Tanja Obradovic: Important PDUFA on June 12th is coming up

Tanja Obradovic shared a post on LinkedIn:

“Important PDUFA on June 12th is coming up that may results in new treatment option with Tarlatamab for patients with advanced small cell lung cancer (SCLC) after disease progression on platinum-based chemotherapy regimens.

Tarlatamab is a first-in-class bispecific T-cell engager that targets CD3 on T cells and delta-like ligand 3 (DLL3) on SCLC cells. DLL3 is expressed in high portion of SCLC patient cells (85% to 96%) with minimal expression in normal cells that provides targeted tumor advantage. If approved, it would be the first bi-specific antibody to treat a solid tumor.
PDUFA application is based on the Tarlatamab DeLLphi-301 Phase 2 results which demonstrated efficacy with a durable response and encouraging survival outcomes in relapse/refractory SCLC patients. An objective response occurred in 40% of the patients in the 10-mg group and in 32% of those in the Tarlatamab 100-mg group.

Among patients with an objective response, the duration of response was at least six months in 59%. The estimates of overall survival at nine months were 68% of patients in the 10-mg group and 66% of patients in the 100-mg group (data available in 2023 published in NEJM).

While Phase 2 supports PDUFA a Phase 3 is already ongoing (DeLLphi-304, NCT05740566) projected for the completion by 3Q 2027. Study is enrolling SCLC patients who progressed or recurred following 1 platinum-based regimen (including under certain conditions those that had platinum-immunotherapy combo).
Considering that SCLC is such aggressive disease with very few treatment advances for a very long time incoming June update on Tarlatamab can hopefully bring much needed option for patients.”

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Source: Tanja Obradovic/LinkedIn

Tanja Obradovic is the Vice President of Oncology Scientific Affairs at ICON PLCh. She has over 20 years of clinical research experience and has led major pharmaceutical companies for 13 years. Her research focuses on small molecules, antibodies, cell and gene therapy, and major immunotherapy of PD1 inhibitors.