TESARO Inc. (NASDAQ:TSRO)
On Monday, Tesaro Stock closed higher by 18.79% after the company had announced over the weekend that its drug was successful in a clinical trial in patients with ovarian cancer. The results were outstanding, and a big reason why the stock closed higher for the day. What makes the results even more impressive is the fact that they were presented at a European Medical Conference. Original data was released earlier in the year, in June, but detailed results of the trial was released over the weekend. Even though a majority of these results were known, it didn’t stop the stock from big gains for the day.
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TSRO Trial Results
The phase 3 clinical trial was known as ENGOT-OV16/NOVA, and it recruited a total of 533 recurrent Ovarian Cancer patients. When it is said that patients have recurrent Ovarian Cancer, that means that no matter how many treatments they take, the cancer comes back after being eradicated from the body. Tesaro’s drug, niraparib, was combined with platinum-based chemotherapy. That combination was tested against the platinum-based chemotherapy alone.
The primary endpoint of the clinical trial was to assess the progression-free survival — PFS — of those patients taking niraparib compared to the chemotherapy. The trial was set up with two cohorts because TSRO was testing two sets of Ovarian Cancer patients. That means one set had the BRCA mutation version of the cancer, and the other set was the non-BRCA mutation cancer version. The trial was successful in both populations, which makes the results even that much more significant.
In the Ovarian cancer patients with the BRCA mutation, the median PFS for niraparib was 21 months compared to 5.5 months in the placebo side. Obviously the drug was clearly built for the BRCA Ovarian cancer patients. While the non-BRCA mutation didn’t succeed with as large as a gap in PFS like the BRCA group it was still successful. The non-BRCA group patients taking niraparbib achieved a median PFS of 9.3 months compared to placebo obtaining 3.9 months. Having both trials successful in Ovarian cancer is no easy feat at all.
There are around 200,000 cases of Ovarian Cancer per year in the United States. It is a difficult type of cancer to treat because there aren’t many treatment options other than platinum-based chemotherapy. It is also a type of cancer that is hard to detect because symptoms don’t become known until the cancer has spread to the pelvis and belly of the patient. The problem with that is that once it has spread to other parts of the body, it becomes a lot more difficult to treat. Surgery and chemotherapy are both current treatments but carry heavy risks. Especially chemotherapy which carried a lot of side effects. TSRO drug niraparib was safe for the most, but had some grade 3 and 4 adverse events reported in the trial. The investigator has noted that most of these were resolved by adjusting the dosage level of the drug.
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Tesaro has a lot going for its drug. With the results helping the stock post some gains, the truth is that there is another catalyst yet to come. That is TSRO stating that it will be able to complete its rolling FDA submission of its NDA for niraparib by the 4th quarter of this year. Considering that the drug was shown to be highly superior to current treatment options along with the fact that there weren’t very many safety issues, then it should be able to easily obtain FDA approval. The market opportunity for targeting Ovarian Cancer could be up to $1.4 billion. This drug has shown that it can help these patients with recurrent ovarian cancer over standard of care, and that will be key for its marketing success.
[Image Courtesy of Wikipedia]