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Tarlatamab can produce durable responses in patients with relapsed or refractory small cell lung cancer (SCLC), according to research published in The New England Journal of Medicine.
These results, from the phase 2 DeLLphi-301 trial, are being used to support the biologics license application for tarlatamab to treat adults with advanced SCLC who have disease progression on or after platinum-based chemotherapy.
The DeLLphi-301 trial (ClinicalTrials.gov identifier: NCT05060016) included 222 patients with previously treated SCLC. They had received a median of 2 (range, 1-8) prior lines of therapy.
Patients received tarlatamab at 10 mg (n=134) or 100 mg (n=88). The median treatment duration was 5.1 months in the 10 mg group and 3.7 months in the 100 mg group. The median follow-up was 10.6 months and 10.3 months, respectively.
The researchers found that the 10 mg dose had a better benefit-to-risk profile than the 100 mg dose.
The objective response rate was 40% with the 10 mg dose and 32% with the 100 mg dose. The complete response rate was 1% and 8%, respectively. The median duration of response was not reached in either dose group.
The median progression-free survival (PFS) was 4.9 months in the 10 mg group and 3.9 months in the 100 mg group. The 6-month PFS rate was 40% and 34%, respectively. The 9-month PFS rate was 28% and 27%, respectively.
The median overall survival (OS) was 14.3 months in the 10 mg group and not reached in the 100 mg group. The 6-month OS rate was 73% and 71%, respectively. The 9-month OS rate was 68% and 66%, respectively.
Treatment-related adverse events (TRAEs) were reported in 90.5% of patients. The most common TRAEs were cytokine release syndrome (55.0%), pyrexia (30.5%), decreased appetite (25.5%), and dysgeusia (20.0%).
Grade 3 or higher TRAEs occurred in 26% of patients in the 10 mg group and 33% of those in the 100 mg group. The rate of TRAEs leading to dose interruption, dose reduction, or both was 13% in the 10 mg group and 29% in the 100 mg group. The rate of TRAEs leading to treatment discontinuation was 3% in both groups. There was 1 fatal TRAE (respiratory failure) in the 10 mg group.
“Tarlatamab, administered as a 10 mg dose every 2 weeks, showed antitumor activity with durable objective responses and promising survival outcomes in patients with previously treated SCLC,” the researchers wrote. “No new safety signals were identified.”
Disclosures: This study was supported by Amgen. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Reference
Ahn M-J, Cho BC, Felip E, et al. Tarlatamab for patients with previously treated small-cell lung cancer. N Engl J Med. 2023;389:2063-2075. doi:10.1056/NEJMoa2307980
This article originally appeared on Cancer Therapy Advisor
