Infinity gets FDA fast track status for IPI-549, Opdivo combo in urothelial cancer

Infinity Pharmaceuticals said that IPI-549 in combination with nivolumab (Opdivo) has been given the fast track designation from the US Food and Drug Administration (FDA) for the treatment of advanced urothelial cancer.

IPI-549 is an oral immuno-oncology candidate which has been designed to preferentially inhibit PI3K-gamma.

The FDA fast track designation will enable the development and accelerate the review of drugs intended for the treatment of serious conditions and those that fill an unmet medical need.

Through the fast track status, Infinity Pharmaceuticals will get early and frequent communication with the FDA and the latter’s encouragement during the entire drug development and review process.

Currently, Infinity Pharmaceuticals is enrolling patients in a phase trial called MARIO-275 in partnership with Bristol Myers Squibb. The mid-stage trial is investigating Infinity Pharmaceuticals’ drug candidate in combination with Opdivo in platinum-refractory, I/O naïve patients suffering from advanced urothelial cancer.

Infinity Pharmaceuticals CEO and chair Adelene Perkins said: "A retrospective analysis of Bristol Myers Squibb’s Checkmate-275 accelerated approval study of Opdivo monotherapy in patients with urothelial cancer revealed an important association between high baseline levels of myeloid derived suppressor cell (MDSC) and poor overall survival.

"These data, combined with our MARIO-1 data that showed IPI-549, both as a monotherapy and in combination with Opdivo treatment, is associated with a reduction in blood MDSC levels, inspired our MARIO-275 study with the goal of improving outcomes for urothelial cancer patients."

The MARIO-275 trial will enroll nearly 160 checkpoint-naïve, advanced urothelial cancer patients whose condition has progressed or recurred after treatment with platinum-based chemotherapy.

The combination of IPI-549 with Opdivo will be compared to Opdivo monotherapy.

The primary objective of the mid-stage trial is objective response rate (ORR) as measured by RECIST v1.1, while the secondary objectives are time to response (TTR), progression-free survival (PFS), and duration of response (DOR).

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