Pharmaceutical company AstraZeneca has revealed that a Phase 3 clinical trial of a drug combination for ovarian cancer has successfully met its primary endpoint. The trial evaluated the efficacy and safety of a combination of chemotherapy, bevacizumab, AstraZeneca’s Imfinzi, and Merck’s Lynparza, in newly diagnosed ovarian cancer patients with advanced illness but no BRCA mutations.
Ovarian cancer is notoriously difficult to treat, and more than two out of every three women diagnosed with the disease have it in an advanced stage. More than half of these women pass away within five years of diagnosis. Therefore, the results of this clinical trial are highly significant.
The trial found that patients who received the combination of chemotherapy, bevacizumab, Imfinzi, and Lynparza had significantly better progression-free survival (PFS) than those who did not receive the treatment. However, the figures for the PFS interim findings were not disclosed.
Imfinzi is a PD-L1 inhibitor that has been approved for the treatment of several cancers, including bladder and lung cancer. Lynparza is a PARP inhibitor that has been approved for the treatment of several cancers, including ovarian and breast cancer.
AstraZeneca and Merck established a strategic oncology partnership in 2017 to jointly develop and market a number of oncology drugs, including Lynparza. The partnership agreement was valued at $8.5 billion.
The safety and tolerability of the drug combination were consistent with earlier clinical studies. This is an important postscript since Lynparza and other PARP inhibitors have come under severe criticism for their safety in treating ovarian cancer patients.
Last year, AstraZeneca and Merck voluntarily withdrew Lynparza’s clearance for use in fourth-line BRCA-mutated advanced ovarian cancer patients due to a fear of an increase in mortality. The FDA approved the action, nullifying AstraZeneca’s 2014 approval of Lynparza.
After its original clearance, Lynparza received initial authorization for the treatment of breast, pancreatic, and prostate cancers in 2018, 2019, and 2020, respectively. Imfinzi gained initial authorization for bladder cancer in 2017, lung cancer in 2020, biliary tract cancer, and unresectable hepatocellular carcinoma in 2022.
AstraZeneca’s R&D Chief of Oncology stated that ultimately, subgroup data analysis and understanding key secondary endpoints would be important in assessing the overall viability of the Imfinzi/Lynparza combo.
AstraZeneca revealed that Imfinzi sales were 15% higher than the year before at $2.8 billion, while Lynparza sales were $2.6 billion, up 12% from 2021. In 2022, Lynparza sales were $1.12 billion, according to Merck.
The combination of Imfinzi and Lynparza will need further analysis, including the evaluation of overall survival data and other secondary endpoints, to determine its overall viability for the treatment of ovarian cancer.
The DUO-O study represents a significant step forward in the treatment of ovarian cancer. However, there is still a long way to go before an effective and safe treatment is available for all patients. The partnership between AstraZeneca and Merck is a promising sign for the future of cancer treatment, as the two companies work together to develop new therapies and improve the lives of patients.
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