top-line commentary around the sessions we attended earlier in the day. Think “Match of the Day” for those in UK or “Sports Center” for those in the US. We’ll be writing more in-depth pieces after the meeting.

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Cancer Immunotherapy will require personalized treatment based on the type of cancer you have, and the immune response your body has generated to the cancer.

Dr Holbrook Kohrt Stanford

Dr Holbrook Kohrt at Immunology 2015

The sadly missed and visionary Dr Holbrook Kohrt was very prescient when he told BSB in New Orleans back in May 2015:

“Today when I see a patient or you go to a cancer center, the first thing they ask is what type of cancer do you have? Most patients respond – breast cancer, a colon cancer – unfortunately we are not in position where patients can say I have a deficiency in my cytotoxic CD8 cells or I have overly active regulatory T cells.

I actually envision a day when patients will know both sites, they will know they have breast cancer and they’ll also know it’s because there’s a lack of effector cytotoxic CD8 T cells. That combination knowledge, of what your immune system is lacking and what tumor you have, that combination will allow you to identify what type of immunotherapy you need.

Patients may need CAR directed T cells and those will be for patients who have completely non-functional T cells themselves, no matter what therapy you give them, you’re not going to create those cells within the body, therefore you need to do it ex-vivo in a petri dish and give it back to them.

Other patients may have T cells that just need to be turned on and so all they need is a checkpoint modulator and that combination is going to be effective enough for them.

So it’s this dual diagnosis, diagnosing their immune system and diagnosing their tumor that’s going to allow us to identify one, two, or three therapies that’s going to be the right cocktail.” 

See post: Holbrook Kohrt leads the way in Targeting CD137, you can also listen to excerpts on the Novel Targets Podcast: Episode 6: Stepping on the Gas

ICYMI do listen to the tribute to Dr Kohrt on the Novel Targets Podcast from two people who knew him at Stanford: Dr Ron Levy and Dr Dan Chen (@DanChenMDPhD). It’s at the start of Episode 11: Cancer Immunity Cycle.

Immunoscore® — a diagnostic test based on the immune profile of a patient is based on the pioneering work of INSERM scientist Dr Jérôme Galon.

Dr Jerome Galon at ASCO 2016

Dr Jérôme Galon at ASCO 2016

We are fans of his work, and interviewed him at the 2015 European Cancer Congress. See post: Immunosurveillance, Immunoscore & Personalized Cancer Immunotherapy – an interview with Jérôme Galon.

Over 10 years ago, Dr Galon’s research published in The New England Journal of Medicine and Science showed that the type, location and density of immune cells within a tumor predicts clinical outcome in early stage colon cancer.

These findings led to the development of an assay called Immunoscore® that’s based on an analysis of cytotoxic T cells, the ones that kill cancer.

In the process, it has led to a new way of classifying stage 2/3 colon cancer patients: those with a high Immunoscore® (good prognosis), and those with a low Immunoscore® (poor prognosis). Dr Galon’s work has shown that irrespective of whether you are MSI high or MSS, colon cancer prognosis correlates with Immunoscore.

Dr Bernard Fox at #AACR16

Dr Bernard Fox at AACR 2016

As we heard from Dr Bernie Fox (@BernardAFox) at AACR 2016. See post: AACR Cancer Immunotherapy Insights from Dr Bernard Fox, listen to excerpts on Novel Targets Podcast Episode 12: Of Mice and Men:

“What I teach the first year medical students is that if you have metastatic cancer, the only thing that makes a difference in your life is whether you’ve got your immune system turned on. If it’s not turned on, it doesn’t make a difference what you get, chemo, radiation, surgery, you aren’t going to do well.”

Immune response is key to outcome, which means that knowing what your immune profile is will be key to deciding which of the many immunotherapy options, either alone or combination will achieve the desired effect.

A large multinational phase 3 clinical trial sponsored by the Society for Immunotherapy of Cancer (@SITCancer) was set up to validate Immunoscore® as a biomarker in Stage 2 colon cancer.

Dr Galon and co-authors reported the results at ASCO 2016. See post: immunoscore validated as an important biomarker for colon cancer. He featured on the ASCO 2016 episode of the Novel Targets Podcast: Immunotherapy or Bust.

Immunoscore® is now being commercialised by Marseille based HalioDx(See post: HalioDx CEO Vincent Fert outlines commercial strategy for Immunoscore in US and Europe).

ciml40During a recent visit to the Marseille Immunopôle for #CIML40, I had the pleasure to do an impromptu tour of the HalioDx lab.

When listening/watching this, do bear in mind this was not a scripted tour, and also the people I spoke to were speaking English as a second language.

It’s not intended to be a definitive guide; if you are a patient you should talk to your doctor about any questions you have about diagnostic assays such as Immunoscore.  At the moment, it’s only available for research or clinical trial use, but HalioDx has plans to make the assay commercially available on the US and Europe.

The company has more information on their website and also recently published a paper in the Journal for Immunotherapy of Cancer (open access) that describes how the test is done in more scientific detail.

In the meantime, subscribers can login to join me for a lunch-time tour, or you can purchase access below. The audio-slideshow tour was for several weeks open access and available to all, but is now for subscribers only:

After some relatively quiet summer months, we have been deluged with questions and requests this month for commentary on some hot topics of late. This seems like a good time to take stock and reflect on some of most frequent ones sent in.

west-acton-tubeThe original Journal Club post slated for today will appear next week instead.

Here, we address numerous queries on the following five topics readers are interested in:

  • APHINITY trial in HER2+ adjuvant breast cancer
  • Array’s BRAF plus MEK data in metastatic melanoma
  • Kite’s interim ZUMA–1 phase 2 announcement
  • Amgen’s Kyprolis in newly diagnosed multiple myeloma
  • BMS nivolumab data in 1L lung cancer (CheckMate-026)

The last two in particular seem to be causing a lot of hand-wringing!

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New York – at the CRI-CIMT-EATI-AACR international cancer immunotherapy conference (Twitter #CICON16) that’s currently underway, one of the plenary oral presentations and posters that attracted my attention was for CPI-444, a small molecule inhibitor of the adenosine 2 A receptor (A2AR). It is in development by Corvus Pharmaceuticals (NASDAQ: CRVS).

Corvus Pharmaceuticals Logo

Stephen Willingham, PhD a Senior Scientist at Corvus presented data yesterday on CPI-444, “A potent & selective inhibitor of the A2AR that induces antitumor responses alone and in combination with anti PD-L1 in preclinical and biomarker studies.”  

Corvus announced a collaboration with Genentech back in October 2015. A phase 1 trial with CPI-444 alone and in combination with Genentech’s anti-PD-L1 checkpoint inhibitor atezolizumab (Tecentriq) is now underway.

Targeting the tumor microenvironment to lower the immunosuppressive adenosine and improve checkpoint point effectiveness could be a big win for both Corvus and Genentech if CPI-444 is able to significantly improve the response rates to atezolizumab.

Corvus Senior Scientist Stephen Willingham, PhD and Chief Business Officer Jason Coloma, PhD kindly spoke to BSB about what the data presented in New York means and the company’s clinical development strategy.

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At the recent scientific meeting to celebrate the 40th anniversary of the Centre d’Immunologie de Marseille-Luminy (#CIML40), Professor Ton Schumacher from the Netherlands Cancer Institute gave an informative presentation on “T cell recognition and tumor resistance in human cancer.”

Professor Ton Schumacher at CIML40

Picture Credit: ATGC Partners

Schumacher started his talk at CIML by saying, “I guess by now I should consider myself a cancer immunologist…”

Cancer immunologist ‘wannabes’ should take note of the level of expertise required to be considered one!

Neon Therapeutics LogoHe is one of the co-founders of Neon Therapeutics and a leading researcher into antigen-specific T cell immunity.

Several companies are seeking to develop personalized cancer vaccines against patient-specific neoantigens.

We previously wrote about the approach Neon Therapeutics is following based on expert interviews with the interim CEO Cary Pfeffer and scientific co-founder Dr Cathy Wu.

BioNTech LogoYesterday the field heated up when it was announced that German biotech BioNTech AG had entered a strategic collaboration with Genentech to develop individualized mRNA cancer therapies (Sept 20, 2016 press release).

This post continues the BSB mini-series on targeting neoantigens that we started last month. Do check out previous posts if you missed them:

After his #CIML40 presentation, Prof Schumacher kindly spoke to BSB.

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