[그린포스트코리아 이민선 기자] Based on the clinical results of Cohort 2, Pogiotinib, developed by Hanmi Pharmaceutical, decided to conduct a preliminary meeting with the FDA to continue commercialization.
Hanmi Pharmaceutical’s partner Spectrum announced on the 23rd that it plans to apply for approval from the US Food and Drug Administration (FDA) for Hanmi Pharmaceutical’s new anticancer drug’Pogiotinib’ next year.
On the 22nd (local time), the FDA agreed to submit a new drug marketing authorization (NDA) at a preliminary meeting based on the clinical results of cohort 2 for HER2 Exon20 mutant-positive non-small cell lung cancer (NSCLC) patients with past treatment experience and approved for marketing next year. It was announced through a press release that it would apply for the application.
Cohort 2 is a clinical trial in which 16 mg of pogiotinib was administered orally to 90 patients with non-small cell lung cancer as a once-a-day (QD) regimen. The ORR (objective response rate) was 27.8% and the total ORR range was 18.9~38.2% (95% confidence interval), reaching the minimum effective value (17%). The mDOR (median duration of response) was 5.1 months, the follow-up period was 8.3 months, and the mPFS (median progression-free survival) was 5.5 months.
Joe Turgeon, President of Spectrum, said, “The agreement with the FDA in the discussion for NDA application is an important milestone for Pogiotinib.” “The safety and effectiveness of Pogiotinib in areas with high unmet medical needs have a significant impact. I expect to be crazy.
The spectrum also revealed the results of another study of Pogiotinib (Cohort 3, Cohort 5). Cohort 3 is a clinical trial evaluating the efficacy of Pogiotinib as a first-line treatment for EGFR Exon20 mutant-positive non-small cell lung cancer patients without treatment experience. A partial response (PR) was confirmed in 22 patients (27.8%) by administering a 16mg dose to 79 patients once a day.
The ORR according to the ITT (Treatment Intention Population Including Randomly Assigned Patients) analysis was 27.8%, and the total ORR range was 18.4 to 39.1% (95% confidence interval), but some patients were based on a pre-defined statistical hypothesis that withdrawal occurred. As the expected minimum effective value (20%) of ORR was not reached, the primary endpoint of cohort 3 was not satisfied.
However, DCR (disease control rate) was 86.1%, mDOR was 6.5 months, and PFS (progression free survival) was significantly improved at 7.2 months. The safety profile was similar to the side effects observed with other second generation EGFR TKIs.
The spectrum also revealed data on Cohort 5 that confirmed the significantly improved safety of Pogiotinib. Cohort 5 was an extended study of non-small cell lung cancer patients with EGFR or HER2 Exon20 mutation, regardless of past treatment, and was administered twice a day (BID, 8 mg per dose).
The changed dosage of twice a day greatly improved the safety of Pogiotinib. Compared to the previous once daily (QD, 16 mg per dose), the incidence of grade 3 or higher side effects (rash, diarrhea and stomatitis) decreased by 32%. Also, the dose interruption decreased by about 38% compared to once a day (QD). No new types of adverse reactions (AEs) were observed in the twice daily dosing regimen.
Francois Lebel, Chief Medical Officer of Spectrum (CMO), said, “Cohort 5 data administered twice a day (BID) as a new regimen significantly improves patient tolerability and reduces side effects above Grade 3 by about a third. “I believe that the improvement of tolerance and reduction of discontinuation of taking the drug can improve the antitumor effect in various EGFR and HER2 clinical trials, which can be helpful for the overall clinical trial of Pogiotinib.”
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