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Puma Biotechnology Announces Presentation of Findings from a Phase I/Ib Study of Alisertib in Advanced EGFR-Mutated Lung Cancer
LOS ANGELES--(BUSINESS WIRE)-- Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the presentation of alisertib for the
About this update from Puma Biotechnology Inc
[{"type":"text","content":" LOS ANGELES--(BUSINESS WIRE)--\nPuma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the presentation of alisertib for the treatment of patients with advanced osimertinib-resistant epidermal growth factor receptor-mutated (EGFR-mutated) non-small cell lung cancer (NCT04085315) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting currently being held in Chicago. The poster (Abstract #8572, Poster Bd #436), entitled, “A Phase I/Ib study of the aurora kinase A inhibitor alisertib in combination with osimertinib in advanced osimertinib-resistant EGFR-mutated lung cancer,” was presented by Turja Chakrabarti, MD., University of California, San Francisco, at the Lung Cancer – Non-Small Cell Metastatic Poster Session, on June 3 at 1:30 p.m. CDT. A copy of the poster is available on the Puma website.\n\n\nThis open-label, single-center Phase I/Ib study enrolled 21 evaluable patients with stage IV EGFR-mutated NSCLC (EGFR driver mutation: 76.1% exon 19 deletion; 14.3% L858R; 9.5 % L861Q) who had progressed on osimertinib monotherapy. 47.6% of patients had previously received only first-line osimertinib monotherapy, while 52.3% had received two or greater prior lines of therapy. In the Phase I portion of the trial, 10 patients were treated in a 3+3 dose escalation phase with alisertib using an intermittent dosing strategy of 30 mg (n = 6) or 40 mg (n = 4) twice daily (BID) in combination with osimertinib 80 mg daily. Alisertib was added to osimertinib treatment at the time of disease progression on osimertinib. Intermittent alisertib 30 mg BID was identified as the MTD and RP2D in combination with osimertinib 80 mg daily.\n\n\nIn the Phase Ib expansion portion of the trial, 11 additional patients were treated at the 30 mg alisertib BID intermittent dosing schedule in combination with osimertinib 80 mg daily with alisertib being added to osimertinib treatment at the time of disease progression on osimertinib.\n\n\nThe most common treatment-related adverse events (AEs) (any grade) included neutropenia (42.9%), anemia (42.9%), diarrhea (38.1%), and lymphopenia (33.3%). Grade 3 or higher AEs neutropenia (4.8%), anemia (4.8%), diarrhea (14.3%), and lymphopenia (4.8%).\n\n\nFor the 21 evaluable patients, the investigator assessed overall response rate was 9.5% (95% CI: 0 to 22%) and disease control ...