TOKUSHIMA, JAPAN--(Business Wire / Korea Newswire)--We are excited to share our latest development status.

We are pleased to announce that the enrollment of patients in the Phase III clinical trial of DFP-14323 in combination with Afatinib (20 mg/day) versus Afatinib (40 mg/day) alone in stage III/IV non-small cell lung cancer patients with uncommon EGFR mutation positive that was approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Feb. 2024, has started as of today in Japan.

This Phase III clinical trial will be conducted at 30 sites with NSCLC experts in Japan and the superiority of the add-on effect of DFP-14323 on progression-free survival (PFS) as primary endpoint will be confirmed.

As DFP-14323 selectively binds to the aminopeptidase N, which is widely expressed on various cells, as lung cancer and inflammatory cells, it is expected to be effective in the treatment of patients with refractory cancer and when the superiority of the add-on effect can be confirmed in this study, it is expected to provide a novel cancer immunotherapy that is independent of EGFR mutation types, uncommon or common mutation.

We will accelerate the progress of the trial by expanding this Phase III clinical trial outside of Japan to Asian countries with large numbers of EGFR mutation-positive non-small cell lung cancer patients, and at the same time, we will promote out-licensing activities to Asian pharmaceutical companies.

Please find out the innovation for the miserable cancer patients by Delta-Fly Pharma Inc. (TOKYO: 4598) and contact with us.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240702506304/en/

Website: https://www.delta-flypharma.co.jp/en/ Contact Delta-Fly Pharma, Inc.
Dr. Yasundo Yamasaki
Director, Business Development Dept.
+81-3-6231-1278
[email protected]
This news is a press release provided by Delta-Fly Pharma, Inc.. Korea Newswire follows these editorial guidelines. Delta-Fly Pharma, Inc. News ReleasesSubscribeRSS 델타플라이파마, DFP-14323의 제3상 확증 비교 임상시험에 환자 등록 개시 고지 델타플라이파마(Delta-Fly Pharma Inc.)가 임상 개발에 대한 최신 소식을 발표했다. 델타플라이파마는 2024년 2월 의약품의료기기종합기구(PMDA)의 승인을 받은 ‘일반적이지 않은 EGFR 변이 양성이 있는 3/4기 비소세포폐암 환자를 대상으로 아파티닙(40mg/일) 단독 투여와 DFP-14323과 아파티닙(20mg/일)의 ... 7월 4일 10:50 델타플라이파마 DFP-14323의 제3상 중추적 비교 임상시험 개시 고지 델타플라이파마는 최신 개발 현황을 공유하게 돼 기뻐하고 있다. 2022년 6월 6일에 2022 ASCO 연례회의(2022 ASCO Annual Meeting)에서 발표된 바와 같이, 제2상 임상시험에서 표피성장인자수용체(Epidermal Growth Factor Receptor, EGFR) 돌연변이 양성인 3/4기 비소세포폐암 환자를 대상으로 아파티닙(20mg... 2월 4일 11:05 ... More  More News Health Clinical Trials Pharmaceutical Company Announcement Overseas Delta-Fly Pharma,... All News Releases 