Roche could soon see Tecentriq become part of the first immunotherapy combination approved to treat triple-negative breast cancer, after gaining a priority review from the FDA.
The company is seeking approval for first-line use of the drug in combination with Abraxane (chemotherapy) to treat unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in those who carry the PD-L1 protein.
The US drug regulator has said it will make its ruling by 12 March 2019, and will base its decision on findings the phase 3 Impassion130 study submitted by the company.
The results of that trial, which was presented at last month’s European Society for Medical Oncology (ESMO) Congress, showed that those taking the drug in combination with Abraxane had a significantly longer progression free survival (median of 1.7 months) over those taking Abraxane alone.
It also showed an improvement in PFS for the PD-L1 positive subgroup of patients (7.5 vs. 5 months). The drug also achieved a clinically meaningful overall survival (OS) improvement for this group as well (25 months vs 15.5 months), but failed to reach an OS statistical significance in the intention-to-treat group of patients.
“Tecentriq in combination with nab-paclitaxel has the potential to meaningfully advance treatment for people with PD-L1-positive, metastatic triple-negative breast cancer. People need more options for this type of breast cancer, which is particularly difficult to treat,” said Sandra Horning, chief medical officer and head of Global Product Development.
“We are working closely with the FDA to bring this Tecentriq combination to people with PD-L1-positive, metastatic triple-negative breast cancer as soon as possible.”
Tecentriq is already approved in the US for certain types of bladder cancer and lung cancer, but has seen sales growth slow of late due to strong competition from other immunotherapies on the market, most especially Merck & Co’s market leader Keytruda.
If all goes well for Roche (and its biotech subsidiary Genetech), then the approval could help boost sales for Tecentriq. The Swiss drug maker was hoping to gain another indication for Tecentriq in first-line non-small cell lung cancer (NSCLC), but it was unable to achieve a significant OS rate.