Amgen Secures Phase 3 Survival Data for Imdelltra in Small-Cell Lung Cancer, Strengthening Its Case for Full FDA Approval
Suggested
Clinical Trial Success:
Amgen's Imdelltra (tarlatamab) demonstrated a "statistically significant and clinically meaningful" improvement in overall survival (OS) in a global Phase 3 trial (DeLLphi-304) for patients with small-cell lung cancer (SCLC) who had progressed after a single line of platinum-based chemotherapy24.
Mechanism of Action:
Imdelltra is a bispecific T-cell engager targeting DLL3, a protein expressed on SCLC cells but minimally found in healthy cells, leading to selective activation of immune T-cells to destroy cancer cells4.
Accelerated Approval Background:
Imdelltra previously received FDA accelerated approval for extensive-stage SCLC in 2024, based on Phase 2 trial data showing tumor reduction in 40% of heavily pretreated patients and a median duration of response of 9.7 months26.
Safety Profile:
Despite initial safety concerns regarding underreporting of adverse events during approval, subsequent data have clarified Imdelltra's tolerability risks, including a black-box warning for cytokine release syndrome (CRS) and neurotoxicity. Its safety in the Phase 3 trial was consistent with prior data24.
Global Implications:
The new survival data bolster Imdelltra's case to become a standard-of-care therapy for SCLC and may support its shift from accelerated to full FDA approval24.
Market Potential:
Imdelltra earned $115 million in sales in 2024, and analysts project it could reach $842 million annually by 2028, reflecting its potential as a blockbuster therapy in a market with limited options2.
Unmet Need:
SCLC is a particularly aggressive cancer with a 5%-10% five-year survival rate. While initial responses to chemotherapy are common, relapse occurs rapidly, emphasizing the need for new treatment options like Imdelltra24.
Sources:
2. https://www.fiercepharma.com/pharma/amgen-pads-imdelltras-case-tough-treat-lung-cancer-subtype-phase-3-survival-win
4. https://www.prnewswire.com/news-releases/imdelltra-demonstrated-superior-overall-survival-in-small-cell-lung-cancer-302426291.html
6. https://www.bmpharmaceuticals.com/amgen-pads-imdelltras-case-in-tough-to-treat-lung-cancer-subtype-with-phase-3-survival-win/