TESARO Moves to Second Stage of Trial of Lung Cancer Combo

• All evaluable patients experienced tumor shrinkage
• Protocol defined response criteria achieved and trial expansion ongoing

Tesaro, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, today announced it has initiated the second stage of the JASPER study that is designed to assess clinical benefit of ZEJULA^® in combination with an anti-PD-1 antibody in first-line non-small cell lung cancer (NSCLC) patients. The decision to advance the trial was based on achieving the protocol defined response criteria in the initial cohort of 16 treated patients with high PD-L1 expression, of which 14 were evaluable for a response. Nine of the 14 patients had objective responses by RECIST criteria at the time of the analysis¹; with all 14 patients experiencing tumor shrinkage.

“These JASPER data provide preliminary evidence that the combination of ZEJULA and an anti-PD-1 antibody could be active as a first-line treatment for patients with non-small cell lung cancer and high levels of PD-L1 expression,” said Mary Lynne Hedley, Ph.D., President and COO of TESARO. “In the second stage of the trial, 36 additional patients will be enrolled and treated with ZEJULA in combination with TSR-042, our anti-PD-1 antibody. TSR-042 is the foundation of our lung cancer strategy, and is also being studied as a monotherapy in our GARNET trial in anti-PD-(L)1 naïve patients who have progressed on chemotherapy, and in combination with TSR-022, our anti-TIM-3 antibody, in AMBER, a study in late-line NSCLC patients that have progressed after anti-PD-(L)1 therapy. We look forward to sharing lung cancer data from both GARNET and AMBER at the Society for the Immunotherapy of Cancer (SITC) Annual Meeting in November.”

https://www.biospace.com/article/tesaro-announces-expansion-to-second-stage-of-jasper-trial-of-zejula-in-combination-with-tsr-042-in-non-small-cell-lung-cancer/