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Pfizer Inc
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Excellent. Well, pleasure to have Pfizer Management join us. We have Chris and Chuck joining us from Pfizer. Before we begin, maybe I'll turn over to Chuck to introduce Chris.
Chris Boshoff, and he is among other things, very involved with our Immuno-Oncology Division, part of Pfizer Oncology. So Chris has a vast scientific background, very fluent in clinical trials, design, all good things like that; and then for myself, I run the Investor Relations Group at the company. So again, thanks for having us and happy to be here. Look forward to the conversation.
Excellent. Well, if you don't mind, Chuck, we might start with a few sort of corporate strategy and high level questions with you before we dig into some more of the R&D stuff.
The first one being, and this is something I've mentioned as a potential risk factor to the street which was when you guys announced your price increases in July and then some tweets happened and you rolled it back, there was a lot of feedback shared on the street that there may have been conversations between the President and Pfizer's CEO on potentially doing something about rebate or else the increases will be back on. We're now seeing that State of California has been notified by this take in price increases in January.
So my question is this; is the administration aware of that and could we -- should we be expecting any tweets like how should we anticipate that going into January as that first week is already stressful as it is?
Yes. You know, back in July, we announced that we were deferring our price increases and we've continued to work with the administration, with the President, members of the Congress; and right, what you saw was the required notification for certain drugs. So we took that opportunity to California filing that we had and we took the opportunity mainly to be transparent on what our plans were for early 2019. So we announced some of those price increases for about 10% of our portfolio, we all know that there is sometimes breathless reporting about list price increases, so we also added the point that in addition to some of those list price increases which were modest, there would be an increase in rebates as well, and that and the net price to Pfizer in fact, would be 0%, really no impact on net price.
So for us, we wanted to be out there, be transparent. Again, our main focus is to work to ensure patients have access to medicine and we're going to continue to work with the administration here. And just, if you look at year-to-date on a net price basis, we're about minus 3% globally, minus 1% in the U.S. So in the U.S., even this year price has not been a factor for us. So, we'll see, I can't predict what the administration...
Is it minus 1% in the U.S.?
Minus 1% in the U.S. year-to-date for 2018. So, we always look at ourselves as pricing responsibly, we are always open to discussions, that's what we're doing and it really comes to ensuring access to patients; so we'll see what happens. We took that approach with being public in the area of transparency and say we're not trying to do anything that we hope nobody notices, and the understanding which I think continues to grow in Washington that a price increase at the manufacturer level doesn't automatically mean that comes straight down to our bottom-line as we know there is a lot of middle man involved here.
Right. So to be clear, when you say minus 1% in U.S. in 2018, that calculation, does that also include the genericizations that happened?
That's all. It doesn't necessarily include generic factors which is another factor if you look at something like Lyrica. That would be generic mid-next year...
Is that included in your 2019 being...
No.
No? Okay, it's not. Okay, that's important. All right, excellent. And then also, M&As, since this is a question that comes up on every call; and one of the questions I get asked is, how do you define 'large'? So Pfizer is saying, 'We're not doing large deals.' Is large $50 billion? Or large $20 billion? Like what...
You know, there is no real cut-off, we continue to always look at all sorts of deals. Maybe if I slip it in this way, if you look at a bolt-on, if you look at Medivation, for example, that was only really involved in terms of an integration standpoint, that only involved Pfizer, the Oncology business unit; Anacorp only involve the I&I division; Hospira, bit bigger, but that was really limited to the established product business. So I think if you look at big, you're thinking more on integration-disruption standpoint, something that would involve many, many parts of the company. And as you probably also heard us say now, our focus really is on growth. So we always look at business development, it remains an enabler of our strategy, it's not a strategy in it of itself, but I think A) from the actions you've seen us in terms of investing more in R&D, investing in the pipeline, looking at capital allocation at this point with the products we have on the market, with the late-stage pipeline that we have and the confidence we have there, part of it is the choice that we've made is well, instead of paying a premium to say large company for their pipeline, we see our pipeline still is undervalued. So we're buying our own pipeline at a discount, as again, as opposed to going out and paying a premium to another company.
So things can always change, but I think at this point we see job # 1 as pivoting to growth post-deliver LOE [ph], making sure that we are investing and organizing for growth, we're not looking for distraction, we don't need to call 'transform ourselves', we think our internal pipeline incurred products are going to transform the company, and look at bolt-on. So, I didn't answer the question directly, I think big is that sort of a description of big and right now we have made comments that that's really not on our radar screen. Things can always change, and a good management team will react as the facts change but right now, are we saying there is a big therapeutic area, we're not in it and we need to be in now, are we saying we have no late-stage pipeline in all these LOEs? No. We have one big LEO left, but we've got a great pipeline. So focus on more of an organic-driven growth story. Accelerate that topline, we've always done a good job of leveraging the topline to the bottom line, and not get involved with distractions.
So that's -- I think that's our view. More apps to see tuck-in's, bolt-ons to further bolster areas that we already have and some further strength. But as far as Pfizer saying, we're not sure what to do -- better do a big deal that is absolutely not the case. And I'd add one thing; generally speaking I think for bigger companies that have the wherewithal, big deals are -- honestly always, the big deals are available, if the time comes, big deals generally are available. But right now we've been clear to say that's really not our focus, it's the internal story, that pivot to growth, and ensuring that the whole company is focused on achieving that, and we think we have a very clear path towards that. So that's where we are now in terms of this [ph].
Excellent. And then the other one from a more high level perspective I do want to touch-up on is; it seems like based on every press release -- incremental press release that has come out on the two divisions of the company, the emerging markets division and the innovative side, it seems like there is an -- both sides are increasingly being run in a distinct manner and the possibility of a split looks more real or stern look again more real, so just curious what that looks like? And I've gone through many iterations for Pfizer model, with three, with two, throughout one…
Yes, I mean listen; job # 1 right now, so you're right. We've organized for growth, we've talked about investing for growth and organizing for growth. So yes, we have a new iteration, so the old established product essentially health business in a sense is completely being rejected, right, biosimilar is coming out going to the innovative side, sterile injectables. So you're right, what is established products will be much more of an emerging markets focused business, our leadership based in China, they will have dedicated manufacturing, so much more autonomous which is what we want given the differing business models and the ability to be very quick to make decisions, being very focused. So job # 1 is to get the new structure, particularly with the established products business, up and running, right to get the management in place, get everything up and running. So that's job # 1, so I think it will be premature to talk about is there are a split.
Again, a split if it ever made sense I think is always available to the company but right now, job # 1 is getting those businesses up and generating the value they can. And then we'll look at it, the market will always pine on value, the old story at one point, it looked like there could be value and then PE multiples moved around a lot and eventually when we look at the split, it didn't create value. So the facts changed, management took a different stand based on the fact. So the short answer is we're always open to creating value, but right now I'd say that discussion is premature at this point. We want first to get those businesses up and running.
One follow-up on the China business; it's currently about 7% of the top line, probably the highest among the pharma; how do you expect that business to grow?
We still see the value of a branded generic product like Lipitor, Norvasc. Still, the original Pfizer products continue to do very, very well, good tailwinds in China, growing little flash to play on quality, well not forever, is still an important play. So I think in terms of China, it's a market that continues, I mean they have emerged and it's a market that continues to move very quickly and one of the key drivers of us putting our management team physically in China as opposed to New York and having a 12-hour time difference is to really be part of that, and continue to be the big part of that market as it evolves very quickly, have on the ground decision-making. So a big investment for Pfizer, big part of the world's population with increasing access to quality medicines. Our ability to serve patients well, we continue to see underlying trends which is cardiovascular disease, right in the emerging markets, Lipitor and Norvasc.
So the portfolio is very focused, very in-tune with what the public wants there, and what the government wants. So for us, that's really key drivers, we saw that the incremental growth for that established products business, more than half or about half is going to come from China and emerging markets which our management team is on the ground. And again, give them dedicated manufacturing so they can make different decisions, slightly different business models. So yes, we are very -- we continue to be bullish on the China market.
And last one, higher level solar [ph] business there?
Nothing latest. We still expect that we will make our decision by the end of the year. I know the end of the year is right around the corner, so we continue to look at...
Is that a full month?
We've got a full month. So 20 working days left there, but I do expect we'll communicate one way or another ultimately.
Is an IPO being contemplated?
I'd say we're still looking at everything from IPO to keeping the business...
Keeping the possibilities?
Absolutely. Keeping has always been a possibility, it's a very good business. The question always has been, would it be better in someone's hands? Can we get the value we think it can potentially deliver externally? But honestly, the answer always has been...
The markets will determine that, too. Is keeping an IPO or two if let's say three possibilities, then the market conditions perhaps...
That's right. So we're not at all opposed to keeping the business. We've been investing in the business, it was an exercise to say, could there be value trapped here? There is no wrong answer to that, and you're right, markets have something to say about them, but yes, it's everything from status quo to full externalization to anything in between. So we're finishing up from that process and we'll communicate that.
Excellent. All right. So Chris, sorry it took a while to get you but we did want to get some of the high level stuff out of the way because people really do focus on those. I want to focus on Ibrance and the adjuvant trial in particular because I feel like over the next 12 to 18 months, this might be one of the more important read outs for a company even as large as Pfizer. First, before I begin, Chuck, please chime in as well; do you agree with the notion that the adjuvant indication for Ibrance could be at least as big, if not bigger than the metastatic indication currently on it?
So, I think that's correct. If we look at patient numbers in the early adjuvant setting, it's probably double the number of patients than in the metastatic setting. However, our studies boasts [indiscernible] both adjuvant study, treats Stage 2 and Stage 3 disease at the higher risk metastatic disease, which rips up adjuvant early disease, higher risk early disease, which represents about 50% of early disease. So the math is more or less the same number -- at least the same number; early disease as metastatic disease.
All right. So same patient number, but isn't the duration more?
We've recently updated the data with PALOMA-2 which is first-line metastatic with palbociclib plus letrozole versus letrozole. And the PFS reached with palbociclib plus letrozole was over 27 months. And of course, PFS is not direct to the duration of treatment but its' a good surrogate, suggesting that there are patients that receiving therapy beyond 24 months. In the adjuvant studies, PENELOPE-B, it's 12 months of adjuvant palbociclib, and in PALLAS, it's 24 months. And PALLAS obviously presenting the bigger patient population because it's the bigger code, it's not only the very high risk.
Can you may be send 30 seconds for the audience on to give some PALLAS trial?
So these are two adjuvant setting studies, PALLAS -- both studies completed recruitment now. PENELOPE-B 1,233 patients; PALLAS 5,600 patients, both completed recruitment, both studies should readout in 2020, that's our current timeline. Is it bank driven? These are early disease, patients with early stage positive HER2 negative breast cancer that usually would be tweeted with an rheumatoid inhibitor with tamoxifen, with endocrine therapy alone. So the studies are testing the hypothesis, adding palbociclib to endocrine therapy would enlarge -- will increase invasive disease-free survival which is the end point for early stage disease. So these are the two biggest adjuvant studies currently running, or PALLAS certainly is and should be the first CDK-4/CDK-6 readouts in the adjuvant study for 2020.
Okay. For the adjuvant setting, how should we think about the compliance rate? You have a Phase 2 feasibility I'll say for the PALLAS which shows high-30s discontinuation rate due to AES [ph] compared to the metastatic setting has only tens of discontinuation rate.
Yes. So I think from -- just at a higher level, overall, over 160,000 women, all patients with breast cancer have now being treated globally with palbociclib. And overall, the adjuvant profile is very manageable and both patient experience, as well as physician's experience has been very favorable for palbociclib. And patients are motivated, and patients want to do the best for themselves, for their families to have the best outcome. So I don't necessarily believe that patients in the adjuvant setting that compliance will be less than it is necessary in the meta study. So the adjuvant setting might be as good if not better than the metastatic setting. I don't know if you want to add to that?
Chris, maybe just taking one step forward, we saw a Phase 2 neo-adjuvant study, not adjuvant because the point with other adjuvant. Neo-adjuvant trial come out. The response rate was 50% and compared to around 54% in the Pablo [ph]. So my question to you is first, how can we use that data to read across into the adjuvant setting? The response rate is not that different, but again CDK 4/6 is not having much response and letrozole gets added in adjuvants. So how do we weigh in all those factors?
So that's an important question. So you're referring to the PALLAS study, the PALLAS study will be presented at San Antonio Breast Cancer Conference in a couple of weeks' time. This was the largest new adjuvant randomized study and conducted, approximately 300 patients randomized for 14 weeks only. So 14 weeks of treatment in the new adjuvant setting, upfront treatment. To letrozole versus letrozole plus palbociclib. And the primary endpoint in that study is biomarkers that are positive drug and it's exploratory study, it's a biomarker driven study with the primary end point or co-primary end point and decrease in proliferation rate as measured by specific histological tests which is called KEY67. KEY67 or KI67 essentially measures tumor cell proliferation, and in that end point, we saw a significant reduction in cancer proliferation using KI67 with the combination of palbo plus letrozole versus letrozole.
Why that's important? Within the new adjuvant setting, in previous endocrine studies, including rheumatoid [ph] inhibitors and with tamoxifen, KI67, and -- a decrease in KI67 or in proliferation has been the best surrogate as a predictable outcome within the crime therapy in the Adjuvant setting...
More so than response rate?
Definitely more so than response rate for three reasons, specifically in this study. And palbociclib as you pointed out, even in our PALOMA-1, 2 and 3 studies, the best measure of benefit is with PFS, is not with response rate. Number 2, this is only 14-weeks of therapy; so for slow luminol EL positive breast cancer, small proliferating cancer or it's a low proliferating cancer, 14-weeks treatment is a short duration. And in thirdly, response rate is measured here only by ultrasound for primary breast lesions. For lesions in the breast, the best way to actually look at decrease in size or increased size with MRI, and this study is only with ultrasound. And KA67 is certainly the most important predictor within the study of the potential benefit in the longer term with adjuvant.
Having said that, we've always said whatever the outcome of the pilot study, doesn't diminish our confidence in the two big Adjuvant studies.
You just brought up a really important point, Chris, that the response rates were measured with ultrasound and MRI in the neo-adjuvant study.
Correct.
In the adjuvant trial, will there be ultrasound or MRI? I actually wasn't aware of this.
So remember, in the Adjuvant study in the 2020 trial and the big studies, the endpoint is not disease recurring just in the breast; the end point is invasive disease-free survival. Invasive disease-free survival is measured, it's the hardest from [indiscernible] criteria. From the time of randomization to any event and that event could be it's tri-lateral or contra-lateral breast cancer, invasive breast cancer. It could be a new cancer, it could be death from any cause, it could be death from breast cancer or it could be new metastatic disease. So the end point in the adjuvant studying is the standard endpoint being used in adjuvant trials, invasive disease-free survival. The new adjuvant studies, this is just measuring disease within the breast.
Is MRI being used then in the…
MRI is not used, but it's not that relevant because that's not the end point.
Okay, got it. And so how is IV best measured then, just to be clear? And you just look for lesions anywhere?
So invasive disease-free survival, patients are followed up and if there is any event and if that event is a necessary it's a new lesion, it's also metastatic lesion, it's a new cancer, it's obviously death from end cause. Any event.
And what do you think is the efficacy bar as measured in DFS [ph]? Is it safe to say 85% in five years?
I don't think that's the right way of saying it. I would come back -- so that's not -- 85% into five years, I don't think that's the -- I'll come back to that.
And just to be clear, in theory then, it's event-driven so wouldn't there be an opportunity for an early infra-red on these adjuvant studies?
These have been driven, that's correct. Currently we're looking at it, it's 2020. For both studies, currently 2020.
And just to be clear, are there any trial design paper published anywhere?
A trial design paper, on clinicaltrials.gov is the published.
That's really important, that gives us a lot of work to do.
During the next 18 months.
So Ibrance itself, there is an issue we've been looking into which is the patent situation. So we were reasonably comfortable that the 2023 patent gets extended. We're now seeing a potential reissue process going on, which means lots of scope for [indiscernible]; so what happened there?
We'll keep our patent strategies with ourselves internally, but we have submitted and it's been accepted for review or re-examination.
And you carried in for 2023 as of the date?
2023 remains the date, and then this is also publicly half-filed to patent term extension applications. If granted, it could be in the 2027 timeframe. We remain very confident in our IP position with Ibrance.
You remain confident?
Absolutely.
Has there been incremental discussions on the recent developments internally?
No.
And then Chris, from your perspective, we saw the PI3K alpha, Novartis come out, pretty good data. How does that impact Ibrance's duration?
That's a good question. You're referring to the SOLO1 [ph] study or BYL719 or pellets have now called [ph] from Novartis, that's an important study for the field because as you know, the PI3K inhibitors have had a very tough kind of apart from an hematological disease and solid tumors for the last 10, 15 years. And a lot of companies have developed PI3K inhibitors because it's likely a pathway that's so active in most solid tumors. So the data from SOLO1 [ph] essentially is in later stage, ER positive breast cancer which [indiscernible] and PALLAS and with a significant PFS benefit. And remember, this study is only in PIK3CA mutated breast cancer, so it's a biomarker selective of sub-population which is approximately 30% of metastatic ER positive breast cancer. Some of the patients in the study did previously receive a CDK 4/6 inhibitor and made tumors progress on a 4/6 inhibitor. I do not think that anyone thinks that palbociclib will replace CDK 4/6 and the setting of first and second line metastatic breast cancer; and however, I believe it's a potential good option for patients with cancers that progress on a CDK 4/6 inhibitor, so it shouldn't impact directly the palbociclib and patient opportunity.
Having said that, we also actually combining palbociclib with GDC-077, the PI3K alpha specific inhibitor from Genentech, and that's also a drug that presumably will be developed specifically in the PIK3CA mutated tumors, and we have an internal PI3K inhibitor called Gedatolisib. Gedatolisib is differentiated from the others because it's an intravenous compound given once every week. The science with the PI3K inhibitor sell-through -- with PI3K tells us that you have to really suppress very deeply the pathway and to do that it's very challenging with the continuous oral dosing, so that's why our PI3K internal inhibitors and PI3K and is intravenous -- intermittently is to really hit the target hard and we combine currently both [indiscernible] palbociclib from data to be presented in 2019 with the Gedatolisib plus palbociclib.
And do you think IV is competitive of Novartis's oral?
So again, the biology tells us that to fool these PI3K inhibitors to work you really need to hit the target very hard. To do that with an oral compound continuously is challenging because of the side-effects including diarrhea, rehumatitis [ph] and other specific side-effects. So that's why the -- we're chasing that process that it could work better to hit the target hard intermittently because you can actually achieve target coverage and still manage the adverse profile. And what if the target is the alpha? It's a pan-PI3K inhibitor, it's also mTOR-inhibitor; so is pan-PI3K plus mTOR; why that's also important. In the PI3K alpha inhibitors, tumors lose a gene called p10 and then the pathway is activated by way of PI3K beta; so this blocks alpha, beta and delta, so it's a pan-PI3K inhibitor and an mTOR-inhibitor.
Have we seen evidence that PI3K is not alpha specific have ever worked in solid tumors?
And the oral compounds are challenging because you can't cover the target by giving constant -- because of the side-effect profile; so that's why the differentiated intravenous approach.
How should we expect in that Phase 1 trial your in-house [indiscernible]?
So the study is actually -- it's a study that's testing an upfront -- in patients upfront with newly diagnosed metastatic disease, all the palbociclib plus Gedatolisib, and then we've got an expansion cohort in tumors that are progressing on [indiscernible] where the treatment is all based on palbociclib plus Gedatolisib because there is a Phase 1b expansion is sort of a randomized study, we look at response rate, we look at complete duration rate and duration of therapy.
Maybe turning to Xtandi; can you give us your thoughts on the metastatic hormone sensitive, how should we sort of think about handicapping that trial with enzalutamide trials etcetera?
So enzalutamide approved obviously in the castrate-resistant prostate cancer, both metastatic and non-metastatic and now moving into earlier prostate cancer, bit like we moving Ibrance into adjuvant early breast cancer, moving enzalutamide into the hormone-sensitive setting of prostate cancer which is again, an obviously a big opportunity and also providing therapy earlier, having that opportunity preparations to have a longer duration of treatment on enzalutamide compared to the metastatic setting preventing castrate-resistant disease; so we've got two big Phase 3 studies ongoing, both studies completed recruitment now, the option [ph] study that should read out in the next couple of weeks which is in the metastatic hormone sensitive disease study and EMBARK study which should readout currently in 2020 which is non-metastatic hormone sensitive disease, so two Phase 3 studies that should readout in this earlier setting for enzalutamide.
And for Zytiga generic, is there an opportunity for Xtandi to compete in that hormone sensitive market?
So, I want Chuck to add to this as well, but remember Zytiga is not a generic for Xtandi, so usually when this erosion it's for generic of a specific product. These are two very different compounds, physicians do not see them actually as interchangeable and Zytiga has a different cited profile, it's concomitant administration of steroids as well, it's different monitoring, so physicians see these as different compounds, so I do not believe.
No, I think that's right. I just emphasize the point we don't really expect any significant degree of therapeutic substitution.
And just to clarify, Zytiga is of course a castration-sensitive prostate cancer and you are targeting the hormone-sensitive prostate cancer; what's the difference there?
Correct. So currently just to start again, so enzalutamide to Xtandi is the only small molecule that's currently approved in both metastatic and the non-metastatic setting, so it's approved to non-metastatic and metastatic -- metastatic castrate-resistant prostate cancer; that is where Zytiga is -- Zytiga is approved currently in the metastatic castrate-resistant prostate cancer and then in the setting of our study which is the metastatic hormone-sensitive prostate cancer.
So Chris, I have to ask you; on the immuno-oncology side I feel like we're praising the lead and then human lead is like all these changes happening. But where do you guys stand? How big a corporate authority is it to being a meaningful IO player or is it not a corporate priority? And [indiscernible] that your titles are on…
It's not about titles. From January, actually I will be doing a little of this. So immuno-oncology for all of us, it's really transformative for many places with cancer, and it will now continue to be one of the backbones for many, many cancers, not for all tumors. However, we do believe that the treatment of cancer will continue not only to evolve with the next -- what's next, what's offered [ph], that also with combinations combining small molecules IO, large molecules with IO chemotherapy we've seen with IO, and also continue to develop new innovative therapies just combining small molecules to small molecules. So IO will play a role that is certainly not the whole of cancer treatment, it's a part of cancer treatment. We've always said that we believe combinations are the future, that is a place where we could potentially play very well because of our track record with small molecules and with the new therapies just been approved or recently for us.
So we will continue to use PD1s and PDL1s as backbone which makes sense to us. As you're seeing, we recently had a positive study, a very clinically meaningful positive study within light of plasovilamab [ph] in light of small molecule for VEGFR inhibitor in first line RCC and that study is now being discussed globally with regulators. The other study that we worked with Keytruda with [indiscernible] was in light of pembrolizumab was also positive readout; so in light has been a very good backbone in the renal cell setting. We've got a number of studies in ongoing including Phase 3 studies with enzalutamide in prostate cancers with PD1s and PDL1s. We've got a Phase 2 study with -- actually two Phase 2 studies with pembrolizumab and a Phase 3 study with axitinib [ph] with enzalutamide in castrate-resistant prostate cancer that should readout in the next 24 months.
And talazoparib; we believe talazoparib is a good positive for some of the immunotherapy and combination studies. So talazoparib recently approved for germline BRCA mutated breast cancers and [indiscernible] is being combined with avelumab in various tumor settings in Phase 3 study in ovarian cancer with ratio of combination because we're selecting for DNA damage response pathway defects ovarian cancer tumors, and thus the Phase 3 study is being combined with tissue agnostic study, a Phase 2 study. Any tumor with BRCA1 or BRCA2 mutated -- mutation are being treated with talazoparib [ph] tested in the study. So we've had a number of -- and strategies for immune checkpoints in combination without in-house molecular therapies. So one of the theories we've been toying with is that the half-life of avelumab looks maturely lower than the other PD1s and PDL1s. And we've been sort of working with subtropins [ph] that since the half-life is less than half or about half and the fact that the dosing interval actually is equivalent to the other PD1s and PDL1s, it's being under-dosed and that might explain some of the trails that have failed.
And we then so often recent amendments on your trials where you're now doing a potential weekly administrations, I'm curious how do you think about that? Is that a consideration?
Just to go back, so the specific study which was very unfortunate that it was a negative study was the second line lung cancer study and which was avelumab is this chemotherapy, and looking back at the data and a lot of the analysis that is now being presented and recently acquired lung, and the conclusion even at world lung was just unlucky patients crossed over in the control arm, with 30% of patients that have controlled went to another checkpoint including avelumab. And compared to other studies we've been below 20%, so that certainly has further study. If we look at specific subgroups within the study with this PDL1 high or specific disease settings and the data comparable was previously published with avelumab or with pembrolizumab. So I think it's difficult from that study for us to say definitely that the drug is under dose or that -- because there is other reasons why that study didn't succeed.
The other study that was negative recently is the ovarian cancer study, so no one has tested in that setting a checkpoint inhibitor; very difficult, very challenging disease, these are platinum-resistant refractory ovarian cancer, and for these patients the long-term outcome is very, very poor, in fact the control arm was doxo and the response rate with doxo was 4%. The response rate with avelumab plus talzo was 14%, so that's significantly higher but it wasn't enough to make it a positive study. Looking back at the study, that study incurred a lot of patients with very refractory disease rather resistant disease which became resistant to platinum, then the other responded to platinum-refractory disease with bulky disease and these are the patients who did particularly poorly in that study.
And I think there is a lot of lessons for everyone and when we present hopefully soon the data from that study including the fact that there are patients that with cold tumors which is going to be very difficult to just expect it to work by adding chemotherapy to immune check, which means a therapy might bring T-cell savings but there is still no new epitopes or responses were made low, and then also patients with very bulky disease with poor prognosis, with low albumin, high LVH, these are patients that do not necessary do good in any combination with immune checkout.
And most of Javelin Medley not workout the combinations in there, the 4-1BB…
Yes, so the 4-1BB and OX40 reading out in 2019 we submit readouts from those, those are the agonist studies, you've seen some data from others, from the other OX40s as well, and -- so that is staged through 2019 combination.
With that timing-wise, I'm curious why that is?
Actually, well we -- to then driven to the readout of the study, I think it's -- perhaps the recruitment was as fast as we hoped in the beginning and so the readouts, getting the readouts in early 2019.
And is it a priority for you to take your monthly PD1 for I think Chuck's one slide, that there is a monthly PD1 in the…
Yes, so we've actually had this in-house we developed at San Francisco site, PD1 as a subcutaneous formulations called [indiscernible]. It's currently being developed as subcutaneous every 4 weeks, and we have a PLC study that will readout in 2019 as well, and currently is very encouraging, it's particularly encouraging the PK data, the PV data, there is no local reactions, skin reactions at the side of the injections and since a potential important molecule for us in the future as well as a backbone.
And my last question is, next-generation Prevnar [ph], so do you think that you need a large Phase 3 outcome for the capital to get approval or it's okay, it's possible to just run a few, maybe antibodies function, measure trial to get it approved?
Sure. So next-generation is [indiscernible] so we've got breakthrough therapy designation based on the Phase 2 data unmet need. So the short answer is no, we don't expect that we'll need a large outcome study, we expect that safety profile. And then, non-inferiority on the 20 serotype, so we use Prevnar 13 for the original 13 serotypes, and then with the 23-valent already on the market, that's how we can get the next 7. So short answer is no, we don't expect that we'll need large outcome study.
And I think that Merck, your competitor could also maybe get approval for their next-generation?
Yes, so they have a 15-valent and I'll just give you some facts, you look at CDC observation, so currently Prevnar 13 being the standard, the two additional serotypes in the 15-valent -- the competitor 15-valent, those two additional serotypes are implicated for probably an incremental 10% to 15% increase in cases of invasive pneumococcal disease. If you take the next five, so we're going from the 15-valent to our 20-valent, that is another 10% to 15% incremental invasive pneumococcal disease prevalent. So basically the 20-valent is twice as effective incrementally as the 15-valent is, or compared to Prevnar 13. So we think we have a very competitive market, we'll be soon starting our Phase 3 study here. I think it will be a very important product in the market.
Your CD19 CAR-T development effort, there is not lot of rumblings that Pfizer had it, then some of the assets were sold to Allogene; so why sell any of them, where do we see the collective collaboration? Is there any data we see…
I'm going to be very quick and then Chuck needs to add to this one. This, we believe CAR-T cells are transformative, we wanted to place it in the hands of a place or a company where it can be very effectively, very efficiently developed where there is a lot of wise investment to do that. So externalizing it, we still own -- we've got a 25% stake in Allogene, so it's very important for us that Allogene is successful, it's an externalization deal with 16 of our preclinical assets that will be developed by Allogene.
And I think the initial perception is actually the inverse of what we thought, right. Given that the development is generally very different from a lot of the other oncology assets [indiscernible] into a company where that's all they do. So really let them focus on one real method here, keep our equity stake here but in terms of most efficiently allocating resources being in both, we thought this was the best way to actually approach this. So that certifies your -- we make an interest but this was based on our confidence in the program, and again, lack of the right term here could have trapped value within Pfizer Oncology and better off somewhere else where we keep the stake, that was our decision; yes, we think it will be developed very successfully in this setting.
Excellent. Thank you so much. Thank you, Chris, great seeing you.
You're welcome. Thanks, Umer.
Thank you.