AstraZeneca’s Imfinzi (durvalumab) and Lynparza (olaparib) have proven to be a powerful combination in treating advanced high-grade epithelial ovarian cancer, according to interim results of the Phase III DUO-O trial released Wednesday. The results showed that the combination therapy met its primary endpoint, providing a potential breakthrough in the treatment of this difficult form of cancer.
Patients who were treated with a combination of Imfinzi and Lynparza, alongside chemotherapy and Avastin (bevacizumab) from Genentech, experienced a remarkable and clinically relevant increase in progression-free survival (PFS) in comparison to a control group that was treated with only chemotherapy and Avastin.
Patients who were treated with Imfinzi, chemotherapy and bevacizumab alone saw a nominal improvement in progression free survival (PFS) compared to those who received the control group treatment, although the difference between the two was not statistically significant.
At the time of the interim analysis, AstraZeneca had yet to publish specific data. Results regarding overall survival and other secondary efficacy endpoints were still in development. Nevertheless, the company remains optimistic as they continue to analyze the data.
Early results from the DUO-O clinical trial show promising potential for the combination of Imfinzi and Lynparza to treat ovarian cancer patients without tumor BRCA mutations. According to Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, the results are a major breakthrough in the field of medicine.
She stated, “These early data from DUO-O point to the potential of the Imfinzi-Lynparza combo in ovarian cancer patients without tumor BRCA mutations.” The advance in this treatment could provide hope to many ovarian cancer patients.
The company will also dig deeper, exploring critical secondary outcomes and patient subgroups to gain valuable insights from the data. Galbraith noted that this analysis is integral to the success of the project.
DUO-O, a groundbreaking randomized, double-blinded, and placebo-controlled trial, enrolled over 1,200 advanced ovarian cancer patients without BRCA mutations. Participants underwent treatment with Imfinzi, Avastin, and platinum-based chemotherapy initially, transitioning into maintenance therapy with Imfinzi, Lynparza, and Avastin thereafter. This revolutionary trial provides a potential breakthrough in the treatment of ovarian cancer.
The combination regimen demonstrated a favorable safety profile, with adverse events and tolerability broadly in line with prior reports.
AstraZeneca Expands Imfinzi’s Indications
Last month, Imfinzi made a major breakthrough in the treatment of early-stage non-small cell lung cancer (NSCLC) by improving event-free survival when used in combination with neoadjuvant chemotherapy prior to surgery and as an adjuvant monotherapy after resection. The encouraging results came from a planned interim analysis of the Phase III AEGEAN study, which has yet to generate mature data for disease-free and overall survival.
In November 2022, AEGEAN’s data drop arrived just in time for Imfinzi to receive approval from the FDA for adults with metastatic NSCLC. The combination of Imfinzi with AstraZeneca’s Imjudo (tremelimumab) and platinum-based chemotherapy was successful in meeting the FDA’s standards and providing a much-needed treatment option for those affected by the disease.
In autumn 2022, Imfinzi saw remarkable success, receiving regulatory approval for treatments of hepatocellular carcinoma in October and locally advanced or metastatic biliary cancer in September. These two victories, combined with previous successes, have propelled Imfinzi to the forefront of cancer treatments.
In March 2022, a major setback occurred for Imfinzi with chemoradiotherapy when the Phase III CALLA trial failed to reach its primary endpoint of significantly improving Progression-Free Survival (PFS) for patients with advanced cervical cancer compared to chemoradiotherapy alone. This was a major disappointment for the research team, as they had high hopes for the potential of Imfinzi in this setting.