A phase 2 study will investigate the efficacy of darovasertib for patients with uveal melanoma and whether the drug can potentially result in lower radiation doses or fewer eye removal surgeries.
Patients can now enroll in a phase 2 clinical trial evaluating darovasertib for the treatment of primary non-metastatic (meaning the disease has not spread) uveal melanoma, a rare form of eye cancer.
“This is a paradigm-shifting opportunity, as there are no approved systemic therapies in these settings,” said Dr. Carol Shields, chief of the ocular oncology service at Wills Eye Hospital and professor of ophthalmology at Thomas Jefferson University in Philadelphia, said in a press release from IDEAYA, the drug’s manufacturer. “The preliminary clinical data shows clear evidence of anti-tumor activity and supports further clinical evaluation of darovasertib to determine its potential to either save the eye by avoiding enucleation (surgical removal of the eye) or to reduce the tumor thickness in the eye, enabling treatment with less radiation to preserve vision.”
The trial will have two groups. Patients with large tumors will be treated with the novel drug, darovasertib, until maximum benefit or for six months. They will then undergo their main treatment for the disease. The goal for this group of patients is eye preservation, as often patients who are not eligible for radiation will have to have their eye removed.
Researchers hope that treatment with darovasertib will help more patients be candidates for radiation.
The other group in the trial will include patients with small or medium tumors, who will also be treated with darovasertib until maximum benefit or six months. These patients will then go on to receive radiation.
The main goal for patients with small or medium tumors include a reduction in the radiation dose that the patient received, compared to what dose they would have been prescribed if they were not treated with darovasertib, as well as functional vision preservation.
Both groups of patients will have six months of follow-up treatment with darovasertib, where they will be monitored for relapse-free survival (the time after treatment when a patient survives without symptoms or signs of that cancer) and useful vision.
Darovasertib, which is also being studied in combination with Xalkori (crizotinib) the NADOM trial in Australia, works by blocking protein kinase C (PKC) signaling involved in tumor progression.
"The primary tumor shrinkage we are observing from just a single month of therapy in our investigator-sponsored NADOM study is very promising,” said Anthony Joshua, head of the department of medical oncology at the Kinghorn Cancer Centre at St. Vincent's Hospital in Sydney, Australia, in the release. “We are looking forward to seeing even greater benefits in the IDEAYA-sponsored phase 2 study where the protocol provides for neoadjuvant treatment (first treatment given to shrink a tumor before the main treatment) to maximum response."
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