I would now like to introduce Erwin Sood, Vice President of Investor Relations. Mr.
Sood, you may begin.
Okay, Carmen. Thank you, and good morning, everybody. Thank you for joining us on such short notice. We wanted to tell you about an exciting development, our acquisition of 5 Prime Therapeutics. This is a company that's focused on developing immuno oncology and targeted cancer therapies.
We are looking forward to discussing 5 Prime's lead product in development, bemaretuzumab, that by the way we'll affectionately call bema going forward. Bema is a novel anti fibroblast growth factor receptor antibody, which is being developed initially for gastric cancer. I was joined this morning by our CFO, Peter Griffith, who will discuss the strategic rationale and complementarity of this asset within oncology, which as you know is one of our key therapeutic domains of expertise. Our Head of R and D, Dave Reese, who is also an oncologist, will then provide a bit of a primer on gastric cancer, a description of the molecule and note future developmental steps. Very much looking forward to your questions after Dave's prepared comments.
Also joining us for the Q and A part is Murdo Gordon, our Head of Global Commercial Operations. Just one last reminder from my side that we may make certain forward looking statements. I would encourage you to review our SEC filings, including our 8 ks that was filed this morning that contains a description of factors that might cause our actual outcomes to differ materially. So with that, I would like to turn the call over to Peter. Peter?
Well, good morning, everyone. Thank you, Arvind, and thank you all for joining us this morning on such short notice. As you know, this morning, we announced an agreement to acquire 5 Prime Therapeutics for $38 per share in cash or representing an equity value of approximately $1,900,000,000 But let's start where we always started Amgen with the Amgen difference, having to work each day discovering, developing, manufacturing and delivering 1st in class, best in class innovative therapeutics to patients with serious and grievous illnesses all over the world. And that's why we are so excited about this opportunity, closely aligning to our strategy and our capital allocation deployment principles to drive long term growth for the enterprise. We often speak about evaluating external innovation with the lens of wanting to be one of the best buyers and where we, as Amgen, see an opportunity to drive attractive returns for our shareholders.
The strong strategic fit here within oncology, one of our core therapeutic focus areas in both research and commercial, is also critical in ensuring we can rapidly execute on our world class integration capabilities. 5 Prime's lead asset, bema, as Arvind has introduced you to it, is a 1st in class Phase III ready therapy with positive Phase II data in first line gastric cancer, the 3rd leading cause of cancer deaths around the world. This acquisition represented a compelling opportunity that strengthens our innovative oncology portfolio, adding a complementary molecule to our own internal gastric cancer programs within our BiTE portfolio. Importantly, this deal advances our strategic imperative to grow our business internationally and in Asia Pacific in particular, where gastric cancer is highly prevalent and where we've previously stated we expect to generate roughly 25% of our revenue growth over the next 10 years. We very much look forward to welcoming the team from 5 Prime and working with them to leverage our industry leading biologics, process development and manufacturing expertise to develop and commercialize this asset for patients around the globe as quickly as possible.
And I'll note they are located within a short walk of our new Amgen South San Francisco facility. We're confident that we will be able to leverage our strengths in any number of our areas in order to accelerate the excellent progress that our colleagues at 5 Prime have achieved, both for shareholders and most importantly, for patients. We expect this deal to close by the end of the second quarter and is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of 5 Prime's common stock and the expiration or termination of the waiting period under the Hart Scott Rodino Act. Finally, I would like to reaffirm our full year financial outlook that we shared with you last month on our Q4 call, with revenue guidance for 2021 of $25,800,000,000 to $26,600,000,000 and non GAAP earnings per share guidance of $16 to $17 per share. I would now like to turn the call over to our Head of Research and Development, Dave Reese, who will talk about the molecule, the unmet need that we can potentially address and the recently disclosed Phase II data, which looks promising.
Dave?
Thanks, Peter, and hello, everyone. Thanks again for joining us on short notice this morning. As Peter said, we're thrilled by today's announcement and believe this is a strong strategic fit. 5 Prime is an innovative clinical stage And this is strongly aligned with our own immuno oncology and targeted cancer therapies for patients with solid tumors. And this is strongly aligned with our own immuno oncology and precision medicine strategy.
1st and foremost, fermirtuzumab or bema has the potential to address a very significant global unmet medical need. Gastric cancer is the 3rd most common cause of cancer death worldwide with over 1,000,000 new cases diagnosed annually. And in Asia, in particular, gastric cancer is a significant public health challenge. For context, annually, there are nearly as many cases of gastric cancer in China, Japan and Korea as there are all major solid tumors in the United States. As we previously discussed, we have 2 clinical programs from our BiTE platform targeting proteins also highly expressed in gastric cancer, AMG199 targeting MUC17 and AMG910, which targets claudin18.2.
The beamer program very nicely complements these efforts and adds to our internal expertise. So let's talk a little bit about more about the miratuzumab, the lead asset. This is a fibroblast growth factor receptor 2b or FGFR2b monoclonal antibody advancing into Phase 3 development as a potential frontline therapy for gastric and gastroesophageal junction or GEJ cancer patients whose tumors over express the receptor. For those who aren't familiar with this receptor signaling pathway, I'd like to give you just a little bit of background biology so that you can put things into context. FGFR2b is a splice variant of fibroblast growth factor receptor 2, which is itself a member of a broad and complex FGFR family.
A variety of oncogenic alterations can occur in FGFRs, including point mutations, fusions, translocations, gene amplification or receptor overexpression. In the case of FGFR2b specifically, which is what we're talking about here, overexpression is most common in gastric cancer and occurs in approximately 30% of tumors based on the extensive screening data 5 Prime generated in the context of the Phase 2 FIGHT study. The marituzumab is an apicosylated antibody and it exerts its antitumor effects by inhibiting ligand binding to the FGFR2b receptor as well as through enhanced antibody dependent cell mediated cytotoxicity. Specifically, the miratuzumab inhibits ligand binding of FGF-seven, 10, and 22, thus avoiding some of the metabolic complications such as hyperphosphatemia that can occur with perturbation of FGF-twenty three, one of the many ligands that combine to receptors in this family. Our interest, of course, like many experts in gastric cancer, was peaked by the clinical data Five Prime has generated to date, which we believe are compelling.
In early phase trials, proof of concept was demonstrated with single agent activity in late line gastric cancer with an overall confirmed response rate of 18%. For context, this is roughly comparable to single agent Herceptin activity in advanced HER2 positive breast cancer or the activity of vectabix alone in colorectal cancer. In November 2020, the company announced positive data in first line gastric cancer from the Phase 2 FIGHT study. And in January, a few months ago, the data were presented at the ASCO GI Conference. In our view, FIGHT was a high quality, randomized, placebo controlled study, quite robust and designed for a Phase 2 oncology trial.
The design was straightforward. Patients with untreated FGFR2b overexpressing gastric cancer were randomized to standard back from chemotherapy with or without the maretuzumab. And as I mentioned, this was placebo controlled. In terms of outcome, the addition of the miratuzumab to FOLFOX backbone chemotherapy resulted in clinically meaningful improvements in all three key endpoints, progression free survival, overall survival and overall response rate versus placebo. 155 patients in total were randomized in this trial.
It's also notable that the efficacy appeared to titrate with target expression. In other words, there was what we call an expression response relationship with higher levels of FGFR2b expression associated with increased efficacy in response to bamartuzumab therapy in combination with standard chemotherapy. This we believe is very encouraging and reinforces the importance of FGFR2b overexpression and the potential of the mirituzumab on top of a standard chemotherapy backbone. In our view, these data provide a strong foundation for the further development of the molecule in gastric cancer and we look forward to discussions with regulators on a potential path forward as we work toward initiation of a pivotal study. We believe bimarituzumab could represent a significant opportunity in gastric cancer alone and that is of course is going to be our immediate focus.
But FGFR2b is overexpressed in other solid tumors and there is the potential to develop amerituzumab in additional indications such as squamous non small cell lung cancer. In these other indications, our first priority will likely be squamous lung cancer and we are also evaluating other potential clinical proof of concept approaches for a variety of other tumors and anticipate initiating signal seeking studies in these indications where the tumors have FGFR2b overexpression. It's worth noting that one limitation in the development manufacturing capabilities can bring significant value to the program. We also see the possibility for combination therapy beyond chemotherapy combinations and we'll be exploring potential approaches with other established and novel agents. Finally, 5 Prime also has additional early stage pipeline assets, which we will carefully review, although our immediate focus, as I mentioned, will be on advancing vamiratuzumab in first line gastric cancer.
In closing, I'd like to welcome all of our new colleagues at 5 Prime and highlight that we are all extremely excited about pemarituzumab. And together, we intend to bring all of our development, manufacturing and commercialization experience to serve what remains a very large global unmet medical need. And with that, I will hand things back to Arvind, who will kick us off into the question and answer session.
Okay. Thank you, Dave. Carmen, let's go ahead and open it up for Q and A. If you can please review the procedure for asking questions. And just a request to our participants, if you can please limit yourself to one question.
We have a lot of people who are dialed in. That way, we can be sure that we get through everybody's questions within the hour. Carmen, why don't you go ahead? Thank
you. Our first question is from Terence Flynn with Goldman Sachs. Your question please.
Great. Good morning. Thanks for taking the question. I was just wondering, Dave, if you could comment about the regulatory path here. Is there an accelerated approval option in your view based on this data set?
Or is it most likely going to require another Phase III trial? And if so, how are you thinking about the initial design, especially given some of the evolution of the IO landscape? Thank
you. Thanks, Terrence. Important question. There will be upcoming regulatory interactions, where we speculate on any speculate on any potential accelerated approval pathway. Of course, as we have those discussions with regulators, we'll provide guidance as we move along.
Our anticipation is that the Phase 3 trial and of course it will be a key component of upcoming regulatory discussions will be an expanded version of the FIGHT trial. We believe that standard chemotherapy in much of the globe will remain a standard of care in advanced gastric cancer and is an appropriate comparator. And so that is our initial intent here. Of course, as you're indicating and we're well aware that there will be the introduction of checkpoint inhibitors in this disease. We will also plan as part of the development program, for example, exploring triplet combinations, which would be standard chemotherapy with a PD-one inhibitor and the mirituzumab.
So more on that as the discussions unfold, but our initial thoughts is that it will be a Phase III trial that resembles the FIGHT Phase IIb study.
Thank you. Our next question comes from Carter Gould with Barclays. Your question please.
Great. Congrats on the deal and
thanks for taking the question. Maybe a follow-up on that point, David. Just in terms of how you expect this asset to, I guess, coexist with checkpoint inhibitors in the space. It seems like you're still committed to first line positioning, but it does seem like checkpoint inhibitors will get there first. So just kind of your expectations and what assumptions were built in on that front?
Thank you.
Yes. I'll take that and then maybe ask Murdo to comment as well here. Obviously, we've given that a lot of thought, Carter. First of all, there will be a partial non overlap, we believe, of the eligible patient population. So not all gastric tumors express PD L1, for example, and we'll have to understand over time what fraction of gastric cancer patients are in fact eligible for immunotherapeutic agents, checkpoint inhibitors.
Some of course have other common contraindications to receiving those agents. And so we think that there will be a population of patients that have FGFR2b overexpression where that is the primary driver in the tumor and they would be of course top of mind for use of amerituzumab. But as always in oncology, we expect these agents to coexist. We believe even with the introduction of checkpoint inhibitors, there's a very large opportunity here given the unmet medical need. Let me ask Murdo if he wants to provide a little additional color because he and his team have given this quite a bit of thought as well.
Yes. Thanks, Dave. And thanks for the question, Kartra. The way I would suggest we are thinking about the market is that the PD L1 and PD-one inhibitors are likely to be indicated in a broad population, but in practice, it is possible that PD L1 high expressing patients are patients that would be ideal candidates for PD-one therapy. As Dave mentioned, we believe there will be a non overlapping population of FGFR2b patients, where clearly a product like bema would be a more appropriate treatment.
And the data that we've seen so far at least from the checkpoint inhibitors, indicate that there is a clear efficacy relationship with PD L1 expression in a gastric population. And beyond that, we do think that possible combination strategies, as Dave highlighted, could be possible down the road. But overall, there's still a significant unmet medical need here. We would do a lot of that biomarker overlap work as we go forward to try and identify the unique population for bema. But clearly, it's a highly active drug that has a nice increase in efficacy profile as FGFR2b expression increases.
So that gives us confidence that there's a patient population there that can be easily identified using a well validated immunohistochemistry assay that the team at 5 Prime developed.
Our next question comes from Geoffrey Porges with SVB Leerink. Your question please.
Yes. Thank you very much for the question. Congratulations on the very interesting transaction. So Dave, it looks as though you missed the primary endpoint, or not you, but the FIGHT study missed the primary endpoint of PFS. And it looks as though it was the PFS signal was dragged down by the result in males and in North America compared to the other geographies.
Is there anything going on there? And does that miss on the primary endpoint limit the ability to file with this trial? And secondly, what is your regulatory position in China? Because clearly, that's a big market. And it appears that even with the small subpopulation in China, you've had positive results on both the primary and the secondary end point.
So just interested in a little bit more nuance on how you're looking at that result. Thanks.
Yes. Thanks, Jeff. Important questions. And you're alluding to the fact that the P value on the PFS primary endpoint was 0.07. There was a reduction in hazard ratios in higher expressing subsets of patients with FGFR2b expression.
And I think one of the things that really gave us confidence here was the overall internal consistency of the data. In fact, highly consistent, some of the most consistent data you'll see in a randomized Phase 2 trial in oncology lining up the progression free survival, overall survival endpoints as well as the overall response data. In terms of potential geographic variation, I'd caution us into reading too much into that. When you start looking at smaller subsets in randomized Phase II trials, it's quite typical to see this. That doesn't give us great pause.
And when we I think the totality of the data really strongly pointed in the direction of indisputable. So again, the weight of that evidence is really what convinced us here. And I would not overly dissect small subsets from the Phase II trial. Thank you.
Our next question comes from Geoff Meacham with Bank of America. Your question please.
Hey guys, it's Aspen on for Jeff. Thanks for taking our question.
We just want to hear more of your thoughts on some
of the potential commercial barriers that Hemip could see, thinking specifically about the management of some of these corneal events and potential screening as well? Thank you.
Yes. Maybe I'll start with that and then again ask Murdo to comment. There is one clearly identified side effect, which is which as you noted are corneal events specifically keratitis which can be an inflammation of the cornea. This was not unexpected. FGFR2b is expressed in corneal epithelium.
This is undoubtedly an on target adverse event. We should point out that in the Phase 2 program, there were no prophylactic or mitigation strategies put into place upfront, Apten. And so one of the key parts of the development program going forward will be to introduce in all patients prophylaxis for ocular toxicity, things like hyperviscus, eye drops, which are intended to restore the normal physiology of that part of the eye. Important to note that these adverse events are reversible. The cornea is an epithelial tissue just like other epithelium like the skin and it does regenerate.
And so we think we have with our colleagues at 5 Prime an appropriate plan to mitigate this going forward. And in discussions with many of the experts in the field, they view this as something that they will manage just as the way they manage many of the other toxicities of oncology agents. With respect to a diagnostic, while FGFR2b is not routinely assessed right now, we expect the standard assay to be mostly immunohistochemistry. There is an assay that Fivetrine has developed with 1 of the diagnostics company that we feel is quite robust. These are standard assays and we believe that there shouldn't be any significant barriers to introduction of the diagnostic into clinical practice, just the way you do immunospec chemistry for HER2 overexpression or EGFR overexpression, for example.
The pathologists are quite familiar with these assays and the scoring system. Murdo again and his team have done a lot of work here on the diagnostic and how we're going to identify the appropriate patients. So let me see if he has a few words he wants to add.
Our next question I
think you covered sorry, hold on operator. Thank you. No problem. I think Dave covered it well. A couple of things that I would just emphasize is the experience we have at Amgen in driving diagnostic testing is fairly broad and extensive.
The other thing that's going to happen, of course, in gastric with the advent of the checkpoint inhibitors and PD-1s coming into the market is there's going to be a drive towards PD-one testing and we'll work on the tail of that to further drive some of the pathology work that you're going to need to work up a gastric patient in the future. And it's a high quality assay. The screening data from the FIGHT trial look very good and 30% of the patients showing higher FGFR2b expression. The other thing on just going back to the corneal toxicity, the other thing we saw in the FIGHT trial despite not having prophylactic measures in place on that protocol, the truncation and the duration of therapy was not that great. And so we believe that as we move into a Phase 3 development program with the mitigation and prophylactic measures that Dave described, we should be able to achieve good duration of therapy without limitations due to the side effect of the ocular toxicity.
So that's just another thing that gave us some confidence that this was not a treatment limiting toxicity.
Thank you. Our next question is from Matthew Harrison with Morgan Stanley. Your question please.
Great. Thanks very much. I was wondering if you could just talk about how you're thinking about some other tumor types beyond gastric. Obviously, there's FGFR2b expression, which seems to be pretty high in certain other tumor types. Are you considering starting other trials there?
Or what potentially would be your expansion strategy? Thanks.
Yes. Thanks, Matt. Important question. Yes, we absolutely will intend to explore the utility of the drug in tumor types beyond gastric cancer. As noted, indications such as squamous cell carcinoma of the lung, breast cancer, ovarian cancer, but some other solid tumors, a subset of those cancers will over express FGFR2b and we would anticipate initiating various signal seeking studies and perhaps a basket trial or umbrella trial to look at other indications.
And the real question is, in which of those is this the true pathogenic driver and where you will then benefit from the mirituzumab added to typically standard therapy, but absolutely part of the development program going forward and we'll be speaking over time about that as we get things up and running. As I noted in my remarks, one of the limitations that has prevented that to date has been a limitation in clinical drug supply and we think we can help to rectify that in short order and bring real value to the program.
Thank you. Our next question is from Evan Spiegerman with Credit Suisse. Your question please.
Hi, all. Thank you for taking my question and congrats on the deal. I wanted to get your take on kind of more framing the opportunity. I understand gastric cancer for the prepared remarks is much larger and more prevalent in Asia. How do you think about the opportunity in the United States?
And I guess what type of assumptions on a high level went into your modeling and thinking behind kind of behind the decision to acquire the target?
Yes. Thanks, Evan. Obviously, the FGFR data are still emerging in terms of having really reliable data in the literature on the true prevalence of FGFR2b over criteria used for the FIGHT enrollment. Overall, gastric and gastroesophageal junction cancer globally is a big number. It's over 500,000, somewhere in the region of 640,000,000 patients That would be HER2 negative.
So that's about 85% of the total pool and then about 30% of that would be FGFR2b positive. So that's in gastric and gastroesophageal. The number in the U. S. Is obviously smaller on a per capita basis given the epidemiology of the disease in China, Japan and other markets in Asia.
We think that the addressable opportunity here is in the neighborhood of about 30,000 patients in the U. S. On an annual incidence perspective.
Our next question comes from Mohit Bansal with Citigroup. Your question please.
Great. Thanks for taking my question and congrats on the deal. So one question for David. So if you look at the so the company 5 Prime basically stratified patients on the basis of patients who were given a single dose of falx prior to dosing versus patients who were not given. And it does appear that the benefit is less for the patients who were given a single dose of FOLFOX prior to dosing.
So could you just help us understand what was the rationale behind this stratification? And what do you think is the mechanistic reason why
giving a
single dose of FOLFOX prior had little bit of
less benefit? Thank you.
Yes. Thanks, Mohit. Again, I perhaps wouldn't over interpret some subsets, which are a little smaller. One thing that we've learned with inhibition of various receptor tyrosine kinases over the year in years in combination with chemotherapy is that there can be a timing effect of the antibody that actually enhances then the cytotoxic chemotherapy. Same time as one is initiating chemotherapy moving forward.
So again, I wouldn't over interpret that. I think when you look across the swath of the data, it really shows a nice interaction between the antibody and standard backbone chemotherapy.
Our next question comes from Chris Raymond with Piper Sandler. Your question please.
Hey, thanks and congrats from us on the deal as well. I just wanted to maybe probe a little bit more on the AE profile. I know you guys in an answer to a previous question talked about a prophylactic strategy to address the ocular side effects. And I think I heard you guys mentioned that duration wasn't that different. But the dropout rate was quite a lot higher in the data that we saw in November.
And just looking at the nature of the AEs, stomatitis was a pretty big driver. So I'm just kind of curious, can you get a little bit more color around the prophylactic strategy that you guys are talking about and how that addresses sort of the spectrum of AEs that were sort of driving the discontinuation rate differential? Thanks.
Yes. Thanks. Again, an important question. The somatitis that was observed was much less of a driver in terms of dropout. And this is a side effect that oncologists are very familiar with.
Part of it may is also potentially due to the 5 FU that's used as part of the backbone chemotherapy here. So commonly encountered with 5MU containing regimens. And for those of you who are not familiar, stomatitis is sort of inflammation in the mouth and those tissues. Again, in terms of the ocular toxicity, there was no prophylaxis in the FIGHT trial based on the biology of this receptor in the corneum. We believe there's probably of the normal physiology and that things like hyperviscus eye drops can help restore that normal physiologic background and hopefully greatly mitigate the toxicity.
In addition, patients will be monitored. And as I mentioned, the adverse event is reversible. So with short pauses in therapy, patients may then be able to resume therapy going on. These are very standard approaches in oncology. And then finally, as Murdo mentioned, despite all of this, the duration of therapy or the exposures, what we would call the dose intensity, were not really compromised at all.
And it clearly did not compromise efficacy. So again, these are clearly real events, no question about it, but we believe that these are things that oncologists are familiar with dealing with and will incorporate into their practice patterns as they treat patients with this antibody.
Our next question comes from Michael Yee with Jefferies. Your question please.
Hi guys, thanks. I had a
question maybe for Murdo and Peter. I'll give David a break. You I think we appreciate there's a lot of growth for this or a lot of opportunity for this product outside the U. S. And even excluding China, which is really the Zai Lab rights.
Can you just maybe comment, do you expect that that could be 2x or 3x what you're thinking for the U. S. Side in terms of revenue opportunity? And can Peter explain what his guidance was for OUS to strategic Amgen growth and what would be driving that in I
won't give you a multiple on what we're doing. I won't give you a multiple on what we're doing outside of the U. S. I do think you've got the overall framing right. There's a significant opportunity in Japan, Korea, Taiwan and other obviously, now that we've been expanding globally, we've investments in Japan.
We started last year, we investments in Japan. We started last year with the advent of our full blown independent affiliate after we bought out the JV share of the Astellas joint venture. And we've been applying a lot of good strong running start in Japan. We're also expanding in South Korea and Taiwan with broader public reimbursement of our portfolio there. So really, really nice opportunity and the royalty just to make sure that we understand the FGFR2b expression by market.
There may be some variability here in the incidence of FGFR2b. And we're going to do the work that's necessary with Dave's team to get that mapped and really assess what the potential revenue opportunity. But we're extremely excited about this. The strategic fit for this asset is solid. And as Peter mentioned, it's really good to help accelerate our growth outside the U.
S. But I'll turn it back to Peter for the other part of your question.
Thank you, Murdo. Thanks for the question, Mike. I'm glad you asked it. As I have previously, we guide that 25% or so of our growth over the next 9 or 10 years we expect to come from the JAPAC region. So the strategic Amgen growth that we've got is going to come from, as Murdo said, the general medicine brands, China, Japan, Southeast Asia.
That's what we expect to see. So we're very delighted that this fits nicely into that profile. So thanks for the question.
Our next question comes from Jay Olson with Oppenheimer. Your question please.
Hey, congrats on the deal and thanks for taking the question. Since 5 Prime has a number of other molecules in the pipeline besides bema, can you maybe talk about the potential for some of those other assets and how they would fit into Amgen's oncology portfolio? Thank you. Yes, let me briefly address that, Jade. This is Dave.
So of course, we're well aware of those assets, most of which are immuno oncology agents. And so what we're going to do going forward, they'll be evaluated on an asset by asset basis for FIT and PROMISE and would become part of the Amgen portfolio and handled as such. So I don't think we're ready to issue guidance on the rest of the portfolio right now, but we'll talk about that over time as we really dig into the scientific data.
Our next question is from Robin Karnauskas with Tuohy Securities. Your question please.
Hi guys. Thanks for taking my question. So I
guess I'll ask the one
I thought would have been asked already. You've done you have KRAS, which is about to be approved. And then this deal, which could be a large product for you in oncology, are you more directed toward oncology or leaning toward more oncology assets that you could leverage and pull in now that you're going to have a sales force in this space or a bigger sales force in this space? And then how much room do you have to do more deals? Should we expect more deals or pause and smaller type transactions?
Thanks.
Dave, do you want to start with the therapeutic question?
Yes, sure. I'll be happy to start with the therapeutic question. Robin, I don't as we've reiterated, we're in 6 therapeutic areas in terms of our marketed products and research. We are concentrated in cardiometabolic disease, inflammation and oncology. I don't think that this changes our perspective that the appropriate assets across that swath of therapeutic areas are of interest and so our Aperture remains open across that landscape with all of the sorts of parameters in terms of capital allocation that Peter has outlined many times.
Myrtle, you may want to talk about the commercial fit component here.
Yes. I mean, this is about as good as it gets when you look at a late stage oncology asset that you want to bring into the portfolio. It fits therapeutically. We already cover a lot of these customers with their existing portfolio. It fits strategically because of the growth that we're generating outside the U.
S. And it fits for Amgen given our capabilities. We've got strength in research and development under Dave's leadership, an extremely strong manufacturing organization under Esteban Santos' leadership that as Dave mentioned can be brought to bear here to accelerate this program. And I'd like to think we've got a world class commercial organization deployed around the world ready to take a product like this as quickly as possible to the market. And I'd just remind you, we did a big inflammation deal recently to acquire a product called Otezla.
So I wouldn't say our focus has shifted to oncology. I think Dave described our strategic focus quite well. We've got 3 development areas where we're active in our own pipeline, 6 commercial therapeutic areas. And we're always on the lookout for high quality assets like this, to add to the Amgen internal pipeline.
If I might jump in too, I'd just like to add Rob and thank you for the question. It's Peter. I think we're going to continue to accelerate what I call our balanced innovation, internal and external innovation. Strong history at Amgen of being balanced between the 2. As Murdo and Dave have both articulated, there's a great opportunity for us to be able to move forward on that.
On the internal side, as we mentioned last month, we're going to look forward to investing more money in our internal innovation in 2021. So to Otezi were great evidence of that working really, really well. And on the external side, I think Murdo hit it. I think Otezla was a deployment of 13 point $4,000,000,000 of our shareholders' capital. We proved we're world class integrators in that one.
So we're excited to team with 5 Prime here and get this one working really, really well as Dave and Murdo and the team are ready to do. And in terms of looking at more transactions, we are going to continue our disciplined capital allocation that reflects our priorities. Capital allocation will continue to be a forethought here at Amgen, not an afterthought. We'll continue to be disciplined, and we'll continue to look for opportunities that where we're a best buyer, one of the best, where the returns are above our hurdle rate with 3 discovery research areas, in this case, as you point out on and where we can promptly integrate. Interrogate through those opportunities as quickly as possible and be patient in selecting the ones that optimize returns for our shareholders and create opportunities most importantly for our patients.
Thanks very much. Carmen, next question please.
From Kennen MacKay with RBC Capital Markets. Your question please.
Hi, congrats on the deal
and thanks for taking the question. Wondering if there's any synergistic overlap within your current pipeline that you were thinking about maybe with a couple of your BiTEs like AMG199 or 910, or whether there was synergy potentially outside your pipeline, as mentioned with sort of checkpoint inhibitors? Thank you very much.
Yes, Kennen, thanks. Important question. Yes, I think obviously this provides a nice complement to the BiTEs and down the road, we would obviously be looking at whether combinations, whether together or sequentially as those assets move forward. So more to come there. And I think that the combination opportunities for this antibody are not restricted to backbone chemotherapies, but other agents such as checkpoint inhibitors, even tyrosine kinase inhibitors, and those sorts of combinations will be things we're interested in exploring as well.
Our next question is from Alethia Young with Cantor Fitzgerald. Your question please.
Hey guys, thanks for taking my question. I just wanted to talk about the next indication squamous. Is there a reason maybe why you chose that over? Is it perhaps a similarity in the prevalence? Or is it your relativity to KRAS?
Or is it something in the biology? Or perhaps it's just a mix? So I would just be curious to kind of get your perspective on that. Thanks.
Yes, Alethia, thanks for the question. I think it's right now that's where there seems to be the strongest evidence in terms of overexpression in squamous non small cell lung cancer. And so that's one reason to put that one near the top of the queue. And then as you're flying there are a variety of other indications where a subset of the tumors have FGFR2b overexpression and we'll be doing signal seeking clinical studies in those areas as well.
Our next question is from Umer Raffat with Evercore ISI. Your question please.
Hi, this is Bo for Umer. Thank you for taking our questions. One if 2 if we may for David. Could you share some thoughts on why the PFS and OS curve seems to separate rather late after 6 months of treatment? And coincidentally, the medium duration of bema exposure is FGS are to be IHC below 5% and that's roughly only 30 presentations also.
Do you see any PFS or OS trend of benefit? Thanks.
Yes. In terms of the later separation of the curves, I mean, this is not unusual when you're combining antibodies with standard back bone chemotherapy. So I don't view that as anything unusual at all. And then as we previously mentioned, there does appear to be an expression response association, increasing levels of FGFR to be over expression appear to be associated with enhanced efficacy. This is also not uncommon at all for other receptor tyrosine kinase kinases in which antibody therapy in combination with chemotherapy is effective.
So one of the again, one of the advantages we believe here is the internal consistency of the data and the fact that you've got analogs from HER2 EGFR and other receptor signaling
Hey, guys.
Good morning. Thanks for
taking my question. I just
Hey guys, good morning. Thanks for taking my question. I just had one more on the deal itself. Just curious if it was a competitive process and whether it was sort of an optimistic acquisition on the back of the Phase II data or whether it may be part of an increased focus in terms of going after product candidates that are addressing genetic drivers, specifically within oncology? Thanks so much.
Yes, Michael, it's Peter. Thank you for your question. I think this was an opportunity as soon as we looked at it. We realized it fit in wonderfully strategically. And I think the really important part of it for us is we really feel like we can leverage, as I said in my opening comment, any number of our strengths in these areas to accelerate it forward from the product development to process development, manufacturing, delivering it around the world, the strength in JPAC that we've demonstrated.
We went through $1,000,000,000 in revenue there in 2020. So we just feel like the fit's outstanding. So we're very pleased with that. On the second part of your question, I think I'll turn that one over to Dave and let him address that.
Yes. And can you just remind me again, Mike, what the second part of that question was?
Dave, it was related to whether or not this deal is refocusing on targeted oncology.
Yes. Go ahead. Thanks.
Look, our general approach is to generate precision oncology. One of our beliefs is that the future of oncology broadly is the marriage of immuno oncology and precision medicine targeting specific molecular alterations. But I think this fits nicely within that broader strategic rubric and as a complement to the other assets in our portfolio.
Our next question comes from Dan Leung with Raymond James. Your question please.
All right. Thank you very much for getting the questions in and congratulations on the deal. 1, I guess, 2 parts for me. The first part being, can you maybe just comment in terms of the FIGHT study and the dropout rate, the substantial dropout rate that we saw in the bemarituzumab arm around corneal tox. On the OSS outcomes in the ITT patient population, were those patients once they dropped out due to corneal tox, were they put into the chemo arm?
So essentially would they count on the OS curve for the ICT patient population even though they were then switched to what was effectively the placebo regimen. So any insight there? And then maybe power sliding to a different topic. A lot of questions we got in this morning was just kind of what you're thinking about targeted oncology in lung, specifically given the ongoing KRAS program importance to your overall oncology franchise. Are you still looking to maybe ratchet up some of the investment both internally and externally around lung and targeted oncology going forward?
Thank you.
Sure. Thanks, Dan. In terms of the FIGHT study and the dropouts due to corneal toxicity, I think we've addressed that. We're hoping we'll be able to mitigate that with prophylaxis measures. And it clearly did not impede the efficacy data that were generated.
In terms of the overall survival outcomes of the trial, patients are still being followed for survival in this trial and there'll be updated looks at that. But when you evaluated intention to treat population, if someone drops off the antibody, you don't switch their data to the control arm, but rather they are assessed in the arm to which they were randomized and that's how it was done here. And then finally, in terms of targeted oncology, I think we've just talked about that. We believe that the future here is a marriage between immuno oncology and precision oncology and we're always looking internally and externally for assets that we believe will provide a complement to our portfolio as we carried out the as we carry out the as we do further drug development in this therapeutic area. Thank you.
Carmen, as we are getting to the end of the hour, why don't we take one last question,
Thank you, sir. Our next question is from Colin Bristol with UBS. Please go ahead.
Thanks for taking the questions and congrats on the acquisition. On your valuation process, can you speak at least qualitatively to how much value you assigned to the assets outside of Demba? It sounds like your comments, it really wasn't much at all. And then I'm just curious, was there any data you had to that is in the public domain, which gave you greater conviction in the strength of the deal? Thanks.
Yes. As we mentioned, the primary driver value driver here was gastric cancer. We view as upside indications beyond that and plan on doing the appropriate development programs to explore those indications and more on that as the data emerge. But you've heard Moto in me describe the large unmet medical need globally in gastric cancer and we believe that is the primary value driver there. Murdo, I don't know if you'd like to add anything.
No, I think that's right, David. Sorry for the echo there. I think that's right. And we also see the broader strategic fit with bema and we saw that we really have an opportunity to accelerate this program, broaden it. And if we do see activity in other malignancies, we'll pursue those quickly.
And if we see combinatorial approaches that work, we'll pursue those quickly. And we're in a really good position to do that broadly across our portfolio and in partnership potentially with others. Yes, if I can add,
Colin, it's Peter here. We're certainly prepared. And as you know, we have the firepower to be able to back up whatever Doctor. Reese in research and development come in with as additional opportunity beyond gastric. So we're thinking about that and we're certainly prepared to back them up and certainly have the firepower to do
that. Great. Thanks, Peter. So with that, I would like to thank all of you for your participation. Hopefully, you have a much better understanding of the strategic value of this acquisition and look forward to keeping the dialogue open and also look forward to your feedback.
Thanks again for your participation. Have a good day.
Thank you. And with that, ladies and gentlemen, we conclude today's conference call. Thank you for participating. You may now disconnect.