Amgen’s BiTE platform to become a pillar of solid tumor strategy

Genetics and AI-driven R&D advancement… improving clinical efficiency and patient access

BiTE proven with Blincyto… expanding to small cell lung cancer with Imdelltra

Bispecific antibody-based immuno-oncology platforms are expanding beyond hematologic malignancies into solid tumors, emerging as a new axis of treatment strategy transformation.

Amgen is rapidly expanding its position as a next-generation immuno-oncology strategy by broadening the application scope of its ‘BiTE (Bispecific T-cell Engager)’ technology based on a research and development system that combines genetics and artificial intelligence (AI).

Meejin Cho, Hematology-Oncology TA Lead, Medical Affairs, Amgen Korea

On the 17th, Amgen Korea held a media session at its Seoul headquarters under the theme “AMGEN INNOVATION TALK BiTE – Innovation Driving Changes in Patient Treatment,” and unveiled its R&D strategy and direction for BiTE platform expansion.

Under its mission of “To Serve Patients,” Amgen has been developing treatment options in areas of serious diseases such as cancer, cardiovascular disease, inflammation, and rare diseases. Recently, the company has been focusing on simultaneously enhancing the precision and speed of new drug development by integrating AI technology based on its understanding of human genetics and disease biology.

The R&D strategy is structured around three pillars: ▲identifying the root causes of diseases and discovering new targets, ▲developing diverse treatment modalities, and ▲innovating clinical trial design.

These strategies are being implemented in actual research processes. Amgen uses large-scale genetic data accumulated through its subsidiary deCODE Genetics to analyze disease causes and treatment responses with high precision. In addition, it applies the AI platform ‘Freyja,’ developed in collaboration with NVIDIA, to predict the probability of success of candidate substances in advance, thereby improving development efficiency.

The use of AI is also expanding in the clinical stage. By analyzing real-world patient data through its proprietary machine learning model ‘ATOMIC’ and identifying institutions with a high likelihood of participating in clinical trials, the company claims to have increased patient recruitment speed by approximately threefold compared to previous methods. This directly contributes to shortening the drug development timeline and improving patient access.

On this foundation, Amgen’s core platform is BiTE. BiTE is a bispecific antibody-based immuno-oncology platform that enables a patient’s immune T cells to directly recognize and attack cancer cells.

Cancer cells evade immune surveillance through various mechanisms. While existing immune checkpoint inhibitors restore T-cell activity by blocking the PD-1/PD-L1 binding, BiTE represents a more advanced approach.

In some cancers, cells evade T-cell recognition by reducing MHC class I expression, but BiTE bypasses this limitation. Its structure allows it to bind simultaneously to the T-cell’s CD3 and the target antigen on the cancer cell, thereby inducing immune cells to directly attack cancer cells without relying on the TCR-MHC class I recognition process.

In other words, unlike previous approaches that only activated immune responses, BiTE physically connects T cells and cancer cells, inducing immediate cell death.

Based on these mechanistic strengths, BiTE is expanding its application across various cancer types and has already proven its clinical value in hematologic malignancies.

‘Blincyto (blinatumomab),’ a treatment for acute lymphoblastic leukemia (ALL), induces anti-cancer effects by linking CD19-positive B cells and T cells and has demonstrated improved survival compared to existing treatments. Based on this evidence, it is recommended as first-line consolidation therapy in the NCCN guidelines.

Building on this success, Amgen is expanding the application of BiTE technology to solid tumors. A prime example is “Imdelltra (tarlatamab),” a treatment for extensive-stage small cell lung cancer.

Small-cell lung cancer is a disease with rapid progression and high recurrence rates, representing an area of significant unmet medical need. Imdelltra is a BiTE-based therapy that targets DLL3 to induce T cells to directly attack cancer cells.

Clinical results have also demonstrated meaningful outcomes. In patients whose disease progressed after receiving at least two prior treatments, including platinum-based chemotherapy, Imdelltra achieved an objective response rate of approximately 40% and a median overall survival (mOS) of 14.3 months. In the Asian patient population, this was extended to 19 months.

Based on these data, Imdelltra was approved in the United States in 2024 and recommended as a subsequent therapy (Category 1) in NCCN guidelines. In Korea, it has been designated as a Global Innovative product on Fast Track (GIFT) and approved, with reimbursement procedures currently underway.

The emergence of Imdelltra is evaluated as a turning point in small cell lung cancer treatment, which has seen little change over the past 30 years.

Meejin Cho, Hematology-Oncology TA Lead at Amgen Korea, explained, “BiTE is particularly effective in diseases with clear target antigens and rapid progression. Expanding from ALL to small cell lung cancer, which has a clear target, DLL3, is an extension of this strategy.”

She added, “Among our current pipeline, we view prostate cancer as the area closest to commercialization. We will continue to expand our scope of application, focusing on cancer types with high unmet medical needs.”