Syros Presents Data from Phase 1/1b Clinical Trial of SY-5609 in Advanced Solid Tumors at ASCO Annual Meeting

Syros Pharmaceuticals, a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, has announced new clinical data from the Phase 1/1b clinical trial evaluating SY-5609, its highly selective and potent inhibitor of CDK7, in patients with relapsed/refractory pancreatic ductal adenocarcinoma (PDAC), HR+ breast cancer and other solid tumors. The data will be presented in two posters at the 2023 American Society for Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6, in Chicago, Illinois.

“We are pleased to share data from our Phase 1/1b clinical trial of SY-5609, which further reinforce the potential of selective CDK7 inhibition as a potentially transformative approach for difficult-to-treat solid tumors,” said David A. Roth, M.D., Chief Medical Officer of Syros. “SY-5609’s best in class selectivity and potency produce a predictable, well-managed tolerability profile, and we have optimized an intermittent dosing schedule that we believe enables broad combination potential. Data from both combination cohorts – evaluating SY-5609 in combination with chemotherapy in PDAC and SY-5609 with fulvestrant in HR+ breast cancer – demonstrate an acceptable tolerability profile, as well as promising clinical activity in heavily pre-treated populations that are unlikely to respond to standard of care. Based on these results, we continue to believe that SY-5609 could play a meaningful role in the evolving treatment landscape and are continuing to explore partnership opportunities to maximize the potential of this program.”

Syros’ Phase 1/1b trial of SY-5609 is a multi-center, open-label study, consisting of two parts: Part 1 is a dose escalation study, evaluating single-agent SY-5609 in patients with select advanced solid tumors and in combination with fulvestrant in HR+ breast cancer. Part 2 included a combination safety lead-in designed to inform a dose expansion study, evaluating the doublet regimen of SY-5609 and gemcitabine and the triplet regimen of SY-5609, gemcitabine and nab-paclitaxel in patients with PDAC in their second or third line of treatment.