FDA授予NUV-422快速通道指定，用于治疗高级别胶质瘤

Gliomas grade 3-4 are high-grade gliomas, which are gliomas with a relatively high degree of malignancy. The prognosis of this disease is very poor, with an average survival period of about one year and a five-year survival rate of 5%-6%. Methods such as surgery, radiotherapy, and chemotherapy are often used to prolong patient survival, so more treatment options are needed.

In a preclinical Phase 1/2 study (NCT04541225), the CDK 2/4/6 inhibitor NUV-422 demonstrated excellent blood-brain barrier penetration in patients with relapsed or refractory high-grade glioma. Additionally, NUV-422 is designed to limit CDK1 inhibition, which may be a source of toxicity for other second-generation inhibitors.

Dr. David Hung, CEO of Nuvation Bio, said: "We are pleased that the FDA has granted Fast Track designation to NUV-422. There is still a large unmet treatment need in patients with brain cancer, and NUV-422 has the potential to become an innovative new treatment option for patients with high-grade glioma, including glioblastoma multiforme."

In this trial, NUV-422 is also being studied in other solid tumors, including breast and prostate cancer. In the phase 1 portion of the non-randomized study, which is estimated to have enrolled 218 patients, patients received NUV-422 in dose escalations until the maximum tolerated dose was reached. In the Phase 2 portion of the study, NUV-422 will be administered at the recommended dose.

The trial's primary endpoints include treatment-emergent adverse reactions, serious adverse reactions, and dose-limiting toxicities in the dose-escalation portion of Phase 1; and objective response rate and duration of response as determined in the Phase 2 dose-expansion cohort.

In March 2021, the FDA granted NUV-422 orphan drug designation and is currently being studied in hormone receptor-positive, HER2-negative advanced breast cancer (with or without brain metastases), and metastatic castration-resistant prostate cancer.

Hung concluded, "We are conducting an expanded Phase 1/2 monotherapy study of NUV-422 in adult patients with relapsed or refractory high-grade glioma and solid tumors. We look forward to continuing to work closely with the FDA to leverage data from the Phase 1 study to accelerate the development of NUV-422, which is expected to be completed in 2022."

References:

https://www.cancernetwork.com/view/fda-grants-fast-track-designation-to-nuv-422-in-high-grade-gliomas