Amgen Details Oncology R&D Push, IMDELLTRA Expansion and LUMAKRAS Updates at Citi Summit

Key Points

• Amgen is prioritizing T‑cell engagers and precision small molecules, aiming to expand T‑cell engagers from hematologic cancers into more common solid tumors while selectively adding modalities (e.g., ADCs) that leverage its biologics and chemistry strengths.
• The company reported commercial momentum for IMDELLTRA—U.S. full approval in 2025 for second‑line+ small cell lung cancer, use at >1,600 U.S. sites and approval in Japan—while running multiple phase III trials (first‑line maintenance, first‑line combo, limited‑stage) and exploring subcutaneous dosing and alternative schedules.
• Amgen is pushing LUMAKRAS into earlier lines after durable responses in frontline NSCLC combinations and a colorectal triplet showing ~55% ORR and >90% disease control, prompting a first‑line colorectal trial and the CodeBreaK 202 phase III in KRAS G12C patients.

Amgen NASDAQ: AMGN executives outlined the company’s oncology research and development priorities and provided updates on several key programs during Citi’s Virtual Oncology Leadership Summit. Jean-Charles Soria, senior vice president of global development in oncology, said Amgen’s framework emphasizes “differentiated and transformative therapies” rather than “marginal benefit,” with a focus on hard-to-treat solid tumors and selected hematologic malignancies.

Oncology strategy centers on T-cell engagers and precision small molecules

Soria described two “clear pillars” for Amgen’s modalities: T-cell engagers and precision therapies using small molecules. He said Amgen has invested in T-cell engagers for decades and described the company as the only one with a T-cell engager approved in both a hematologic malignancy and a solid tumor, adding that expanding T-cell engagers into more common solid tumors is an important frontier.

On the small-molecule side, Soria highlighted Amgen’s chemistry capabilities and said the company has pursued difficult targets such as KRAS and PRMT5. He added that Amgen is also looking to diversify modalities selectively, including antibody-drug conjugates (ADCs), but said the company will be selective in areas that leverage its strengths as a biologics company with chemistry expertise.

IMDELLTRA rollout and expansion plans in small cell lung cancer

Investor relations representative Casey Capparelli discussed the commercial backdrop for IMDELLTRA, noting that it received full approval in the U.S. in 2025 for second-line or later small cell lung cancer. Capparelli said NCCN guidelines have been updated to reflect IMDELLTRA’s benefit in that setting and described “momentum commercially” in reaching patients.

According to Capparelli, more than 1,600 sites in the U.S. administer IMDELLTRA, with the majority of doses provided in the community setting—an adoption dynamic the company had previously viewed as an open question. He also said IMDELLTRA has approval in Japan, with additional geographies pending based on the phase III study supporting U.S. full approval.

Soria said Amgen launched multiple phase III trials after observing compelling activity in phase I and II studies. Beyond the already disclosed positive second-line phase III trial, he highlighted three additional ongoing phase III studies:

• A first-line metastatic maintenance study (trial 305), which he said is fully enrolled
• A first-line metastatic study (trial 312) enrolling IMDELLTRA in combination with chemotherapy and PD-L1 therapy upfront
• A phase III study in limited-stage small cell lung cancer

Soria also discussed efforts aimed at improving convenience and easing administration burdens for T-cell engager therapies, including exploration of alternative dosing intervals (q2 weeks, q3 weeks, q4 weeks) and prospective testing of shorter monitoring periods after administration. He said Amgen is also exploring a subcutaneous formulation of IMDELLTRA in an ongoing phase Ib trial.

On potential expansion beyond small cell lung cancer, Soria said Amgen has reported activity for its DLL3 T-cell engager in neuroendocrine prostate cancer, describing it as a neuroendocrine differentiation that can occur under therapeutic pressure after multiple prior prostate cancer therapies.

LUMAKRAS: earlier-line studies and colorectal triplet data discussed

Soria said LUMAKRAS is currently available in second-line non-small cell lung cancer and third-line colorectal cancer in combination with Amgen’s Vectibix. He added that longer-term growth is expected to come from moving into earlier lines of therapy.

In non-small cell lung cancer, Soria said the combination of LUMAKRAS with chemotherapy produced durable responses with a “very good manageable safety profile” in treatment-naïve patients with KRAS G12C mutations. He said this supported initiation of the CodeBreaK 202 phase III trial evaluating chemotherapy plus LUMAKRAS versus chemotherapy plus pembrolizumab in KRAS G12C patients who are PD-L1 negative.

In colorectal cancer, Soria said a triplet regimen of LUMAKRAS, Vectibix, and FOLFIRI showed an objective response rate of around 55% and a disease control rate “north of 90%.” He added that responses were observed regardless of prior lines of therapy, including in patients who had progressed on irinotecan, and said this led Amgen to launch a first-line colorectal cancer trial that is currently enrolling.

BLINCYTO development: earlier lines, subcutaneous formulation, and autoimmune studies

Soria said Amgen has observed that moving BLINCYTO into earlier lines of therapy has been associated with higher efficacy and better tolerability—an approach he described as a “blueprint” for IMDELLTRA development. He highlighted the Golden Gate phase III study in older adults (mostly 55+) with newly diagnosed B-ALL, emphasizing the importance of chemotherapy-sparing regimens for patients with lower chemotherapy tolerability.

He also discussed development of subcutaneous blinatumomab, citing phase Ib data suggesting improved convenience and potentially higher activity versus continuous IV infusion, while noting that broader validation will depend on additional studies.

Capparelli added that Amgen is also exploring blinatumomab in autoimmune disease, with phase II studies underway in systemic lupus erythematosus (with and without nephritis) and in refractory rheumatoid arthritis. Soria said the approach is mechanistically logical given CD19’s role on B cells and the role of autoantibodies in autoimmune disease.

Xaluritamig: prostate cancer differentiation and Ewing sarcoma rationale

Soria described xaluritamig as leveraging a mechanism not currently approved in prostate cancer, noting that checkpoint inhibitors such as PD-1 and CTLA-4 therapies do not have approvals in the disease. He said Amgen has seen signs of efficacy across PSA-related measures (PSA90 and PSA50) and objective response rate.

He said Amgen’s phase III strategy aims to differentiate in a competitive market by prioritizing overall survival evidence versus highly active chemotherapy comparators in both post-taxane and pre-taxane settings. He also emphasized monotherapy development in the post-taxane setting to address unmet need, a broad addressable population without a biomarker “gate,” and a chemo-free approach in the pre-taxane setting designed to show a survival advantage versus chemotherapy without combining with chemotherapy.

Soria added that Amgen is already conducting three ongoing phase Ib studies in earlier prostate cancer settings: neoadjuvant (before surgery), biochemical recurrence, and hormone-sensitive prostate cancer. Capparelli said the company’s experience suggests T-cell engagers can show improved outcomes when moved earlier into lower tumor burden settings, citing BLINCYTO and IMDELLTRA as supporting examples.

On Ewing sarcoma, Soria said Amgen pursued development based on disease biology, very high target expression, and significant unmet need—particularly for patients who fail frontline therapy. He noted the program is feasible because Amgen is already investing in development for a more common tumor type.

Additional pipeline discussion included AMG 193 for MTAP-null solid tumors, where Soria said Amgen has focused development in lung and gastrointestinal tumors, including phase Ib combinations with standards of care and a randomized dose optimization effort in lung cancer. He also referenced a pancreatic cancer trial combining AMG 193 with a Revolution Medicines RAS inhibitor.

Soria said Amgen is leveraging AI and machine learning across target identification, molecule design, antibody generation, translational insights, and clinical data analysis, while emphasizing the need for high standards in a regulated environment. He cited a deal with DISCO Pharmaceuticals as an example tied to “surfaceome” analysis to identify new targeting opportunities in small cell lung cancer.

On bemarituzumab, Capparelli said Amgen has decided not to pursue a regulatory submission in frontline gastric cancer and is determining next steps. Soria said the company is analyzing the phase III results and will share more later.

In response to a question on cell therapy, Soria said Amgen will be selective, pointing to complexities in manufacturing, availability, and cost, and said the company has not seen cell therapy deliver benefits in solid tumors comparable to what it is observing with its T-cell engagers.

About Amgen NASDAQ: AMGN

Amgen Inc NASDAQ: AMGN is a global biotechnology company founded in 1980 and headquartered in Thousand Oaks, California. The company focuses on discovering, developing, manufacturing and delivering human therapeutics that address serious illnesses. Amgen's work centers on biologic medicines derived from cellular and molecular biology, with an emphasis on translating advances in human genetics and protein science into therapies for patients.

Amgen's commercial portfolio has historically included biologics used in oncology, supportive care, nephrology, bone health and cardiovascular disease.

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