AstraZeneca’s groundbreaking drug Tagrisso (osimertinib) has demonstrated a remarkable boost to overall survival (OS) as an adjuvant treatment for early non-small cell lung cancer (NSCLC) after curative resection, according to findings from the Phase III ADAURA trial reported on Thursday.
AstraZeneca’s Imfinzi (durvalumab) has shown promising results in an interim analysis of the Phase III AEGEAN study. The analysis revealed that when combined with neoadjuvant therapy before surgery and as an adjuvant monotherapy after surgery, Imfinzi significantly improved event-free survival (EFS) in early non-small cell lung cancer (NSCLC). This is an encouraging step forward in the fight against this deadly disease.
The ADAURA study was an innovative, double-blinded and placebo-controlled trial that enrolled 682 individuals with early-stage non-small cell lung cancer (NSCLC) with mutations in the EGFR gene. Participants were randomized to receive Tagrisso 80-mg tablets daily or an identical placebo for up to three years, or until the cancer recurred. This cutting-edge study set out to determine the efficacy of Tagrisso in preventing recurrence of NSCLC.
Patients in the Tagrisso arm experienced a remarkable and clinically relevant improvement in overall survival (OS), an important secondary efficacy metric of ADAURA. This improvement was proven to be statistically significant.
Tagrisso has delivered impressive results in its primary endpoint of disease-free survival, reducing the risk of recurrence or death by an astonishing 83% in Stage II and IIIA patients. Even more remarkably, when considering the overall cohort of NSCLC Stages IB to IIIA, Tagrisso still managed to slash the risk of recurrence or death by a whopping 79%. This success story was further confirmed in May 2020.
Due to its remarkable efficacy, the Independent Data Monitoring Committee recommended in April 2020 that the data readout for the ADAURA study be unblinded two years earlier than initially scheduled. This decision was made two years before the planned readout date of 2022.
In September 2022, AstraZeneca made a monumental announcement surrounding Tagrisso – the updated data from ADAURA demonstrated a median DFS of 5.5 years, a groundbreaking result in the world of cancer research.
Imfinzi Aces Phase III in NSCLC
On Thursday, AstraZeneca reported positive results from the Phase III AEGEAN study for its immunotherapy drug, Imfinzi. The study showed that Imfinzi was able to significantly and clinically improve the event-free survival rate of non-small cell lung cancer patients, one of the study’s two primary endpoints. This is encouraging news for the millions of people suffering from this deadly disease.
In June 2022, Imfinzi, the PD-L1 blocker, made headlines as it achieved the primary endpoint of pathologic complete response (pCR) for AEGEAN and surpassed expectations with a significant improvement in major pathologic response. This milestone marks an exciting breakthrough for the company.
The AEGEAN trial was a groundbreaking Phase III clinical trial that enrolled 802 patients living with early-stage non-small cell lung cancer (NSCLC). Participants were randomized to receive either Imfinzi with chemotherapy every three weeks for four cycles before surgery, or a placebo. After surgery, the Imfinzi group received the drug as a monotherapy every four weeks for up to 12 weeks. This innovative trial has the potential to revolutionize the treatment of NSCLC.
AEGEAN is dedicated to furthering its research and collecting data for its secondary endpoints of Disease Free Survival (DFS) and Overall Survival (OS). By doing so, AEGEAN is actively striving to advance its knowledge and bring improved treatments to those affected by the diseases it studies.
Early intervention with Imfinzi could provide significant benefit to patients with resectable non-small cell lung cancer (NSCLC), according to a recent study. John Heymach, M.D., Ph.D., chair of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center, noted that such treatment options are “urgently needed” to improve long-term survival outcomes. The study found that Imfinzi could be a promising solution to this pressing need.
The exciting results from the AEGEAN trial indicate that the novel durvalumab regimen has the potential to significantly improve outcomes in contexts where a curative intent is desired. This is an exciting development that promises to revolutionize the way we approach treatment in this setting.