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Encouraging New Data from Yale Cancer Center Shows Correlation to PD-L1 Expression from KEYNOTE-061

May 28, 2020

New findings led by Yale Cancer Center researchers show data sharing improved survival for patients with advanced gastric cancers. The data will be presented on May 30 at 11:00 a.m., during the virtual Scientific Program at the annual meeting of the American Society of Clinical Oncology (ASCO). The KEYNOTE-061 phase III trial compared pembrolizumab versus paclitaxel as second-line therapy for previously treated patients with PD-L1–positive advanced gastric or gastroesophageal junction cancer. Patients with these types of cancers that progress on chemotherapy have historically poor outcomes.

Updated data from the KEYNOTE-061 study, led by Charles S. Fuchs, M.D., M.P.H., Director of YCC and Physician-in-Chief of Smilow Cancer Hospital, shows second-line pembrolizumab showed a trend toward prolonged OS among patients with PD-L1–positive gastric cancer, although the result did not reach statistical significance. Of note, the benefit associated with pembrolizumab appeared to increase with increasing levels of PD-L1 expression in tumors. Moreover, pembrolizumab led to fewer treatment-related adverse events versus paclitaxel.

“The long-term data from KEYNOTE-061 provides an important signal regarding the benefit for immunotherapy as a treatment option for our patients with advanced gastric cancers, who have had limited options,” Dr. Fuchs said.

The primary endpoint for this follow-up study was OS and progression-free survival (PFS) in the CPS ≥1 population. In patients with CPS ≥5 and CPS ≥10, median survival was 10.4 months, versus 8.3 and 8.0 months with paclitaxel, respectively. This trend towards a numerically prolonged OS when compared to paclitaxel, suggests a potential benefit of pembrolizumab over paclitaxel for the treatment of these patients.

The study was funded by Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., and included investigators from around the world.

Submitted by Jess Collins on May 28, 2020