Tesaro Inc (TSRO) was edging higher in late Tuesday trading, rising less than 1%, after the specialty drugmaker said it has begun the second phase of Phase II testing of a combination of its previously approved Zejula oncology drug with its TSR-042 anti-PD-1 antibody, adding another 36 patients with first-line non-small cell lung cancer to the study.
The move follows Tesaro saying all of the 14 patients available for evaluation during the first portion of the mid-stage study experienced tumor shrinkage and nine of 14 patients also demonstrating objective responses under Response Evaluation Criteria In Solid Tumors, also known as RECIST, at the time of the analysis.
Patients enrolled in the initial portion of the study received a starting dose of 200 milligrams of niraparib once daily and 200 milligrams of the TSR-042 anti-PD-1 antibody. The primary endpoint of that stage 1 was an objective response rate per RECIST, with the secondary endpoints including durability of response and disease control rate as well as progression-free and overall survival rates, safety and tolerability.
Zejula was approved for U.S. sales in April 2017. The TSR-042 anti-body also is being studied in separate trials as a monotherapy and together with Tesaro’s TSR-022 anti-TIM-3 anti-body in late-stage cancer patients whose disease has progressed on chemotherapy. The company expects to provide data on both TSR-042 studies at the Society for the Immunotherapy of Cancer industry conference in November.
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