On March 8, the FDA granted the accelerated approval of Roche’s programmed cell death protein 1 (PD-1) inhibitor Tecentriq in combination with Abraxane (protein-bound paclitaxel) for the treatment of locally advanced or metastatic triple-negative breast cancer (TNBC).

Adam Pearson, PhD, Oncology and Hematology Analyst at GlobalData, a leading data and analytics company, offers his view on the FDA approval of Tecentriq for TNBC:

“The emergence of Tecentriq as the first-in-class PD-1 inhibitor in breast cancer marks the first approval of an immuno-oncology drug in breast cancer and signifies the introduction of a new treatment strategy in a therapeutically elusive subset of breast cancer. It represents a win for Roche in a PD-1 inhibitor market dominated by Merck & Co.’s Keytruda and Bristol-Myers Squibb’s (BMS) Opdivo. Tecentriq is poised to temporarily monopolize the TNBC market until Merck & Co. is expected to release its Keytruda data from two Phase III trials this year.

“Therefore, despite the first-in-class success for Tecentriq in TNBC, Merck & Co.’s active testing of Keytruda in a single-agent setting and in combination with chemotherapy of physician’s choice, may ultimately allow Keytruda to be used in broader patient populations.

“Further opportunities exist in the neoadjuvant/adjuvant setting, in hormone-receptor-positive, and HER-2-positive breast cancers and finally, through novel combinations of PD-1 inhibitors with the approved poly ADP ribose polymerase (PARP) inhibitors in breast cancer patients harboring BRCA1 (breast cancer type 1 susceptibility protein) mutations. Each is an active area of investigation.

“Needless to say, competition will be fierce and each of the immuno-oncology players will strive to carve out a therapeutic niche within the breast cancer market.”