Biotech Strategy Blog

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

Posts from the ‘Melanoma’ category

In honour of Armistice / Veteran’s Day 11/11

National Harbor – We’re continuing our SITC 2019 coverage with a look at some intriguing and likely controversial data.

The Best Clinical Data at SITC wasn’t NextCure’s NC318 Siglec–15 (more on that tomorrrow)

But…

Nektar’s pegylated IL–2, bempeg, in combination with nivolumab in frontline metastatic melanoma.

The controversy will no doubt continue to rage with fervent fans and equally intense deniers, but what can we learn from the latest data that was presented by Dr Adi Diab and where are things likely headed?

Included in this latest update are an in-depth thought provoking expert interview with Nektar’s Dr Jonathan ‘JZ’ Zalevsky, plus commentary and analysis on what this all means when we look at the bigger strategic picture.

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La Tour Eiffel par nuit

Paris, France:  It’s the dog days of summer and my reading stack of interesting science and cancer research papers is particularly high at the moment despite reading voraciously over the last few weeks…

So much excellent research keeps on piling up as fast as one can get through it.

It’s beginning to feel like Ravel’s Bolero…

Still, there’s one particular batch of important papers that draws together some interesting findings in an area we have been following for a little while now and these data most certainly advance the field in more ways than one.

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Dr Mario Sznol

Dr Mario Sznol at SITC 2015 Patient Forum

Novel Immunotherapies and Combinations” was the title of the talk by Dr Mario Sznol (Yale) at the recent Immunotherapy Patient Forum co-hosted by Global Resource for Advancing Cancer Organization (GRACE) and the Melanoma Research Alliance at the 2015 SITC annual meeting.

At the forum, Dr Sznol also led a breakout session, where he reviewed what is melanoma, the treatment of primary melanoma and management of advanced disease, as well as answering questions from the patients and patient advocates.

Often at medical meetings you hear the results of a clinical trial that is but one piece of the jigsaw, so it was interesting to hear a more comprehensive overview of the disease.

Dr Sznol kindly spoke with BSB about his vision for the future of cancer immunotherapies. This post includes excerpts from the interview along with additional commentary.

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Oxford based Immunocore is an emerging UK biotechnology company that should be on your radar if you’re following companies such as Kite Pharmaceuticals and Juno Therapeutics. If it isn’t already you can expect to hear a lot more about them in the forthcoming year as they start clinical trials with the many leading global pharma companies who have already partnered with them.

Dr Namir Hassan, Immunocore

Immunocore is an immuno-oncology company with an innovative approach to targeting T Cell Receptors (TCR) using their proprietary ImmTAC (Immune mobilising monoclonal TCRs against cancer) technology platform.

Namir Hassan, D.Phil (pictured right) is Director of Translational Research and Head of Development at Immunocore. BSB met with him and Chief Business Officer, Eva-Lotta Allan at the company offices located in a science and business park near Oxford.

Immunocore recently raised $320M in Europe’s largest private life sciences funding. (Link to Press Release)

Earlier this year preliminary clinical data for IMCgp100 their first-in-class novel immunotherapy was presented at the annual meeting of the American Association for Cancer Research (AACR) in Philadelphia by Mark Middleton, Professor of Experimental Cancer Medicine at the University of Oxford.

In the interview, excerpts of which you can read below, Dr Hassan explained why their exciting and innovative approach that targets the T Cell Receptor is different from other companies in the field, what they have learned from the preliminary clinical data, and the potential immTACs may offer in combination with other cancer immunotherapies.

If you’re not a cancer immunologist, this type of science is complex, so the aim of the interview was to put into context the data already in the public domain and gain some insights into the excitement behind ImmTACs and what immunocore are doing. If you don’t understand the potential of TCRs and ImmTACs as immunotherapies, this post is for you!

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With the news hot off the press at the 2015 annual meeting of the American Association for Cancer Research (AACR) that Merck’s pembrolizumab (Keytruda) beat out BMS’s ipilimumab (Yervoy) in advanced melanoma, quite a few readers wrote in asking whether this signals the end for ipilimumab?

The short answer is no, and here’s why…

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Recently, Merck have been on a roll in the immuno-oncology space, with the announcement that their anti-PD–1 antibody, pembrolizumab (Keytruda), beat out BMS’s anti-CTLA4 antibody, ipilimumab (Yervoy) in a Phase 3 head-to-head frontline trial in metastatic melanoma. The two primary endpoints of OS and PFS were met and the trial will therefore be stopped early based on the IDMC recommendation. No further details are available until the presentation.

merck_logoThe data from the KEYNOTE–006 study is being presented at the annual American Association for Cancer Research (AACR) next month in the opening plenary session by Dr Antoni Ribas (UCLA).

While it’s nice to see evidence that one checkpoint inhibitor is potentially superior to another, in the long run, combinations are likely to be the best way forward.  This approach is more likely to yield improved responses in immunogenic tumours, but also to make non-immunogenic tumours more responsive, thereby improving patient outcomes further.

This begs the all important question – what hints from new emerging data can we glean that will help us figure out novel combination approaches with checkpoint inhibitors?

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Yesterday’s biotech and pharmaceutical industry news was dominated by the FDA approval of PD-1 inhibitor pembrolizumab (Keytruda) from Merck for the treatment of advanced or unresectable melanoma in patients who no longer respond to other drugs (FDA announcement). Approval was widely expected after the compelling data presented at ASCO 2014 for both pembrolizumab, and another PD-1 checkpoint inhibitor, nivolumab (Opdivo), which was was approved in July in Japan for sale by Ono Pharmaceuticals, a partner of Bristol-Myers Squibb (BMS).

It was amusing to see some of the Academic thought leader reactions to the branding of these drugs:

Not sure if Master Yoda would approve of the names, but no one can doubt that the companies in this space are executing and getting it done expeditiously!   We’ve written extensively about the potential of PD-1/PD-L1 inhibitors from quite a few meeting over the last couple of years so it is good to see them market it market. Melanoma is certainly an area where there is a lot happening in immuno-oncology, and the standard of care will likely be changed by these new agents as they gain approval earlier in the disease and optimal combination strategies are developed that shift the survival curves not only to the right, but also upwards.

BMS recently announced that they had stopped their phase 3 clinical trial of nivolumab first-line clinical trial in untreated BRAF wild type melanoma early in June (press release).  It’s good news for patients with advanced melanoma that there are now new treatment options that will help them live considerably longer.  Skin cancer rates are going up unfortunately, with a third more hospital admissions in the UK over the past five years, which experts believe is down to foreign holidays and the use of sunbeds in tanning salons (BBC Health story).

I expect we’ll hear a lot of excitement at the forthcoming European Society of Medical Oncology (ESMO) meeting in Madrid about what’s happening in immuno-oncology, along with concerns about how countries will afford these new life-saving medicines.

Subscribers can login below to read the next in our ESMO 2014 preview series on what’s hot in melanoma? If you don’t already have access to Premium Content (available only to subscribers) you can purchase access by clicking on the blue button below. Not only does your purchase give you access to future content for the time period selected, but also (at the moment) the back library of all the posts we’ve written to date, so if you missed the data at ASCO 2014, there’s still time to catch up.

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Today’s post focuses on another question from a reader, who asked: “How will we decide which therapies to give patients with metastatic melanoma once the new immunotherapies are available?”

This is not an easy question to answer, but first let’s remember that as little as five years ago there were only treatments such as DTIC (dacarbazine), temozolamide, interferon, chemotherapy and not much else as choices for people with advanced melanoma. Survival rates were generally poor, yet despite the low barrier to entry, many agents failed miserably to beat them. The disease was therefore widely considered to be a graveyard for Pharma R&D.

Fast forward to 2014. We now have several targeted therapies and combinations approved including BRAFV600E (vemurafenib and dabrafenib) and MEK inhibitors (trametinib), as well as a number of others that may soon be on the way in the near term such as cobimetinib in combination with vemurafenib.  Along similar lines, GSK recently announced that the combination of dabrafenib plus trametinib was superior to vemurafenib alone in terms of overall survival.  Hopefully, we will see the full data for both combinations at a medical meeting such as ESMO or EADO in the Fall.

Immunotherapies such as ipilimumab (Yervoy) have also been shown to improve patient outcomes. In addition, others are also in the queue including anti-PD–1 antibodies, which are likely to be reviewed soon by the Health Authorities (e.g. pembrolizumab and nivolumab). Indeed, Japan already approved nivolumab (Opdivo) in advanced melanoma on July 4th, making it the first anti-PD–1 checkpoint inhibitor to be available globally. Meanwhile, in the US Merck had a jump start with their rolling NDA for pembrolizumab already started (the PDUFA is Oct 28th, 2014). Their data at ASCO included probably one of the largest trials I’ve seen in advanced melanoma with over 400 patients included. BMS are not far behind with nivolumab, however, and are expecting to begin their filing in the 3Q this year following the frontline trial (CHECKMATE 037) in BRAF wild type (wt) metastatic melanoma versus dacarbazine successfully meeting its primary endpoint earlier than expected.

You can read about the clinical results relating to the three key melanoma trials reported at ASCO by Ribas et al., Hodi et al., and Sznol et al., in our earlier review but today, I wanted to focus on a broader, more strategic perspective, now that several events post meeting are shaking out more clearly.

A couple of years ago (was it really that long?!), many of us were quite disappointed to see the combination of vemurafenib plus ipilimumab scuttled due to unexpected liver toxicity, although the good news from ASCO is that a dual immunotherapy combination (ipilimumab plus nivolumab) appears not to have met the same fate.

The landscape for metastatic melanoma is therefore rapidly changing, but where is this field likely to go and what can we expect to see?

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Melanoma oral abstracts at ASCO 2014

A packed theatre in Arie Crown at ASCO

The melanoma oral abstracts session at ASCO 2014 was packed as a full house in the Arie Crown lecture theatre listened to the latest on new immuno-oncology therapies that are leading a revolution in melanoma treatment.

In the Clinical Science Symposium on PD-1 blockade and in the oral session at ASCO 2013 we heard how PD-1 antibodies nivolumab, MK-3475 (now pembrolizumab) and the PD-L1 antibody MPDL3280A had high response rates, long durations of response with favourable toxicity. This led to melanoma suddenly becoming one of the hottest areas of cancer drug development.

Global incidence of stage III melanoma continues to rise, with a high 5 year relapse rate (89% in stage IIIc), so there remains a need for more effective treatment options. It’s particularly sad to see so many young people end up with metastatic melanoma from over-exposure to tanning beds or too much sun! After going to several melanoma sessions, I don’t go out as much in the mid-day sun here in Florida.

So what did latest data show at ASCO 2014? Is pembrolizumab better than nivolumab?

Will combinations be more effective than single agent therapies alone and will toxicities impact the risk:benefit profile?

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