The designation was granted to DKN-01 for the treatment of patients with gastric and gastroesophageal junction adenocarcinoma whose tumors express high levels of DKK1.
The FDA granted fast track designation to DKN-01 for the treatment of patients with gastric and gastroesophageal junction adenocarcinoma whose tumors express high Dickkopf-1 protein (DKK1), following disease progression on or after prior fluoropyrimidine- and platinum- containing chemotherapy and if appropriate, HER2/neu-targeted therapy, according to Leap Therapeutics, the developer of the agent.
Notably, the first patient was dosed in a combination study of DKN-01 plus tislelizumab (BGB-A317) in patients with gastric or gastroesophageal junction cancer in September 2020.
"We are pleased with the FDA's decision to grant fast track designation for the development of DKN-01 to treat patients with gastric and gastroesophageal junction cancer whose tumors express high levels of DKK1," Douglas E. Onsi, president and chief executive officer of Leap, said in a press release. "The designation highlights the existing unmet medical need for new and effective treatments for this patient population. We believe that DKN-01 shows promise as a novel treatment option for biomarker-selected patients with these cancers, and this designation provides us with earlier and more frequent opportunities to interact with the FDA during the development of DKN-01."
DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of DKK1 protein, a modulator of Wnt/Beta-catenin signaling, which is a signaling pathway often involved in tumorigenesis and suppressing the immune system. Currently, DKN-01 is being evaluated in clinical trials for gastroesophageal, gynecologic, hepatobiliary, and prostate cancers.
DKN-01 has also previously received orphan drug designation for the treatment of gastric and gastroesophageal junction cancer from the FDA.
Reference:
Leap Therapeutics Announces FDA Fast Track Designation Granted to DKN-01 for the Treatment of Gastric and Gastroesophageal Junction Cancer [news release]. Cambridge, Massachusetts. Published September 24, 2020. Accessed September 24, 2020. https://investors.leaptx.com/news-releases/news-release-details/leap-therapeutics-announces-fda-fast-track-designation-granted
Sintilimab Combo Shows Modest Efficacy, Safety in HER2– Gastric/GEJ Cancer
February 18th 2024Over half of the patients with HER2-negative gastric or gastroesophageal junction adenocarcinoma achieve a major pathological complete response following treatment with sintilimab plus FLOT in a phase 2 trial.
Oncology On-The-Go Podcast: ASCO 2023 Recap
June 19th 2023Experts from University of California, Los Angeles Health and Mayo Clinic discuss key data presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in the gynecologic and gastrointestinal cancer spaces and how they may impact patient care.
Fruquintinib/Paclitaxel Improves PFS, ORR in Gastric/GEJ Adenocarcinoma
February 7th 2024Findings from the FRUTIGA study support fruquintinib plus paclitaxel as a promising second-line treatment for those with advanced gastric or gastroesophageal junction adenocarcinoma following prior chemotherapy.