Amgen Inc 2026 European Society for Medical Oncology (ESMO) Annual Congress

Mr. Capparelli, you may- Joining our call from ESMO here in Madrid.

The slides that we'll be reviewing are now available on our Amgen IR website. Please see in the slides that accompany this presentation our safe harbor statement. I'll now turn it to Myrtle boarding to get us started.

Casey, thank you, and thanks everybody for being on the call this evening or this afternoon if you're on the West Coast of the U.S. It's our pleasure here at Amgen to host this discussion which will recapitulate some really exciting and important data that were presented, as Casey mentioned, here in Madrid at the 26th edition of the ESMO Medical Congress. So joining me this evening is our Head of Oncology Development, Jean-Charles Soria, our Senior Vice President of Oncology Global Development. Also joining me is Kaveh Niksefat, our Senior Vice President of Global Marketing and Access. And we're privileged to be joined by Dr. Charles Rudin, Director of the Memorial Sloan Kettering Cancer Center, who's one of the world's preeminent small-cell lung cancer physician researchers who joins us to lend us his perspective.

Dr. Rudin led the pivotal second-line phase III DeLLphi-304 study that established IMDELLTRA as a standard of care for relapsed small-cell lung cancer and is here today to provide his perspective on the first-line maintenance phase III study, the DeLLphi-305 results that were presented just a few hours ago here in Madrid. And of course, Casey will be here to answer questions as well who you are all familiar with. Today is one of those days where at Amgen we are able to live the company mission and our mission at Amgen is very simple, it's to serve patients. And as you know my experience, I've been to many congresses and many ESMO meetings over the last few decades, but this meeting has been a special one, an extremely special one.

Today was the kind of day that here at Amgen we all appreciate because it allows us to fulfill that company mission. It allows us to work on a devastating type of cancer, small-cell lung cancer, and transform survival expectations. Our BiTE platform has demonstrated transformative survival benefit in hematologic malignancies and now in solid tumors. IMDELLTRA clearly demonstrates durable survival benefit in small-cell lung cancer. IMDELLTRA is becoming the cornerstone therapy for extensive stage small-cell lung cancer regardless of the combination choice including PD-L1s. We have broad global development program that has the potential to further expand the impact that IMDELLTRA can have on patients. Our innovative oncology portfolio is well positioned as one of our core six key growth drivers. It is our pleasure to be able to delve into these data with a bit more detail.

Before we do that, just a reminder of the strength of Amgen's portfolio of first-in-class and best-in-class medicines with Repatha in cardiovascular disease, Evenity in osteoporosis, Tezspire in severe asthma and nasal polyps and soon eosinophilic esophagitis, Dupixent for rare autoimmune diseases, BLINCYTO in ALL, and IMDELLTRA in small-cell lung cancer. We are committed to delivering these first-in-class and best-in-class medicines. We have a broad innovative pipeline across these therapeutic areas, and these differentiated medicines are in leadership positions in populations with strong opportunities where we address significant unmet need. In oncology, of course, BLINCYTO and IMDELLTRA illustrate our ability to translate biology and deep biological insight into differentiated medicines.

Just as a reminder, as we reported our second quarter results, we have a very strong portfolio with these medicines delivering over 26% year over year in Q2 and comprises now 70% of our second quarter sales. We are definitely building strong commercial momentum with these growth drivers. We are enthusiastic about the outlook given the momentum for these products with patients that still continue to be underserved across these diseases. Without further ado, I do want to transition to Jean-Charles so that we can delve deeper into our program.

Thank you. Amgen Oncology R&D strategy is focused on delivering differentiated and transformative therapies for patients with hard-to-treat solid tumors and hematological malignancies. Our strategy is anchored in two core pillars, the T-cell engagers and precision therapies, which include small molecules directed at difficult-to-drug targets and antibody drug conjugates. Today, we will focus on the T-cell engager platform called BiTE. T-cell engagers are bispecific antibodies that physically connect a patient's T-cell directly to cancer cells, forcing an artificial synapse that allows the immune system to recognize and destroy the tumor. One arm of the T-cell engager, which is an antibody, latches onto a specific protein, which is a tumor-associated antigen on the cancer cell, while the other arm of this bispecific antibody binds to the CD3 receptor on the T-cell.

This close physical link activates the T-cell to release cytotoxic molecules that will kill the cancer cell or aim at least at killing the cancer cell. At Amgen, we are pioneers of BiTE medicines. The column on the left is where we started this story of bispecific T-cell engagers or BiTEs when the technology was new and the impact was uncertain. We have learned and built upon the innovation that brought us BLINCYTO, which was the first-ever T-cell engager approved, and we have expanded the impact of BiTE medicines into solid tumors. We have engineered second-generation BiTEs with convenient IV infusions and are exploring the potential for subcutaneous administration. We have navigated treatment concerns and have achieved mostly outpatient administration and reduced monitoring for our BiTE medicines, improving the overall patient experience. We have also improved the tolerability of our medicines through effective management strategies.

These were not trivial undertakings, and we have generated a high degree of institutional knowledge and expertise along the way for how to develop, manufacture, and commercialize BiTE medicines. This is clearly a strong platform for the company. The evolution of our BiTE platform is what brought us BLINCYTO, a CD19 targeting BiTE that has revolutionized survival in B-cell acute lymphoblastic leukemia. BLINCYTO was our first approved BiTE medicine and has dramatically changed the treatment on B-ALL. IMDELLTRA, a DLL3 targeting BiTE, has revolutionized survival in small-cell lung cancer. Xaluritamig is an investigational STEAP1 targeting BiTE that is rapidly advancing through phase III in prostate cancer. Xaluritamig, as you can see, is designed to bind STEAP1 on tumor cells and CD3 on T-cells, directing T-cell activity towards STEAP1-expressing prostate cancers.

Xaluritamig is being developed for all comers with no biomarker testing needed as the STEAP1 is highly expressed in prostate cancer. Xaluritamig development is significant and encompasses broad different stages of prostate cancer. With Xaluritamig, we are covering the waterfront of prostate cancer by pursuing a parallel development path across various prostate cancer disease stages, where there remain large patient populations with significant unmet need. The phase III MCRPC, Metastatic Castration-Resistant Prostate Cancer program, is testing two chemo-free regimens, Xaluritamig as monotherapy and Xaluritamig in combination with abiraterone in distinct late-stage treatment settings. We are also quickly moving to the earlier stage of prostate cancer, following the approach we pioneered first with BLINCYTO and now with IMDELLTRA. Our conviction in Xaluritamig's potential has led us also to this parallel investment approach.

We have introduced the BiTE strategy and platform, and now let's return to IMDELLTRA, a medicine that is transforming the standard for survival in small-cell lung cancer. Small-cell lung cancer is a devastating and rapidly progressing disease with survival often counted in months. There has been limited innovation in the field, and recent advancements have generated modest improvements in overall survival in the first-line setting. The question for us when designing the DeLLphi-305 study was whether adding IMDELLTRA to continued durvalumab treatment could improve outcomes in patients whose disease had not progressed after induction therapy. We gain initial insight into this approach from a phase I-B first-line maintenance study, DeLLphi-303. Some of you may recall that data from this study were presented last year and provided us insights into IMDELLTRA's ability to improve survival.

Today, we are pleased to share updated survival that are available in an e-poster and will be presented on Monday here at ESMO. With an additional year of data, we have now observed in the first-line maintenance setting a median overall survival of 37.9 months. This is remarkable data in this difficult-to-treat disease. It is now my pleasure to introduce Dr. Charles Rudin, a world expert physician scientist in small-cell lung cancer, to walk you through the transformative data from the DeLLphi-305 first-line maintenance phase III trial that was just presented a few hours ago during the presidential symposium here in Madrid at ESMO.