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Presentations highlighted the potential of tarlatamab in treating solid tumor cancers.
At the World Conference on Lung Cancer 2024 meeting in San Diego, California, data on tarlatamab-dlle (Imdelltra; Amgen) was presented, highlighting its manageable safety profile, sustained short- and long-term disease control and positive survival outcomes in patients with first-line maintenance extensive-stage small cell lung cancer (ES-SCLC).1
Tarlatamab targets cancer cells in the lung. © catalin | stock.adobe.com
These results were demonstrated in the global phase 1b and phase 2 DeLLphi-303 study of tarlatamab-dlle combined with PD-L1 inhibitors. In phase 1b, the combination showed a manageable safety profile, with sustained disease control and positive survival outcomes in patients.1
In phase 2, which included extensive follow-up data, patients with ES-SCLC previously treated with platinum-based chemotherapy showed continued anticancer activity with a manageable safety profile. Across 100 enrolled patients, the median overall survival (OS) for this cohort was 15.2 months, and there was an objective response rate (ORR) of 40%.1
"Tarlatamab has been a major breakthrough for patients with [ES-SCLC], who have had limited options for the past 30 years, and these data are impressive as a potential first-line maintenance treatment as well," said Sally Lau, MD, assistant professor of medicine at Perlmutter Cancer Center, NYU Grossman School of Medicine, in a news release.1
Earlier this year, the FDA granted an accelerated approval to tarlatamab-dlle to treat ES-SCLC that has progressed during or after platinum-based chemotherapy. It’s approval was based on the DeLLphi trial, during which individuals received the drug until signs of disease progression or unacceptable toxicity, with investigators evaluating ORR and duration of response (DOR).2
In the the DeLLphi trial, the investigators observed a median OS of 14.3 months, with 40% of patients in the cohort responding to tarlatamab-dlle. Additionally, the median DOR was 9.7 months. This prior approval, combined with the new data presented at WCLC, lay the groundwork for a future traditional approval of the drug to treat ES-SCLC.1,2
A bispecific T cell engager (BiTE), tarlatamab-dlle is a specialized form of a traditional bispecific that binds a T cell and a cancer cell. This is to activate a patient’s T cells to fight back against specific cancer cells in the body, leveraging the toxicity of T cells to achieve a highly targeted immune response.3
Trial Name: First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)
ClinicalTrials.gov ID: NCT05361395
Sponsor: Amgen
Estimated Study Completion: June 30, 2029
In an article in the October issue of Pharmacy Practice in Focus: Oncology, authors Amir Ali, PharmD, BCOP; Phoebe Kim; Stacey Cheung; Samantha Shi, PharmD, BCOP; Harry Shamamian, PharmD, MBA, FACHE; and Hien Tang, PharmD, BCOP, discuss the potential for tarlatamab-dlle to “restructure traditional standards of care,” calling the drug a “promising concept for solid tumor cancers.”3
Although the current standard of care for ES-SCLC often includes platinum-based chemotherapy combined with an immune checkpoint inhibitor, some patients still fail this therapy. The authors noted that, as they wait for a second phase 3 trial and further pharmacovigilance data to be released, “we can position tarlatamab as a second-line or later therapy for ES-SCLC for relapsed/refractory patients.”3
As positive data for tarlatamab-dlle abounds and trials continue, it is crucial for pharmacists to educate themselves on the administration of bispecific therapies. When new drugs are onboarded, pharmacists are the individuals who set-up initial treatment protocols and standard procedures.3
For example, since step-up dosing of tarlatamab is the preferred method of administration, Ali et al noted that patients should be monitored in a health care facility. Further, interprofessional collaboration is necessary to consider tarlatamab for patients to begin with. This process is eased by the fact that tarlatamab comes with a series of benefits, including a lower risk of infection and the ability to be administered in an outpatient setting, which increases patient quality of life.3
“As we embrace these innovations, ongoing education and collaboration will be essential in optimizing the role of tarlatamab in therapy for multiple indications and ensuring the success of clinical operations in practice,” Ali et al concluded.3
