Expanding Innovation in BiTE® Technology for Patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC) | Amgen


Expanding Innovation in BiTE® Technology for Patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

Amidst the lung cancer landscape, small cell lung cancer (SCLC) comprises about 15% of the 2.4 million plus patients diagnosed with lung cancer worldwide each year.1-3 SCLC progresses rapidly, with approximately 70% of newly diagnosed patients having extensive-stage disease, meaning the cancer has spread to both lungs and/or beyond the lungs to other parts of the body.4 A diagnosis of SCLC paints a stark picture, as the average 5-year relative survival rate for SCLC is only 7%.5-7 After decades of minimal advancements in the SCLC treatment landscape, there is now a new treatment option available for patients living with this advanced disease.

BiTE® Technology Targeting Cancer: The DLL3 Breakthrough

“Amgen's relentless pursuit of innovation in Bispecific T-cell Engager (BiTE®) immunotherapies, now targeting DLL3, marks a pivotal stride against cancer,” said Paul Burton, M.D., senior vice president and chief medical officer at Amgen. “Our track record in BiTE® immunotherapies has reshaped patient care, delivering significant efficacy in hematologic malignancies and now solid tumor malignancies, as evidenced by this approval, underscoring our commitment to patients with aggressive cancers who are in urgent need of new innovative therapies.”

For more than a decade, Amgen has pioneered BiTE® technology, a targeted treatment that brings a person’s own immune cells, called T cells, close to the cancer cells to help fight them. Delta-like ligand 3 (DLL3) represents an exciting potential therapeutic target for patients with SCLC, as approximately 85% to 96% of patients have expression of DLL3 on the cell surface of SCLC cells, with minimal expression in normal cells.8,9

“Bispecific T-cell Engagers work a little bit like glasses for T cells, helping the T cells to better see and recognize cancer cells so that they can target and fight those cancer cells. Investigational Bispecific T-cell Engagers may be designed to target DLL3-expressing tumor cells in SCLC,” said Peter Kufer, vice president of BiTE® Technology, Amgen Oncology. “We are aiming to continue to develop new treatments for challenging cancers like SCLC.”

Inside the SCLC Patient Experience

Individuals like Rayanne, who shared her story of living with SCLC in the video below, shed light on the pressing need for innovative treatments as the average survival rate has remained stagnant for decades.10

“Unfortunately, with small cell [lung cancer], there aren't as many treatment choices. I found support from one particular national organization that helps the patients to understand what's going on and what's coming their way, what improvements in treatment that are coming forward, what new things people are studying, and opportunities to participate in research. It makes me feel really good because you're not alone anymore,” she said.*

*In loving memory of Rayanne

Driven by a relentless commitment to patient care, Amgen scientists continually refine and expand the BiTE® platform, exploring novel targets to enhance the treatment landscape for the toughest-to-treat cancers.

Amgen is committed to delivering new options for patients who are often overlooked, no matter where they are in their treatment journey. This new treatment is offering hope for ES-SCLC patients who have long-awaited new and effective treatments.

To dive deeper into Amgen's latest milestone, click here.


  1. Oronsky B, et al. J Cancer. 2022;13(9):2945-2953.
  2. World Health Organization. Lung. 2020. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf. Accessed March 15, 2024.
  3. Sabari JK, et al. Nat Rev Clin Oncol. 2017;14(9):549-561.
  4. Megyesfalvi Z, et al. CA: A Cancer Journal for Clinicians. 2023;73:620-652.
  5. Cleveland Clinical. Small Cell Lung Cancer. Available at: https://my.clevelandclinic.org/health/diseases/6202-small-cell-lung-cancer. Accessed March 5, 2024.
  6. Li C, et al. Cancer Biology & Medicine. 2022;19:591-608.
  7. ACS. Lung Cancer Survival Rates. Available at: https://www.cancer.org/cancer/types/lung-cancer/detection-diagnosis-staging/survival-rates.html. Accessed February 23, 2024.
  8. Rojo F, et al. Lung Cancer. 2020;147:237-243.
  9. Ahn MJ, et al. N Engl J Med. 2023;389:2063-2075.
  10. Wang S, et al. Scientific reports. 2017;7:1339.

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