PAOLA 1 trial results : Lynparza (olaparib), a cancer drug which was jointly developed by AstraZeneca and MSD, in combination with bevacizumab, met the primary endpoint of the phase 3 PAOLA 1 clinical trial in patients with advanced ovarian cancer.
The PAOLA 1 primary endpoint is the statistically-significant and clinically-meaningful improvement shown by Lynparza plus bevacizumab in progression-free survival (PFS) of the patients. As per the PAOLA 1 trial results, women treated with the Lynparza, bevacizumab combination survived longer without progression of their disease or death compared to those treated with only bevacizumab.
Bevacizumab is currently the standard-of-care (SoC) treatment for the disease.
The PAOLA 1 clinical trial assessed the Lynparza, bevacizumab combination in the first-line maintenance setting treatment of advanced ovarian cancer in women with or without BRCA gene mutations, in comparison to bevacizumab monotherapy. It is now the second phase 3 trial with Lynparza in first-line advanced ovarian cancer to have yielded positive results.
Commenting on the PAOLA 1 trial results, Jose Baselga – Executive Vice President of AstraZeneca Oncology R&D, said: “The positive results from the PAOLA-1 trial demonstrate a clear potential benefit of adding Lynparza to the standard-treatment bevacizumab for women with advanced ovarian cancer.
“Following positive results from the SOLO-1 trial for women with a BRCA gene mutation, the PAOLA-1 trial marks yet another positive Phase III trial for Lynparza as a 1st-line maintenance treatment for women with advanced ovarian cancer. We look forward to discussing the results with global health authorities as soon as possible.”
The PAOLA 1 trial results also showed that the safety and tolerability profiles recorded in the phase 3 clinical trial were similar to those associated with Lynparza and bevacizumab.
Lynparza, which is a poly ADP-ribose polymerase inhibitor (PARP inhibitor), has approvals for various cancer indications across different countries. Included in this is the recent approval for the treatment of a type of advanced breast cancer in the European Union (Lynparza EMA approval).
The PARP inhibitor has been engineered to kill cancer cells preferentially by exploiting BRCA mutations and other DNA damage response (DDR) pathway deficiencies.
Roy Baynes – Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer at MSD Research Laboratories, commenting on the PAOLA 1 trial results, said: “The Phase III PAOLA-1 trial demonstrates MSD’s and AstraZeneca’s continued commitment to improving clinical outcomes for women with advanced ovarian cancer. In this co-operative group trial sponsored by ARCAGY Research, maintenance treatment with Lynparza when added to a standard-of-care treatment was evaluated in an environment representative of real clinical practice.
“By studying Lynparza in this broader patient population, we have learned more about how it may help even more patients with advanced ovarian cancer in the future.”
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