Amgen Announces Positive Phase 2 Results for BiTE Therapy Tarlatamab in Heavily Pretreated Small Cell Lung Cancer

Dec 05, 2023 08:00 CST Updated 08:00

Amgen

Developer of Treatment Drugs for Serious Diseases

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Bispecific T-cell Engager (BiTE) technology is an innovative approach for cancer immunotherapy that connects cancer cells with T cells from the immune system through specific bispecific antibodies. This connection facilitates T cell recognition and killing of cancer cells.

Currently, there are three FDA-approved BiTE therapies: blinatumomab (developed by Amgen, Inc.), teclistamab (developed by Johnson & Johnson), and tebentafusp (developed by Immunocore in the UK). However, their indications are mainly for hematologic malignancies or melanoma, including certain types of acute lymphoblastic leukemia (ALL), multiple myeloma, and unresectable or metastatic uveal (ocular) melanoma in HLA-A*02:01-positive patients.

On November 30, 2023, the New England Journal of Medicine (NEJM) published the results of a pivotal large-scale lung cancer clinical trial, evaluating the BiTE developed by Amgen, Inc.TarlatamabEfficacy in Extremely Malignant Lung Cancer - Small Cell Lung Cancer (NCT05060016).

The study objective is to evaluate only 2 dose levels in Part 1.TarlatamabSafety and efficacy (assessed by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1],Through blinded independent central review (BICR), objective response rate (ORR) was assessed according to RECIST 1.1 in Part 1 and Part 2.TarlatamabThe anti-tumor activity, finallyEvaluation of Shortening Part 3 Selected in Cycle 1DoseTarlatamabSafety During the Mandatory Monitoring Period.

This study enrolled 220 patients with SCLC who had received at least two prior regimens. They were administered Tarlatamab (aDLL3 x aCD3, DLL3 being a tumor antigen expressed in SCLC and various neuroendocrine tumors) at doses of 10 or 100 mg every two weeks. The two dose groups were followed up for 10.6 months and 10.3 months, respectively, with a final total of 188 patients receiving Tarlatamab.

The primary endpoint of the study is the objective response rate - two dose groupsObjective response rate is40% and 32%, respectively.In patients who achieved objective response, 59% (40 out of 68 patients) had a duration of response lasting at least 6 months. At the data cutoff, the median progression-free survival was 4.9 months (95% CI, 2.9-6.7) in the 10 mg group and 3.9 months (95% CI, 2.6-4.4) in the 100 mg group; the estimated overall survival at 9 months was 68% and 66%, respectively.

Results:TarlatamabAdministered once every 2 weeks, 10 mg each time, in patients who have previously received treatment.SCLCPatients demonstrated anti-tumor activity, durable objective responses, and favorable survival outcomes. No new safety signals were identified.

Reference: Ahn MJ, Cho BC, Felip E, et al. Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer. N Engl J Med. Published online October 20, 2023. doi:10.1056/NEJMoa2307980