- Amgen's Imdelltra combined with AstraZeneca's Imfinzi reduced the risk of death by 58% in patients with extensive-stage small cell lung cancer (ES-SCLC), according to results from the Phase 3 DeLLphi-305 trial.
- The combination therapy extended the median overall survival to 21.1 months compared to 12.7 months with Imfinzi alone.
- Nearly 80% of patients receiving the combination therapy were alive at one year, compared to 53% of those on Imfinzi alone.
- Amgen plans to share these significant findings with regulatory authorities worldwide.
- The results from the trial are considered a landmark advance for patients with ES-SCLC, demonstrating a survival benefit rarely seen in this aggressive disease.
- Dr. Paul Burton, Amgen's chief medical officer, stated that the data could transform the standard of care for patients with this type of cancer.
Amgen's Imdelltra, in combination with AstraZeneca's Imfinzi, has demonstrated a groundbreaking 58% reduction in the risk of death for patients with extensive-stage small cell lung cancer (ES-SCLC). The late-stage trial results, released Saturday, revealed a median overall survival of 21.1 months compared to 12.7 months for those receiving Imfinzi alone.12
Dr. Paul Burton, Amgen's chief medical officer, stated, "I think there are moments in medicine when you see a piece of data that is so profound that it's going to transform the standard of care for patients, and I think, honestly, we're at that moment." The combination therapy not only extends survival but also has the potential to convert this aggressive cancer into a chronic disease.6
The trial indicated that nearly 80% of patients on the combination therapy were alive at one year, compared to 53% for those on Imfinzi alone. Additionally, the combination reduced the risk of disease progression or death by 66% and showed substantial anti-tumor activity, with 26.4% of patients achieving an objective response compared to 4.1% for Imfinzi alone.
Amgen's Imdelltra, which generated $288 million in sales during the second quarter, is on track to become a blockbuster drug, with expectations of surpassing $1 billion in sales. The findings underscore the importance of early treatment, positioning Imdelltra as a potential "indispensable backbone therapy" for small cell lung cancer.
As Dr. Jacob Sands noted, "For a disease where durable survival has remained extremely difficult to achieve, the magnitude and consistency of benefit in DeLLphi-305 are striking."
“The DeLLphi-305 trial also showed a 66% reduction in risk of disease progression or death, with median progression-free survival of 7.4 months versus 1.9 months. Amgen's chief medical officer called the data 'so profound' that it could transform the standard of care.”
CNBC
