Batiraxcept did not significantly improve rates of survival without disease progression in patients with platinum-resistant ovarian cancer, according to high-level findings from a phase 3 trial.
Patients from the phase 3 AXLerate-OC trial who did not obtain a survival benefit without disease progression were those who have not previously been treated with Avastin (bevacizumab), according to a press release from Aravive, the manufacturer of the drug. Of note, findings from the trial did not demonstrate a difference in patients treated with or without batiraxcept, regardless of whether they previously have received Avastin before.
“Although AXLerate-OC did not meet the primary endpoint, I look forward to working with Aravive to analyze the phase 3 data and determine the most appropriate path to bring batiraxcept to those patients who may benefit most,” Dr. Katherine Fuh, associate professor in the division of gynecology oncology at UCSF, said in the release.
In this phase 3 study, researchers enrolled 366 patients with platinum-resistant recurrent ovarian cancer to assess the efficacy and safety of treatment with batiraxcept. Patients were randomly assigned either batiraxcept with paclitaxel or placebo plus paclitaxel. Half of the patients enrolled in this trial previously received treatment with Avastin.
The main focus of the study — also referred to as the primary endpoint — was to assess progression-free survival, defined as the time between treatment assignment and either disease progression or death, whichever occurred first. Other areas of interest for the researchers included overall survival (the time from treatment until death), duration of response (measured from the date of complete or partial response to treatment until cancer progression) and side effects.
In 179 patients who were not treated with Avastin before the trial, the median progression-free survival rate was 5.4 months in both the groups treated with batiraxcept plus paclitaxel and with paclitaxel plus placebo. For all patients regardless of Avastin receipt status, the median progression-free survival was 5.1 months in patients treated with batiraxcept plus paclitaxel compared with 5.5 months in those treated with paclitaxel plus placebo.
In the release, researchers noted that the safety profile of batiraxcept was as expected from previously conducted studies, with no new safety signals identified.
Batiraxcept is a decoy protein, according to the release, that binds to GAS6, which results in the inhibition of tumor growth and metastasis (cancer that spreads from where it first formed to another part of the body).
The drug’s manufacturer plans to investigate whether batiraxcept may be beneficial for patients with other cancers, according to the release.
“We are conducting additional analyses on the AXLerate-OC phase 3 trial to further evaluate the results of this study and determine the best path forward with our two other planned indications in renal cell carcinoma and pancreatic cancer,” Gail McIntyre, president and chief executive officer of Araviva, said in the release. “We want to thank the patients who participated in this trial, the clinical investigators and the Aravive team for their hard work, as we continue to pursue our goal of finding innovative cancer treatments for patients in need.”
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