Sapanisertib
(CB-228)

Sapanisertib is a dual TORC 1/2 inhibitor that targets a key survival mechanism in KEAP1/NRF2-mutated tumor cells. These mutations are found in a considerable sub-population of patients across multiple solid tumor types.

NRF2-mutated lung cancer cells have been shown to be selectively more sensitive to dual TORC1/2 inhibitors both in vitro and in vivo. As a next-generation TORC inhibitor, sapanisertib provides dual inhibition of TORC 1 and 2, and in early clinical studies has demonstrated durable single-agent responses and clinical benefit in patients with relapsed/refractory NRF2-mutated squamous non-small cell lung cancer (sqNSCLC), with a well-tolerated safety profile.

Sapanisertib is a clinically well-characterized next generation dual TORC1/2 inhibitor, including its safety profile, PK/PD relationship and monotherapy efficacy data.

More than 235,000 individuals are diagnosed with NSCLC in the US each year, and approximately 25-30% of these are sqNSCLC. KEAP1/NRF2 mutations are present in approximately 27% of these sqNSCLC patients’ tumors and confer a poorer prognosis than wild type NSCLC.

A Phase 2 study planned to begin in the first quarter of 2022 will further evaluate sapanisertib as a monotherapy in patients with squamous NSCLC harboring a NRF2 mutation, KEAP1 mutation, or wild-type NRF2/KEAP1.

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