Amgen, a company listed on NASDAQ under the symbol AMGN, has unveiled the findings from the global Phase 2 DeLLphi-301 study. This study assessed the efficacy of tarlatamab, an experimental molecule targeting delta-like ligand 3 (DLL3), in patients diagnosed with advanced-stage small cell lung cancer (SCLC) who had previously not responded to at least two lines of treatment. The data was presented at the European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain and is set to be published in the New England Journal of Medicine.

Based on a median follow-up period of 10.6 months, an intention-to-treat analysis of 100 patients who received a 10 mg dose of tarlatamab revealed an objective response rate (ORR), the primary endpoint, of 40% (with a 97.5% Confidence Interval (CI) of 29, 52). Key secondary endpoints included a median progression-free survival (mPFS) of 4.9 months (95% CI: 2.9, 6.7) and a median overall survival (mOS) of 14.3 months (95% CI: 10.8, not estimable). The median duration of response was not reached, and 58% of patients who responded to tarlatamab at the 10 mg dose experienced at least six months of response, with 55% of responses still ongoing at the data cutoff.

Amgen, highlighted the significance of these results, emphasizing the long-standing challenges in treating small cell lung cancer. The results from tarlatamab suggest potential progress in combatting this cancer type, and Amgen looks forward to discussing these potentially registrational findings with regulatory authorities.

The safety profile of tarlatamab remained consistent with the Phase 1 study, with few discontinuations related to treatment-related adverse events (4%). Among patients in the tarlatamab 10 mg group, the most common treatment-emergent adverse events (TEAEs) included cytokine release syndrome (CRS; 49%), pyrexia (38%), decreased appetite (25%), and dysgeusia (24%). CRS, predominantly of grade 1 or 2, was mainly observed after the first and second doses and was generally manageable with supportive care. Grade 3 CRS was low (0%) at the 10 mg dose, and there were no reported grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) or associated neurologic events (0%). No cases of grade 4 or 5 adverse events were reported for these two categories.

Tarlatamab is an investigational immunotherapy developed by Amgen researchers. It brings a patient's T cells in close proximity to SCLC cells by binding to CD3 on T cells and DLL3 on SCLC cells, resulting in the destruction of cancer cells. DLL3 is a promising therapeutic target for SCLC, as it is expressed in a high percentage of SCLC cells but minimally in normal cells.

In a Phase 1 study, tarlatamab demonstrated responses in 23.0% of patients, including durable responses in heavily pre-treated SCLC patients. Amgen is currently conducting multiple trials involving tarlatamab, including the DeLLphi-304 Phase 3 study, which compares tarlatamab to standard chemotherapy in second-line SCLC treatment. Amgen also has plans to initiate two additional Phase 3 studies in earlier SCLC settings.

Small cell lung cancer (SCLC) is a highly aggressive and devastating solid tumor with a low median survival rate and a low five-year relative survival rate. While first-line chemotherapy can result in high response rates, patients quickly develop resistance to subsequent therapies, leading to limited survival options. There are currently no approved third-line treatments for SCLC.

 

Source: prnewswire.com

 

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