FDA Approves Tarlatamab-dlle for Extensive-Stage Small Cell Lung Cancer


Amgen’s Tarlatamab-dlle (Imdelltra) is the first and only approved DLL3-targeting bispecific T-cell engager therapy for the aggressive form of lung cancer.

The FDA has granted accelerated approval to tarlatamab-dlle (Imdelltra) for the treatment of extensive-stage small cell lung cancer (SCLC) in adults with disease progression on or after platinum-based chemotherapy, Amgen announced in a news release.1 Tarlatamab-dlle is now the first and only approved DLL3-targeting bispecific T-cell engager therapy for the aggressive form of lung cancer.

FDA Approves Tarlatamab-dlle for Extensive-Stage Small Cell Lung Cancer / maurice norbert - stock.adobe.com

FDA Approves Tarlatamab-dlle for Extensive-Stage Small Cell Lung Cancer / maurice norbert - stock.adobe.com

The approval of tarlatamab-dlle was based on data from the DeLLphi-301 trial (NCT05060016), in which the therapy demonstrated antitumor activity with durable objective responses and promising survival outcomes when administered as a 10 mg dose every 2 weeks. Results from the trial were published in the New England Journal of Medicine.2

About DeLLphi-301

Trial Name: A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)

Clinicaltrials.gov Identifier: NCT05060016

Sponsor: Amgen

Summay: The main aim of this study is to:

  • evaluate safety and efficacy (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] by investigator) of 2 dose levels of tarlatamab for Part 1 only
  • evaluate anti-tumor activity of tarlatamab as determined by objective response rate (ORR) per RECIST 1.1 by blinded independent central review (BICR) for Part 1 and 2
  • evaluate safety of reduced mandatory monitoring period in Cycle 1 at selected dose of tarlatamab for Part 3

"Lung cancer is a complex and devastating disease, and less than 3% of patients with [extensive-stage] SCLC live longer than five years," David P. Carbone, MD, PhD, professor of internal medicine and director of the James Thoracic Oncology Center at the Ohio State University Medical Center, said in a release.1 "In the DeLLphi-301 trial, the median overall survival was 14.3 months, with 40% of patients responding to treatment with tarlatamab. These responses were remarkably durable, representing a major advancement in the SCLC treatment paradigm."

READ MORE: Navigating Ethical, Financial Considerations When Delivering Cancer Care

DeLLphi-301 was a randomized, open-label, multi-center, multi-cohort phase 2 study evaluating the efficacy, safety, tolerability, and pharmacokinetics of tarlatamab-dlle in patients with previously treated small-cell lung cancer. The primary study endpoint was objective response rate. Secondary study endpoints included duration of response and overall survival. The study cohort included 220 adult patients who had received a median of 2 lines of treatment.

The study found that patients who received the 10 mg every two weeks dosing regimen had an objective response rate of 40%, as well as a median duration of response of 9.7 months. Additionally, the median overall survival was 14.3 months, with final data yet to mature. The most common adverse events were cytokine-release syndrome, decreased appetite, fatigue, pyrexia, dysgeusia, musculoskeletal pain, constipation, anemia, and nausea.

The label for Imdelltra includes a boxed warning for serious or life-threatening cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome, according to the FDA.3 Amgen noted that the continued approval for this indication “may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).”

In October 2023, tarlatamab-dlle was granted breakthrough therapy designation by the FDA. The application process was under the Project Orbis framework, an initiative from the FDA Oncology Center of Excellence providing the ability to concurrently submit oncology products among certain countries.4

"The FDA's approval of Imdelltra marks a pivotal moment for patients battling ES-SCLC,” Jay Bradner, MD, executive vice president of research and development, and chief scientific officer at Amgen, said in a release.1 “This DLL3-targeting therapy in ES-SCLC comprises a transformative option demonstrating long-lasting responses in pretreated patients. This approval further demonstrates our commitment to addressing aggressive cancers through our second FDA-approved Bispecific T-cell Engager molecule. Imdelltra offers these patients who are in urgent need of new innovative therapies hope, and we're proud to deliver this long-awaited effective treatment to them."

READ MORE: FDA Updates Resource Center

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1. FDA APPROVES IMDELLTRA™ (TARLATAMAB-DLLE), THE FIRST AND ONLY T-CELL ENGAGER THERAPY FOR THE TREATMENT OF EXTENSIVE-STAGE SMALL CELL LUNG CANCER. News Release. Amgen. May 16, 2024. Accessed May 17, 2024. https://www.amgen.com/newsroom/press-releases/2024/05/fda-approves-imdelltra-tarlatamabdlle-the-first-and-only-tcell-engager-therapy-for-the-treatment-of-extensivestage-small-cell-lung-cancer
2. Ahn MJ, Cho BC, Felip E, et al. Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer. N Engl J Med. 2023;389(22):2063-2075. doi:10.1056/NEJMoa2307980
3. FDA grants accelerated approval to tarlatamab-dlle for extensive stage small cell lung cancer. News Release. FDA. May 16, 2024. Accessed May 17, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer
4. FDA GRANTS PRIORITY REVIEW TO AMGEN'S TARLATAMAB APPLICATION FOR ADVANCED SMALL CELL LUNG CANCER. News Release. Amgen. December 13, 2023. Accessed May 17, 2024. https://www.amgen.com/newsroom/press-releases/2023/12/fda-grants-priority-review-to-amgens-tarlatamab-application-for-advanced-small-cell-lung-cancer
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