The oncology-focused biopharmaceutical company, TESARO, has just released Wednesday its topline results for an experimental study that uses PARP inhibitor niraparib for patients who suffered from Breast Cancer susceptibility gene (BRCA), and for those who do not have the condition. The results were so positive that it is expected file later this year.
According to the study, the niraparib Phase III trial met its primary goal of progression-free survival (PFS) against placebo across several patients. The patients were separated into three groups. The first group included patients who were positive in carrying the BRCA mutation (the same genetic mutation that Angelina Jolie carries), the second included patients who do not carry this mutation, and the third group included patients who have Homologous recombination deficient (HRD) tumors as determined by a diagnostic test.
The analyst at Mizuho Securities Eric Criscuolo said that the results were positive in all three groups and that investor should take a look at this new study.
“The data was even better than our bullish expectations,” he Eric Criscuolo said.
Every year, in the United States, about 22,000 women are diagnosed with ovarian cancer and 80 percent of them are also diagnosed after it has progressed to a severe stage.
Although PARP inhibitors are not so known in oncology media as PD-1 and PD-L1 inhibitors with drugs from Merck, Bristol-Myers Squibb and most recently, Roche, all of them available on the market, PARP inhibitors are designed for patients who also do not have cancer cells. This component does not affect a patient’s healthy cells.
Progression-free survival Phase III met its goal
The aim of the study was slowing down the time before tumors grow or advance. Scientists called this a progression-free survival or PFS. The study revealed that patients carrying a BRCA mutation had 73 percent less risk of cancer progression.
The PSF study was conducted on all 500 patients. Patients had to take once a day the PARP inhibitor. In 21 months, patients with positive BRCA mutation show positive results in the testing comparing with the 5.5 months for the control group.
According to the study, patients who had BRCA gene, the PFS was 9.3 months vs. 3.9 months for niraparib, regarding the group who did not have BRCA mutation but still were diagnosed with HRD tumors—the patients had 12.9 months with the drug compared with 3.8 months for the final group control. This means that for the second group the risk of progression was reduced 62 percent with a PFS. During the study, no patients died.
Although further information about this study has not been released yet, in the secondary endpoints it is expected to see the impact of PARP on patient’s life expectancy.
According to a statement from the biopharmaceutical company TESARO, it is supposed to file this study for a maintenance indication for ovarian cancer patients in the fourth quarter of this years. They say that this maintained therapy is mainly for women who had prior treatment and did not want their tumors to make a comeback. This study will help slow the progression of cancer in patients who already had initial treatment.
Regarding adverse effects on health, the company said the drug’s side effects are manageable through dose modifications, only 14,7 percent of patients stopped their treatment with niraparib. The drug’s side effects included thrombocytopenia, anemia, and neutropenia. More than 10 percent of the patients were diagnosed with anemia, low platelet counts and low amounts of white blood cell. However, the risk of leukemia did not increase, which could be a potential side effect, and during the study, patients who took this inhibitor did not die during the study.
PARP inhibitors for ovarian cancer patients
Regarding finances, this new survey might bring high revenues to TESARO’s CEO Lonnie Moulder, a well-known biotech dealmaker.
This study is introducing a not so popular class of drugs like PARP inhibitors that have the ability to damage some cancer cells more than the healthy ones in patients with ovarian cancer.
“New treatment options are needed to extend the time in between cycles of platinum-based chemotherapy for these patients, and the results from the NOVA study suggest that niraparib could represent an important new treatment option for many patients with ovarian cancer,” said Tom Herzog, clinical director at the University of Cincinnati Cancer Institute
If the study is approved in the United States, the company said right now there is a high rate of platinum-based chemotherapy advanced treatment, but after that treatment, 90 percent of the patients might experience a recurrence within in two years. He said that in case this new drug is approved, the niraparib will probably face the painful “watchful waiting” that patients have to experience with recurrent ovarian cancer during the cycles of platinum-based chemotherapy.
Source: Fierce Biotech