Apealea, a water-soluble formulation of the chemotherapy paclitaxel, is not inferior to the standard formulation, Taxol (cremophor- EL paclitaxel), and may even improve the survival of ovarian cancer patients who responded to platinum-based chemotherapy, updated Phase 3 trial data suggests.
The data will be presented June 4 at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, being held June 1-5 in Chicago, in a poster titled “Nanoparticle micellar formulation of paclitaxel in combination with carboplatin for women with recurrent platinum sensitive ovarian cancer (OAS07-OVA): Overall survival results of a phase 3 randomized trial.”
The chemotherapeutic agent paclitaxel has a low solubility in water and needs to be coupled with substances that increase its solubility in order to reach cancer cells and exert its effects. Bristol-Myers Squibb has developed Taxol as a combination of paclitaxel and Cremophor EL.
But while Cremophor EL is widely used for molecules with low water solubility, the molecule can cause hypersensitivity reactions that are potentially life-threatening.
Oasmia Pharmaceutical of Uppsala, Sweden, developed Apealea (also known as Paclical), a new formulation made of micellar nanoparticles (lipid molecules that arrange themselves into spheres).
Oasmia calls its technology XR17, defined as “a type of nanotechnology where insoluble substances are contained within a nano-sized water soluble enclosure, a so-called micelle.”
Apealea does not contain Cremophor EL and is expected to cause fewer adverse events.
Apealea was tested in a Phase 3 trial (NCT00989131) comparing it to Taxol. The trial, designed to determine if Apealea was at least as good as Taxol, included 789 patients with ovarian, fallopian tube, or peritoneal cancer who had responded to platinum-based chemotherapy but whose cancer returned.
Participants were randomly assigned to either Apealea or Taxol followed by treatment with Paraplatin (carboplatin). Apealea was given as a one-hour infusion, and Taxol as a three-hour infusion. Each treatment was given for six cycles, with an interval of three weeks between treatments.
In 2016, the trial met its primary endpoint, showing that Apealea treatment led to similar overall survival rates as Taxol. In fact, among patients who completed the six treatment cycles, those who received Apealea lived for 25.7 months, compared to 24.8 months for those on Taxol.
A recent analysis now shows that this is also true for select subgroups of patients, namely those experiencing their first relapse, and those with serous adenocarcinoma — the most common and malignant type of ovarian cancer — at diagnosis.
Subgroup analyses also show that Apealea is not inferior in terms of survival without disease progression (progression-free survival).
Although the trial was a pivotal study not designed to show superiority, analyses also reveal a consistent tendency favoring Apealea as a better treatment, improving patients’ survival.
The 2018 ASCO Annual Meeting is major opportunity for experts in the field of clinical oncology to gather. This year about 32,000 people from around the world are expected.
“The ASCO Annual Meeting is an important opportunity to raise awareness of Oasmia in this forum where clinicians and other attendees are interested in the latest news regarding cancer treatment,” Nina Heldring, head of clinical development at Oasmia, said in a news release.
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