By sarms4muscle | 06 March 2024 | 0 Comments

Puma New Drug Alisertib 1028486-01-2

Chemical Name: Alisertib

R&D Code:MLN8237
Company: Puma Biotechnology

On September 20, 2022, Puma Biotechnology declared that it had signed an exclusive license deal with Takeda for the creation and marketing of alisertib, and that Puma intended to concentrate the drug's development on treating breast and small-cell lung cancer.

On August 8, 2023, the US Food and Drug Administration informed Puma Biotechnology that their investigational new drug (IND) application had been submitted for consideration.

For the treatment of small cell lung cancer, the FDA designated Alisertib as an orphan medication on September 21, 2023.

A study by Puma Biotechnology on Alisertib and Pembrolizumab for the treatment of rb-deficient head and neck squamous cell carcinoma was presented at the 2023 AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapy on October 14, 2023. The results of the study were released.

Phase I of the trial involved the enrollment of ten patients with advanced solid malignancies. There was no requirement for Rb insufficiency during the Phase I of the experiment.At doses of 30 mg, 40 mg, or 50 mg, alesitib was administered twice daily for seven days every 21 days; pembrolizumab was administered intravenously at a dosage of 200 mg every three weeks.Dose-limiting effects were seen to be mostly hematologic, which is in line with what was expected from the safety profile. These results informed the selection of a 40 mg dosage for the Phase II trial. Patients with a variety of solid tumors were enrolled in the Phase I section of the trial, including squamous cell carcinoma of the head and neck, thyroid cancer displaying thymus-like differentiation, oropharyngeal cancer, salivary cancer, and small cell lung cancer. While one patient with small cell lung cancer remained stable for 245 days, another patient with hpv-positive pharyngeal cancer remained stable after 209 days, and a third patient with thymus-like differentiation of thyroid cancer remained stable for more than 811 days.

In phase II of the trial, 14 patients with HPV+ HNSCC resistant to immunotherapy and platinum underwent testing. Rb1 deletion was confirmed in 2 of the 14 cases using next-generation sequencing. Despite the presence of stable disease in seven patients, three of whom achieved progression-free survival (PFS) of over 8 months, no discernible objective response was detected. Seven patients remained and made progress. In this study, the median PFS was 1.4 months and the median OS was 13.5 months. There were no new warning signs detected.

A Phase 2 clinical trial of Alisertib was designed to be conducted for the treatment of her2 negative, hormone receptor positive metastatic breast cancer, according to an announcement made by Puma Biotechnology on December 11, 2023.

Puma Biotechnology launched ALISCA-Lung1, a Phase II Alisertib trial for small cell lung cancer, on February 13, 2024.

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