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By Anette Breindl, Senior Science Writer
MUNICH – With more than three years of follow-up, median progression-free survival (PFS) has not yet been reached in the treatment group of the SOLO-1 study. Patients receiving placebo had a median progression-free survival of 13.8 months, giving a risk ratio of 0.3 and data that could transform Lynparza (olaparib, Astrazeneca plc) into first-line treatment for women with BRCA mutations.
SOLO-1 has tested the use of Lynparza in patients with advanced and newly diagnosed ovarian cancer, as a cancer maintenance treatment. Ovarian after platinum-based chemotherapy. In the trial, 391 patients with serous ovarian cancer or high grade endometrioid who responded to platinum-based chemotherapy were randomized to 2: 1, Lynparza tablets to 300 mg of BD or placebo for two years.
Although the median PFS has not yet been reached in the olaparib group, it should be about three years longer than the placebo group.
Principal Investigator Kathleen Moore, Associate Professor at the Stephenson Cancer Center at the University of Oklahoma, presented the results of the 2018 conference of the European Society of Medical Oncology (ESMO) and predicted a new era in the treatment of women diagnosed with advanced ovarian cancer who wear a BRCA mutation."
This is an indication that could use a new era. The current standard treatment for ovarian cancer is platinum chemotherapy, which is very successful at first inducing remission. Three years later, however, more than 70% of patients have recurred and the long-term disease-free survival rate is about 15%. Lynparza and other poly (ADP) ribose polymerase inhibitors (PARPs) are currently approved in recurrent diseases.
The data presented at ESMO was in some ways more reminiscent of immunotherapies than other targeted therapies. At 41 months old, it is too early to really know if frontline olaparib is able to achieve the same type of treatment as immunotherapy. However, the Kaplan-Meier survival curves of the SOLO-1 trial appear to indicate the beginning of a "tail", which flattens to a level well above zero, indicating the presence of long-term survivors.
The ability to cure even a small fraction of patients would be unprecedented for targeted therapies, which collectively have not found a way to convert initially strong responses into lasting benefit for patients.
This is particularly encouraging given that in women with no signs of disease, olaparib treatment was discontinued after two years – a trial pattern for which more than one patient protested and Moore admitted to being initially skeptical.
Until now, however, this skepticism has not been proven. "It does not appear that the curves meet" after the end of treatment, Moore said, indicating that treatment with Lynparza may have a beneficial effect that exceeds the duration of treatment.
Lynparza does not directly stimulate the immune system as checkpoint inhibitors do. But since inhibition of PARP prevents the repair of damaged DNA, it can increase the neoantigen load, which can make tumors more visible to the immune system, which could explain its long-lasting effects.
"Is olaparib eradicating the disease or is there something else? We do not know yet, "said Jonathan Ledermann BioWorld.
Ledermann works at the University College London Cancer Institute and is the principal investigator of Study 19, a randomized, double-blind, placebo-controlled, phase II study that showed that Lynparza improved the quality of life. Progression-free survival and overall survival of women with serous ovarian cancer, had already shown that some patients were "super-responders" to PARP inhibition, with ongoing response rates at six years.
But while these answers are ongoing, in study 19, the treatment is also.
"We do not dare to remove them from therapy," Ledermann said.
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