Phase 3 SRG-514 ketorolac COX-1/2 inhibitor hydrogel placed in lumpectomy cavity in TNBC

SURGE Therapeutics is running a randomized, blinded Phase 3 study testing SRG-514, a ketorolac (NSAID) hydrogel placed intraoperatively into the breast-conserving surgery resection cavity, versus breast-conserving surgery with standard care alone. Ketorolac inhibits cyclooxygenase (COX-1/2), lowering prostaglandin-mediated inflammatory signaling; the commercial/scientific bet is that a high local perioperative exposure at the wound bed could reduce pro-tumor inflammatory effects around surgery without requiring prolonged systemic dosing. Eligible patients have clinical stage II–III, resectable triple-negative breast cancer and are neoadjuvant-therapy naïve, a population where early systemic therapy is commonly used to improve pathologic response and long-term outcomes. Today’s care for stage II–III TNBC is typically neoadjuvant chemotherapy plus pembrolizumab (when eligible), then surgery (lumpectomy or mastectomy) followed by radiation after lumpectomy, with adjuvant capecitabine for residual disease and olaparib for germline BRCA carriers. A key context point is that at least one prior randomized Phase 3 trial of single-dose perioperative ketorolac did not improve disease-free survival, so this program’s differentiated angle is the intra-cavity hydrogel delivery strategy and its timing at the surgical wound microenvironment.