Biotech Strategy Blog

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

Posts tagged ‘avelumab’

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). You can listen to excerpts from this interview on Episode 4 of the Novel Targets podcast (See: The non-inflamed tumour show).

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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We’ve been saying for a while that 2017 and onwards would be when we start to see a few IO combination trials start to shake out. Interestingly, that process seems to have already started, if recent news is any thing to go by.

With this in mind, the annual meeting of the American Association for Cancer Research (AACR) coming up this weekend gives us a timely moment to explore combinations that are looking interesting… or not.

In the last of our AACR 2017 Conference Previews, we take a look at what to expect on this year’s program in the IO and Checkpoint arena. In short, it’s quite a lot and not without some controversy either!

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Part 3 of our series on Gems from the Poster Halls at ESMO continues with a look at another four important combination studies that may be of keen interest to readers.

These include both targeted therapies as well as immunotherapies.

Some of the posters I was originally keen to write about turned out a little unexpectedly with some issues to address i.e. lack of efficacy or unwanted toxicities based on the dosing schedule used and may require tweaking of the dosing, schedule or trial design. Others will unfortunately be destined for dog drug heaven unless a new tumour type offers more promise. Such is the R&D roller coaster that is oncology – sometimes we forget that more compounds fail than make it market.

The good news is that there were plenty of promising approaches that are worthy of writing up and discussing. In the third part of our poster mini-series, we take another deeper dive with a careful look at some new data in Copenhagen.

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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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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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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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Updated data are often presented at conferences and therefore the results can differ from the submitted abstracts, which are sometimes submitted as placeholders based on immature data cutoffs. That was certainly the case in several examples at the ASCO GI conference in San Francisco last weekend.

San Francisco HerculesAfter Monday’s look at new developments in the lower GI tract, we now turn our attention today to the upper GI tract with a focus on oesophageal, gastric (stomach), and gastro-esophageal junction (GEJ) cancers.

Over the last five years we have seen new approvals for targeted therapies such as HER2+ gastric cancer and relapsed refarctory gastric cancers with a VEGF inhibitor. Will that trend continue over the next five years or will we see new approaches such as immunotherapy enter the market and dominate?

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Today the immunotherapy and related data flooding out of the annual meeting of the San Antonio Breast Cancer Symposium (SABCS) is pretty exciting!

Data was presented on a number of drugs including pembrolizumab, avelumab and atezolizumab, which put together with some recent publications, highlights some potentially exciting opportunities in this fast moving space.

Here, we explore the potential for checkpoint therapy combinations in TNBC, HER2 and even the ER+ subsets.  There’s a lot of new findings to take in and contemplate here.

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We’ve heard a lot about agents that target the PD–1/PD-L1 pathway over the last two years, in particular, from:

  • Nivolumab (BMS)
  • Pembrolizumab (Merck)
  • Atezolizumab (Roche/Genentech)
  • MEDI–4736 (AstraZeneca/MedImmune)

What about other agents against this pathway that are in earlier development? It really doesn’t take long for a new space to become quickly crowded and very competitive, as the Pharma R&D machines start cranking out results from clinical trials.

A critical question that will to be considered is how will the third, fourth or even 19th agent to market differentiate themselves from those already approved and established? Is it realistic to expect a blue ocean strategy approach or will the pieces of the pie become ever smaller?

At the annual meeting of the American Society of Clinical Oncology (ASCO) earlier this month, there was new data presented from other companies on checkpoint inhibition.  We took at look at some of the emerging data in more detail.

To learn more about the increasingly competitive anti-PD1/PDL1 pathway market, check out our insights in the mini report below.

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