The US Food and Drug Administration (FDA) has Imfinzi approved (durvalumab) from AstraZeneca. It is the first treatment for adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed after platinum-based chemotherapy and radiotherapy. This advance marks an important milestone in the fight against this type of cancer, one of the most aggressive and difficult to treat.
The approval of Imfinzi adds to other advances in the treatment of lung cancer, such as Tagrisso recommended by the EU for inoperable lung cancerThese advances reinforce the global commitment to develop more effective therapies for this type of disease.
ADRIATIC trial: Imfinzi treatment results
Imfinzi approval depends on the results of the phase III ADRIATIC trial. Researchers presented their findings at the 2024 American Society of Clinical Oncology (ASCO) annual meeting and published them in the journal New England Journal of Medicine.
This study showed that treatment with Imfinzi reduced the risk of death by 27% compared to placebo. This represents a significant advance in the treatment of this type of cancer, which historically has a very poor prognosis.
Imfinzi and its impact on lung cancer survival
The ADRIATIC trial showed that patients treated with Imfinzi achieved a median overall survival of 55.9 months versus 33.4 months on placebo. 571 TP3T of patients treated with Imfinzi were still alive at three years, compared with 481 TP3T of patients in the placebo group.
In progression-free survival (PFS), Imfinzi reduced the risk of disease progression or death by 24%. The median PFS was 16.6 months for Imfinzi, compared with 9.2 months for patients receiving placebo.
Opinions on treatment with Imfinzi
The doctor Suresh Senan, principal investigator of the ADRIATIC trial and professor of Experimental Clinical Radiotherapy at the University Medical Center Amsterdam, highlighted that “Durvalumab is the first and only systemic treatment after platinum-based chemoradiotherapy that has been shown to improve survival in patients with this aggressive form of lung cancer. This advance is the first in four decades for the disease.”
For its part, Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, said: “This approval marks a major step forward for patients with limited-stage small cell lung cancer, who will now be able to receive immunotherapy for the first time. Imfinzi has set a new standard of care, with a significant improvement in median overall survival.”
The approval of Imfinzi has also been welcomed as a paradigm shift by patient organisations. Dusty Donaldson, founder of LiveLung, commented: “This new treatment option is a game-changer for patients with limited-stage small cell lung cancer, a disease known for its high recurrence rate. We are excited that more people now have access to this treatment that can significantly improve outcomes.”
Limited-stage SCLC is a particularly aggressive form of lung cancer. It has a five-year survival rate of 15-30%. Although standard chemotherapy and radiotherapy produce initial responses, the disease often recurs rapidly. This highlights the urgency for new therapeutic options.
Global expansion of Imfinzi treatment
In addition to obtaining approval in the US, Switzerland has also authorized the use of Imfinzi for this indication. Its approval is currently being reviewed by the European Union, Japan and other countries. AstraZeneca is expanding access to this innovative treatment worldwide.
The potential of Imfinzi in the treatment of lung cancer
Imfinzi, a human monoclonal antibody that blocks the interaction of the PD-L1 protein with PD-1 and CD80, has demonstrated efficacy in several types of cancer, including Non-small cell lung cancer (NSCLC) and other solid tumors. In the context of SCLC, this approval follows other significant advances in its use in combination with chemotherapy and other treatments.
Since its approval in 2017, more than 374,000 patients have been treated with Imfinzi. It is currently being evaluated in clinical trials for a variety of cancer types. This comprehensive approach aims to improve the treatment of cancers, including more aggressive forms of lung cancer.
The approval of Imfinzi for patients with limited-stage SCLC in the US is a crucial step forward against this disease. This treatment has been shown to improve survival and reduce the risk of disease progression. It represents a turning point in the treatment of SCLC.
