We travelled all the way to the Marsden for my result to my scan. We were in there 5 mins then could come home ?
It was worth it and I report to facebook —Well That was great news. Still in remission and the Doctor said that I’m leading the Medical world and they are learning from me so we just cannot predict what will happen next ! –happy with that so another 2 months has been laid at my feet
So many family, friends and Mesowarriors so many likes and comments we are all celebrating that we can believe. It is so very hard to have the confidence to believe.
I went back to Oak Ward to say hi to all the staff there. So many changes though. Our favourite nurse has been promoted to CNS Congratulations Lorraine so very well deserved. Rex is now a Senior Staff Nurse another well deserved promotion. so many new nurses i had forgotten its september when a new intact was done.
Two mesowarriors were there, two lovely men. One with 41% shrinkage and Alan who has a scan next week, but has shrinkage so far and doing really well.
We had lots of laughter and hugs and kisses when I left.
So I have made an appointment for November and now relaxed to enjoy those months.
We came home and relaxed as we hadn’t slept the night before although Ray had to collect the motorhome as we had the brakes looked at.
Today has been so lovely again with the sun beaming away. We took Louis out early around the field and gave him a run around with a new ball we bought yesterday.
I sat out in the garden as it is the last we will see the sunshine for a while as the end of the Hermine hits us from US.
BRITAIN will be hit by TORRENTIAL rain and 60mph gales as the remnants of Hurricane Hermine, which devastated the US coast hits the UK.
It comes after Britain baked in an unusually hot start to September with thermometers hitting 29.3C (84.7F) on Wednesday in Gravesend, Kent.
Although summer officially ended on the last day of August, this week brought some of the highest temperatures for the past three months.
Although it will feel fresher into the weekend the mercury will still hover above-average for the time of year.
I had an interview published which I love it has been written very well.
Earlier this year, the Mesothelioma Cancer Alliance had the privilege of sharing the story of Mavis Nye, a woman from the United Kingdom who was diagnosed with mesothelioma in June 2009. Since then, Mavis has undergone a number of treatments in an effort to defeat this deadly disease.
One of those treatments included a clinical trial for a new immunotherapy drug known as Keytruda (pembrolizumab). This emerging treatment has shown promise in treating a variety of cancers, most recently having been approved by the U.S. Food and Drug Administration (FDA) to treat head and neck squamous cell carcinoma (HNSCC). The drug was also famously credited with removing any trace of brain cancer from former President Jimmy Carter last year.
The effectiveness of Mavis’ treatment using Keytruda is a promising development for those who have mesothelioma, and her story offers a bright light of hope for those who suffer from this usually deadly disease. As it has been almost six months since we first brought Mavis’ story to our blog, we wanted to reach back out to her to find out how she has been doing since the trial was completed. Mavis generously responded and shared her current status and thoughts with us.
The last time we spoke with you, you were in the middle of a clinical trial that was testing Keytruda. Now that the trial is finished, are you still feeling positive effects from the treatment? Have you seen any recurrence of the disease?
Mavis: Yes I have positive effects from the trial as I have complete response. My tumours are very small and benign, too small to have a PET scan even. I’m the first person to be able to say I’m in remission in the UK. If I stay that way for 5 years, we can talk about a cure, but if it grows again I can have another year of the drug at the Royal Marsden.
All my scans show complete response and I have been finished the trial for two months now, and so a scan on September 9 will be the one they will do all their report from as they compare with the one I had May 2014. That will finalize the two year trial.
So no recurrence of the disease has shown to date.
How has your experience with the Keytruda trial helped you connect with other mesothelioma awareness advocates?
Mavis: I have found everyone wants me to talk at their conferences or write an article about my trial and the conclusion. iMig [the international Mesothelioma interest group] was brilliant as all the doctors from around the world were present and I answered all their questions and spoke to so many.
My work with McMillian, British Lung Foundation, Mesothelioma UK, Cancer Research UK, and Patient Rep has increased, so I feel very involved now creating awareness of mesothelioma and the dangers of asbestos. I’m more involved with the removal of asbestos and the safety of the men that work in the industry.
What are some things you would want others who are considering participating in clinical trials to know about beforehand?
Mavis: I have guided the Mesowarriors UK on Facebook and Sufferers on emails and contacts from my blog into the next trial at The Royal Marsden (MK3475-158) and have answered all their worries and questions as they go through treatment. PDL1 [a cell receptor tied to cancer cell death] plays a big part, and they have to have this in their biopsy, the one that was done for diagnosis, so you may not have another one taken.
One big thing is, if you want treatment other than palliative care, you must be prepared to travel to the few hospitals that carry out trials. The trials cost too much to have them in every hospital. I always say have chemo first to knock the mesothelioma back to shrinkage so you have time to search for a trial.
There are many trials starting, and 2017 will be even bigger than 2016. So stay positive and find a trial. Mesothelioma UK publishes a good chart or go to ClinicalTrials.gov.
In the U.S., Vice President Joe Biden is leading a “Cancer Moonshot” initiative, part of which is focused on developing new immunotherapy drugs like Keytruda. In your opinion, how important is this type of effort in finding a cure for mesothelioma?
Mavis: Any publicity for new drugs out there is good. I spent so much time, money and energy finding treatment. Google has been my friend as I have searched. Cancer Moonshot was a great source, and one day that cure for all will be found, so keep up the good work Vice President – you will be our hero!
The Mesothelioma Cancer Alliance wants to thank Mavis Nye for the time she took to answer our questions and share her continued story of survival against mesothelioma. We wish her the best as she continues to fight this disease and spread awareness at home and around the world.
I have just recieved this info on a discussion about Keytruda so I include it here
Merck & Co’s (MRK) Management Presents at Wells Fargo Healthcare Conference
Sep. 8, 2016 4:49 PM ET|
1 comment |
About: Merck & Co Inc. (MRK)
Merck & Co Inc. (NYSE:MRK)
Wells Fargo Healthcare Conference
September 8, 2016 01:45 PM ET
Roger Dansey – SVP, Clinical Research of Oncology
Teri Loxam – VP, IR
David Maris – Wells Fargo
Good afternoon, everyone. I’m David Maris, Wells Fargo’s specialty pharmaceutical analyst and a large-cap pharmaceutical analyst too, although I haven’t launched on the large-cap pharmaceuticals yet. So, I don’t know if I can officially say that. But since we’re introducing a large-cap pharmaceutical company, I’ll take that title too.
Very pleased to have the management from Merck here with us. Joining us from Merck, Roger Dansey, Senior Vice President, Clinical Research of Oncology, the lead clinical for KEYTRUDA and oncology. So, certainly the most, I guess I can say the most important product for Merck, but I’m sure they have several most. Teri Loxam, the Vice President of Investor Relation is also joining us on the dais.
This is a fireside chat. Since we have not launched coverage, I’m fairly limited in our questions. So, but I’m going to kick it off and talk a little bit about our recent meeting at Merck. But I’m going to move on over because it’s awkward if I’d ask from here. So, but thank you for joining us.
So one of the questions I have, during our meeting, Ken talked about KEYTRUDA and at some point, I don’t know if it was Ken or someone else said, I mean this could be, this is in our guidance, this isn’t, but what if this is a $10 billion or $15 billion or $20 billion drug? And people hear numbers like $10 billion and it’s hard to fathom for an individual drug, but maybe talk about the different markets and the number of patients and is that a number that, even though you’re focused on the clinical side that you say, oh, yeah, if we look at the overall market, the patients are treating, how it’s treating the patients, that’s something that’s achievable?
So I think the, we’re in an unusual place. We’ve discovered a PD-1 inhibitor or the pathway that looks like it’s generally relevant, almost across all tumors to some degree. And that almost differs, there is really not a good example in oncology of an agent that may work all the way from say, ovarian cancer, treat to Hodgkin lymphoma. So the clinical opportunity based on our ability to identify the right person to get treated and conducting the right trial and choosing the right combination, if indeed combinations is the future beyond monotherapy is extremely broad and if you look at the Merck development program, our lead effort was in melanoma, we’ve followed that with a robust plan in non-small cell lung cancer.
We’ve just achieved approval in head and neck cancer, we have a robust plan for bladder cancer, for triple-negative breast cancer, Hodgkin lymphoma, [indiscernible] gastric cancer. So if you look at the, at what I’m describing, and it’s so high, the clinical utility of something like pembrolizumab can be broadly applied, and it becomes — I think we see it as foundational and as the backbone potentially of many therapies. So, the addressable population of patients obviously under the sort of construct that I’m describing is large and take lung cancer by itself is a dominant cancer. There are many, many thousands of patients who will benefit. What that turns into in terms of potential monetary value, I think I will ask Teri to comment on, but we are choosing to develop pembrolizumab appropriately in multiple different tumors where we see strong signals and that translates into hopefully many patients benefiting.
And I think it’s difficult to put a number on what this opportunity could be for a number of reasons, one being that as Roger stated, this is very early and it’s never been seen before for a drug to be so active across so many tumor types. So it is really difficult for even us internally to be able to put a revenue number on that. Analyst estimates for the market size, not just from us, but across the market, I mean, we’ve been 10 billion, 20 billion, 30 billion for an, for the IO space across many different market models that the analysts have put together. We can’t comment one way or another kind of where we think it all lands, because we really just don’t know. I think the important part is that, it will be a very big opportunity. Merck is very well positioned to be a very big part of that opportunity, especially given some of our recent news around first line lung cancer, which is a very large opportunity in and of itself. And so we’ll see where it goes, but it’s an important product for the company and we’ve often described it as kind of a pipeline within a product. And it’s definitely something that we’re pursuing pretty strongly.
One of the things that you mentioned in your opening comments is that and you’re also looking at combination therapy if it turns out to be the case. Most people believe that combination therapy is just that’s where it will be, is there a reason to think that maybe that won’t be the case or that patients won’t take the tradeoff of what the combination therapy might entail?
That’s a great question. So, take for example melanoma. We’ve established pembrolizumab as a standard of care for ipilimumab-naive patients based on monotherapy and the results in that monotherapy population are excellent. Will the combination beat that in terms of something like overall survival, we don’t yet know, but certainly the monotherapy has a very favorable sort of safety tolerability profile, is readily administered and has a very specific safety profile related to immunotherapy, but doesn’t necessarily overlap or sort of cross contaminate other potential combinations. We’ve taken — in the monotherapy space, we’ve taken a biomarker based approach to try and increase and identify the patients that are most likely to benefit and what that has translated into is us being able to do standard of care. So, again, lung cancer is a good example, with KEYNOTE-010, which was in a second line non-small cell lung cancer population, we were able to beat to demonstrate superior overall survival against a drug like docetaxel. Although the results are not public, as you know, we’ve read out on KEYNOTE-024, which is a frontline monotherapy population, enriched now to a 50% cut point, where we have in fact consistently shown really excellent outcomes, all the way from an advanced population up to frontline and this randomized trial I think confirms that.
So for monotherapy, for patients with cancer who are often ill and maybe have advanced disease, monotherapy is an attractive option, not only from an efficacy perspective, but also from a tolerability and a safety perspective and the place of monotherapy is well established in melanoma, the place of monotherapy is pretty well established in non-small cell lung cancer. We’re going to add to that in front line, but obviously the combination represents an alternative treatment option and so in a non-biomarker based approach, looking to test a combination therapy, again, lung cancer is a good example. We’ve already begun chemotherapy pembrolizumab combination trials to see if we can in fact improve the outcome for the entire population, but the monotherapy biomarker based approach is a very strong one and I think we have really good data to support the clinical benefit.
So in your discussions, have you — do you think you’re at the point where you have an understanding of where it might not work and where it might go?
Specifically in, by tumor type. It’s early, so for example, if on taxol [ph] myeloma, I think we were aware of data from other companies demonstrating not too much of an activity and then when we combine our drug with 09:02 we’ve got excellent responses. I think it’s hard to shut the door on anything in particular, because even if a monotherapy plan doesn’t necessarily produce significant results, it’s quite possible that a combination will. I don’t think we have a very broad based plan which doesn’t exclude specifically any disease at this point.
Are there any trials that are ongoing where you say, well, if we have the answer to that, we will know the answer to four or five other tumor types or is it just going to be one by one?
I think as a principle, the question of combination of a PD-1 inhibitor with chemotherapy is a general principle, sort of the answered. Obviously, one can’t extrapolate from one trial to the other, but if one study read out positive in one disease, it would give one some encouragements that other trials may point in that direction, but in the end, it is disease by disease, trial by trial in terms of understanding what the outcomes are.
What are the next catalysts, between now and a year from now that you think are the highest priority catalysts?
You mean from a clinical development perspective?
Yeah. Data readouts.
Data readouts, well, obviously, there is a lot of focus in lung cancer. We have, we will have some more information on chemotherapy plus pembrolizumab later in the year. Our chemotherapy combination trials have got specific plans that we’ll read out over the next while. That’s of course in our safety combination, will also be potentially informative, but I think for us, from a catalyst perspective, we have a broad swap of combinations trials that are going on that are essentially signal detection with collaborators and partners and so on and in terms of making decisions about what would we do next, I mean, we base our decisions on data. So we see strong signal of efficacy and acceptable safety.
That would be a catalyst for us to proceed internally with a further development plan. So, I think it’s the, and this term, I think it’s been coined before, we’re likely to see all the data coming in the next while, because there is so much activity going on and my expectation is that we will be informed significantly by those readouts as to what the next step will be. And then obviously, if we have our internal pipeline, which would be a catalyst for proceeding to something that would have a registration gland, if one of the internal pipeline molecules in combination say with KEYTRUDA read out something positive.
And if you think, if you want to think through kind of a investor catalyst, right, from an external perspective, obviously ESMO is coming up in October and it’s a very big important meeting for Merck, for KEYTRUDA. We obviously have the first time that you will see the first line lung data from KEYNOTE-024 will be presented at ESMO and I think that’s how I wanted the biggest catalysts for the company at this time. In addition, we’ve got, I want to say, data across 12 different tumor types, we’ve got late breaker for front line bladder for instance, that will be really the first time that people see KEYTRUDA and bladder, we’ve got head and neck data, we’ve got other lung data.
So I think ESMO in and of itself is a really important meeting for Merck and a catalyst as well in addition to a whole host of other trials that read out between now and 12 months from now, both monotherapy and combo therapy. I think there is going to be a lot of catalysts out there that you will be able to understand both KEYTRUDA and the opportunities of monotherapy and combination therapy over the next 12 months, there is a lot of data.
So I’ve seen a lot of drug companies over the years and usually, the scientist with the winning products gets pretty much an unlimited budget. Is there any — are there any studies that if you had an unlimited budget that you would want to do that you’re not doing?
I think we have a pretty fully fledged [indiscernible] program at this point and the company’s commitment to immunooncology is very significant and I think if you did some cost comparison potentially, we probably have the biggest and the broadest program currently in existence.
And I think as we think through at the corporate level and we look at the R&D budget, KEYTRUDA is a very important product and it’s the IO space, it’s moving very, very quickly. So it’s something that as a company, we have prioritized resources to KEYTRUDA so that we can be ahead of the curve and so that we can fully build out the program across. We’ve got over 300 clinical trials ongoing for KEYTRUDA across 30 different tumor types. And because it’s moving so quickly, it is important to fund that. We are doing everything we can within the company then to be prioritizing across the rest of our portfolio. So, making those tradeoffs more so than we ever have before to make sure that we can appropriately fund KEYTRUDA, keep the rest of our programs moving forward, but really taking a critical look at, can something be pushed six months and not be detrimental and will that allow a difference, another arm put in a KEYTRUDA trial for instance. We’re having those types of conversations within the company but it’s important for us to make sure KEYTRUDA is successful over the long term.
Let’s talk about competitors for a second, what data in the last six months have you seen from a competitor where you said wow that’s really interesting. And what’s on your radar for competitor data that you really want to see?
Well, since we have ESMO, we’re very interested in seeing Bristol-Myers data CheckMate-026, they’ve done analogy between 24 and 26, now it’s a frontline monotherapy biomarker-based trial, obviously there are different cut points have been chosen but I think we’re very interested in trying to understand, you know, interpret the data. We’re also interested in seeing data from Roche, there is a lung trial I believe that will be presented, OAK that will be very informative. So, going forward those would be the two sort of most near-term data points that I’m aware of. Going backward, at ASCO, there were obviously interesting data presented again around I/O combinations in lung, all small data sets and so obviously the caveat around interpretation of this data is both from the size of the dataset. And in 2017 obviously a lot of these trials are driven by event numbers or timing, it’s not clear but I do believe there will be a readout potentially from AstraZeneca on a PD-L1 combination with CTLA-4 in lung cancer, so that would be an interesting thing to look at. So, it is always, you know it’s complicated to do with cross-trial comparisons, studies that sit up in a randomized content to earnings fashion to ensure that there isn’t variability or you can try and reduce the amount of variability, so cross-trial comparisons do have their limitations but obviously it’s important to look at other data.
Let me also turn it over to any questions from the audience if there are any. There is a microphone in the back. Have we stunned you all into silence? I can goad you into something. So, feedback on pricing, I know that’s not your area and Teri maybe you can give us the perspective that you’ve heard, but I’m sure you’ve heard from at least internally from payers group but maybe externally from physicians that – has there been any pushback, is there pricing sensitivity?
I mean there is always pricing sensitivity, right, you have to make sure that you’ve got the right clinical data to be able to show the benefit risk analysis and the value of the product. And I think our clinical trials are designed in order to be able to put that value proposition forward. So from that perspective KEYTRUDA has shown a significant value proposition and because of that I think we haven’t seen too much pushback yet. Globally obviously pricing is becoming a bigger topic and healthcare spending in general obviously is difficult across the globe. So it’s something that we pay attention to. I think if we’re talking just about KEYTRUDA, the real question is going to come down around when combination start rolling out, how does that work and how does that work both within the US pricing system when potentially the two components of the combination, one might be through a part B system and one might be through a part D system, how does that play out, does one plus one equal two or is there some other way to price these combinations. As we go forward as well across different tumor types, how does that play out when you’re trying to launch a drug in a small indication versus a very large indication. I don’t think that we have those answers and I think collectively as an industry it’s going to be something that we’ll all be playing out over time but I think at the end of the day what we’ve been able to see consistently is that if you can show the data and the clinical benefit and show that value proposition then you can generally make sure that it makes financial sense. And that is really at Merck the foundation of what we do is making sure that we’re bringing forth products that can show that value.
Do you think they were still in the position where survival wins numeric advantages in survival win or are we at the point where the dialog for well what’s the meaningful difference in survival if you have two successful drugs in the same tumor type and there is survival differences. So first, what is the meaningful difference in your opinion and are we ready for that dialog of well this is what it means, the personal preference. I’m going for the longer survival, I don’t care what it costs, but is that part of the debate or no that’s not really, we’re still in the longer survival win.
So until now, I don’t think things have changed, survival remains the goal standard. It is going to get more complicated because as the availability of drugs like pembrolizumab and others start to play out the ability in a controlled environment like a clinical trial to demonstrate a long-term outcome like survival may be more complex because of unintended or unplanned crossover to another agent that’s active. But it remains the gold standard and obviously for every — it almost goes — some diseases, for example, myeloma would be an example to show an overall survival signal, it takes a very long time, so more proximal surrogate endpoints are expectable for diseases that are moving fast, survival is more likely something you’d be able to show for Adjuvant trial survival is as an important outcome. So it is quite a nuance conversation around survival but it still remains the key outcome if we can demonstrate it, I think it does come from pretty much everything else.
Like I said, for me it does as well, so if we talk a little bit about first line lung, KEYTRUDA data was clearly better than OPDIVOs. Does that change your strategy at all in development plans or just a confirmation of what you suspected all along?
If you look at the data we presented with KEYTRUDA in lung cancer it’s remarkably stable. So all the way from KEYNOTE-001, which is very small phase 1 trial, which was planned initially to enroll 32 patients or so, ended up a 1,000 patients with multiple approvals. We were able to demonstrate using a biomarker-based approach of identifying the patient we think most likely to benefit but both in second-line class and in first line in an uncontrolled trial in KEYNOTE-001 results looked very encouraging. Then KEYNOTE-010 comes along in a randomized comparison to standard of care using again a biomarker-based approach we show improvements in survival because now we capitulated that result in frontline with a higher cut point using the 50% cut point but again monotherapy against standard of care. So our only data internally is very consistent based on our biomarker choices. In terms of what do we do going forward we already have plans in place as I’ve mentioned in chemotherapy combinations to see if we can improve the outcome combining pembro with chemo. We continue to look at other novel combinations in lung cancer for example, the IDO inhibitor is under evaluation. We presented some data at ASCO looking at pembro and a dose of ipilimumab at 1 milligram per kilogram for four doses and that data is potentially informative. And I think we are continually scanning environment both internal and external trying to make the best possible choice for the next move whatever that may be and it’s all data driven. So, I don’t think any of our plans are sort of locked and loaded and that’s the end we’ll do no more, I think every time we see an important signal with good safety and potentially significant efficacy is something we seriously consider should that be taken forward. A good example of that approach could be say myeloma where we’ve clearly demonstrated tremendous benefit in monotherapy but we’re not stopping there so we have a combination both with T-VEC engines oncolytic virus, a combination trial that’s running in phase 3, we have a combination trial with Incyte IDO1 inhibitor in phase 3 both of those are based on what we thought early in strong signals to try and improve the outcomes further. And I think that’s a good model for how we approach and how we will approach other tumors, we’ll choose based on data what the best possible combination we think is and/or combination we think we should take forward and it’s an evolving process.
So one of the things I always ask companies is and I think anyone who works for a company of more than maybe five people there is always an interesting answer of, oh, how much time do you have, if people really knew length, they’d really be surprised about the pipeline, about what you’re working on, I mean I don’t want you to tell us something again personal?
I think that the excited data, so it is you know we are obviously seeing information all the time, it’s remarkable, I mean, we are in almost a revolution from a therapeutic perspective and the future I don’t want to hyperbolize it too much but it feels like the sky is the limit with so much innovative sign such clever thinking and strong scientific underpinnings for potential future combinations and approaches, its remarkable, if you simplify all of that together and say what could the future look like it really looks very encouraging.
So when you think about that runway, do you think that they, oh my gosh, when people say the future is really exciting sometimes they mean the next three years.
I think it’s now and it’s three and five and beyond. I think this is a continuous; the readouts for data are going to be they’re already beginning – they have begun and they will continue – the data flow will continue and that will inform future plans.
And David I was just going to add to what people and investors in particular have sound surprising as they’ve started to dig into market especially our oncology program is the talents that we have amassed both on the commercial and the R&D side both from within the organization but as well from the outside the organization. And we’ve brought people and the experts from across a number of pharmaceutical companies, Roger being one of them coming in that has a wealth of oncology experience over a career have come to Merck to work on the future program because how exciting this is. And I think a lot of investors once they start digging in are surprised by the talent that we’ve got working on this program and one of the reasons that we have been able to execute so well is because of that talent we’ve been able to bring in.
Now this is an odd question but if you couldn’t work on KEYTRUDA but you could work on another novel program you’re aware of in oncology at Merck, what would it be?
We have a really – I’m a late stage developer, so my strong desire is to get drugs approved and that’s why I get most of my gratification from. But from an early perspective, we have lots of interesting targets but just interesting possibilities, it goes all the way from recent deal signed I think with Moderna around personalized RNA vaccines to Ablynx with nanobodies to pipeline molecules such as things like [indiscernible] I can’t select one. I think they’re all interesting.
All right. Ed? Let’s wait for the, since we’re webcast I believe, so let’s wait for the microphone.
Q – Unidentified Analyst
Doe the recent Bristol and your data make you more interested in just as an insurance mechanism to first line trials [indiscernible]?
I think our position right now is we’re continuously evaluating and the development plans will evolve appropriately. So, I think it will be helpful for us to see the monotherapy trial we understand the interest around [indiscernible]. It’s one way to go and it’s something that we have already looked at, we’ve looked at ipi and pembro in melanoma, we’ve presented some data with ipi and pembro in lung, so it’s obviously part of our consideration.
Well, great I want to thank Roger and Teri for their participation and it’s always great to speak to us on the front line, it was something so exciting. The industry gets such a bad rap from so many and these are the stories that really need to be told about life-saving medications that are revolutionizing the treatment. So thank you for all the work, but thank you for your participation.
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I cant thank Merck (or MSD here in UK) enough for saving my life. I have been on the Keytruda Trial here in the UK for Mesothelioma and have complete response. I had another CT scan yesterday and still Complete response. How do you put a price on Life. Keep up the great work as there are so many Meowarriors waiting for the drug to be Licensed.
08 Sep 2016, 05:42 PM Edit/Delete