Adding iniparib to a regimen of gemcitabine and carboplatin failed to significantly increase overall survival (OS) and progression-free survival (PFS) in patients with metastatic triple-negative breast cancer, according to sanofi-aventis, the agent’s developer along with BiPar Sciences.
In a randomized, phase 3 trial, the combination therapy failed to meet the prespecified co-end points for OS and PFS. A subgroup analysis, however, showed that women receiving the combination for second- and third-line treatment achieved improvement in OS as well as PFS. This finding is consistent with those of the phase 2 trial. In addition, no significant increase in toxicity was added to that of the chemotherapy regimen.
“While this trial did not meet its primary goal, we believe that the improvement in overall survival and progression-free survival in patients in the second- and third-line setting are important findings,” said Debasish Roychowdhury, MD, senior vice president and head of sanofi-aventis oncology in a prepared statement. “We are conducting in-depth analysis to gain further insight into the Phase III results.”