Biotech Strategy Blog

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

Posts from the ‘Ovarian’ category

esmo-poster-hallThis post started out as a look a one of the Gems from the Poster Halls at ESMO, including an interview with a thought leader in biomarkers, then morphed into a broader Op Ed that includes a strategic analysis of where we are, where we are going, and how we could get there more effectively and efficiently.

It’s time to turn tables to start challenging the status quo and slow pace of development if we really want to make a difference in advanced ovarian cancer.  I was recently challenged by a well respected GYN oncologist to delineate how we could do things differently so here are some ideas, along with the scientific rationale in my response to his gauntlet.

Is the ideal situation one where multiple companies randomly throw mud at the wall hoping something sticks the best approach? Or are there more effective ways to make a difference?

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One of the surprising things I learned over the summer was how many people misunderstand how advanced ovarian cancer is treated as a disease… it isn’t really one disease to start with, but is actually a series of subsets depending on the molecular underpinnings and also how women with the condition react to therapy.

Imagine then, when we see a series of press releases and abstracts emerge on PARP inhibitors followed by a rather indecent and sudden rush to judgment by Wall St and investors on the ‘Winner takes All’ out of the lot?

Except that real life doesn’t work that way in clinical practice.

A head/desk moment to be sure, and a frustrating one for those who understand what this is actually all about. To address this siituation, we had the pleasure of communicating with KOLs remotely or sitting down with several thought leaders in gynecologic cancer in Copenhagen to debate various aspects relating to current treatment paradigms, new clinical trial data with PARPs, and what they are most excited about going forward.

Copenhagen Waterfront

Copenhagen Waterfront

Today’s post highlights our latest thought leader interview with an experienced GYN oncologist and their perspectives on the rucaparib and niraparib data presented earlier this month at ESMO.

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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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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.

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westminster-embankmentToday’s news that an FDA Oncologic Drugs Advisory Committee (ODAC) review will not be required for rucaparib is good news for Clovis Oncology. The company announced this via an SEC 8K filing:

“The Food and Drug Administration (“FDA”) has notified Clovis Oncology, Inc. that FDA is not currently planning to hold an advisory committee meeting to discuss the Company’s New Drug Application for rucaparib.”

However, given the unmet medical need in ovarian cancer, a lot of companies are targeting both platinum sensitive and platinum resistant disease.

In our fourth preview of the forthcoming European Society for Medical Oncology (#ESMO16) meeting we’re looking at 9 key ovarian cancer abstracts to watch out for at ESMO.

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Prof Fran Balkwill Barts Cancer InstituteWhen it comes to cancer immunotherapy drug development, one of the challenges is that we can’t accurately predict from preclinical mouse models what will happen in people. The result is a rush into the clinic to test in human subjects.

We do need better preclinical models, which is why it was interesting to hear recently on an episode of Health Check (BBC World Service) about a 3D tumour model that is being developed at Barts Cancer Institute.

Professor Fran Balkwill (pictured), who leads the Centre for Cancer and Inflammation, kindly spoke to BSB about the work she and colleagues are doing to model the tumour microenvironment (TME) in high-grade serous ovarian cancer.

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Tesaro’s niraparib is a highly selective poly(ADP-ribose) polymerase (PARP) 1/2 inhibitor that can induce synthetic lethality in tumor cells with homologous recombination DNA repair deficiencies (HRD), including germline BRCA-mutated tumours.  It received a lot of attention yesterday following the company’s announcement that the phase 3 trial successfully met its primary endpoint.  The trial was expected to readout this month, so it was bang on schedule.

ASCO 2016 Posters 5

Braving the scrum in the ASCO 2016 poster hall

The results generated a lot of discussion and also a bunch (half a dozen!) of questions from readers, since there was a lot noise around the top-line data in the press release, but very little real analysis or context.

I was planning on rolling out the draft posts we have been working on Gems from the Poster Halls, which included one focused on ovarian cancer.  It therefore makes sense to combine the poster analysis with a reader Q&A on ovarian cancer, including a detailed look at Tesaro’s niraparib as there are some important subtleties that many have missed.

Inevitably this ended up as a rather meaty analysis rather than the quick review I originally intended!

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One of the (many) highlights for me at the recent annual meeting of the American Association for Cancer Research (AACR) was a “Meet the Expert” session presented by Professor George Coukos.

Prof George Coukos AACR 2016

Prof George Coukos AACR 2016

Professor Coukos is Director of Oncology at the University Hospital of Lausanne and Director of the Ludwig Institute for Cancer Research in Switzerland.

Ovarian cancer is becoming a fascinating battleground for cancer immunotherapy, with multiple challenges that must be overcome before we see improvements in outcomes, especially for women advanced disease.

The interview with Prof Coukos is a follow-on to the one we did on advanced ovarian cancer and checkpoint blockade at ECCO 2015 in Vienna with Dr Nora Disis (Link).

If you missed it, you can still listen to highlights in Episode 7 of the Novel Targets Podcast (Link).

After his AACR presentation, Prof Coukos kindly spoke with BSB and in a wide ranging discussion, highlighted some of the innovative clinical trial strategies he is working on to move the cancer immunotherapy field forward in ovarian cancer.

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Dr Nora Disis ECC 2015

Dr Nora Disis, U Washington

At the recent European Cancer Congress in Vienna, Austria, Dr Nora Disis  (pictured right) kindly spoke with BSB about her clinical research with avelumab (Merck KGaA/Pfizer), a cancer immunotherapy that targets the programmed death-ligand 1 (PD-L1).

Dr Disis (@DrNDisis) who is Editor in Chief of JAMA Oncology (@JAMAOnc) and a Professor of Medicine at the University of Washington, presented a poster at the meeting (Abstract #2749) with updated data for the phase 1b trial of avelumab in relapsed/refractory ovarian cancer.

In addition to reviewing the results with avelumab and in particular, the biomarker results for PD-L1 and CA125 expression, Dr Disis talks about why avelumab is different from other anti PD-L1 checkpoint inhibitors.

This is particularly important when considering a competitive and crowded marketplace where path-to-market strategies become more focused and critical.  Certainly some of the issues discussed in detail present a nice case study of some the challenges facing pharma companies when you are 5th, 6th or more to market.  Differentiation becomes a key driver that needs to be considered and incorporated into the clinical development plan.

She also talked candidly with BSB about some of the challenges and opportunities for checkpoint inhibitors and the PD-L1 in ovarian cancer, a disease where there is a high unmet medical need for effective new therapies.

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Photo: National Institutes of Health

After last week’s post on therapeutic tumor infiltrating lymphocytes (TILs), we received a bunch of questions from readers.

I don’t have time to answer them all in detail individually (sorry!), but it does provide an opportunity to review the evolving landscape and address some of them within the latest article.

It seems to be a good time to take a broader look at T cell manipulation, especially as it pertains to the application of TILs, chimeric antigen receptors (CAR), and T cell receptors (TCR).

We’ve certainly come along way since the historic lecture in 1991 pictured right (photo: National Institutes of Health), but there’s still some way to go before the full potential of cancer immunotherapy is reached.

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